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pdf Stander, The Family Study, Protocol # NHRC.2015.0019
HUMAN USE PROTOCOL
ROUTING SLIP
FROM (Principal Investigator):
Valerie Stander, PhD
(PI SIGNATURE)
(TYPED NAME)
In accordance with NAVHLTHRSCHCENINST 3900.2G, I am submitting the attached human use protocol for
consideration.
TITLE OF PROTOCOL: Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study
ABBREVIATED TITLE: Family Study
PROPOSED DATES OF RESEARCH: 25Apr2015 to 30Sep2032
FUNDING SOURCE: Congressional Mandate Research (CORE funding) USAMRMC (MOMRP) and Defense Health
Agency (DHA)
WORK UNIT TITLE AND NUMBER: Family Cohort N1240
JON FUNDING THIS PROTOCOL: 8LH3H6
SUBMISSION (CHECK ONE):
INITIAL SUBMISSION
MODIFICATION OF PREVIOUS SUBMISSION
CONTINUING/ANNUAL REVIEW
PROTOCOL OBJECTIVE (Brief sentence or two): The primary objective is to compare the adjusted probabilities of
new onset diseases and conditions among military spouses and children.
DoD PROTOCOL NUMBER (Assigned by IRB Administrator upon submission for initial review. Be sure to add this
number where indicated on the title page): NHRC.2015.0019
Note: You must obtain required
signatures before you submit the
protocol to the IRB.
Date
Received
Date
Reviewed
Initials
Approved
JON
Initials
1
DEPARTMENT HEAD
2
DIRECTOR*
N/A
3
SCIENCE DIRECTOR*
N/A
4
IRB ADMINISTRATOR
Version Date 20 FEBRUARY 2018
N/A
N/A
NOTES
Stander, The Family Study, Protocol # NHRC.2015.0019
I.
COVER PAGE(S)
1. Protocol Number: NHRC.2015.0019
2. Title: Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study
3. Date of Submission:20 April 2015
Approved Work Unit Title Family Study and Full Work Unit Number: N1240
4. Approximate Dates of Research: 2015MAR03 to 2032SEP30
5. Principal Investigator: Valerie Stander, PhD
Behavioral Science and Epidemiology; Military Population Health
Naval Health Research Center, San Diego, CA
6. Co-Investigator(s):
Hope McMaster, PhD
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Cynthia LeardMann, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
7. Key Support
Denise Lovec-Jenkins
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Lauren Bauer, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Evelyn Sun, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Beverly Sheppard
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Jennifer Walstrom
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Anet Petrosyan
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Alexis Takata
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Deanne Millard
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Version Date: 20 FEBRUARY 2018
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Stander, The Family Study, Protocol # NHRC.2015.0019
Steven Speigle
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
William Lee
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Daniel Vaughan
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Gordon Lynch
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Jacqueline Pflieger, PhD
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Sabrina Richardson, PhD
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Kristen Walters, PhD
NHRC, San Diego, CA
Leidos, Inc.
Chris Phillips, MD, MPH
NHRC, San Diego, CA
Ben Porter, PhD
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Teresa Powell, MS
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Richard Armenta, PhD, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Daniel Trone, PhD
NHRC, San Diego, CA
Rudolph Rull, PhD, MPH
NHRC, San Diego, CA
Felicia Carey, PhD
NHRC, San Diego
Henry M. Jackson Foundation, Inc.
Anna Rivera, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Claire Kolaja, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
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Stander, The Family Study, Protocol # NHRC.2015.0019
Carlos Carballo, MS
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Toni Geronimo, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Kelly Woodall, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Alejandro Esquivel, MPH
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Anna Bukowinski
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
Satbir Boparai, MBA
NHRC, San Diego, CA
Henry M. Jackson Foundation, Inc.
8.
Identification of Medical Monitor: Not applicable
9.
Primary Performing Institution(s):
Deployment Health Research Department,
Naval Health Research Center, San Diego, CA
10.
Collaborating Institution(s):
• The Millennium Cohort Family team provides de-identified datasets per a data
use agreement and a funding contract established with Abt Associates and Center
for Child and Family Health (CCFH).
• Additional institutions may be identified for future unfunded collaborations.
These institutions will be added to this protocol through future modifications
specifying the nature of their role.
11.
Funding Source: Congressional Mandate Research (CORE funding) and Defense
Health Agency (DHA)
12.
Subjects:
Number of Subjects: 9,928
Number of Female Subjects: 8,625
Number of Male Subjects: 1,303
Number of Civilian Subjects: 9,269
Number of Active-Duty Subjects: 659
a.
b.
c.
d.
e.
13.
Is an IAIR/IIRR needed? Not applicable
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Stander, The Family Study, Protocol # NHRC.2015.0019
II.
SIGNATURE PAGE
1. Principal Investigator
_______________________________
Valerie Stander, PhD
Behavioral Science and Epidemiology;
Military Population Health
Naval Health Research Center, San Diego, CA
2. Directorate Head/Dept Head
_______________________________
Natalie Wells MD, MPH
CDR, MC, USN
Directorate Head;
NHRC, San Diego, CA
_______________________________
Susan Farrish, MD, MPH
LtCol, USAF, MC
Department Head,
NHRC, San Diego, CA
3. Principal Director of Research
_______________________________
Kenneth Earhart, MD
NHRC, San Diego, CA
4. Ombudsman (if applicable)
_______________________________
N/A
5. Medical Monitor (if applicable)
_______________________________
N/A
6. Commanding Officer:
_______________________________
M. R. MONTEVILLE, CAPT, MCS, USN
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Stander, The Family Study, Protocol # NHRC.2015.0019
III.
RECORD OF CHANGES TO THE PROTOCOL
FEBRUARY 2018 CONTINUING REVIEW – STAFF UPDATE
Under this continuing review report, we respectfully request to modify the study protocol
to remove Christopher Lo as he is no longer at NHRC and to add Alexis Takata, Deanne
Millard and Felicia Carey, PhD as key personnel. They will be located at the Naval
Health Research Center. Alexis Takata and Deanne Millard will serve as key support
staff as research assistants. Dr. Carey, will serve as key support staff as an
epidemiologist.
NOBVEMBER 2017 STAFF UPDATE AND 2018 MILLENNIUM COHORT FAMILY
STUDY CALENDAR
1. Revise the role of Alejandro Esquivel, MPH from Research Assistant to Data Analyst.
2. We are also submitting to the IRB for review and approval the 2018 Millennium Cohort
Family Study calendar and cover letter, which will be sent to all current Family Study
participants.
OCTOBER 2017 STAFF UPDATE AND SSA DATA
We respectfully request IRB approval to:
1. Add, Christopher Lo, BS and Daniel Vaughan, BS as key personnel. In addition, due to the
recent Chang of Command from CAPT Simmons to CAPT Monteville we have updated the
CO signature line to CAPT Monteville. Also CDR Faix has received new orders and will be
leaving NHRC; therefore, we have removed him as a co-investigator. In line with the abovementioned update, we have updated the Directorate Head from CDR Faix to CDR Wells.
Along with these updates we have removed Danielle Mitchell and Kyna Long due to their
recent resignations.
2. Also, we would like to request permission to transfer social security numbers of study
members, names, and dates of birth, along with some information about those study members
from the family study survey and other DoD administrative sources, to the Social Security
Administration (SSA) for matching against SSA records on annual earnings subject to Social
Security and Medicare taxes, on social security retirement and survivor benefits, on
Supplemental Security Income (SSI) benefit payments, and on Social Security Disability
Insurance (SSDI) benefit payments.
3. We are also submitting to the IRB for review and approval the text for the annual Month of
the Military Family postcard, which will be sent to all current Family Study participants.
FEBRUARY 2017 CONTINUING REVIEW MODIFICATION—STAFF UPDATE
We would like to notify the IRB that Toni Geronimo’s position changed from Research Assistant
to Data Analyst.
DECEMBER 2016 MODIFICATION—STAFF UPDATE 2017 MAILINGS
We respectfully request the following modifications to the protocol:
1. We are submitting to the IRB for review and approval three emails to be sent to Family Study
participants in February 2017, July 2017 and October 2017. These emails will serve as
reminders to submit their children’s artwork for the 2018 Family Study calendar.
2. We are submitting to the IRB for review and approval the text for the annual Month of the
Military Child postcard, which will be sent to all current Family Study participants.
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Stander, The Family Study, Protocol # NHRC.2015.0019
3. We are submitting to the IRB for review and approval the text for birthday cards we will be
sending to all current Family Study participants at the beginning of their birth month.
4. This protocol has undergone a change of staff; therefore, we request approval to remove
Carrie Donoho, PhD; Christopher O’Malley, MPH; Gia Gumbs, MPH; Toni Geronimo,
Dennis Hernando and Kathleen Gunn as they are no longer affiliated with the study.
Additionally, we request to add Alejandro Esquivel to the protocol as key personnel. His
training certificates (HIPAA and CITI) are included with this submission and his duties are
provided below:
Alejandro Esquivel will be located at the Naval Health Research Center and will serve as
key support staff as a Research Assistant. As a research assistant he will collect and
organize survey data and forms for research projects. In addition, his duties as an
assistant are to scan and verify survey data, perform data entry, literature searches, and
assist with maintenance of databases for research projects.
FEBRUARY 2017 EMAIL
Subject: Now accepting submissions for the 2018 calendar
We hope you received the 2017 Family Study calendar last month and are considering submitting
some of your child(ren)’s artwork for the 2018 calendar! Perhaps you have a beautiful winter
mural hanging on your refrigerator or a decorative Valentine’s Day drawing sitting on your
kitchen counter that would make a great addition to the calendar.
To review the contest guidelines and make a submission, please visit
http://www.familycohort.org/calendar. As a reminder, your Subject ID is ######. We are excited
to see your child(ren)’s artistic creations!
Very respectfully,
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval #
0720-0029, and Primary Institutional Review Board Protocol # NHRC.2015.0019.
JULY 2017 EMAIL
Subject: Have your child’s artwork featured in the Family Study Calendar
Happy 4th of July from the Millennium Cohort Family Study Team! We thank you and your
family for your past, present, and future contributions in preserving our nation’s independence.
We hope you take this opportunity to submit your child(ren)’s artistic depiction of 4th of July
fireworks and summer festivities! Their drawing could be featured in our 2018 Family Study
Calendar and online gallery!
To review the contest guidelines and make a submission, please visit
http://www.familycohort.org/calendar. As a reminder, your Subject ID is ######. We are excited
to see your child(ren)’s artistic creations!
Very respectfully,
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
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Stander, The Family Study, Protocol # NHRC.2015.0019
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval #
0720-0029, and Primary Institutional Review Board Protocol # NHRC.2015.0019.
OCTOBER 2017 EMAIL
Subject: Last chance to submit your child’s artwork
Have you submitted your child(ren)’s artwork for the 2018 Family Study Calendar contest yet?
The deadline is quickly approaching! We hope you consider submitting your child(ren)’s fall and
pumpkin-themed drawings by Monday, October 17, to be considered for the 2018 Calendar that
will be mailed to nearly 10,000 of your fellow Family Study participants!
To review the contest guidelines and make a submission, please visit
http://www.familycohort.org/calendar. As a reminder, your Subject ID is ######. We are excited
to see your child(ren)’s artistic creations!
Very respectfully,
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval #
0720-0029, and Primary Institutional Review Board Protocol # NHRC.2015.0019.
MONTH OF THE MILITARY CHILD POSTCARD TEXT
Dear Name,
During the Month of the Military Child, the Millennium Cohort Family Study Team recognizes
the strength and resilience of all military families. We join the nation in honoring military
children and families for their contributions to our country.
We want to remind you that your children have the opportunity to contribute artwork for the 2018
Family Study calendar, which will be sent to nearly 10,000 households. Please visit
http://www.familycohort.org/calendar for more details and instructions to submit your child’s
artwork!
As a member of the Millennium Cohort Family Study, you are contributing to an effort of
profound importance. Please know that you are making a difference in the lives of current and
future generations of military families by remaining engaged in this important study.
Thank you for your continued participation!
Very respectfully,
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval #
0720-0029, and Primary Institutional Review Board Protocol # NHRC.2015.0019.
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Stander, The Family Study, Protocol # NHRC.2015.0019
BIRTHDAY CARD TEXT
Dear Name,
On behalf of the Millennium Cohort Family Study team, I would like to wish you a very Happy
Birthday!!!
I would also like to tell you how much I personally appreciate your commitment and
thoughtfulness as a participant in this study. It's an honor for our team to be a small part of your
life and the life of your family.
May this next year bring you great health and happiness!
Very respectfully,
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval #
0720-0029, and Primary Institutional Review Board Protocol # NHRC.2015.0019.
NOVEMBER 2016 MODIFICATION—CALENDAR
We respectfully request the following modification to the protocol:
We are submitting to the IRB for review and approval the 2017 Family Study calendar and cover
letter which will be sent to all Family Study participants. This calendar contains artwork of the
children of Family Study participants. All submitted artwork required a signed release form from
the child’s parent/legal guardian.
COVER LETTER
Dear NAME,
Happy holidays to you and your family from the Millennium Cohort Family Study team!
As a member of the Family Study, the information you provide makes it possible to understand
the health and well-being of military families over time. Even though our study is currently off
cycle, we would like to extend a token of our appreciation for your continued involvement, and
have enclosed a 2017 Family Study calendar, featuring the artwork made by the children of your
fellow Family Study participants.
Beginning January 1, 2017, once again we will be accepting submissions of artwork created by
the children of study participants throughout the year, and posting as many as possible to our
online art gallery on the Family Study website. At the end of the year, 12 submissions will be
selected to be included in the 2018 calendar. To review the submission guidelines and upload
your child's drawing or painting, please visit www.familycohort.org/calendar.
Thanks again to all of you for being a part of this program of research and part of the
Millennium Cohort Family Study community! We wish you all the best for a happy holiday
season and healthy New Year!
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
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Stander, The Family Study, Protocol # NHRC.2015.0019
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol
#DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review
Board Protocol # NHRC.2015.0019.
Adobe Acrobat
Document
SEPTEMBER 2016 MODIFICATION (ANNUAL MONTH OF THE MILITARY
FAMILY
We are submitting to the IRB for review and approval the text for the annual Month of the
Military Family postcard, which will be sent to all current Family Study participants.
Incorporate a staff change to include Dr. Sabrina Richardson as key personnel. Her required
training certificates (HIPAA, CITI and Research Integrity and Responsible Conduct) are included
with this submission. Her duties and responsibilities are provided below:
Dr. Sabrina Richardson will be located at the Naval Health Research Center and will serve as key
support staff as a Research Psychologist. Her duties will include assisting in program design and
maintenance of survey instruments alongside research team; planning epidemiologic studies and
designing the study methodology; performing statistical analyses for diverse research projects
with complex study designs; working with team members to derive an in-depth understanding of
the data findings; drafting proposals and writing peer-reviewed publications.
Month of the Military Family Postcard – 2017
During National Military Family Month, the Millennium Cohort Family Study Team would like
to thank you for your commitment and support of our military. We honor the dedication, strength
and sacrifices made by the families of our nation’s Service members.
We appreciate your participation in the 2014-2015 Family Study follow-up survey. Your
continued involvement in this important study makes it possible for the Family Study to provide
instrumental information to policymakers and military leaders to make a positive difference for
all military families.
Very respectfully,
Dr. Valerie Stander,
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol #
DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2015.0019.
