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pdfAttachment 23: Phase IV Health Follow-Up IRB Approval Signature Pages
23.1). AHS Health Follow-Up Office of Protocol Services Continuing
Review Approval under the AHS AutoImmuneII Protocol
23.2). AHS Health Follow-Up Copernicus Group IRB Continuing
Review Approval under the AHS AutoImmuneII Protocol
23.3). AHS Health Follow-Up Office of Protocol Services Amendment
Approval under the AHS AutoImmuneII Protocol
CLINICAL RESEARCH PROTOCOL
CONTINUING REVIEW APPLICATION
PROTOCOL TITLE:
PROTOCOL NO.
PRINCIPAL INVESTIGATOR (NIH Employee Name, Inst/Br, Address, Telephone and email):
11-E-N196
Jane A. Hoppin, ScD, NIEHS/EB, 919-541-7622, P.O. Box 12233, RTP, NC 27709, hoppin1@niehs.nih.gov
Agricultural Health Study: Health Followup
PROTOCOL STATUS:
Renew
-Recruitment of participants has not yet begun.
Renew
-Participants are currently being recruited or enrolled.
X
Renew
-No longer recruiting or enrolling participants, subject follow-up only.
Renew
-Participants have completed study; study and data analyses ongoing.
Renew
-Clinical Hold/Recruitment or enrollment of participants suspended.
Terminate -Study closed. Participants have completed study. Recruitment and
data analysis complete.
IONIZING RADIATION USE (X-rays, e.g., CT; radioisotopes, e.g. PET, etc.) check all
that apply:
X
None
Medically indicated
Research indicated. Since the last review,
Research usage HAS NOT changed.
Research usage HAS changed. (Explain in summary report)
INVESTIGATIONAL NEW DRUG/DEVICE: X
None
IND
*If reporting more than one IND/IDE, list on attached sheet.
SUMMARY OF PROTOCOL ENROLLMENT (Aggregate): Only when the NIH is the
coordinating site, provide totals and enrollment table for other site.
NIH Site
Other Sites
0
FDA No.
Total
Accrual ceiling by IRB
Name:
0
903
903
New subjects accrued since last CR
Sponsor:
0
903
903
Aggregate total accrued
Who is the manufacturer of the above entity?
89656
89656
IDE
Are you currently recruiting healthy volunteers?
No
Will the protocol involve adults unable to give informed consent?
No
X Yes
X Yes
Does the protocol involve a Tech Transfer Agreement?
X
No
Yes
Does the protocol involve a drug/device/product that may lead to you or the NIH
receiving payment and/or royalties?
X
No
Yes (Append a statement of disclosure)
Have analyses by sex, racial/ethnic subgroups been conducted for Phase 3 Clinical
No
Yes (answer a and b) X
N/A
Trials as required?
a. Have analyses been reported?
No (explain in narrative)
Yes
b. Have significant differences been found?
No
Yes
Have there been any amendments since the last review?
No
X
Yes (Describe briefly in the attached narrative.)
Have any non-NIH Investigators or sites been added since the last review?
X No
Yes (Identify the persons or sites and describe the collaboration in the
summary report)
Have there been any changes in the informed consent process or documentation since
the last review?
No
Yes (Describe in Summary report)
X
WITH THIS REVIEW, I AM REQUESTING A CHANGE TO THE FOLLOWING:
*Include Name, Inst/Branch, Telephone, Address, e-mail. Check box if an NIH Employee and initial
line. Attach sheet if necessary.
PRINCIPAL INVESTIGATOR:
Have there been any changes in the subject population, recruitment or selection criteria
since the last review?
No
X
Yes (Explain changes in the attached narrative.)
Delete:
Add*:
EXTRAMURAL ADJUNCT PRINCIPAL INVESTIGATOR:
Have any unexpected complications or side effects been noted since the last review?
X
No
Yes (Identify and explain in the attached narrative.)
Delete:
Add:
MEDICAL ADVISORY INVESTIGATOR:
Have any subjects withdrawn from this study since the last IRB approval?
No
X
Yes (Discuss in the attached narrative.)
Delete:
Add*:
Has any information appeared in the literature, or evolved from this or similar research,
that might affect the IRB’s evaluation of the risk/benefit analysis of human subjects
involved in this protocol?
No
X
Yes (Discuss in the attached narrative.)
