Attachment 4 NHLBI Protocol 13-H-0183 Consent Document

MEDICAL RECORD

CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY
• Adult Patient or
• Parent, for Minor Patient

INSTITUTE:

National Heart, Lung and Blood Institute

STUDY NUMBER:

13-H-0183

STUDY TITLE:

PRINCIPAL INVESTIGATOR: Tiffany M. Powell-Wiley, M.D., MPH

Cardiovascular Health and Needs Assessment in Washington D.C. – Development of a CommunityBased Behavioral Weight Loss Intervention

Initial Review Approved by the IRB on 7/16/13
Amendment Approved by the IRB on 11/19/13 (B)
Standard

Date Posted to Web: 12/05/13
INTRODUCTION

We invite you to take part in a research study at the National Institutes of Health (NIH).
First, we want you to know that:
NIH research studies are voluntary, and you may drop out or leave the study at any time without losing any
benefits to which you are otherwise entitled. However, to receive care at the NIH, you must be a taking part in a
study or be under evaluation to take part in a study.
You may receive no benefit from taking part. The research may give us knowledge that may help people in the
future.
Anyone with personal, religious or ethical beliefs that will not allow them to take part in certain medical or research
projects (such as blood transfusions) should tell the NIH doctors or research team before agreeing to join the study.
Before choosing to join the project, please take as much time as needed to read all the information and talk it over with
your family, friends, and/or your medical doctor. If you have any questions or concerns regarding the study or the
NIH, please feel free to contact us here at the NIH. We are here to help you.
1. Why is this research being done?
The purpose of this research is to conduct a community health and needs assessment for individuals in predominantly
African-American (Black) churches in Washington D.C. Past studies suggest that community-based programs are
needed to improve cardiovascular (heart) health in the African-American community. This assessment is being
conducted in partnership with DC community leaders. In this assessment, we will study the levels of heart health
factors in the church population, such as levels of diabetes (blood sugar), high blood pressure, high cholesterol, and
obesity. We will also study the use of technology to measure exercise and food intake, and we will study the use of
web-based tools for keeping track of one’s own heart health factors. We plan to use the information collected in this
study to evaluate the health needs of this church-based community. With this information, we plan to work in
partnership with community leaders to create an intervention for future programs to improve heart health in AfricanAmerican churches in the District of Columbia.
2. Why are you being invited to participate?
You are being asked to participate in this research study because you attend a church in the District of Columbia.
PATIENT IDENTIFICATION

CONSENT TO PARTICIPATE IN A CLINICAL
RESEARCH STUDY

• Adult Patient or • Parent, for Minor Patient
NIH-2514-1 (4-97)
P.A.: 09-25-0099
File in Section 4: Protocol Consent (1)

MEDICAL RECORD
STUDY NUMBER:

CONTINUATION SHEET for either:
NIH 2514-1, Consent to Participate in A Clinical Research Study
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study

13-H-0183

CONTINUATION: page 2 of 6 pages

3. How many people will take part in this research study?
Up to 100 participants will take part in this study.
4. How long will you take part in this research study?
You will be a part of this study for one (1) month, only.
5. How can one be eligible to join this study?
For this study, you must be:
• Between 19 to 85 years old
• Attend one of the churches in this study
6. What procedures are involved in this research study?
You will be asked to come to your church for a health examination. You should not eat anything after midnight the
day before the exam, except for water for taking medications. After signing the consent, you will have blood testing
for blood sugar and blood cholesterol and get your body weight measurements. You will get a snack during the exam
after blood testing and body weight measurements. You will also complete a survey after measurements and receive
a physical activity monitor to use. The exam will take approximately 4 hours to complete. The following are steps for
testing, which are described below:
Procedure
Blood pressure measurements
Fingerstick blood sample for blood sugar,
cholesterol levels
Body weight measurements
Questionnaire (survey)
Instructions for use of Fitbit® Flex
Monitoring use of Fitbit® Flex Physical
Activity Monitor and Fitbit® website
Instructions for use of Actigraph GT3X
accelerometer (optional)
For those using Actigraph GT3X
accelerometer:
- Return device to study team
Instructions for use of digital camera for
three-day digital food record (optional)
For those using Digital camera:
- Return device to study team
For those with untreated high blood
pressure, diabetes, or high cholesterol
- Call from study team about followup with primary care