SEPTEMBER 2016 MODIFICATION—APPROVED FEBRUARY 28, 2017
We respectfully request IRB approval to:
1. We would like to request permission to obtain selected variables regarding employment from
individual level income and earnings data from tax returns filed with the Internal Revenue
Service (IRS) as well as linked data from the U.S. Census Bureau. To do so, we plan to work
with the U.S. Census Bureau’s Center for Administrative Records and Research (CARRA) to
obtain permission from the IRS to access these tax records, as well as obtaining the necessary
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permission to access Census data from the Census itself. CARRA has experience in obtaining
such access and has been successful in doing so for the purposes of program evaluation and
research.
The IRS tax data include, for each individual, wage information from W-2 forms, selfemployment income from 1099 forms, and much additional information from the full tax
forms on both earned and unearned income. It also has self-reported occupational information
and industry sector information for each employer. The data is longitudinal, so it can be
obtained for a sequence of consecutive years. Thus it can provide a great deal of information
about the employment outcomes of study members before, during, and after the relevant
period of military service.
This data can also be linked to Census data from various sources. We propose using data
from the American Community Survey and/or other census databases as appropriate to create
a comparison group of individuals from the general U.S. non-military-affiliated population
similar to the military spouses on available characteristics such as gender, race and ethnicity,
residence, and educational level. We would also pull data from IRS records on this
comparison group to compare the employment outcomes of our study group with the
comparison group,
Once permission to access has been obtained from IRS and Census, NHRC will provide the
Census with a list of family study participant names, SSNs, and DOBs so that Census can
match cases with IRS and Census data. This file will also contain an ID unique to the family
study. We will also send to Census a set of variables from the family cohort study survey
which will be used for analysis and for the construction of a comparison group, along with
this same unique family study ID.
After matching has occurred, Census will assign each case a Protected Identity Key (PIK) and
will remove all identifiers (SSN, name, DOB), creating a de-identified dataset for transfer to a
Census Research Data Center (RDC), of which there are several around the county. Due to
the sensitive and confidential nature of the data involved, Census and IRS require that the
data be accessed at an RDC and that no microdata leave the RDC. Our analytic dataset
containing family study data will also be transferred to the RDC.
At that point, after undergoing a rigorous Census background check, a Family Study research
member will travel to one of the RDCs to access and analyze the de-identified data. All
analytic results will be reviewed for data disclosure by the Census Bureau staff to ensure that
no identifiable data about any individuals leaves the RDC. Only aggregate data results are
released. Information that is based on an individual respondent, on a small sample, or on a
highly concentrated cell will not be released. All family study data stored at the RDC will be
erased from Census’s computers after we complete our work at the RDC.
2. We would like to request permission to obtain selected variables regarding education from
the National Student Clearinghouse. The NSC is a non-profit organization that collects data
on student enrollment, degree earned, and other credential completion from most institutions
of higher education in the country. The NSC has the most extensive database of enrollments
and credentials available. Over 3,600 colleges and universities, enrolling 98 percent of all
students in public and private institutions, provide data to the clearinghouse. NSC provides
educational history information that confirms an individual’s degrees, academic credentials,
and enrollment status.
The relevant NSC database for Family Study analytic purposes is called StudentTracker. It
includes both enrollment and credential data. StudentTracker can be queried in one of two
ways, either by using a combination of name and date-of-birth, or by using Social Security
Number (SSN). The NSC requires student consent in order to match on SSN, but NOT to
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match on name and date-of-birth. We propose a non-consent-based data match which will not
require the transfer of SSNs to NSC; rather, the data match will be performed using names
and dates of birth as personally-identifiable information.
3. We would like to request permission to obtain selected variables regarding mortality status
from the Social Security Administration (SSA) Death Master File. The SSA collects death
information in order to implement their programs. The SSA receives death reports from many
sources, including funeral directors, family members, financial institutions, and state and
federal agencies. The data is then compiled into one file, the Death Master File. While this
file does not capture all deaths in the United States, previous studies have found it captures
between 83-95% of the deaths.
There are two primary reasons for obtaining mortality data from the SSA. First, the mortality
data will be used to remove participants from mailing lists so to not inadvertently contact next
of kin. The death data from the SSA will be received on a monthly basis, with minimal lag
time between the date of death and receipt of the data to endure minimal burden on next of
kin. Secondly, this data will be part of an algorithm to verify identity and mortality status of
Family participants in conjunction with mortality data obtained through the National Death
Index. This algorithm relies on using multiple data sources to verify mortality status and its
accuracy will be comprised if SSA mortality data is not included.
Once permission to access the Death Master File has been obtained from the SSA, NHRC
will provide the SSA with the list of Family study participants’ SSN, full name, date of birth,
and gender for matching purposes. The Army Safe Site (AMRDEC) will be use to transfer
the encrypted data.
JULY 2016 MODIFICATION
We respectfully request the IRB approval to:
1. Incorporate a staff change to include Kelly Woodall, MPH as key personnel. Ms. Woodall a
former employee is scheduled to rejoin the team 15AUG2016. Her required training
certificates (HIPAA, CITI and Research Integrity and Responsible Conduct) will be
submitted upon her arrival and before she begins working with any human subjects data. Her
duties and responsibilities are provided below:
Kelly Woodall, MPH will be located at the Naval Health Research Center and will serve as
key support staff as a Data Analyst. Her duties will include assisting in program design and
maintenance of survey instruments alongside research team; planning epidemiologic studies
and designing the study methodology; performing statistical analyses for diverse research
projects with complex study designs; working with team members to derive an in-depth
understanding of the data findings; drafting proposals and writing peer-reviewed publications.
2. Remove Hector Lemus, PhDfrom the protocol as he is no longer affiliated with the
Deployment Health Research at the Naval Health Research Center, San Diego.
JUNE 2016 MODIFICATION
We respectfully request the IRB approval to:
1. Incorporate a staff change to include Satbir Boparai as key personnel. Her training certificates
(HIPAA and CITI) are included with this submission and her duties and responsibilities are
provided below:
Satbir Boparai will be located at the Naval Health Research Center and will serve as key
support staff as Data Manager. As data manager, Ms. Boparai will be responsible for
processing and managing data and related programs.
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2. Incorporate the two emails that will be sent out to all of the participants as reminders to
submit their childrens' artwork for the 2017 Family Calendar.
3. Remove Serguey Parkhomovosky and Kristen Motylinski from the protocol as they have
resigned and they are no longer affiliated with the Deployment Health Research at the Naval
Health Research Center, San Diego.
July 2016 email Subject: Have your child’s artwork featured in the Family Study Calendar
Happy 4th of July from the Millennium Cohort Family Study Team! We thank you and your
family for your past, present, and future contributions in preserving our nation’s independence.
We hope you are enjoying your summer and would like to remind you to submit your child’s
artwork for our 2017 calendar. Your child’s drawing could be featured in our 2017 Family Study
Calendar and online gallery!
To review the contest guidelines and submit your child’s artwork, please visit
http://www.familycohort.org/calendar
Very respectfully,
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval #
0720-0029, and Primary Institutional Review Board Protocol # NHRC.2015.0019.
October 2016 email
Subject: Last chance to submit your child’s artwork
Have you submitted your child’s artwork for the 2017 Family Study Calendar contest yet? The
deadline is quickly approaching! Submit your child’s drawing by Tuesday, November 1, to be
considered for the 2017 Calendar that will be mailed to nearly 10,000 of your fellow Family
Study participants!
Simply visit http://www.familycohort.org/calendar for the contest guidelines and online gallery.
We can’t wait to see your child’s masterpiece!
Very respectfully,
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval #
0720-0029, and Primary Institutional Review Board Protocol # NHRC.2015.0019.
MARCH 2016 CONTINUING REVIEW
Under this continuing review submission we have included for IRB review and approval the
following three participant contacts:
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Millennium Cohort Family Study Month of the Military Child Postcard
Millennium Cohort Family Study Calendar Artwork Reminder Email (July 2016)
Millennium Cohort Family Study Calendar Artwork Reminder Email (October 2016)
In addition, we respectfully request permission to add Carlos Carballo. Mr. Carballo will be
located at the Naval Health Research Center and serve as key support staff as a Data Analysts.
His duties will include providing statistical and analytical support for diverse research projects;
assist in processing and maintenance of research databases; assist in writing of reports and
scientific manuscripts for peer-reviewed professional journals and presentations.
Mr. Carballo’s training certificates (HIPAA, CITI and Research Integrity and Responsible
Conduct) are included with this submission.
Also, due to Kari Sausedo’s recent resignation we are removing her from the protocol.
DECEMBER 2015
We have included for IRB review and approval the calendar submission website for Family Study
participants to submit their children’s artwork for possible inclusion in the 2017 Family Study
calendar and online gallery. The submission page includes the media release form, which was
drafted by NHRC PAO Regena Kowitz, who received guidance from the NMRC PAO, Doris
Ryan.
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NOVEMBER 2015
We would like to request permission to obtain selected variables regarding military assessment
and treatment provision, as well as other medical care referral from the Department of Defense
Family Advocacy Program (FAP) Central Registry Database. The Family Advocacy program
provides various treatment and support services for perpetrators and victims, and makes referrals
for additional care where needed. Within the DON, the Family Advocacy Program services are
provided as part of the Fleet and Family Counseling Support Centers. We would request the
specified variables for all incidents involving Family Study research participants, with recurring
data extracts at the conclusion of each cycle of data collection.
Permission to receive these data will be obtained from DoD FAP, as well as from the Defense
Manpower Data Center (DMDC) which is the repository for the database. Once permission has
been obtained, NHRC will provide DMDC with a list of the SSNs for family study participants.
DMDC will then provide NHRC with all matching records in the Central Registry for those
SSNs. All data transfers will be made using encrypted files either using the Army’s AMRDEC
Safe Site or a secure data transfer site supported by DMDC.
The requested variables include the following personnel and treatment information for Service
members and spouses in the Family Study with substantiated cases of intimate partner violence
victimization or intimate partner/child abuse offending:
Name
Social Security Number
Incident report date
Legal event context code (emotional maltreatment, neglect, physical abuse, sexual abuse)
Person Association reason code (only codes AA = spouse, AD=parent, BH=former spouse,
BE=intimate partner, CC=relationship unknown)
Victim maltreatment severity level (mild, moderate, severe)
Clinical intervention program provided to Family Study participant as a victim (FAP, Other DoD,
Other Non-DoD, None, missing)
Clinical intervention program provided to Family Study participant as an offender (FAP, Other
DoD, Other Non-DoD, None, missing)
We have included for IRB review and approval the 2016 Family Study calendar and cover letter
which will be sent to all Family Study participants. This calendar will serve as an example for the
calendar we are planning to send in 2017. Over the next year, participants will be able to submit
their child(ren)’s artwork to be posted on the Family Study website. At the end of the year, 12
images will be selected to be featured as the monthly artwork in the 2017 calendar. The Family
Study Team is currently in the process of working with BUMED to create an appropriate release
form for participants to sign prior to submitting their child(ren)'s artwork. Once finalized, this
release form and the submission website will be submitted for review at a later time.
OCTOBER 2015
Submitting under this modification for IRB for review and approval is the Cover Letter for the
Millennium Cohort Family Study Shortened Survey Mailing #2 that is within the permissible
number of contacts.
In addition a change of staff request to remove Dr. David Luxton, Laura Tobin, and Madeline
Cross as they are no longer involved with the study. We also request permission to add Claire
Kolaja and Kyna Long as key personnel. Their roles are outlined below:
Claire Kolaja, MPH and Kyna Long, will be located at the Naval Health Research Center and
serve a key support staff as a Data Analyst. There duties will include providing statistical and
analytical support for diverse research projects; assist in processing and maintenance of research
databases; assist in writing of reports and scientific manuscripts for peer-reviewed professional
journals and presentations.
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Millennium Cohort Family Study Shortened Survey Mailing #2 – Cover Letter
Dear NAME,
During National Military Family Month, the Millennium Cohort Family Study Team would like
to thank you for the many contributions you make every day in support of the military and our
nation. We join the country in celebration of the Military Family and honor the commitment and
sacrifices made by the families of our nation's Service members.
Through your continued involvement, the Family Study will be able to provide vital information
to military leaders and policymakers working to support families like yours. We value your
participation, even if your marital status has changed or your spouse is no longer in the military.
We know your time is valuable, so we have created a shortened paper version of our 2014 online
survey with carefully selected questions. Please consider taking 5 minutes to complete this brief
survey and return it in the postage pre-paid envelope.
Alternatively, if you would prefer to complete the full survey, please visit our study website,
www.familycohort.org, click “Start Survey,” and enter your Subject ID: XXXXXXX.
Thank you for your continued commitment to current, former, and future military families.
Very respectfully,
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval #
0720-0029, and Primary Institutional Review Board Protocol # NHRC.2015.0019.
JUNE 2015
This protocol has undergone a change of staff; therefore, we request approval to add Jacqueline
Pflieger, PhD, as key personnel. Her role is outlined below.
Jacqueline Pflieger, PhD will be located at the Naval Health Research Center and will serve as
key support staff as Research Psychologist. Her duties will include assisting in program design
and maintenance of survey instruments alongside research team; planning epidemiologic studies
and designing the study methodology; performing statistical analyses for diverse research projects
with complex study designs; working with team members to derive an in-depth understanding of
the data findings; drafting proposals and writing peer-reviewed publications.
APRIL 2015
This protocol has undergone a change of staff; therefore, we request approval to remove Lauren
Kearney, MPH, and Andrew Lin as they are no longer affiliated with the study. We also request
approval to add Toni Geronimo, and Richard Armenta, MPH, as key personnel. Their roles are
outlined below.
Toni Geronimo, will be located at the Naval Health Research Center and will serve as key support
staff as Research Interns. As Research Interns they will collect and organize survey data and
forms for research projects. In addition, their duties as an intern are to scan and verify survey
data, perform data entry, literature searches, and assist with maintenance of databases for research
projects.
Richard Armenta, MPH, will be located at the Naval Health Research Center and will serve as
key support staff as a Biostatistician. His duties will include assisting in program design and
maintenance of survey instruments alongside research team; planning epidemiologic studies and
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designing the study methodology; performing statistical analyses for diverse research projects
with complex study designs; working with team members to derive an in-depth understanding of
the data findings; drafting proposals and writing peer-reviewed publications.
Kristen Walter, Ph.D., will be located at the Naval Health Research Center and will serve as key
support staff as subject matter expert in Depression and PTSD comorbidity. Her duties will
include assisting in data analytic design and the development of research questions regarding
depression among military spouse. Dr. Walters will assist in reviewing literature and writing
research reports on this topic.
Also, included for IRB review and approval is the Memorial Day postcard and the Memorial Day
follow-up email. These mailings are within the permissible number of contacts.
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Subject: Last Chance to Participate
[NAME],
As we remember the sacrifices made by our Service members and their families, we ask that you consider
representing current and future military spouses by completing your follow-up Family Study survey. The
Millennium Cohort Family Study Team recognizes the importance of your contribution to protecting
America’s freedom, and our goal is to understand the unique effects of military life on the health and
well-being of military families.
Your opportunity to be a part of this important study will be ending very soon, so don’t delay in sharing
your unique thoughts and experiences.
To complete your survey, please visit the following link: www.familycohort.org,
Your Subject ID is: XXXXXXX
Thank you so much for your participation.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board Protocol #
NHRC.2015.0019.