LEAD ASSOCIATE INVESTIGATOR:
Delete:
Add*:
RESEARCH CONTACT:
Has the NIH IRP COI Guide been distributed to new NIH investigators?
No
Yes
N/A
X
Delete:
Add*:
Has the NIH IRP COI Guide been distributed to new Non-NIH investigators?
No
Yes
N/A
X
ASSOCIATE INVESTIGATOR(S):
Delete:
CONFLICTS OF INTEREST REVIEW?
Add*:
4/2/12
Date submitted to IC DEC:____________
Date cleared by IC DEC:_____________
SIGNATURE
RECOMMENDATION
Jane A. Hoppin
____________________________________
Principal Investigator
Dale P. Sandler
Jane A. Hoppin, ScD
Dale P. Sandler, Ph.D.
Accountable Investigator
Dale P. Sandler
Frederick W. Miller
Dale P. Sandler, Ph.D.
C.Bonds-Beeken
Date
e-Signed on 4/5/12 12:24 PM
Send to Branch Chief, or CC
Dept. Head of Accountable Investigator
e-Signed on 4/5/12 12:24 PM
Date
Frederick W. Miller, M.D., Ph.D.
Send to Clinical Director
e-Signed on 5/4/12 1:41 PM
Date
Send to Chair, Institutional
Review Board
Print/Type Name
David B. Resnik, J.D., Ph.D.
Chair, For Institutional Review Board
COMPLETION
Send to Accountable Investigator
Print/Type Name
Clinical Director
David B. Resnik
e-Signed on 4/2/12 11:33 AM
Print/Type Name
Br Chief/CC Dept. Head of Acct. Invest
APPROVALS
Date
Print/Type Name
Print/Type Name
Date
5/11/12
Date
e-Signed on 5/7/12 5:17 PM
Protocol & Consent
Approved Effective
Send to Office of Protocol Services,
through IRB Protocol Coordinator
Protocol Specialist
Clinical Research Protocol Continuing Review Application
NIH-1195-1 (9-06) Page 1 of 1
Signature Page
Title
SSS1-11-220_Hoppin_Jane_Approvals_2012-06-06
Summary Hoppin Jane
Signed By:
Reason:
Date/Time:
Ashley Jacobs
Authorized Signature
June 7, 2012 10:33:54 AM EDT
June 7, 2012
Jane Hoppin ScD
National Institute of Environmental Health Sciences (NIEHS)
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Re:
Protocol #: 11-E-N196
IRB Tracking #: SSS1-11-220
Dear Hoppin,
Enclosed please find an Approval Notice dated June 6, 2012 for the above- mentioned protocol.
This is to inform you that the Copernicus Group IRB has approved the above-referenced study for
another year. Please continue to use the latest IRB approved Site-Specific Subject Information and
Consent Form(s). Note that any changes in the study must be communicated to the Copernicus Group
IRB.
If you have any questions regarding the contents of this letter or your working relationship with
Copernicus Group IRB, please do not hesitate to call us at 1-888-303-2224 or email us at
irb@cgirb.com. To avoid delay in locating your records we ask that you refer to the IRB Tracking
number located in the header of this letter. Send faxes for this project to 1-919-654-7197.
Copernicus Group IRB
cc: Elizabeth Long O'Connell, NIEHS (Web Portal)
Copernicus Group IRB
One Triangle Drive Suite 100
Durham, NC 27713
M ailing Address:
P.O. Box 110605
Research Triangle Park, NC 27709
Experience and Innovation in Ethical Review ™
Telephone:
Toll-Free:
Fax:
E-M ail:
Web:
919-465-4310
888-303-2224
919-465-4311
irb@cgirb.com
www.cgirb.com
Confidentiality Notice: This document is for the sole use of the intended recipient(s) and may contain confidential and privileged information.
Any unauthorized review, use, disclosure or distribution is prohibited.
If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.
IRB APPROVAL DATED:
June 6, 2012
STUDY EXPIRATION DATE: June 5, 2013
Protocol #: 11-E-N196
Investigator: Jane Hoppin ScD
Approval Includes:
Re-Approval of Study
Investigator Address: Jane Hoppin ScD
National Institute of Environmental Health Sciences (NIEHS)
111 T.W. Alexander Drive
Research Triangle Park, NC 27709
Sponsor:
NIEHS
CRO:
Social & Scientific Systems, Inc.