PATIENT IDENTIFICATION

Visit 1

1 month

X
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X
X
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X
X
X

CONTINUATION SHEET for either:

NIH-2514-1 (10-84)
NIH-2514-2 (10-84)
P.A.: 09-25-0099

MEDICAL RECORD
STUDY NUMBER:

CONTINUATION SHEET for either:
NIH 2514-1, Consent to Participate in A Clinical Research Study
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study

13-H-0183

CONTINUATION: page 3 of 6 pages

a) Blood Pressure Measurements: We will measure your blood pressure during the screening and let you know
your results.
b) Fingerstick blood draw for Blood Sugar and Blood Cholesterol Levels: We will take a small drop of blood
from your finger using a fingerstick. The amount of blood drawn in the fingerstick will be less than one-fourth of
a teaspoon of blood. All of the blood tests will be taken during the screening exam only. None of the blood
sample will be kept. We will provide you with the results of the blood tests.
c) Body weight measurements: We will measure height, weight, waist size, and distance around your hips
during the exam. We ask that you wear lightweight, loose-fitting clothing with empty pockets to the event so it is
easier to take these exact measurements.
d) Questionnaire (Survey): You will be asked to complete a survey about your medical history, physical activity
(exercise) and dietary (eating) habits. You will also be asked about psychological/emotional factors, like stress,
that might affect your exercise and eating habits. Finally, you will be asked questions that can help us create a
church-based program to increase physical activity and improve diet for better heart health.
e) Instructions for use of Fitbit® Flex/Monitoring of Use of Fitbit® Flex and Fitbit® website: At the
screening, you will be given a physical activity monitor called a "Fitbit® Flex" with instructions on how to use the
device. The device will be worn as a wristband, and it will record your levels of physical activity during the day
and will record the number of hours you sleep each night. You will be asked to use this device for one (1) month
and will be taught how to follow your physical activity levels on the Fitbit® website. The website will also let you
keep track of your dietary intake (types and amounts of food you eat), types of physical activity (exercise) that
you do, and heart health factors such as weight, heart rate, blood pressure, and blood sugar. During the one
month, we will check your use of the Fitbit® Flex and the Fitbit® website. After one month, we will no longer
check the use of the Fitbit® Flex or the Fitbit® website, and the device will be yours to keep.
f) Instructions for use of Actigraph GT3X accelerometer (OPTIONAL): At the screening, you will have the
choice to receive another type of physical activity device called the “Actigraph GT3X accelerometer”. This device
will be worn each day around the waist. The device will record your physical activity each day. You will be asked
to wear this activity device each day for one month. If you are willing to be in this part of the study, we will ask
that you wear both the Actigraph GT3X accelerometer and the Fitbit® Flex for one month. After one month, we
will collect the Actigraph GT3X accelerometer back from you to read the physical activity data.
g) Instructions for use of digital camera for three-day food record (OPTIONAL): At the screening, you will
also have the choice to get a digital camera to count your food intake over a three-day period. If you are willing
to be in this part of the study, you will be given directions on how to take pictures of each meal for three days in
a row (2 weekdays and 1 weekend day). You will be asked to take pictures before and after eating a meal. After
taking pictures for the three-day food record, the digital camera will be collected back from you to review the
food intake pictures.