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IV. TABLE OF CONTENTS
I. COVER PAGE(S) ...................................................................................................................................... i
II. SIGNATURE PAGE ............................................................................................................................... iv
III. RECORD OF CHANGES TO THE PROTOCOL ................................................................................ v
IV. TABLE OF CONTENTS ..................................................................................................................... xx
V. SCIENTIFIC BACKGROUND AND OBJECTIVES ........................................................................... 1
1. Background......................................................................................................................................... 1
2. Primary Objectives ............................................................................................................................. 2
3. Secondary Objectives ......................................................................................................................... 2
VI. EXPERIMENTAL METHODS ............................................................................................................. 2
1. Experimental Procedures and Rationale ............................................................................................ 2
A. Subjects ....................................................................................................................................... 2
B. Methods and Informed Consent Plan ......................................................................................... 3
2. Sample Size Determination With Statistical Power Calculation ...................................................... 5
3. Justification for Exclusion of Specific Groups .................................................................................. 6
4. Required Equipment and Supplies..................................................................................................... 6
VII. ORGANIZATION OF RESEARCH EFFORT ................................................................................... 6
1. Duties and Responsibilities ................................................................................................................ 6
VIII. RISKS AND DISCOMFORTS TO RESEARCH VOLUNTEERS .................................................. 8
1. Risk to the Volunteer and Means of Mitigation ................................................................................ 8
2. Special Risks to Pregnant Women ..................................................................................................... 9
3. Safety Precautions and Emergency Procedures ................................................................................ 9
4. Assessment of Sufficiency of Plans to Deal With Untoward Events or Injuries ............................. 9
5. Qualification of Medical Monitor and Medical Support Personnel.................................................. 9
IX. DESCRIPTION OF THE SYSTEM FOR MAINTENANCE OF RECORD ...................................... 9
1. Experimental Data .............................................................................................................................. 9
2. Research Protocol, Consent Forms, and Related Documents for Protection of Human Research
Volunteers ............................................................................................................................... 12
3. Individual Medical Records ............................................................................................................. 13
4. Conflict of Interest............................................................................................................................ 13
X. APPENDICES........................................................................................................................................ 13
B. INVESTIGATOR COMPLIANCE ATTESTATION .......................................................... B-1
C. REFERENCES .................................................................................................................... C-17
D. SUPPLEMENTAL DOCUMENTS ...................................................................................... D-1
E. SUPPLEMENTAL DOCUMENTS—ABT COLLABORATION PROTOCOL ................ E-1
F. SUPPLEMENTAL DOCUMENTS—ABT DATA USE AGREEMENT ........................... F-1
G. SUPPLEMENTAL DOCUMENTS—FAMILY MAILINGS ............................................. G-1
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V. SCIENTIFIC BACKGROUND AND OBJECTIVES
1. Background
In recent decades, mental health and related outcomes for US military Service members
following war zone deployment(s) have been documented empirically for multiple conflicts,
beginning with Vietnam and continuing through the conflicts in Iraq and Afghanistan. Much
less attention has been paid, however, to deployment-related outcomes for spouses and other
family members (e.g., children, parents) of those deployed.
Stressors associated with Service member deployment(s) can have important consequences
for their family members, particularly when tours are long and multiple deployments are
required. Family member functioning can be degraded by separation and associated worries,
and Service member functioning is degraded when concern over events at home reduces their
ability to concentrate or to be attentive and vigilant. Additionally, war zone stress exposure
has been shown to have substantial impact on Service members after they return home, which
can produce additional stressors for both the Service members and their families when they
are re-united. Post-deployment stress also erodes readiness for future deployment.
In essence, the geographic separation and life threat that are inherent in war zone
deployment(s) open the door to anxiety and mood changes and alcohol abuse among Service
members and their families that can degrade the functioning of both in multiple ways, prior to
(e.g., via anticipatory anxiety) and during deployment. Compounding the problem, family
relationships and dynamics can be negatively affected when the Service member returns
home if s/he is among the estimated 20-30% of returning troops who suffer the negative
mental health and related outcomes (e.g., PTSD, depression, substance use) associated with
high levels of war zone stress exposure and/or has sustained significant physical injuries.
Prior research documents that military families are significantly affected by a Service
member’s war-related mental health problems, as well as the chronic stress of multiple and
extended wartime deployments characterized by diminished “dwell” time. Findings from the
National Vietnam Veterans Readjustment Study indicated that children of veterans with
PTSD had higher levels of behavioral and emotional problems than children of veterans
without PTSD. Families of veterans with PTSD are also more likely to suffer domestic
violence or intimate partner violence than families of veterans without PTSD. In the U.S.
Army, younger couples, and those with a previous incident of domestic violence, are at
greatest risk for an episode of domestic violence post-deployment.
Adverse childhood experiences (ACE), such as having a parent with a severe mental illness
and exposure to domestic violence and child maltreatment have been found to contribute to
negative adolescent trajectories, including early school drop-out, substance abuse, severe
obesity and promiscuity. In addition, adverse childhood experiences contribute significantly
to adverse adult outcomes, such as depression, PTSD, substance abuse, poorer medical
health, and low occupational attainment. The Department of Defense Plan to Achieve the
Vision of the DoD Task Force on Mental Health (September, 2007) addressed these concerns
directly by recommending the following actions to better understand the role that deployment
stress and war-related PTSD has on military families:
• DoD should conduct research on the processes of post-deployment adjustment for family
members
• DoD should conduct research on children who have been separated from their parents by
deployment, including their access to support for psychological health issues
Although much of the existing research suggests that war-time stress and deployments are
associated with a host of negative sequelae for both the Service member and their family, the
relationships are not linear, in that some Service members and their families demonstrate
resiliency in the face of adversity. Moreover, studies have demonstrated that other potential
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factors (e.g., social support, previous exposure to violence) may either moderate (i.e., reduce
or exacerbate the impact of the stressor) or mediate this relationship suggesting alternate
pathways and trajectories. To this end, the FamilyCohort sub-study seeks to address both the
risk and protective factors associated with the process of post-deployment adjustment for
family members. This line of inquiry has significant implications for both early intervention
efforts and future research, given the potential information gained on patterns of risk and
resiliency, and targets for intervention, particularly for the families of deployed Service
members.
Systematic documentation of both negative and positive outcomes associated with
deployment to Iraq and Afghanistan, along with detailed analysis of risk and resilience
factors, will provide a scientifically sound foundation for understanding the relationships
among multiple factors related to family member functioning and family dynamics. This
information will facilitate identification of specific interventions aimed at: reducing
deployment-related stress, increasing family member resilience, and increasing the capability
of family members to support service members with negative outcomes resulting from war
zone stressor exposures.
2.
•
•
•
•
3.
•
•
•
•
•
•
Primary Objectives
To assess the impact of military service and deployment on the physical and mental
health and related outcomes of spouses and co-resident children of Service members
To assess the impact of military service and deployment on the quality of the
relationships between Service members, spouses and their children
To examine the association between family member outcomes and Service member
outcomes
To identify vulnerability and resilience factors for deployment stress-related outcomes for
spouses and children of deployed Service members
Secondary Objectives
Explore the association between Service member deployment (e.g. combat, duration,
dwell time, and frequency) and the health and well-being of spouses and children.
Explore the association between Service member readjustment issues (e.g., PTSD,
anxiety, depression, alcohol misuse/abuse) and the health and well-being of spouses and
children.
Examine factors related to resiliency and vulnerability that moderate the association
between deployment experiences and Service member readjustment issues, and the health
and well-being of spouses and children.
Examine factors related to marital quality and family function.
Evaluate methodological approaches to ensure adequate representation of spouses from
all service branches, Reserve and National Guard; and assess validity of assessment
measures and instruments.
Contribute data to the Service member cohort study on spouse and child factors that are
associated with service member health and well-being, as well as length of service.
VI. EXPERIMENTAL METHODS
1. Experimental Procedures and Rationale
A. Subjects
In order to assess the interrelated health effects of military service and deployment on Service
members, spouses, and their children a Family Cohort sub-study was added to the main study
(The Millennium Cohort Study) in August 2009 under protocol #NHRC.2000-0007. The
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Millennium Cohort Family Study team and collaborators enrolled 10,065 participants during the
2011-2013 baseline survey cycle. During the data cleaning phase between baseline and the 20142015 follow-up survey cycle, 137 participants were removed from the study sample and were not
included in analyses. The reasons for exclusion were questionnaires submitted without a signed
consent form, multiple questionnaires submitted by the same participant, and submitted
questionnaires that were found to be completed by the incorrect individual. During additional data
cleaning in 2016, an additional 49 surveys were removed from the study sample, because it was
discovered that the 49 Family participants had completed both Millennium Cohort and Family
Cohort surveys. Therefore, to date, there are 9,872 participants enrolled in the Millennium Cohort
Family Study. The first follow-up survey cycle was launched on October 1, 2014 and closed on
February 9, 2016. The follow-up response rate is 67.4% with 6,625 completed surveys.
B. Methods and Informed Consent Plan
Due to logistical reasons, the Family component of the Millennium Cohort study is now
submitted to the Naval Health Research Center’s Institutional Review Board as a standalone substudy as of April 25, 2015. Previously all approvals for this project were included under the
primary protocol for the Millennium Cohort Study (NHRC.2000.0007). For all background and
historical information prior to the standalone sub-study start date, please refer to the Millennium
Cohort Study protocol. All regulatory approvals/requirements related to the Millennium Cohort
Family study up to and through the 2014-2015 survey cycle remain under the Millennium Cohort
regulatory approvals (OMB Control Number 0720 – 0029 RCS: DD-HA(AR) 2016 and SORN
N06500-1). Any future regulatory approvals needed for the Millennium Cohort Family study will
be submitted under this protocol. A separate website (www.familycohort.org) for this sub-study
has been established under the main study (Millennium Cohort; NHRC.2000.0007), and is linked
directly to the Millennium Cohort Study website, www.millenniumcohort.org.
As described in the Primary Millennium Cohort Study protocol, baseline data for Family Study
were collected beginning in 2011. Furthermore, the first follow-up wave collected data from
October 2014 to February 2016 and utilized a secure online data collection survey method
previously approved and documented in the primary protocol. Over the course of this longitudinal
study, spouses will be asked to complete a total of 7 follow-up surveys over 21 years, with one
survey to be completed approximately every 3 years. These survey cycles will be conducted at the
same time as the Millennium Cohort Study data collection cycle in order to maintain
methodological consistency and to ensure that both the Family Study spouse participants and
their Millennium Cohort Study military marital partners complete their surveys within a close
time frame. Starting with the 2017 data collection cycle, revised survey documents and
procedures that are developed for each new wave of data collection will be submitted to the IRB
for approval as part of a modification to this new protocol.
Informed consent has already been obtained from all current study participants during the
baseline enrollment process in the 2011 data collection cycle. This process is documented in the
IRB protocol for the primary Millennium Cohort Study. At present, no additional participants will
be enrolled in the Family study. Additional participants may be enrolled in a future wave of data
collection. However, if that opportunity arises, all methods for informed consent and enrollment
will be documented and submitted along with the modification including the new survey
materials to be used in that data collection cycle.
Survey data collection methods have been developed based on empirical research regarding
effective subject recruitment strategies (e.g., modified Dillman survey methodology). Multiple
modes of contact will continue to be utilized, including email and mail. For those who provided
phone information to the study team for contact purposes, phone calls may also be used. Nominal
incentives will be offered to participants for completing the survey, such as the choice of a $10
gift card to the military exchange (AAFES/NEX gift card), Starbucks, or Amazon.com. No gift
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cards are exchangeable for cash. Additional nominal pre-incentives may be sent to participants as
part of the recruitment process (e.g., small reusable lunch bag, magnetic picture frame, $2 bill).
All specific contact scripts and procedures previously approved up through April 24th 2015 will
continue to be documented through the primary Millennium Cohort Study protocol. The exact
nature, scripts, and procedures for all future contacts from April 25th 2015 onward will be
submitted under this sub-study. The first of these contacts are submitted for approval as detailed
in Appendix G that are within the number of contracts previously approved by the IRB under the
Millennium Cohort Study (primary study). Any other future contacts will be submitted to the IRB
for approval as modifications to this protocol.
During the 2014-2016 follow-up survey cycle, the type of contact and incentive offered alternated
in order to ensure they do not become redundant or repetitive for participants. Furthermore,
participants did not receive more than two email contacts in any individual month or more than
twelve postal contacts total during the duration of the follow-up survey cycle. During the followup survey cycle, we sent recruitment solicitations to participants until (a) we received a
completed survey from them, (b) they explicitly declined to participate, or (c) the survey cycle
completion timeframe ended. Participants receive occasional contacts during off-cycle
timeframes in order to update them about the progress of the study, to obtain updated contact
information from them, and to maintain a relationship with them during the long off-cycle
periods.
Family Component Domains and Measures. Based on our conceptual model and the existing
literature, the previously approved Family Study surveys documented in the primary protocol
assess four broad domains: (1) spouse physical health; (2) spouse mental health and adjustment;
(3) spouse’s reports of their children’s mental/physical health and functioning; and (4) family
functioning and protective and vulnerability factors (See Table 1).
Table 1. Family Component Domains and Measures
Construct
Inventory
#
Items
Physical Health History
Self-reported Medical
46
Conditions
General Health and Functional Status
SF-36
36
Mental Disorder Screening (depression,
somatization, panic disorder, anxiety, alcohol
PHQ
15-16
abuse/dependence, binge eating disorder, and
bulimia nervosa)
PTSD Symptoms
PCL-C
17
Adverse Childhood Events
ACE
8
Alcohol Use
CAGE
4
Sleep Quality
ISS
9
Child Health
CDC: National Survey
23
of Children’s Health
Child Functioning
Adapted Strengths and
15
Difficulties Questionnaire
Family Satisfaction
FACES-IV
10
Family Communication
FACES-IV
10
Marital Satisfaction
Adapted Quality of
4
Marriage Index
Spouse’s Work and Family Conflict
Adapted Work-Family
5
Conflict Scale
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SF-36 = Short-Form 36 Health Survey; PHQ = Patient Health Questionnaire; PCL = PTSD check
list; ACE = Adverse Childhood Events; ISS = Insomnia Severity Index; FACES-IV = Family
Adaptability and Cohesion Evaluation Scale, fourth version
2. Sample Size Determination With Statistical Power Calculation
The statistical power of this study depends on the prevalence of the various mental health
disorders and the percent of spouses married to Service members with and without exposure to
deployment. Based on the percent of Service members who have already been enrolled in the
Millennium Cohort Study and who have deployed in support of the wars in Iraq and Afghanistan,
it is estimated that 30% to 50% of the Service members who were enrolled in the 2010 cohort
already will have been deployed in support of the current conflicts. Further, it was estimated that
the overall prevalence of mental health outcomes will be from 5% to 10% for spouses of nondeployed military Service members. The following formula estimates the necessary sample size:
(Z
N=
α
P(1 − P)(1 / q1 + 1 / q 2 ) + Z β P1 (1 − P1 )(1 / q1 ) + P2 (1 − P2 )(1 / q 2 )
)
2
∆2
Where: N = sample size required
P1 = proportion of outcome among group 1 (spouses of non-deployed)
P2 = proportion of outcome among group 2 (spouses of deployed)
Zα = standardized normal deviate for a two-tailed probability of an α-error, set at α = 0.05
Zβ = standardized normal deviate for a two-tailed probability of an β-error, set at β = 0.80 or 0.90
q1 = proportion of sample population in group 1
q2 = proportion of sample population in group 2
P = q1 P 1 + q2 P 2
Δ = P1 - P2
The necessary study sample size for spouses of military Service members to detect specified odds
ratios with 80% and 90% power and the alpha error level set at <0.05 are shown in Table 1. With
a study sample of 10,000 spouses, odds ratios of 1.3 and higher with 80% power will be
detectible across the expected range of service members deployed.
Table 2.