Protocol Title:
Agricultural Health Study Health Follow Up
Approval is granted subject to the following considerations:
Responsibilities of the Principal Investigator as found in the Investigator Guidebook
In the event that non-English speaking subjects are recruited, a cert ified translation
of the informed consent must be approved by the IRB befo re recruit ment.
If subjects who cannot read are recru ited, there should be an impartial witness to attest to the
adequacy of the consent process and to the subject's voluntary agreement to be in the study. This
witness should also verify the subject's signature or mark on the consent form.
Please note that if revisions are required for any approved item (part icularly advertisements), they
must be approved prior to use.
If pediatric subjects are to be enrolled then they should be re-consented when they become of legal age.
Please note that CGIRB requires the reporting of any unanticipated problems involving risks to subjects
or others as soon as possible, but in all cases within 10 business days in accordance with the applicable
regulatory standards and CGIRB requirements.
IF YOU HAVE ANY QUESTIONS, CALL COPERNICUS GROUP IRB AT 1-888-303-2224
This signature certifies that the information contained in this IRB Approval Notice is true and correct as verified by the
minutes and records of The Copernicus Group, Inc. It also certifies that The Copernicus Group, Inc. is in full co mpliance
with FDA Code of Federal Regulat ions (21 CFR Parts 50, 56, 312, and 812 and 45 CFR) and ICH Gu idelines.
Signature
See appended electronic signature page
Authorized Signature
Copernicus Group IRB
One Triangle Drive Suite 100
Durham, NC 27713
M ailing Address:
P.O. Box 110605
Research Triangle Park, NC 27709
IRB TRACKING # SSS1-11-220
Experience and Innovation in Ethical Review ™
Telephone:
Toll-Free:
Fax:
E-M ail:
Web:
919-465-4310
888-303-2224
919-465-4311
irb@cgirb.com
www.cgirb.com
Confidentiality Notice: This document is for the sole use of the intended recipient(s) and may contain confidential and privileged information.
Any unauthorized review, use, disclosure or distribution is prohibited.
If you are not the intended recipient, please contact the sender by reply e-mail and destroy all copies of the original message.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
DATE:
TO:
FROM:
SUBJECT:
National Institutes of Health
National Institute of
Environmental Health Sciences
P. O. Box 12233
Research Triangle Park, NC 27709
http://sharepoint.niehs.nih.gov/ohrc/default.aspx
June28, 2012
NIEHS IRB Chair
Through:
The Office of Human Research Compliance
Branch Chief, Dale Sandler, PhD
(Acting) Clinical Director, CRP, OCR
Jane Hoppin, ScD
Expedited Amendment to Protocol # 11-E-N196 titled “Agricultural Health Study Health
Follow-up“
An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more
experienced reviewers designated by the chairperson from members of the IRB in accordance with the requirements set forth in 45 CFR
46.110. Additional information on determining the appropriate level of review for a submission can be found at
http://ohsr.od.nih.gov/irb/Attachments/Chapter7.htm.
Note: If an NIH investigator is added to the protocol, attach a signed/cleared Personal Financial Holding Clearance form along with an email from the new investigator stating they are aware they are being added to the protocol.
Expedited Amendment Summary and Justification:
We propose to amend the Agricultural Health Sstudy (AHS) Health Follow-up protocol to collect
updated information on medical history and other important covariates through follow-up interviews of
the cohort. Currently, we plan to contact cohort members to complete follow-up interviews allowing
one of three modes of response: self-administered paper questionnaire, self-administered web survey
(CAWI), and interviewer-administered telephone interview (CATI). We will contact proxy respondents
if the participant is deceased or is unable to provide information. AHS participants were re-interviewed
in 1999-2003 (Phase 2 follow-up). AHS farmers and their spouses were contacted again in 2005-2010
(Phase 3 follow-up). The AHS enrollment and previous follow-up questionnaires collected self-reported
data on the participants’ disease history to identify new cases of disease. Enrollment and subsequent
follow-up interviews in the AHS was based on questionnaire return and consent was implied.
Consistent with AHS and other cohort studies, additional written consent for this follow-up will not be
obtained.
The planned Phase 4 follow up will continue this identification of newly reported non-cancer health
outcomes from AHS participants in order to include in current and future validation efforts. Under this
protocol, cohort members or their proxies will be re-interviewed in 2013 -2014 (Phase 4 follow-up).