PATIENT IDENTIFICATION

CONTINUATION SHEET for either:

NIH-2514-1 (10-84)
NIH-2514-2 (10-84)
P.A.: 09-25-0099

MEDICAL RECORD
STUDY NUMBER:

CONTINUATION SHEET for either:
NIH 2514-1, Consent to Participate in A Clinical Research Study
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study

13-H-0183

CONTINUATION: page 4 of 6 pages

h) Referral for untreated high blood pressure, diabetes, and high cholesterol: If you are found to have
high blood pressure, high blood sugar or high cholesterol that is not being treated, we will provide you with some
information on a primary care doctor to follow-up for further evaluation and possible treatment. We will contact
you one month after screening to determine if a follow-up appointment has been made with a primary care
doctor.
7. What are the risks and discomforts of this research study?
a) Fingerstick blood draw: You may feel a slight pinch of pain from the small needle when collecting your blood
sample. There is a small chance that you will feel lightheaded or faint with the needlestick.
b) Questionnaire: You may be a little frustrated with answering the questions.
c) Measurement of blood pressure, blood sugar, cholesterol levels: We may find signs of high blood
pressure, high blood sugar, and/or high cholesterol during the medical exam, which may cause you to be a little
anxious. As a study participant, you will experience a heart health examination with the principal investigator, Dr.
Powell-Wiley. Based on the results, she will talk to you about the status of your blood pressure, blood sugar,
cholesterol, or body weight.
d) Use of the Fitbit® Flex: The Fitbit Flex activity monitor is an item you can buy in a store, and it is not painful
to wear this plastic monitor around the wrist. You may feel a little skin irritation or itching if the monitor is worn
too tightly around the wrist.
8. Are there any benefits to you if you take part in this research study?
It is possible that you will benefit from participating in this study by getting an evaluation of your heart health. This
may assist in managing your blood pressure, blood sugar, cholesterol and body weight.
9. What other choices do you have?
You do not have to participate in this study if you do not want to. You may stop participating in this study at any
time.
10. Will your clinical and test results be shared with you?
We will provide you with the blood pressure, blood sugar, cholesterol, and body weight results that we obtain. We
will also provide you with a cardiovascular risk assessment during the screening.
11. Will the results of this research study be shared with you?
We will tell you about our research results. However, it may not be ready for several months in order to compare all
the results from the participants in the study as a whole. We will also announce the research results at each of the
participating churches; however, no one would be able to identify you when the research results are presented. We
will share the published information of this study with you.
By agreeing to participate in this study, you do not give up any rights that you may have regarding access to and
disclosure of your records. For further information on those rights, please contact Dr. Powell-Wiley.

PATIENT IDENTIFICATION

CONTINUATION SHEET for either:

NIH-2514-1 (10-84)
NIH-2514-2 (10-84)
P.A.: 09-25-0099

MEDICAL RECORD
STUDY NUMBER:

CONTINUATION SHEET for either:
NIH 2514-1, Consent to Participate in A Clinical Research Study
NIH 2514-2, Minor Patient’s Assent to Participate In A Clinical Research Study

13-H-0183

CONTINUATION: page 5 of 6 pages

12. Will any of your blood, tissue, other samples, or data be stored and used for research in the future?
In this protocol, we will obtain heart-related health factor data and questionnaire data that will be stored. We will
also include certain information in your medical record. Other information will be for scientific research, publication,
and teaching. Your name and other personal information will not be revealed and it would be private. When we do
so, your information will identified by a code to link your test samples with your name and other personal
information. The code will be stored in a secret password-protected database under the control of Dr. Powell-Wiley.
If we share or publish these data, your name or personal information will not be told to ensure your identity will be
protected. We may contact you in the future about taking part in the intervention to improve heart health in the
community. JUST TO NOTE: You are under no contract to participate in any future studies with NIH.
13. Will you receive any compensation (money or other) for taking part in this research study?
The following table describes the compensation for this study:
Description of tests or procedures
Completion of all Testing at Screening Event, including
blood draw and survey
Completion of 1 month of data collection with physical
activity (exercise) monitor
Return of accelerometer to research team (up to 15
participants)
Return of digital camera to research team (up to 15
participants)

Compensation
$25 Visa gift card
$25 Visa gift card
$25 Visa gift card
$25 Visa gift card