Sample Size Necessary at Different Levels of Statistical Power to Detect a Given
Magnitude of Prevalence (as reflected by the Odds Ratio) for Spouses of Service Members
% Prevalence
of Exposure
(Deployment)
30%
30%
30%
30%
Detectable
Odds
Ratio
1.2
1.3
1.5
2.0
Low-End Estimate (5%)
N Required for
N Required for
80% Power
90% Power
21,555
29,034
9,999
13,504
3,903
5,295
1,167
1,596
High-End Estimate (10%)
N Required for N Required for
80% Power
90% Power
11,502
15,480
5,363
7,234
2,113
2,861
645
879
40%
40%
40%
40%
1.2
1.3
1.5
2.0
18,988
8,836
3,468
1,049
25,497
11,880
4,673
1,418
10,124
4,733
1,874
578
13,589
6,360
2,522
779
50%
50%
50%
50%
1.2
1.3
1.5
2.0
18,348
8,563
3,378
1,031
24,562
11,462
4,521
1,379
9,775
4,581
1,822
566
13,085
6,132
2,438
756
Based on these analyses, the estimated sample size of spouses of military Service members with
adequate power to detect differences in mental health outcomes was determined to be
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approximately 10,000. To achieve this spouse sample size, we began baseline enrollment with a
probability sample of personnel 250,000 Service members who were invited to participate in the
2010 cohort. Based on previous cohorts of the Millennium Cohort Study a response rate of 25%
(62,500 enrolled service members) was expected. Of those, we estimated that 35% (21,875)
would be married, and that 75% (16,407) of married Service members would refer their spouses
for enrollment in the Family Study. We further estimated a spouse response rate of 60%, thus
giving an estimated sample size of approximately 10,000 spouses of military Service members for
this study. Based on the above table, a sample size of 10,000 will provide adequate power to
detect the targeted mental health outcomes among this population.
3. Justification for Exclusion of Specific Groups
Sample selection and recruitment criteria were documented in the original Millennium Cohort
Study protocol. No additional subject recruitment will be conducted under this protocol without a
specific modification and further review by the IRB. Selection and exclusion criteria for future
subject enrollment will be provided in such potential future modifications.
4. Required Equipment and Supplies
Supplies needed for this protocol will include mailing supplies, participant incentives, and other
standard office supplies. Computer equipment and support as provided through the Naval Health
Research Center will facilitate data management and security as discussed further below.
VII. ORGANIZATION OF RESEARCH EFFORT
1. Duties and Responsibilities
Valerie Stander, PhD, will serve as a Principal Investigator for this study. She will be
responsible for the implementation of and compliance with this protocol. She will have primary
responsibility for supervising study enrollments, data collection and analyses and protection of
human subjects. She will also be responsible for ensuring that all NHRC personnel involved with
this protocol are properly trained and qualified. She is responsible for assisting with the design of
the study and will be involved with data interpretation and publication.
Hope McMaster, PhD, will be located at the Naval Health Research Center and will serve as a
co-investigator Research Psychologist. Duties will include assisting in program design and
maintenance of survey instruments alongside research team; planning epidemiologic studies and
designing the study methodology; performing statistical analyses for diverse research projects
with complex study designs; working with team members to derive an in-depth understanding of
the data findings; drafting proposals and writing peer-reviewed publications.
Cynthia LeardMann, MPH will be located at the Naval Health Research Center and serve as a
co-investigator Epidemiologist. Duties will include planning epidemiologic studies and
designing the study methodology; performing statistical analyses for diverse research projects
with complex study designs; working with team members to derive an in-depth understanding of
the data findings; drafting proposals and writing peer-reviewed publications.
Denise Lovec-Jenkins will serve will serve as key support staff as the Regulatory Affairs
Manager. She will prepare IRB submission and other research activities to ensure compliance
with relevant federal and local regulations and policies of research for this protocol.
Lauren Bauer, MPH, will serve as key support staff as Study Coordinator. Duties will include
assisting in program design and maintenance of survey instruments alongside research team, as
well as assisting with writing peer-reviewed publications; assisting in the development of
strategies to maintain study participant retention, including the utilization of newsletters, mailers,
and other incentives.
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Evelyn Sun, MPH will serve as key support staff as Assistant Study Coordinators and will assist
with coordinating the study, and web site and survey testing. She will manage and organize the
on-site work, including responding to any emails from participants.
Beverly Sheppard, Study Coordinator for the Millennium Cohort Study and Jennifer Walstrom
study will serve as key support staff and will work with the Millennium Cohort Family study
team with coordinating the Millennium Cohort study and sub-study data as well as web site and
survey testing.
Alexis Takata, Deanne Milliard and Anet Petroysan will be located at the Naval Health
Research Center and will serve as key support staff as Research Assistants. As a Research
Assistant, they will collect and organize survey data and forms for research projects. In addition,
their duties will include scanning and verifying survey data, performing data entry and literature
searches, and assisting with the maintenance of databases for research projects. .
Steven Speigle has extensive knowledge in computer and internet technology, website
maintenance and development. He will work with Mr. Lee to ensure data security and integrity,
as well as designing, creating, modifying, and updating web pages. He will also be responsible
for building and maintaining the web-based component of the survey along with Mr. Lee in
addition to cleaning and maintaining email addresses, as well as implementing a system to track
incorrect email addresses.
William Lee has extensive knowledge in computer and internet technology, website
maintenance and development. He will work with Mr. Speigle to ensure data security and
integrity, as well as designing, creating, modifying, and updating web pages. He will also be
responsible for building and maintaining the web-based component of the survey along with Mr.
Speigle in addition to cleaning and maintaining email addresses, as well as implementing a
system to track incorrect email addresses.
Daniel Vaughan, BS will be located at the Naval Health Research Center and will serve as key
support staff as a Programmer Analyst. His duties will include ensuring data security and
integrity and assist in processing and maintenance of research databases. He will also be
responsible for cleaning and maintaining email addresses, and maintaining the current system to
track incorrect email and postal addresses.
Gordon Lynch will be located at the Naval Health Research Center and will serve as key support
staff as a web designer. As the web designer Mr. Lynch will work with Mr. Speigle and Lee in
creating and maintaining the study website.
Jacqueline Pflieger, PhD, and Sabrina Richardson, PhD, will be located at the Naval Health
Research Center and will serve as key support Research Psychologists. Their duties will include
assisting in program design and maintenance of survey instruments alongside research team;
planning epidemiologic studies and designing the study methodology; performing statistical
analyses for diverse research projects with complex study designs; working with team members
to derive an in-depth understanding of the data findings; drafting proposals and writing peerreviewed publications.
Kristen Walter, PhD, will be located at the Naval Health Research Center and will serve as key
support staff as subject matter expert in Depression and PTSD comorbidity. Her duties will
include assisting in data analytic design and the development of research questions regarding
depression among military spouse. Dr. Walter will assist in reviewing literature and writing
research reports on this topic.
Christopher Phillips, MD, MPH, is a Senior Epidemiologist at the Naval Health Research
Center in San Diego, CA. Dr. Phillips has spent many years working in both the military and
civilian sectors of healthcare, as an active duty provider, bioinformaticist, and epidemiologist.
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Dr. Phillips will be responsible for conducting the statistical analyses for the project. In addition,
he will be responsible for assisting with the writing of the methods for this project and will assist
with scientific manuscript preparation.
Ben Porter, PhD, Teresa Powell, MS and Richard Armenta, PhD, MPH will be located at the
Naval Health Research Center and will serve as key support personnel as a Biostatistician. Duties
will include assisting in program design and maintenance of survey instruments alongside
research team; planning epidemiologic studies and designing the study methodology; performing
statistical analyses for diverse research projects with complex study designs; working with team
members to derive an in-depth understanding of the data findings; drafting proposals and writing
peer-reviewed publications.
Rudolph Rull, PhD, Daniel Trone, PhD and Felicia Carey, will be located at the Naval
Health Research Center and will serve as key support staff as Epidemiologists. Their
duties will consist of planning epidemiologic studies and designing the study
methodology; performing statistical analyses for diverse research projects with complex
study designs; working with team members to derive an in-depth understanding of the
data findings; drafting proposals and writing peer-reviewed publications.
Anna Rivera, MPH, Claire Kolaja, MPH, Carlos Carballo, MS, Toni Geronimo, MPH,
Kelly Woodall, MPH and Alejandro Esquivel, MPH will be located at the Naval Health
Research Center and serve as key support staff as Data Analysts. Duties will include assisting in
program design and maintenance of survey instruments alongside research team; planning
epidemiologic studies and designing the study methodology; performing statistical analyses for
diverse research projects with complex study designs; working with team members to derive an
in-depth understanding of the data findings; drafting proposals and writing peer-reviewed
publications.
2. Chain of Command
All the co-investigators, key-personnel and consultants will report directly to the principal
investigator, who will be responsible to the Commanding Officer of Naval Health Research
Center, through the usual chain of command.
VIII. RISKS AND DISCOMFORTS TO RESEARCH VOLUNTEERS
1. Risk to the Volunteer and Means of Mitigation
The procedures for data storage and security will continue under this protocol as they were
previously under the primary study protocol. This research study will collect data using a selfreport survey. Study staff will store all identified data in secure server locations at the Naval
Health Research Center and maintain limited password access. Only personnel on this protocol
who need to make use of specific data files will have access. All results will be reported as
aggregate data without identifying any individuals. Thus, this study poses no physical risk to the
participant. The primary risk to participants is the potential for a breach of confidential data.
Personal identifiable health information is collected, and strict procedures will be followed to
minimize any risk of exposure.
The following procedures will be followed to ensure that confidential information will not be
used or abused in way that might directly or indirectly harm the individuals involved:
• All study staff will receive training in confidentiality protection procedures.
•
Supervisors will monitor staff to ensure that they follow proper confidentiality procedures.
•
If study staff resign or otherwise leave the program, they will no longer have any access to
any stored data. However, they will still remain under obligation indefinitely to keep any
information confidential that they may have learned about individual participants.
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•
Based on previous agreements in the Primary study protocol, study staff will store study
paper records in locked metal cabinets at NHRC. Paper records that are no longer needed
will be shredded.
•
New data collected for the ongoing survey cycle under the present protocol are all electronic.
No new paper is currently collected. All new data are stored securely on the dedicated
Millennium Cohort Survey server at the Naval Health Research Center. No transfer of data or
changes in the storage process are necessary as part of the initiation of this new protocol.
•
To gain entry into the study database, staff will be required to have a military CAC card and
pin.
•
The NHRC network fire wall is in place to deter unauthorized access to these files.
•
Participant identifiers and study data are linked with a nonidentifying study number and are
stored separately. Only study personnel on this protocol with authorized access will link
personal identifiers with the data in order to match multiple data files including different
waves of data and military personnel records. Identifiers will again be stripped following the
match for analyses.
•
For online data collection purposes, participant survey information transmitted over the
Internet will be done using SSL-encrypted transmission lines. Further, participants will have
to enter their unique study ID number and last four digits of their social security number to
send completed questionnaires securely.
•
The study database will primarily reside within the NHRC network environment. Any
external data transfers will be limited to deidentified data and will be dependent on formal
data use agreements established with NHRC and external partners. Only secure FTP will be
used to transfer encrypted, deidentified data.
2. Special Risks to Pregnant Women
This study does not pose any specific risks to pregnant women.
3. Safety Precautions and Emergency Procedures
This study is an observational epidemiologic study and does not involve the administration of any
medications or therapeutics. Participants participate remotely and will not have direct contact
with study staff.
4. Assessment of Sufficiency of Plans to Deal With Untoward Events or Injuries
Previous studies at NHRC involving similar procedures have not led to significant injury of a
subject. The use of standard Navy medical procedures has been deemed sufficient to deal with
any untoward events and/or injuries. However, in the event of potential data compromise, action
will be taken in compliance with NAVMED Policy 09-016.
5. Qualification of Medical Monitor and Medical Support Personnel
NA
IX. DESCRIPTION OF THE SYSTEM FOR MAINTENANCE OF RECORD
1. Experimental Data
All study data, including previously collected baseline paper questionnaires, will be managed by
the principal investigator and stored in locked rooms at NHRC. Computerized Privacy Act data
will be handled in a confidential, controlled access fashion in compliance with
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NAVHLTHRESCENINST 3900.2F and NAVHLTHRESCENINST 6500.1A.
A Data Use Agreement (DUA; Appendix F) between NHRC and Abt Associates and their
subcontractors Center for Child and Family Health (CCFH) has been established. These external
collaborators will not have any contact with research participants and will only have access to
deidentified data under the terms of an existing DUA. Abt associates and their affiliates will only
maintain deidentified data on secure servers at their institutions for the duration of specific tasks
they are contracted to perform. At the conclusion of said projects, those data files will be returned
or deleted. Deidentified data may include demographics, health conditions and symptoms,
functional health, habits (e.g., smoking, alcohol use, exercise, and diet), family relationship
quality, parenting and child-related data, as well as military history information. Relative dates of
events may be shared with Abt Associates for specific analyses; these dates will be coded as time
(days) since an agreed upon baseline reference point. No specific dates will be shared with
external collaborators.
Data transfers will only occur using password-protected encrypted files transferred through a
secure FTP process employing an additional layer of password protection. The data provided by
NHRC to the Abt Associates team is restricted to the minimum necessary to complete approved
Elected variables regarding military assessment and treatment provision, as well as other medical
care referral from the Department of Defense Family Advocacy Program (FAP) Central Registry
Database will be obtained. The Family Advocacy program provides various treatment and
support services for perpetrators and victims, and makes referrals for additional care where
needed. Within the DON, the Family Advocacy Program services are provided as part of the Fleet
and Family Counseling Support Centers. We would request the specified variables for all
incidents involving Family Study research participants, with recurring data extracts at the
conclusion of each cycle of data collection.
Permission to receive these data will be obtained from DoD FAP, as well as from the Defense
Manpower Data Center (DMDC) which is the repository for the database. Once permission has
been obtained, NHRC will provide DMDC with a list of the SSNs for family study participants.
DMDC will then provide NHRC with all matching records in the Central Registry for those
SSNs. All data transfers will be made using encrypted files either using the Army’s AMRDEC
Safe Site or a secure data transfer site supported by DMDC.
The requested variables include the following personnel and treatment information for Service
members and spouses in the Family Study with substantiated cases of intimate partner violence
victimization or intimate partner/child abuse offending:
Name
Social Security Number
Incident report date
Legal event context code (emotional maltreatment, neglect, physical abuse, sexual abuse)
Person Association reason code (only codes AA = spouse, AD=parent, BH=former spouse,
BE=intimate partner, CC=relationship unknown)
Victim maltreatment severity level (mild, moderate, severe)
Clinical intervention program provided to Family Study participant as a victim (FAP, Other DoD,
Other Non-DoD, None, missing)
Clinical intervention program provided to Family Study participant as an offender (FAP, Other
DoD, Other Non-DoD, None, missing)
We plan to work with the U.S. Census Bureau’s Center for Administrative Records and Research
(CARRA) to obtain permission from the IRS to access these tax records, as well as obtaining the
necessary permission to access Census data from the Census itself. CARRA has experience in
obtaining such access and has been successful in doing so for the purposes of program evaluation
and research.
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The IRS tax data include, for each individual, wage information from W-2 forms, selfemployment income from 1099 forms, and much additional information from the full tax forms
on both earned and unearned income. It also has self-reported occupational information and
industry sector information for each employer. The data is longitudinal, so it can be obtained for a
sequence of consecutive years. Thus it can provide a great deal of information about the
employment outcomes of study members before, during, and after the relevant period of military
service.