Individuals who were eligible for the Phase 3 interview will be contacted to complete Phase 4. The
Phase 4 follow up is designed to take approximately 20 minutes to complete. OMB clearance for this
follow up questionnaire will be obtained.
Our basic strategy involves: 1) mailing a letter to participants to inform them of the health follow-up; 2)
include in the initial mailing a self-administered paper questionnaire; 3) provide a web link and login
instructions for those who prefer completing the self-administered questionnaire via CAWI; and 4)
contact those who do not respond by mail or web to complete the follow-up by CATI.
This amendment also contains minor changes to the validation effort language, allowing for more
flexibility regarding case selection for saliva collection.
The specific requested revisions are detailed below:
I. Protocol
{Page number, section and detailed description of each change, if applicable}
All pages: in footer, protocol version date changed to 6/26/2012
Page 1: date changed from March 2012 to May 2012. Also, Laura Beane Freeman and Michael
Alavanja of NCI were added as co-investigators
Page 2, Section A Precis, first paragraph: added language to include the purpose of the Phase 4 follow
up
Page 2, Section A Precis, second paragraph: Updated the language regarding collection of saliva to read
"We may also collect a saliva or cheek swab sample from cases….." instead of "We will also collect a
saliva or cheek swab sample from all cases….." to allow investigators more flexibility in selection of
cases for saliva collection.
Page 2, Section B.1 Background: The Agricultural Health Study, first paragraph: Added sentence
"Under the current protocol, cohort members or their proxy who were eligible for the Phase 3 interview
will be re-interviewed in 2013 -2014 (Phase 4 follow-up)."
Page 3, Section B.1 Background: The Agricultural Health Study, second paragraph, Added missing
word from sentence "farming" and added new sentence "Of particular interest are non-cancer outcomes,
as there are no formal registries for these important adult chronic diseases."
Page 3, Section B.1 Background: The Agricultural Health Study, third paragraph, last sentence: updated
language to read "The AHS will continue to collect data……." instead of "The AHS has collected
data……."
Page 3, Section B.1 Background: Validation of Disease Outcomes: Updated section name to "Health
Follow-up and Validation of Disease Outcomes"
Page 3, Section B.1 Background: Validation of Disease Outcomes: first paragraph, added second
sentence "This protocol will update information on medical history and other important covariates
through follow-up interviews of the cohort."
Page 3, Section B.1 Background: Validation of Disease Outcomes: second paragraph, updated first two
sentences to read "The Agricultural Health Study enrollment and previous follow-up questionnaires
collected self-reported data on the participants’ disease history to identify new cases of disease. The
planned Phase 4 follow up will continue this identification of new cases of disease."
Page 4, Section C Objectives: Added last sentence "The Phase 4 follow-up will allow us to identify
newly reported non-cancer health outcomes among AHS participants in order to include in current and
future validation efforts."
Page 5, Section D.1 General Design: added new first paragraph describing the general design of the
follow up and added "In addition…" to beginning of second paragraph and "Finall…." to third
paragraph.
Page 6, Figure 1: added "for some" to buccal/saliva collection bubble.
Page 7, Section D.1.3 Design: Initial Contact: Added last sentence . "We will receive updated contact
information that may be obtained by the outside investigator as well as participation outcomes in order
to assist in cohort maintenance."
Page 7, Section D.2 Study Team: Added "co" to co-PI to describe Dr. Hoppin's role on AHS.
Page 8, Section D.2 Study Team: Added "Drs. Alavanja and Beane Freeman of NCI are both co-PIs of
the AHS and are the lead investigators on cancer in the cohort.
Page 8, Section D.3 Project Timeline: added last sentence indicating that the Phase 4 follow up would
begin in the first quarter of 2013.
Page 8, Section D.4 Population and sampling: added second sentence indicating that the Phase 4 follow
up would begin in the first quarter of 2013 and updated third sentence indicating that we plan to use selfreported information from enrollment and all follow-up interviews to identify possible cases for
validation.
Page 9, Section D.5 Methods: added new first paragraph to describe the Phase 4 and other subsequent
health outcome follow-up efforts.
Page 11, Section E. Inclusion and Exclusion Criteria: Changed first paragraph to read "All members of
the AHS cohort who were eligible for the Phase 3 interview will be eligible for the health follow-up and
disease validation study. Individuals who only completed the enrollment questionnaire were excluded
from Phase 3 eligibility. For individuals who are unable to provide information, we will allow a proxy
to provide that information." and clarified that the second paragraph describes criteria for the validation
efforts.