14. Do any of the researchers or the NIH have a financial interest related to this research study?
No, the researchers or the NIH do not have a financial interest related to this research study.
The National Institutes of Health reviews NIH staff researchers at least yearly for conflicts of interest. The following
link contains details on this process: http://ethics.od.nih.gov/forms/Protocol-Review-Guide.pdf. You may ask your
research team for additional information or a copy of the “Protocol Review Guide.”
15. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. This Web
site will not include information that can identify you. At most, the Web site will include a summary of the results. You
can search this Web site at any time

PATIENT IDENTIFICATION

CONTINUATION SHEET for either:

NIH-2514-1 (10-84)
NIH-2514-2 (10-84)
P.A.: 09-25-0099

CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY
• Adult Patient or
• Parent, for Minor Patient

MEDICAL RECORD
STUDY NUMBER:

13-H-0183

CONTINUATION: page 6 of 6 pages

OTHER PERTINENT INFORMATION
1. Confidentiality. When results of an NIH research study are reported in medical journals or at scientific meetings,
the people who take part are not named and identified. In most cases, the NIH will not release any information about
your research involvement without your written permission. However, if you sign a release of information form, for
example, for an insurance company, the NIH will give the insurance company information from your medical record. This
information might affect (either favorably or unfavorably) the willingness of the insurance company to sell you insurance.
The Federal Privacy Act protects the confidentiality of your NIH medical records. However, you should know that the Act
allows release of some information from your medical record without your permission, for example, if it is required by the
Food and Drug Administration (FDA), members of Congress, law enforcement officials, or authorized hospital
accreditation organizations.
2. Policy Regarding Research-Related Injuries. The Clinical Center will provide short-term medical care for any
injury resulting from your participation in research here. In general, no long-term medical care or financial compensation
for research-related injuries will be provided by the National Institutes of Health, the Clinical Center, or the Federal
Government. However, you have the right to pursue legal remedy if you believe that your injury justifies such action.
3. Payments. The amount of payment to research volunteers is guided by the National Institutes of Health policies. In
general, patients are not paid for taking part in research studies at the National Institutes of Health. Reimbursement of
travel and subsistence will be offered consistent with NIH guidelines.
4. Problems or Questions. If you have any problems or questions about this study, or about your rights as a
research participant, or about any research-related injury, contact the Principal Investigator: Tiffany M. Powell-Wiley, MD,
Building 10, Room 5-3340, Telephone 301-594-3735.
You may also call the Clinical Center Patient Representative at (301) 496-2626.
5. Consent Document. Please keep a copy of this document in case you want to read it again.
A.

Adult Patient’s Consent

COMPLETE APPROPRIATE ITEM(S) BELOW:
B. Parent’s Permission for Minor Patient.

I have read the explanation about this study and have been given the
opportunity to discuss it and to ask questions. I hereby consent to take
part in this study.

I have read the explanation about this study and have been given the
opportunity to discuss it and to ask questions. I hereby give permission
for my child to take part in this study.
(Attach NIH 2514-2, Minor’s Assent, if applicable.)

Signature of Adult Patient/Legal Representative

Signature of Parent(s)/Guardian

Date

Print Name

C.

Date

Print Name

Child’s Verbal Assent (If Applicable)

The information in the above consent was described to my child and my child agrees to participate in the study.

Signature of Parent(s)/Guardian

Date

Print Name

THIS CONSENT DOCUMENT HAS BEEN APPROVED FOR USE
FROM JULY 16, 2013 THROUGH JULY 15, 2014.
Signature of Investigator
Print Name

PATIENT IDENTIFICATION

Date

Signature of Witness
Print Name

CONSENT TO PARTICIPATE IN A CLINICAL
RESEARCH STUDY (Continuation Sheet)
• Adult Patient or • Parent, for Minor Patient
NIH-2514-1 (07-09)
P.A.: 09-25-0099

File in Section 4: Protocol Consent

Date