This data can also be linked to Census data from various sources. We propose using data from the
American Community Survey and/or other census databases as appropriate to create a
comparison group of individuals from the general U.S. non-military-affiliated population similar
to the military spouses on available characteristics such as gender, race and ethnicity, residence,
and educational level. We would also pull data from IRS records on this comparison group to
compare the employment outcomes of our study group with the comparison group,
NHRC will provide the Census with a list of family study participant names, SSNs, and DOBs so
that Census can match cases with IRS and Census data. This file will also contain an ID unique to
the family study. We will also send to Census a set of variables from the family cohort study
survey which will be used for analysis and for the construction of a comparison group, along with
this same unique family study ID.
After matching has occurred, Census will assign each case a Protected Identity Key (PIK) and
will remove all identifiers (SSN, name, DOB), creating a de-identified dataset for transfer to a
Census Research Data Center (RDC), of which there are several around the county. Due to the
sensitive and confidential nature of the data involved, Census and IRS require that the data be
accessed at an RDC and that no microdata leave the RDC. Our analytic dataset containing family
study data will also be transferred to the RDC.
At that point, after undergoing a rigorous Census background check, a Family Study research
member will travel to one of the RDCs to access and analyze the de-identified data. All analytic
results will be reviewed for data disclosure by the Census Bureau staff to ensure that no
identifiable data about any individuals leaves the RDC. Only aggregate data results are released.
Information that is based on an individual respondent, on a small sample, or on a highly
concentrated cell will not be released. All family study data stored at the RDC will be erased
from Census’s computers after we complete our work at the RDC.
We would like to obtain selected variables regarding education from the National Student
Clearinghouse. The NSC is a non-profit organization that collects data on student enrollment,
degree earned, and other credential completion from most institutions of higher education in the
country. The NSC has the most extensive database of enrollments and credentials available. Over
3,600 colleges and universities, enrolling 98 percent of all students in public and private
institutions, provide data to the clearinghouse. NSC provides educational history information that
confirms an individual’s degrees, academic credentials, and enrollment status.
The relevant NSC database for Family Study analytic purposes is called StudentTracker. It
includes both enrollment and credential data. StudentTracker can be queried in one of two ways,
either by using a combination of name and date-of-birth, or by using Social Security Number
(SSN). The NSC requires student consent in order to match on SSN, but NOT to match on name
and date-of-birth. We propose a non-consent-based data match which will not require the transfer
of SSNs to NSC; rather, the data match will be performed using names and dates of birth as
personally-identifiable information.
We would like to obtain selected variables regarding mortality status from the Social Security
Administration (SSA) Death Master File. The SSA collects death information in order to
implement their programs. The SSA receives death reports from many sources, including funeral
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directors, family members, financial institutions, and state and federal agencies. The data is then
compiled into one file, the Death Master File. While this file does not capture all deaths in the
United States, previous studies have found it captures between 83-95% of the deaths.
There are two primary reasons for obtaining mortality data from the SSA. First, the mortality data
will be used to remove participants from mailing lists so to not inadvertently contact next of kin.
The death data from the SSA will be received on a monthly basis, with minimal lag time between
the date of death and receipt of the data to endure minimal burden on next of kin. Secondly, this
data will be part of an algorithm to verify identity and mortality status of Family participants in
conjunction with mortality data obtained through the National Death Index. This algorithm relies
on using multiple data sources to verify mortality status and its accuracy will be comprised if
SSA mortality data is not included.
NHRC will provide the SSA with the list of Family study participants’ SSN, full name, date of
birth, and gender for matching purposes. The Army Safe Site (AMRDEC) will be use to transfer
the encrypted data.
Family Study tasks and access to these data will be limited to a minimum number of individuals
necessary at each institution to achieve the required purpose. Data will be stored in a manner
consistent with Federal and DoD regulations and data security best practices as described under
section IX “Description Of The System For Maintenance Of Records”.
All contacts mailed to the participants will be identified by bar codes, which will contain
embedded Subject Identification Numbers (SID), mailing numbers, and item codes. The SID is
randomly generated and unique to each participant. It is assigned and attached to each record that
is obtained from DoD health and administrative files upon receipt at NHRC. From all the files
that come to NHRC, two databases will be created for study use. The first database will contain
participant identification information such as name, current address, address history, last 4-digits
of the social security number, and SID. This database will be the source of names and addresses
when the questionnaire is mailed out and will be used for tracking purposes. Currently, all data
collection is conducted through an online survey portal. However, we plan that any possible
future paper questionnaires that may be submitted for approval through the IRB will have the SID
bar coded onto them when they are mailed to the participant so that can be scanned for
identification purposes once returned.
The second database created will contain participant questionnaire responses along with
corresponding information linked by SID only from administrative and medical files. This
procedure will separate individual identifiers from participant data, while making it possible to
pair names and addresses with SIDs for update and longitudinal tracking purposes. Once all the
files (survey response, medical, and administrative) have been matched by SID, the SID will be
stripped from this database. At the end of all longitudinal data collection and final study dataset
completion, all identifying information will be destroyed. Prior to study completion, for back-up
purposes, a list pairing the SID with the last 4-digits of the social security number will be created
and stored separately by the Principal Investigator in a locked file cabinet.
2. Research Protocol, Consent Forms, and Related Documents for Protection of Human Research
Volunteers
Based on procedures approved previously in the primary Millennium Cohort Study protocol, the
principal investigator will keep the research protocols and consent forms in a locked file at
NHRC. Computer data files will be stored in compliance with NAVHLTHRESCENINST
3900.2F and NAVHLTHRESCENINST 6500.1A.
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3. Individual Medical Records
Individual computerized medical records will be used to abstract demographics, lifestyle, and
medical data into the study database. Personal identifiers will be stored in a separate data file that
can be linked only be the study statistician and the principal investigator.
4. Conflict of Interest
No person involved in the design, conduct, or reporting of this research has a financial or other
interest that could reasonably appear to be affected by the carrying out or the results of this
research.
X. APPENDICES
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APPENDIX A: Consent Documents
Current Informed Consent Form and survey instrument are approved under the main study (Millennium
Cohort Study NHRC.2000.0007). The survey instrument for the survey cycle to begin in 2017 will be
submitted to the IRB for review and approval prior to implementation and when all regulatory approvals
such as OMB, RCS and SORN have been received.
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B. INVESTIGATOR COMPLIANCE ATTESTATION
INVESTIGATOR COMPLIANCE ATTESTATION
As a researcher or team member responsible for performing and monitoring the research under the
protocol titled Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study, I have read
and understand the provisions of Title 32 Code of Federal Regulations Part 219 (Protection of Human
Subjects), Department of Defense (DoD) Instruction 3216.02 (Protection of Human Subjects in
DoD-Supported Research), DoD Instruction 6025.18-R (Privacy Rule), SECNAV Instruction 3900.39D
(Human Research Protection Program), OPNAV Instruction 5300.8C (Personnel Surveys),
NAVHLTHRSCHCEN Instruction 3900.2F (Protection of Human Subjects), NAVHLTHRSCHCEN
Notice 6500 (Protection of Health Information in Research), Title 21 Code of Federal Regulations Parts
50, 56 if applicable (clinical investigations regulated by the FDA), and all relevant local instructions. I
have disclosed all potential and actual conflict of interest(s) related to the design, conduct, analysis, or
reporting of this research. I will abide by all applicable laws and regulations, and I agree that in all cases,
the most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during the
conduct of this Navy-sponsored project, I have ready access to each of these regulations, as either my
personal copy or available on file from the Chairperson of the Institutional Review Board. I understand
that my immediate resource for clarification of any issues related to the protection of research volunteers
is the Chairperson of the Institutional Review Board.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
Valerie Stander, PhD
Principal Investigator
______/______/______
_________________________________________________
David D. Luxton, PhD, MS
Co-Investigator
______/______/______
_________________________________________________
Dennis Faix, MD, MPH
CDR, MC, USN
Co-Investigator
______/______/______
_________________________________________________
Lauren Bauer, MPH
Key Personnel
______/______/______
_________________________________________________
Hector Lemus, DrPh
Key Personnel
______/______/______
_________________________________________________
Christopher Phillips, MD, MPH
Key Personnel
______/______/______
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INVESTIGATOR COMPLIANCE ATTESTATION
As a researcher or team member responsible for performing and monitoring the research under the
protocol titled Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study, I have read
and understand the provisions of Title 32 Code of Federal Regulations Part 219 (Protection of Human
Subjects), Department of Defense (DoD) Instruction 3216.02 (Protection of Human Subjects in
DoD-Supported Research), DoD Instruction 6025.18-R (Privacy Rule), SECNAV Instruction 3900.39D
(Human Research Protection Program), OPNAV Instruction 5300.8C (Personnel Surveys),
NAVHLTHRSCHCEN Instruction 3900.2F (Protection of Human Subjects), NAVHLTHRSCHCEN
Notice 6500 (Protection of Health Information in Research), Title 21 Code of Federal Regulations Parts
50, 56 if applicable (clinical investigations regulated by the FDA), and all relevant local instructions. I
have disclosed all potential and actual conflict of interest(s) related to the design, conduct, analysis, or
reporting of this research. I will abide by all applicable laws and regulations, and I agree that in all cases,
the most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during the
conduct of this Navy-sponsored project, I have ready access to each of these regulations, as either my
personal copy or available on file from the Chairperson of the Institutional Review Board. I understand
that my immediate resource for clarification of any issues related to the protection of research volunteers
is the Chairperson of the Institutional Review Board.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
Carrie Donoho, PhD
Co-Investigator
______/______/______
_________________________________________________
Hope McMaster, PhD
Co-Investigator
______/______/______
_________________________________________________
Ben Porter, PhD
Key Personnel
______/______/______
_________________________________________________
Rudolph Rull, PhD
Key Personnel
______/______/______
_________________________________________________
Daniel Trone, PhD
Key Personnel
______/______/______
_________________________________________________
Lauren Kearney, MPH
Key Personnel
______/______/______
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INVESTIGATOR COMPLIANCE ATTESTATION
As a researcher or team member responsible for performing and monitoring the research under the
protocol titled Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study, I have read
and understand the provisions of Title 32 Code of Federal Regulations Part 219 (Protection of Human
Subjects), Department of Defense (DoD) Instruction 3216.02 (Protection of Human Subjects in
DoD-Supported Research), DoD Instruction 6025.18-R (Privacy Rule), SECNAV Instruction 3900.39D
(Human Research Protection Program), OPNAV Instruction 5300.8C (Personnel Surveys),
NAVHLTHRSCHCEN Instruction 3900.2F (Protection of Human Subjects), NAVHLTHRSCHCEN
Notice 6500 (Protection of Health Information in Research), Title 21 Code of Federal Regulations Parts
50, 56 if applicable (clinical investigations regulated by the FDA), and all relevant local instructions. I
have disclosed all potential and actual conflict of interest(s) related to the design, conduct, analysis, or
reporting of this research. I will abide by all applicable laws and regulations, and I agree that in all cases,
the most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during the
conduct of this Navy-sponsored project, I have ready access to each of these regulations, as either my
personal copy or available on file from the Chairperson of the Institutional Review Board. I understand
that my immediate resource for clarification of any issues related to the protection of research volunteers
is the Chairperson of the Institutional Review Board.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
Christopher O’Malley, MPH
Key Personnel
______/______/______
_________________________________________________
Cynthia LeardMann, MPH
Co-Investigator
______/______/______
_________________________________________________
Teresa Powell, MS
Key Personnel
______/______/______
_________________________________________________
Beverly Sheppard
Key Personnel
______/______/______
_________________________________________________
Gia Gumbs, MPH
Key Personnel
______/______/______
_________________________________________________
Jennifer Walstrom
Key Personnel
______/______/______
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INVESTIGATOR COMPLIANCE ATTESTATION
As a researcher or team member responsible for performing and monitoring the research under the
protocol titled Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study, I have read
and understand the provisions of Title 32 Code of Federal Regulations Part 219 (Protection of Human
Subjects), Department of Defense (DoD) Instruction 3216.02 (Protection of Human Subjects in
DoD-Supported Research), DoD Instruction 6025.18-R (Privacy Rule), SECNAV Instruction 3900.39D
(Human Research Protection Program), OPNAV Instruction 5300.8C (Personnel Surveys),
NAVHLTHRSCHCEN Instruction 3900.2F (Protection of Human Subjects), NAVHLTHRSCHCEN
Notice 6500 (Protection of Health Information in Research), Title 21 Code of Federal Regulations Parts
50, 56 if applicable (clinical investigations regulated by the FDA), and all relevant local instructions. I
have disclosed all potential and actual conflict of interest(s) related to the design, conduct, analysis, or
reporting of this research. I will abide by all applicable laws and regulations, and I agree that in all cases,
the most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during the
conduct of this Navy-sponsored project, I have ready access to each of these regulations, as either my
personal copy or available on file from the Chairperson of the Institutional Review Board. I understand
that my immediate resource for clarification of any issues related to the protection of research volunteers
is the Chairperson of the Institutional Review Board.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
Evelyn Sun
Key Personnel
______/______/______
_________________________________________________
Danielle Mitchell
Key Personnel
______/______/______
_________________________________________________
Dennis Hernando
Key Personnel
______/______/______
_________________________________________________
Anet Petroysan
Key Personnel
______/______/______
_________________________________________________
Anna Bukowinski
Key Personnel
______/______/______
_________________________________________________
Andrew Lin
Key Personnel
______/______/______
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INVESTIGATOR COMPLIANCE ATTESTATION
As a researcher or team member responsible for performing and monitoring the research under the
protocol titled Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study, I have read
and understand the provisions of Title 32 Code of Federal Regulations Part 219 (Protection of Human
Subjects), Department of Defense (DoD) Instruction 3216.02 (Protection of Human Subjects in
DoD-Supported Research), DoD Instruction 6025.18-R (Privacy Rule), SECNAV Instruction 3900.39D
(Human Research Protection Program), OPNAV Instruction 5300.8C (Personnel Surveys),
NAVHLTHRSCHCEN Instruction 3900.2F (Protection of Human Subjects), NAVHLTHRSCHCEN
Notice 6500 (Protection of Health Information in Research), Title 21 Code of Federal Regulations Parts
50, 56 if applicable (clinical investigations regulated by the FDA), and all relevant local instructions. I
have disclosed all potential and actual conflict of interest(s) related to the design, conduct, analysis, or
reporting of this research. I will abide by all applicable laws and regulations, and I agree that in all cases,
the most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during the
conduct of this Navy-sponsored project, I have ready access to each of these regulations, as either my
personal copy or available on file from the Chairperson of the Institutional Review Board. I understand
that my immediate resource for clarification of any issues related to the protection of research volunteers
is the Chairperson of the Institutional Review Board.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
William Lee
Key Personnel
______/______/______
_________________________________________________
Steven Speigle
Key Personnel
______/______/______
_________________________________________________
Serguey Parkhomovsky
Key Personnel
______/______/______
_________________________________________________
Gordon Lynch
Key Personnel
______/______/______
_________________________________________________
Kari Sausedo, MA
Key Personnel
______/______/______
_________________________________________________
Denise Lovec-Jenkins
Key Personnel
______/______/______
Version Date: 20 FEBRUARY 2018
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Stander, The Family Study, Protocol # NHRC.2015.0019