Page 11, Section F Montioring Subjects and Criteria for Withdrawal of Subjects from the Study: first
sentence added "….health follow-up and…."
Page 11, Section G Analysis of the Study: first sentence, added "….update the medical history and other
important covariates, and to….".
Page 11, Section G.1 Statistical Analysis: Added "The health follow-up interviews will aid in the
identification of new cases of all diseases, thus increasing the overall power of the AHS to look at
incident disease, for both rare and common outcomes."
Page 12, Section Rationale for Subject Selection: added first sentence "For the health follow-up
interview, we will conduct the study among all participants who were Phase 3 eligible." and edited
following paragraph to refer to validation efforts.
Page 13, Section H.2 Strategies and Procedures for Recruitment: moved sentences 4-6 to paragraph 3,
added paragraph 2 to describe strategies and procedures for recruitment for the follow up. Added "For
the validation efforts" to the third and fourth paragraphs for clarity.
Page 14, Section H.3 Justification for Exlcusions: second paragraph, added "…into a validation effort"
for clarity.
Page 14, Section H.4 IRB Review and Approval: second paragraph, frist sentence, added "Health
follow-up and…." Added last sentence "OMB clearance will be sought for the health follow up." and
clarified that OMB exemption was obtained for the validation efforts.
Page 15, Section H.6 Consent Processes and Documents: added new first paragraph regarding the health
follow up.
Page 15, Section H.6 Consent Processes and Documents: second paragraph, updated second sentence
from "…..the telephone recruitment call by…." to "…..all subsequent contacts with….".
Page 15, Section H.6 Consent Processes and Documents: third paragraph, added reference to linkage
with National Death Index.
Page 15, Section H.6 Consent Processes and Documents: updated paragraphs 5 and 6 to include
reference to the validation efforts.
Page 15, Section H.6 Consent Processes and Documents: added final paragraph "For initial contact
efforts, the outside institution conducting the research is responsible for obtaining consent in accordance
with their Institutional Review Board."
II. Consent(s)
{Document title, page number, section and detailed description of each change, if applicable}
III. Recruitment Material/Participant Information Sheet
{Document title, page number, section and detailed description of each change, if applicable}
Health Follow up Phase 4 initial invitation mailing to participant - new
Health Follow up Phase 4 second invitation mailing to participant including website - new
Health Follow up Phase 4 invitation mailing to next of kin - new
IV. Other
{Document title, page number, section and detailed description of each change, if applicable}
Health Follow up Phase 4 questionnaire - participant - new
Health Follow up Phase 4 questionnaire - proxy - new
Jane Hoppin, ScD
Principal Investigator, NIEHS
I authorize the above changes to my study and have included updated edited and clean versions of all
revised documents as attachments for submission via my NIH e-mail account to the NIEHS Office of
Human Research Compliance.
For Approving Official Use Only:
The attached expedited amendment request is a minor change in the research that does not increase risks to subjects
or reduce potential benefits and falls within the OHRP Categories of Research that May be Reviewed by the IRB
through an expedited review procedure. Approval is hereby granted.
N. Almodovar
Protocol Specialist
Office of Protocol Services
8/13/12
Date
F
Amendment
Letter
Protocol eSign History
Protocol Number:
Date/Time
06/29/2012 4:02 PM
Review: Amendment 06/29/2012
11-E-N196
User
Jane Hoppin
06/29/2012 4:31 PM
Dale Sandler
06/29/2012 4:31 PM
Dale Sandler
07/15/2012 8:37 PM
Bruce Androphy
07/16/2012 11:12 AM
Frederick Miller
07/17/2012 12:03 PM
David Resnik
Type
(6)
Action
Electronic signature
eSignature Verified Principal
access
Investigator
Electronic signature
eSignature Verified Accountable
access
Investigator
Electronic signature
eSignature Verified Branch
access
Chief
Electronic signature
Date/Time Cleared by IC DEC:
access
Sun Jul 15 20:37:36 EDT 2012
Electronic signature
eSignature Verified Clinical
access
Director
Electronic signature
access
eSignature Verified IRB Chair
| File Type | application/pdf |
| File Title | ÿþM |
| Author | ÿþE |
| File Modified | 2012-10-09 |
| File Created | 2012-10-09 |