INVESTIGATOR COMPLIANCE ATTESTATION
As a researcher or team member responsible for performing and monitoring the research under the
protocol titled Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study, I have read
and understand the provisions of Title 32 Code of Federal Regulations Part 219 (Protection of Human
Subjects), Department of Defense (DoD) Instruction 3216.02 (Protection of Human Subjects in
DoD-Supported Research), DoD Instruction 6025.18-R (Privacy Rule), SECNAV Instruction 3900.39D
(Human Research Protection Program), OPNAV Instruction 5300.8C (Personnel Surveys),
NAVHLTHRSCHCEN Instruction 3900.2F (Protection of Human Subjects), NAVHLTHRSCHCEN
Notice 6500 (Protection of Health Information in Research), Title 21 Code of Federal Regulations Parts
50, 56 if applicable (clinical investigations regulated by the FDA), and all relevant local instructions. I
have disclosed all potential and actual conflict of interest(s) related to the design, conduct, analysis, or
reporting of this research. I will abide by all applicable laws and regulations, and I agree that in all cases,
the most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during the
conduct of this Navy-sponsored project, I have ready access to each of these regulations, as either my
personal copy or available on file from the Chairperson of the Institutional Review Board. I understand
that my immediate resource for clarification of any issues related to the protection of research volunteers
is the Chairperson of the Institutional Review Board.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
Laura Tobin
Key Personnel
______/______/______
_________________________________________________
Madeline Cross
Key Personnel
______/______/______
_________________________________________________
Kathleen Gunn
Key Personnel
______/______/______
_________________________________________________
Kristin Motylinski
Key Personnel
______/______/______
_________________________________________________
Anna Nagel
Key Personnel
______/______/______
Version Date: 20 FEBRUARY 2018
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Stander, The Family Study, Protocol # NHRC.2015.0019
INVESTIGATOR COMPLIANCE ATTESTATION
As a researcher or team member responsible for performing and monitoring the research under the
protocol titled “Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study”, I have
read and understand the provisions of Title 32 Code of Federal Regulations Part 219 (Protection of
Human Subjects), Department of Defense (DoD) Directive 3216.02 (Protection of Human Subjects in
DoD-Supported Research), DoD Instruction 6025.18-R (Privacy Rule), SECNAV Instruction 3900.39D
(Human Research Protection Program), OPNAV Instruction 5300.8C (Personnel Surveys),
NAVHLTHRSCHCEN Instruction 3900.2F (Protection of Human Subjects), NAVHLTHRSCHCEN
Notice 6500 (Protection of Health Information in Research), Title 21 Code of Federal Regulations Parts
50, 56 if applicable (clinical investigations regulated by the FDA), and all relevant local instructions. I
have disclosed all potential and actual conflict of interest(s) related to the design, conduct, analysis, or
reporting of this research. I will abide by all applicable laws and regulations, and I agree that in all cases,
the most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during the
conduct of this Navy-sponsored project, I have ready access to each of these regulations, as either my
personal copy or available on file from the Chairperson of the Institutional Review Board. I understand
that my immediate resource for clarification of any issues related to the protection of research volunteers
is the Chairperson of the Institutional Review Board.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
Valerie Stander, PhD
Principal Investigator
Naval Health Research Center, San Diego, CA
______/______/______
_________________________________________________
Toni Geronimo
Key Personnel
______/______/______
_________________________________________________
Richard Armenta
Key Personnel
______/______/______
_________________________________________________
Kristen Walters
Key Personnel
______/______/______
Version Date: 20 FEBRUARY 2018
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Stander, The Family Study, Protocol # NHRC.2015.0019
INVESTIGATOR COMPLIANCE ATTESTATION
As a researcher or team member responsible for performing and monitoring the research under the
protocol titled “Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study”, I have
read and understand the provisions of Title 32 Code of Federal Regulations Part 219 (Protection of
Human Subjects), Department of Defense (DoD) Directive 3216.02 (Protection of Human Subjects in
DoD-Supported Research), DoD Instruction 6025.18-R (Privacy Rule), SECNAV Instruction 3900.39D
(Human Research Protection Program), OPNAV Instruction 5300.8C (Personnel Surveys),
NAVHLTHRSCHCEN Instruction 3900.2F (Protection of Human Subjects), NAVHLTHRSCHCEN
Notice 6500 (Protection of Health Information in Research), Title 21 Code of Federal Regulations Parts
50, 56 if applicable (clinical investigations regulated by the FDA), and all relevant local instructions. I
have disclosed all potential and actual conflict of interest(s) related to the design, conduct, analysis, or
reporting of this research. I will abide by all applicable laws and regulations, and I agree that in all cases,
the most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during the
conduct of this Navy-sponsored project, I have ready access to each of these regulations, as either my
personal copy or available on file from the Chairperson of the Institutional Review Board. I understand
that my immediate resource for clarification of any issues related to the protection of research volunteers
is the Chairperson of the Institutional Review Board.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
Valerie Stander, PhD
Principal Investigator
Naval Health Research Center, San Diego, CA
______/______/______
_________________________________________________
Jacqueline Pflieger
Key Personnel
______/______/______
Version Date: 20 FEBRUARY 2018
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Stander, The Family Study, Protocol # NHRC.2015.0019
INVESTIGATOR COMPLIANCE ATTESTATION
As a researcher or team member responsible for performing and monitoring the research under the
protocol titled “Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study”, I have
read and understand the provisions of Title 32 Code of Federal Regulations Part 219 (Protection of
Human Subjects), Department of Defense (DoD) Directive 3216.02 (Protection of Human Subjects in
DoD-Supported Research), DoD Instruction 6025.18-R (Privacy Rule), SECNAV Instruction 3900.39D
(Human Research Protection Program), OPNAV Instruction 5300.8C (Personnel Surveys),
NAVHLTHRSCHCEN Instruction 3900.2F (Protection of Human Subjects), NAVHLTHRSCHCEN
Notice 6500 (Protection of Health Information in Research), Title 21 Code of Federal Regulations Parts
50, 56 if applicable (clinical investigations regulated by the FDA), and all relevant local instructions. I
have disclosed all potential and actual conflict of interest(s) related to the design, conduct, analysis, or
reporting of this research. I will abide by all applicable laws and regulations, and I agree that in all cases,
the most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during the
conduct of this Navy-sponsored project, I have ready access to each of these regulations, as either my
personal copy or available on file from the Chairperson of the Institutional Review Board. I understand
that my immediate resource for clarification of any issues related to the protection of research volunteers
is the Chairperson of the Institutional Review Board.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
Valerie Stander, PhD
Principal Investigator
Naval Health Research Center, San Diego, CA
______/______/______
_________________________________________________
Claire Kolaja, MPH
Key Personnel, Henry M. Jackson Foundation
______/______/______
_________________________________________________
Kyna Long
Key Personnel, Henry M. Jackson Foundation
______/______/______
Version Date: 20 FEBRUARY 2018
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Stander, The Family Study, Protocol # NHRC.2015.0019
INVESTIGATOR COMPLIANCE ATTESTATION
As a researcher or team member responsible for performing and monitoring the research under the
protocol titled “Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study”, I have
read and understand the provisions of Title 32 Code of Federal Regulations Part 219 (Protection of
Human Subjects), Department of Defense (DoD) Directive 3216.02 (Protection of Human Subjects in
DoD-Supported Research), DoD Instruction 6025.18-R (Privacy Rule), SECNAV Instruction 3900.39D
(Human Research Protection Program), OPNAV Instruction 5300.8C (Personnel Surveys),
NAVHLTHRSCHCEN Instruction 3900.2F (Protection of Human Subjects), NAVHLTHRSCHCEN
Notice 6500 (Protection of Health Information in Research), Title 21 Code of Federal Regulations Parts
50, 56 if applicable (clinical investigations regulated by the FDA), and all relevant local instructions. I
have disclosed all potential and actual conflict of interest(s) related to the design, conduct, analysis, or
reporting of this research. I will abide by all applicable laws and regulations, and I agree that in all cases,
the most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during the
conduct of this Navy-sponsored project, I have ready access to each of these regulations, as either my
personal copy or available on file from the Chairperson of the Institutional Review Board. I understand
that my immediate resource for clarification of any issues related to the protection of research volunteers
is the Chairperson of the Institutional Review Board.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
Valerie Stander, PhD
Principal Investigator
Naval Health Research Center, San Diego, CA
______/______/______
_________________________________________________
Carlos Carballo, MS
Key Personnel, Henry M. Jackson Foundation
______/______/______
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Stander, The Family Study, Protocol # NHRC.2015.0019
INVESTIGATOR COMPLIANCE ATTESTATION
As a researcher or team member responsible for performing and monitoring the research under the
protocol titled “Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study”, I have
read and understand the provisions of Title 32 Code of Federal Regulations Part 219 (Protection of
Human Subjects), Department of Defense (DoD) Instruction 3216.02 (Protection of Human Subjects in
DoD-Supported Research), DoD Instruction 6025.18-R (Privacy Rule), SECNAV Instruction 3900.39D
(Human Research Protection Program), OPNAV Instruction 5300.8C (Personnel Surveys),
NAVHLTHRSCHCEN Instruction 3900.2G (Protection of Human Subjects), NAVHLTHRSCHCEN
Notice 6500 (Protection of Health Information in Research), Title 21 Code of Federal Regulations Parts
50, 56 if applicable (clinical investigations regulated by the FDA), and all relevant local instructions. I
have disclosed all potential and actual conflict of interest(s) related to the design, conduct, analysis, or
reporting of this research. I will abide by all applicable laws and regulations, and I agree that in all cases,
the most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during the
conduct of this Navy-sponsored project, I have ready access to each of these regulations, as either my
personal copy or available on file from the Chairperson of the Institutional Review Board. I understand
that my immediate resource for clarification of any issues related to the protection of research volunteers
is the Chairperson of the Institutional Review Board.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
Valerie Stander, PhD
Principal Investigator
Naval Health Research Center, San Diego, CA
______/______/______
_________________________________________________
Satbir Boparai, MBA
Key Personnel, Henry M. Jackson Foundation
______/______/______
Version Date: 20 FEBRUARY 2018
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Stander, The Family Study, Protocol # NHRC.2015.0019
INVESTIGATOR COMPLIANCE ATTESTATION
As a researcher or team member responsible for performing and monitoring the research under the
protocol titled “Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study”, I have
read and understand the provisions of Title 32 Code of Federal Regulations Part 219 (Protection of
Human Subjects), Department of Defense (DoD) Instruction 3216.02 (Protection of Human Subjects in
DoD-Supported Research), DoD Instruction 6025.18-R (Privacy Rule), SECNAV Instruction 3900.39D
(Human Research Protection Program), OPNAV Instruction 5300.8C (Personnel Surveys),
NAVHLTHRSCHCEN Instruction 3900.2G (Protection of Human Subjects), NAVHLTHRSCHCEN
Notice 6500 (Protection of Health Information in Research), Title 21 Code of Federal Regulations Parts
50, 56 if applicable (clinical investigations regulated by the FDA), and all relevant local instructions. I
have disclosed all potential and actual conflict of interest(s) related to the design, conduct, analysis, or
reporting of this research. I will abide by all applicable laws and regulations, and I agree that in all cases,
the most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during the
conduct of this Navy-sponsored project, I have ready access to each of these regulations, as either my
personal copy or available on file from the Chairperson of the Institutional Review Board. I understand
that my immediate resource for clarification of any issues related to the protection of research volunteers
is the Chairperson of the Institutional Review Board.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
Valerie Stander, PhD
Principal Investigator
Naval Health Research Center, San Diego, CA
______/______/______
_________________________________________________
Kelly Woodall, MPH
Key Personnel, Henry M. Jackson Foundation
______/______/______
Version Date: 20 FEBRUARY 2018
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Stander, The Family Study, Protocol # NHRC.2015.0019
INVESTIGATOR COMPLIANCE ATTESTATION
As a researcher or team member responsible for performing and monitoring the research under the
protocol titled “Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study”, I have
read and understand the provisions of Title 32 Code of Federal Regulations Part 219 (Protection of
Human Subjects), Department of Defense (DoD) Instruction 3216.02 (Protection of Human Subjects in
DoD-Supported Research), DoD Instruction 6025.18-R (Privacy Rule), SECNAV Instruction 3900.39D
(Human Research Protection Program), OPNAV Instruction 5300.8C (Personnel Surveys),
NAVHLTHRSCHCEN Instruction 3900.2G (Protection of Human Subjects), NAVHLTHRSCHCEN
Notice 6500 (Protection of Health Information in Research), Title 21 Code of Federal Regulations Parts
50, 56 if applicable (clinical investigations regulated by the FDA), and all relevant local instructions. I
have disclosed all potential and actual conflict of interest(s) related to the design, conduct, analysis, or
reporting of this research. I will abide by all applicable laws and regulations, and I agree that in all cases,
the most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during the
conduct of this Navy-sponsored project, I have ready access to each of these regulations, as either my
personal copy or available on file from the Chairperson of the Institutional Review Board. I understand
that my immediate resource for clarification of any issues related to the protection of research volunteers
is the Chairperson of the Institutional Review Board.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
Valerie Stander, PhD
Principal Investigator
Naval Health Research Center, San Diego, CA
______/______/______
_________________________________________________
Sabrina Richardson, PhD
Key Personnel, Henry M. Jackson Foundation
______/______/______
Version Date: 20 FEBRUARY 2018
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Stander, The Family Study, Protocol # NHRC.2015.0019
INVESTIGATOR COMPLIANCE ATTESTATION
As a researcher or team member responsible for performing and monitoring the research under the
protocol titled “Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study”, I have
read and understand the provisions of Title 32 Code of Federal Regulations Part 219 (Protection of
Human Subjects), Department of Defense (DoD) Instruction 3216.02 (Protection of Human Subjects in
DoD-Supported Research), DoD Instruction 6025.18-R (Privacy Rule), SECNAV Instruction 3900.39D
(Human Research Protection Program), OPNAV Instruction 5300.8C (Personnel Surveys),
NAVHLTHRSCHCEN Instruction 3900.2G (Protection of Human Subjects), NAVHLTHRSCHCEN
Notice 6500 (Protection of Health Information in Research), Title 21 Code of Federal Regulations Parts
50, 56 if applicable (clinical investigations regulated by the FDA), and all relevant local instructions. I
have disclosed all potential and actual conflict of interest(s) related to the design, conduct, analysis, or
reporting of this research. I will abide by all applicable laws and regulations, and I agree that in all cases,
the most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during the
conduct of this Navy-sponsored project, I have ready access to each of these regulations, as either my
personal copy or available on file from the Chairperson of the Institutional Review Board. I understand
that my immediate resource for clarification of any issues related to the protection of research volunteers
is the Chairperson of the Institutional Review Board.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
Valerie Stander, PhD
Principal Investigator
Naval Health Research Center, San Diego, CA
______/______/______
_________________________________________________
Alejandro Esquivel
Key Personnel, Henry M. Jackson Foundation
______/______/______
Version Date: 20 FEBRUARY 2018
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Stander, The Family Study, Protocol # NHRC.2015.0019
INVESTIGATOR COMPLIANCE ATTESTATION
As a researcher or team member responsible for performing and monitoring the research under the
protocol titled “Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study”, I have
read and understand the provisions of Title 32 Code of Federal Regulations Part 219 (Protection of
Human Subjects), Department of Defense (DoD) Instruction 3216.02 (Protection of Human Subjects in
DoD-Supported Research), DoD Instruction 6025.18-R (Privacy Rule), SECNAV Instruction 3900.39D
(Human Research Protection Program), OPNAV Instruction 5300.8C (Personnel Surveys),
NAVHLTHRSCHCEN Instruction 3900.2G (Protection of Human Subjects), NAVHLTHRSCHCEN
Notice 6500 (Protection of Health Information in Research), Title 21 Code of Federal Regulations Parts
50, 56 if applicable (clinical investigations regulated by the FDA), and all relevant local instructions. I
have disclosed all potential and actual conflict of interest(s) related to the design, conduct, analysis, or
reporting of this research. I will abide by all applicable laws and regulations, and I agree that in all cases,
the most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during the
conduct of this Navy-sponsored project, I have ready access to each of these regulations, as either my
personal copy or available on file from the Chairperson of the Institutional Review Board. I understand
that my immediate resource for clarification of any issues related to the protection of research volunteers
is the Chairperson of the Institutional Review Board.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
Christopher Lo, BS
Key Personnel, Henry M. Jackson Foundation, Inc.
______/______/______
_________________________________________________
Daniel Vaughan, BS
Key Personnel, Henry M. Jackson Foundation, Inc.
______/______/______
Version Date: 20 FEBRUARY 2018
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Stander, The Family Study, Protocol # NHRC.2015.0019
INVESTIGATOR COMPLIANCE ATTESTATION
As a researcher or team member responsible for performing and monitoring the research under the
protocol titled “Millennium Cohort Family Study: A Sub-study of the Millennium Cohort Study”, I have
read and understand the provisions of Title 32 Code of Federal Regulations Part 219 (Protection of
Human Subjects), Department of Defense (DoD) Instruction 3216.02 (Protection of Human Subjects in
DoD-Supported Research), DoD Instruction 6025.18-R (Privacy Rule), SECNAV Instruction 3900.39D
(Human Research Protection Program), OPNAV Instruction 5300.8C (Personnel Surveys),
NAVHLTHRSCHCEN Instruction 3900.2G (Protection of Human Subjects), NAVHLTHRSCHCEN
Notice 6500 (Protection of Health Information in Research), Title 21 Code of Federal Regulations Parts
50, 56 if applicable (clinical investigations regulated by the FDA), and all relevant local instructions. I
have disclosed all potential and actual conflict of interest(s) related to the design, conduct, analysis, or
reporting of this research. I will abide by all applicable laws and regulations, and I agree that in all cases,
the most restrictive regulation related to a given aspect of research involving protection of research
volunteers will be followed. In the event that I have a question regarding my obligations during the
conduct of this Navy-sponsored project, I have ready access to each of these regulations, as either my
personal copy or available on file from the Chairperson of the Institutional Review Board. I understand
that my immediate resource for clarification of any issues related to the protection of research volunteers
is the Chairperson of the Institutional Review Board.
Signatures and dates:
(DD/MM/YY)
_________________________________________________
Valerie Stander, PhD
Principal Investigator
Naval Health Research Center, San Diego, CA
______/______/______
_________________________________________________
Alexis Takata, BS
Naval Health Research Center
Henry M. Jackson Foundation, Inc.
______/______/______
_________________________________________________
Deanne Millard, BS
Naval Health Research Center
Henry M. Jackson Foundation, Inc.
______/______/______
_________________________________________________
Felicia Carey, PhD
Naval Health Research Center
______/______/______
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Stander, The Family Study, Protocol # NHRC.2015.0019
Henry M. Jackson Foundation, Inc.C. REFERENCES
1. Dillman DA. Mail and telephone surveys : the total design method. New York: Wiley, 1978:xvi, 325.
2. Willett WC, Colditz GA. Approaches for conducting large cohort studies. Epidemiol Rev 1998;
20:91-9.
3. Mueller, J. Research on-line: human participants ethics issues. Retrieved September 12, 2000 from
the World Wide Web: http://www.psych.ucalgary.ca/research/ethics/online.html
4. On-line payment systems. A congressional budget office study, Emerging electronic methods for
making retail payments. Retrieved September 13, 2000 from the World Wide Web:
http://minneapolisfed.org/banking/payments/cbo3.html
5. Azar, B. Online experiments: ethically fair or foul? Monitor on psychology 2000; 31: retrieved
September 12, 2000 from the World Wide Web: http://www.apa.org/monitor/apr00/fairorfoul.html
6. Frankel, F, Siang, S. Ethical and legal aspects of human subjects research on the internet; a report of
a workshop June 10-11, 1999, Washington, DC. American Association for the Advancement of
Science. Retrieved September 12, 2000 from the World Wide Web:
http://www.aaas.org/spp/dspp/sfrl/projects/intres/main.htm
7.
United States General Accounting Office. Operation Desert Storm: Potential for Reproductive
Dysfuction Is Not Being Adequately Monitored. Washington, DC: United States General
Accounting Office, 1994.
8.
United States General Accounting Office. Operation Desert Storm: Questions on Possible Exposure
to Reproductive Toxicants. : GAO; 1994. Washington, DC: US General Accounting Office, 1994.
9.
United States General Accounting Office. Operation Desert Storm: Health Concerns of Selected
Indiana Persian Gulf War Veterans. Washington, DC: United States General Accounting Office,
1995.
10.
United States General Accounting Office. Foreign Assistance: Contributions to Child Survival Are
Significant, But Challenges Remain. Washington, DC: US General Accounting Office, 1996.
11.
United States General Accounting Office. Defense Health Care: Medical Surveillance Improved
Since Gulf War, But Mixed Results in Bosnia. Washington, DC: United States General Accounting
Office, 1997.
12.
United States General Accounting Office. Gulf War Illnesses: Improved Monitoring of Clinical
Progress and Reexamination of Research Emphasis Are Needed. Washington, DC: United States
General Accounting Office, 1997.
13.
United States General Accounting Office. Operation Desert Storm: Evaluation of the Air
Campaign. Washington, DC: United States General Accounting Office, 1997.
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D. SUPPLEMENTAL DOCUMENTS
1. Other Documentation (as required)
a. For Research involving Children—Parental Permission and Child Assent
b. Recruitment materials (advertisements/flyers, email solicitations, telephone screen,
scripts, recruitment briefing scripts and/or Power Point presentations).
c. Instruments, Data Collection Forms and Case Report Forms—including surveys,
questionnaires, subject diaries, subject correspondence (letters, emails, postcards,
etc.)
d. Product package or Label Sample
e. For FDA-Regulated Studies and/or studies using drugs, biologics or devices
i. For Investigational Drug, Biologics and Devices:
1. FDA Letter for Investigational New Drug application (IND) or
Investigational Device Exemption (IDE) application
2. FDA Form 1571 and FDA Form 1572
3. Investigator Brochure
ii. For Approved Drug, Biologics and Devices:
1. FDA letter of approved IND or IDE
2. Package Insert or User’s Manual
f.
Survey/OPNAV Approval (if required for questionnaire survey)
[Usually obtained after IRB approval].
g. Foreign Country Host Government Approval (if research is performed abroad) and
foreign language translations of consent and survey instruments)
2. Collaborative Studies (as required)
a. Collaborating Institution’s Federalwide Assurance or DoD Assurance and/or DON
Assurance Addendum
b. Institutional Agreement for IRB Review (IAIR)
c. Institution and Investigator Roles and Responsibilities (IIRR) form
d. Documentation of review and action taken by all collaborating institution(s)
i. Acceptable results of review are: approval, exemption from review, joint
review, or other formal review agreement
ii. Certification by the principal investigator that protocol submitted for review is
the same final copy approved or under simultaneous review by collaborating
institution(s)
3. Minutes of the Meeting of the IRB (to be added by IRB)
4. Command Recruitment Endorsements (to be obtained post-IRB approval)
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Stander, The Family Study, Protocol # NHRC.2015.0019
E. SUPPLEMENTAL DOCUMENTS—ABT COLLABORATION PROTOCOL
Signed_FamilyCollab
orationProtocol_2014
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F. SUPPLEMENTAL DOCUMENTS—ABT DATA USE AGREEMENT
NMR-4171 BUMED
APPROVED DUA btw N
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Stander, The Family Study, Protocol # NHRC.2015.0019
G. SUPPLEMENTAL DOCUMENTS—FAMILY MAILINGS
Results of the 2015 Nonresponder Family Study Phone Call Pilot Test
The pilot test phone calls submitted in a previous IRB modification, which was approved
on March 5, 2015 were conducted Tuesday, March 10 2015 through Friday, March 13 2015. We
attempted to contact a total of 38 Millennium Cohort Family Study participants who had yet to
complete their follow-up survey by calling phone numbers provided by the participant on their
baseline survey as a means to remain in contact. All participants were called between the hours
of 8am and 7pm within their respective time zones. No participant received more than three
phone calls, and no phone messages were left for any participant. A copy of the call log has
been included in this submission for reference.
We attempted to call 13 participants lacking a correct mailing address and a correct email
address. Of this group, 3 participants (23.1%) provided updated contact information, 6
participants (46.2%) were unable to be reached, 3 phone numbers (23.1%) were found to be
incorrect or no longer in service, and 1 participant (7.6%) asked to be removed from this wave of
contacts, but would like to contacted again for future follow-ups.
We attempted to call 11 participants lacking a correct mailing address. Of this group, 4
participants (36.4%) provided updated contact information, 4 participants (36.4%) were unable
to be reached, 1 phone number (9.1%) was found to be incorrect or no longer in service, and 2
participants (18.1%) asked to be removed from the study.
We attempted to call 14 participants lacking a correct email address. Within this group, 2
participants (14.3%)provided updated contact information, 6 participants (42.9%) were unable to
be reached, 5 phone numbers (35.7%) were found to be incorrect or no longer in service, and 1
participant (7.1%) was removed from this wave of contacts since they are currently incarcerated
and unable to complete the survey.
In summary, 9 participants (23.7%) provided updated contact information, 16 participants
(42.1%) were called, but we only reached their voicemails, 9 (23.7%) of the dialed phone
numbers were no longer current phone numbers for the intended participant, 2 participants
(5.3%) asked to be removed from this wave of contacts, and 2 participants (5.3%) asked to be
removed from the study.
Overall, findings from this pilot test resulted in the retrieval of updated contact
information and positive feedback from the majority of reached participants. Due to these
results, we would like to request to call the remaining 860 Family Study participants who have
not completed a follow-up survey and provided a phone number on their baseline survey as a
means to remain in contact. Subjects will be contacted via telephone Monday through Friday
between the hours of 8am and 7pm within their time zone. A maximum of three phone call
attempts will be made per subject and a log of every attempt will be kept. If a specific
participant is not able to be reached, a message will be left for the participant on the third call
attempt.
Calls will be made by a third-party company hired for the sole purpose of this phone call
outreach task. The company hired will sign a confidentiality agreement, and will return all data
and call logs upon completion of the calls. All callers will be provided the below script, and
trained by the Millennium Cohort Family Study Coordinator prior to contacting any participants.
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2015 Nonresponder Family Study Phone Call Script
Phase II 2015: Contact by Phone
Subjects will be contacted via telephone between the hours of 8am and 7pm within their
respective time zones. A maximum of three phone call attempts will be made per participant and
a log of each attempt will be maintained. A message will be left on the participant’s voicemail if
a person cannot be reached by the third phone call attempt. For participants contacted during the
pilot study we request to attempt one more call in order to leave them a message this time if they
do not answer the phone. In total, we will attempt to contact a total of N = 860 participants who
provided phone numbers to the study team at baseline.
Script
Hello, my name is (insert name) and I’m calling on behalf of the Department of Defense Family
Study. Am I speaking with (participant name)?
[When participant is clearly not the one answering]
My name is (insert name) and I’m calling on behalf of the Department of Defense Family Study.
May I speak with (insert participant name).
[If not available] Is there a better time for me to call to reach (insert name)?
[When number is incorrect]
I apologize for the inconvenience. Have a nice day. [Mark the number as a wrong phone number
in the call log]
[When speaking to the correct participant]
A few years ago you and your spouse participated in a very important and unique Department of
Defense study designed to follow military families over time in an effort to understand the
impact of military life on the health and well-being of spouses, service members, and children.
We have been trying to reach you over the last several months to ask for your continued
participation in the Millennium Cohort Family Study survey, and to provide you with a small
token of our appreciation.
In the last several months have you received emails from the Family Study team?
[If Yes or No]
We have also sent Postal mailings that have included a lunch bag, a sample survey, and a $5 gift
card. Have you received these mailings?
[If Participant has received both Emails and Postal mailings]
Great! We are glad you are receiving information about the study.
Do you currently plan on completing your online follow-up survey?
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[If Yes] That’s wonderful to hear. Your continued participation makes it
possible to provide evidence-based policy recommendations to military and
civilian leaders and to guide interventions that have the potential to make life
better for military families. An email will arrive in a few days that includes a
link to the survey to make completing the survey easier. Thank you for
participation. Have a nice day!
[If No/Not sure] Did you know that the Family Study is unique from other
surveys you may be asked to complete? It is the only study that follows
military families from all branches of the military, including Reserve and
National Guard, over time. Even if your marital status has changed or if
your spouse has separated from the military, your participation is still
vital! This year’s survey has been modified to make the questions as relevant
as possible to our 10,000 members. In addition, we tailor every survey to the
unique circumstances of the person completing it, so we don’t waste your time
with questions that don’t apply to you.
•
Would you like to speak to a member of the Family Study research
team to find out more about the study?
♦ [If Yes] Please let me know the best time to call and I will have a
member of the research team call you at this number. (Record
suggested time and a phone number to call if different.)
Thank you. A team member will call you in a few days. We
appreciate your interest in the Family Study and your
participation. Have a nice day.
♦ [If No] Would you like the website address? It provides contact
information, study background, a link to the survey, and other
useful information.
[If Yes] www.familycohort.org
We hope you choose to complete the follow-up survey.
From the website you can easily select the Start Survey
button to complete your survey. We will also send you an
email in a few days with a link to the survey to make
completing it easier. Thank you for your time, have a nice
day.
[If No] Would you like to be removed from this wave of the
study, and touch base again during the next follow-up?
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[If Yes] We respect your decision. You will be removed
from future contacts for this follow-up period. . Have a nice
day.
[If No] We hope you choose to complete your online
follow-up survey. Thank you for your time, have a nice
day.
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[If Participant has not received one or both methods of contact]
We want to make sure that our gifts of appreciation are making it to your door. Would you like
to update your contact information, so we can make sure that you receive your invitation to take
the survey and study gifts?
[If Yes] Great! Thank you for providing the study team with updated contact
information. If your contact information changes in the future, you can securely and
simply update it via the study website. Go to www.familycohort.org and select
“Update Contact Information.” We will be sending you an email in a few days that
includes a link to the survey to make completing the survey easier. Your continued
participation makes it possible to provide evidence-based policy recommendations to
military and civilian leaders and to guide interventions that have the potential to make
life better for military families. Thank you for your participation in the Family Study.
Have a nice day!
[If No] Your email and home address information make it possible for us to send you
study updates and gifts of appreciation. The survey is only once every three years and
is the Department of Defense’s only military family study that follows families over
time, and includes families from all branches of the military, including Reserve and
National Guard. Even if your marital status has changed or if your spouse has
separated from the military, your participation is still vital! This year’s survey
has been modified to make the questions as relevant as possible to our 10,000
members. In addition, we tailor every survey to the unique circumstances of the
person completing it, so we don’t waste your time with questions that don’t apply to
you.
• Would you like to speak to a member of the Family Study research
team to find out more about the study?
♦ [If Yes] Please let me know the best time to call and I will have a
member of the research team call you at this number. (Record
suggested time and a phone number to call if different.)
Thank you. A team member will call you in a few days. We
appreciate your interest in the Family Study and your
participation. Have a nice day.
♦ [If No] Would you like the website address so you can update
your contact information simply and securely?
[If Yes] Just go to www.familycohort.org and select “Update
Contact Information.” We hope you choose to complete the
follow-up survey. From the website you can easily select the
“Start Survey” button to complete your survey. We will also
send you an email in a few days with a link to the survey to
make completing it easier.
[If No] Would you like us to stop contacting you?
[If Yes] We respect your decision. You will be removed
from all future contacts. Thank you for your past
participation. Have a nice day.
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[If No] We hope you choose to complete your online
follow-up survey. Thank you for your time, have a nice
day.
[When leaving a message]
Hello, my name is (insert name) and I’m calling (insert name) on behalf of the Department of
Defense Family Study. We want to let you know that we have been trying to contact you via
postal mail and email over the last few months. A few years ago you and your spouse
participated in a very important and unique Department of Defense study designed to follow
military families over time called the Millennium Cohort Family Study. The Family Study is part
of a strategic plan to understand the impact of military life on the health and well-being of
spouses, service members, and children. We hope you have heard from us and received your
gifts of appreciation. We have sent you a lunch bag, a sample survey, and a $5 gift card, in
addition to post cards, and study updates with the hope that you will complete your online
follow-up survey. The information you provide is completely confidential and provides the
Department of Defense with vital information about military families. You are one of only
10,000 people chosen to represent military families from all branches of service, including the
Reserve and National Guard. Your feedback allows us to provide military and civilian leaders
with evidence-based policy recommendations and helps guide the development of interventions
that have the potential to improve the lives of military families. We hope you choose to complete
this year’s survey by visiting our study website www.familycohort.org. We will send you an
email in the next few days with a link to the survey to make completing it easier. Thank you for
your past participation and for your service as a military spouse.
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Phone Call Follow-Up Email
This email will be sent to all participants who were included in the call outreach and received a
phone call or voice message during the two previous weeks (n=860)
Subject line: Following Up
Dear NAME,
Over the last two weeks, we have had the privilege to speak to several hundred of our valued
Family Study participants. We appreciated the opportunity to personally emphasize how your
input and participation in the Family Study will make a difference in the lives of military
families. Please consider sharing your unique perspective by completing your follow-up survey
today.
To login to your survey, please visit www.familycohort.org, click Start Survey and enter your
Subject ID: XXXXXXX.
Thank you for your dedication to our Service members and their families.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval
# 0720-0029, and Primary Institutional Review Board Protocol # NHRC.2000.0007.
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April Reminder Email
This email will be sent to all partial survey completers who were not included in the phone call
outreach method
Subject line: Don’t forget to complete your survey
Dear NAME,
Thank you for the time you have already dedicated to start your follow-up Family Study survey.
As a valued member of this important Department of Defense study, your participation is critical
to better understand the strengths and needs of military families. In order to ensure your input is
included in future study results, please log back in to complete the remaining questions on your
survey.
To login to your survey, please visit www.familycohort.org, click Start Survey and enter your
Subject ID: XXXXXXX.
Thank you for your dedication to our Service members and their families.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval
# 0720-0029, and Primary Institutional Review Board Protocol # NHRC.2000.0007.
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April Non-Responder Email
This email will be sent to all Non-responders who were not included in the call outreach method
Subject line: Make an Impact on Military Family Health
Dear NAME,
As a member of the Millennium Cohort Family Study, you are part of a select group of
individuals with the unique opportunity to make a lasting impact in the lives of millions of
military spouses and children.
Your participation in the initial 2011-2013 survey helped to create a preliminary understanding
of the challenges and opportunities uniquely associated with military life, but there is still so
much to learn. Help us build a better understanding of military families by completing your
follow-up survey today.
To complete your survey, please visit the study website www.familycohort.org, click Start
Survey and enter your Subject ID: XXXXXXX.
Thank you for helping us fill in the gaps.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval
# 0720-0029, and Primary Institutional Review Board Protocol # NHRC.2000.0007.
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May Pre-Incentive Mailing– Card Text
This card will be sent to all Non-responders and Partial completers. Mailing will include a 5X7
Family Study note card, a $2 bill and will be sent via FedEx or a special envelope/box.
Paragraph for the bold comment on the top half of the card:
As a member of the Family Study, you are sending a strong message that you care about
the health and well-being of Service members and families, and that you are committed to
scientific research efforts dedicated to this mission!
Card Body:
Dear Name,
We want to take this opportunity to thank you for your past participation in the
Millennium Cohort Family Study and for your support of military family research! Please accept
this token of our appreciation.
The Family Study team is comprised of active duty Service members, military spouses,
and civilian scientists committed to understanding the impact of military life on Service
members and their families. Your dedication to the Family Study makes it possible to provide
evidence-based policy recommendations to military and civilian leaders, and to develop
interventions informed by your survey responses.
Even if your marital status has changed or if your spouse has separated from the military,
your participation is still vital! This year’s survey has been modified to make the questions as
relevant as possible to our 10,000 members. In addition, we tailor every survey to the unique
circumstances of the person completing it, so we don’t waste your time with questions that don’t
apply to you.
We hope you decide to complete your Family Study follow-up survey in the near future.
Simply go to WWW.FAMILYCOHORT.ORG and click on START SURVEY, and enter your
Subject ID: XXXXXXX.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval
# 0720-0029, and Primary Institutional Review Board Protocol # NHRC.2000.0007.
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Pre-Incentive Email
This email will be sent to all Non-responders and Partial completers.
Subject Line: Proudly participate in the Family Study
Dear NAME,
We hope you received our card last week with a small token of our appreciation for your
continued involvement as a valued member of the Millennium Cohort Family Study.
By sharing your personal experiences with us, you are helping to shape the future health and
well-being of military couples and families. We hope that you realize how valuable your
continued participation is, and are proud to play a part in such groundbreaking and impactful
research.
Your past participation helped begin the process of identifying the unique characteristics that
define a military family. In order to develop a deeper understanding of the evolving
complexities of military life, we are asking for your continued participation in this important
study.
To complete your survey, please visit the study website www.familycohort.org, click Start
Survey and enter your Subject ID: XXXXXXX.
Thank you for your important contribution to this significant research study.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval
# 0720-0029, and Primary Institutional Review Board Protocol # NHRC.2000.0007.
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Subject: Last Chance to Participate
[NAME],
As we remember the sacrifices made by our Service members and their families, we ask that you consider
representing current and future military spouses by completing your follow-up Family Study survey. The
Millennium Cohort Family Study Team recognizes the importance of your contribution to protecting
America’s freedom, and our goal is to understand the unique effects of military life on the health and
well-being of military families.
Your opportunity to be a part of this important study will be ending very soon, so don’t delay in sharing
your unique thoughts and experiences.
To complete your survey, please visit the following link: www.familycohort.org,
Your Subject ID is: XXXXXXX
Thank you so much for your participation.
Very Respectfully,
Carrie Donoho, PhD
Captain, MS, USA
Spouse of a Veteran and Active Duty Family Study researcher
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol # DDHA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board Protocol #
NHRC.2015.0019.
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Millennium Cohort Family Study Shortened Survey Mailing #2 – Cover Letter
Dear NAME,
During National Military Family Month, the Millennium Cohort Family Study Team would like
to thank you for the many contributions you make every day in support of the military and our
nation. We join the country in celebration of the Military Family and honor the commitment and
sacrifices made by the families of our nation's Service members.
Through your continued involvement, the Family Study will be able to provide vital information
to military leaders and policymakers working to support families like yours. We value your
participation, even if your marital status has changed or your spouse is no longer in the military.
We know your time is valuable, so we have created a shortened paper version of our 2014 online
survey with carefully selected questions. Please consider taking 5 minutes to complete this brief
survey and return it in the postage pre-paid envelope.
Alternatively, if you would prefer to complete the full survey, please visit our study website,
www.familycohort.org, click “Start Survey,” and enter your Subject ID: XXXXXXX.
Thank you for your continued commitment to current, former, and future military families.
Very respectfully,
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval #
0720-0029, and Primary Institutional Review Board Protocol # NHRC.2015.0019.
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July 2016 email
Subject: Have your child’s artwork featured in the Family Study Calendar
Happy 4th of July from the Millennium Cohort Family Study Team! We thank you and your family for
your past, present, and future contributions in preserving our nation’s independence.
We hope you are enjoying your summer and would like to remind you to submit your child’s artwork for
our 2017 calendar. Your child’s drawing could be featured in our 2017 Family Study Calendar and online
gallery!
To review the contest guidelines and submit your child’s artwork, please visit
http://www.familycohort.org/calendar
Very respectfully,
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report
Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and
Primary Institutional Review Board Protocol # NHRC.2015.0019.
October 2016 email
Subject: Last chance to submit your child’s artwork
Have you submitted your child’s artwork for the 2017 Family Study Calendar contest yet? The deadline is
quickly approaching! Submit your child’s drawing by Tuesday, November 1, to be considered for the
2017 Calendar that will be mailed to nearly 10,000 of your fellow Family Study participants!
Simply visit http://www.familycohort.org/calendar for the contest guidelines and online gallery. We can’t
wait to see your child’s masterpiece!
Very respectfully,
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report
Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and
Primary Institutional Review Board Protocol # NHRC.2015.0019.
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Month of the Military Family Postcard – 2017
During National Military Family Month, the Millennium Cohort Family Study Team would like
to thank you for your commitment and support of our military. We honor the dedication, strength
and sacrifices made by the families of our nation’s Service members.
We appreciate your participation in the 2014-2015 Family Study follow-up survey. Your
continued involvement in this important study makes it possible for the Family Study to provide
instrumental information to policymakers and military leaders to make a positive difference for
all military families.
Very respectfully,
Dr. Valerie Stander,
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report Control Symbol #
DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and Primary Institutional Review Board
Protocol # NHRC.2015.0019.
2017 CALENDAR-ARTWORK SOLICITATION
COVER LETTER
Dear NAME,
Happy holidays to you and your family from the Millennium Cohort Family Study team!
As a member of the Family Study, the information you provide makes it possible to understand
the health and well-being of military families over time. Even though our study is currently off
cycle, we would like to extend a token of our appreciation for your continued involvement, and
have enclosed a 2017 Family Study calendar, featuring the artwork made by the children of your
fellow Family Study participants.
Beginning January 1, 2017, once again we will be accepting submissions of artwork created by
the children of study participants throughout the year, and posting as many as possible to our
online art gallery on the Family Study website. At the end of the year, 12 submissions will be
selected to be included in the 2018 calendar. To review the submission guidelines and upload
your child's drawing or painting, please visit www.familycohort.org/calendar.
Thanks again to all of you for being a part of this program of research and part of the
Millennium Cohort Family Study community! We wish you all the best for a happy holiday
season and healthy New Year!
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
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FEBRUARY 2017 EMAIL
Subject: Now accepting submissions for the 2018 calendar
We hope you received the 2017 Family Study calendar last month and are considering submitting
some of your child(ren)’s artwork for the 2018 calendar! Perhaps you have a beautiful winter
mural hanging on your refrigerator or a decorative Valentine’s Day drawing sitting on your
kitchen counter that would make a great addition to the calendar.
To review the contest guidelines and make a submission, please visit
http://www.familycohort.org/calendar. As a reminder, your Subject ID is ######. We are excited
to see your child(ren)’s artistic creations!
Very respectfully,
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval #
0720-0029, and Primary Institutional Review Board Protocol # NHRC.2015.0019.
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JULY 2017 EMAIL
Subject: Have your child’s artwork featured in the Family Study Calendar
Happy 4th of July from the Millennium Cohort Family Study Team! We thank you and your
family for your past, present, and future contributions in preserving our nation’s independence.
We hope you take this opportunity to submit your child(ren)’s artistic depiction of 4th of July
fireworks and summer festivities! Their drawing could be featured in our 2018 Family Study
Calendar and online gallery!
To review the contest guidelines and make a submission, please visit
http://www.familycohort.org/calendar. As a reminder, your Subject ID is ######. We are excited
to see your child(ren)’s artistic creations!
Very respectfully,
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval #
0720-0029, and Primary Institutional Review Board Protocol # NHRC.2015.0019.
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OCTOBER 2017 EMAIL
Subject: Last chance to submit your child’s artwork
Have you submitted your child(ren)’s artwork for the 2018 Family Study Calendar contest yet?
The deadline is quickly approaching! We hope you consider submitting your child(ren)’s fall and
pumpkin-themed drawings by Monday, October 17, to be considered for the 2018 Calendar that
will be mailed to nearly 10,000 of your fellow Family Study participants!
To review the contest guidelines and make a submission, please visit
http://www.familycohort.org/calendar. As a reminder, your Subject ID is ######. We are excited
to see your child(ren)’s artistic creations!
Very respectfully,
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval #
0720-0029, and Primary Institutional Review Board Protocol # NHRC.2015.0019.
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MONTH OF THE MILITARY CHILD POSTCARD TEXT
Dear Name,
During the Month of the Military Child, the Millennium Cohort Family Study Team recognizes
the strength and resilience of all military families. We join the nation in honoring military
children and families for their contributions to our country.
We want to remind you that your children have the opportunity to contribute artwork for the 2018
Family Study calendar, which will be sent to nearly 10,000 households. Please visit
http://www.familycohort.org/calendar for more details and instructions to submit your child’s
artwork!
As a member of the Millennium Cohort Family Study, you are contributing to an effort of
profound importance. Please know that you are making a difference in the lives of current and
future generations of military families by remaining engaged in this important study.
Thank you for your continued participation!
Very respectfully,
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval #
0720-0029, and Primary Institutional Review Board Protocol # NHRC.2015.0019.
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BIRTHDAY CARD TEXT
Dear Name,
On behalf of the Millennium Cohort Family Study team, I would like to wish you a very Happy
Birthday!!!
I would also like to tell you how much I personally appreciate your commitment and
thoughtfulness as a participant in this study. It's an honor for our team to be a small part of your
life and the life of your family.
May this next year bring you great health and happiness!
Very respectfully,
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval #
0720-0029, and Primary Institutional Review Board Protocol # NHRC.2015.0019.
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Month of the Military Family postcard
Postcard text:
During National Military Family Month, the Millennium Cohort Family Study Team honors the
invaluable sacrifices of our military families, past and present. Along with all Americans, we
recognize and thank you and your family for the important role you play in protecting our nation.
Additionally, we value your continued connection with the Family Study during our off-cycle. In
2018, we will launch our next follow-up survey and hope to have your support and participation.
Your involvement in the study makes it possible to inform military leaders and policymakers of
the experiences of military families and to improve measures that impact families like yours.
Very respectfully,
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note
Report Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval #
0720-0029, and Primary Institutional Review Board Protocol# NHRC.2015.0019.
Version Date: 20 FEBRUARY 2018
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Stander, The Family Study, Protocol # NHRC.2015.0019
2018 Calendar Cover Letter
Dear NAME,
Happy holidays to you and your family from the Millennium Cohort Family Study team!
As a member of the Family Study, the information you provide makes it possible to understand the health
and well-being of military families over time. We would like to extend a token of our appreciation for
your continued involvement, and have enclosed a 2018 Family Study calendar, featuring the artwork
made by the children of your fellow Family Study participants.
Beginning January 1, 2018, once again we will be accepting submissions of artwork created by the
children of study participants throughout the year, and posting as many as possible to our online art
gallery on the Family Study website. Submissions will be accepted until October 14, 2018, at which
point 12 submissions will be selected as monthly photos and 1 will be selected as the cover art for the
2019 calendar. To review the submission guidelines and upload your child's drawing or painting, please
visit www.familycohort.org/calendar.
Thanks again for being a part of this program of research and part of the Millennium Cohort Family Study
community! We wish you all the best for a happy holiday season and a healthy New Year!
Dr. Valerie Stander
Principal Investigator of the Millennium Cohort Family Study
The Millennium Cohort Family Study is an authorized Department of Defense project. Note Report
Control Symbol # DD-HA(AR)2106, Office of Management and Budget Approval # 0720-0029, and
Primary Institutional Review Board Protocol # NHRC.2015.0019.
Version Date: 20 FEBRUARY 2018
G-25
Stander, The Family Study, Protocol # NHRC.2015.0019
Family Calendar.pdf
Version Date: 20 FEBRUARY 2018
G-26
| File Type | application/pdf |
| File Modified | 2018-03-23 |
| File Created | 2018-03-22 |