Att_14 Clinic Exam Frequently Asked Questions

Att_14 Clinic Exam Frequently Asked Questions.pdf

Gulf Long-Term Follow-Up Study for Oil Spill Clean-Up Workers and Volunteers (NIEHS)

Att_14 Clinic Exam Frequently Asked Questions

OMB: 0925-0626

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Answers to Your Questions
1. What is the purpose of the GuLF STUDY Clinical Exam?
The purpose of the clinical exam is to learn more about possible health effects of the oil spill in the Gulf of
Mexico through advanced medical testing. The comprehensive exam will include advanced
measurements of lung and nervous system function, assessment of mental health, and screening for
diabetes and cholesterol.

2. Who is conducting the exam?
The National Institute of Environmental Health Sciences (NIEHS) designed and leads all aspects the
GuLF STUDY. SRA International (SRA), a professional research firm, and their partners are helping
NIEHS conduct the exams. The clinical examinations will be carried out by the University of South
Alabama (USA) and Louisiana State University (LSU) Health Sciences Center. Social & Scientific
Systems trained, equipped, and manages all participating medical centers. All of these partners follow
guidelines and procedures approved by the NIH Office of Human Subjects Research. This office exists to
protect people in research studies.

3. Who is eligible for the exam?
You are eligible for the exam in you enrolled in the GuLF STUDY and completed a home visit. You are
eligible whether you worked on the spill or not and whether you are feeling sick or well. By comparing
different groups of participants, we can learn understand why some participants experience health
problems and others do not.

4. What will I be asked to do?
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Provide blood, hair, toenail, saliva, and urine samples
Have your vital signs and body measurements taken
Complete lung function tests
Complete tests of nervous system function
Complete a questionnaire about your health

5. Will I receive compensation for completing the exam?
You will receive a $100 dollar gift card for the time and effort required for the clinical exam and you will be
reimbursed for your travel expenses based on your distance from the clinic. You will receive your gift card
when you complete your exam. Participants who provide saliva samples will receive an additional $20 gift
card. There is no cost associated with accepting a gift card.

6. What tests will be done with my samples?
All of your samples will be frozen and stored in a secure laboratory. At a later date, we will use your
samples for research. We will look for signs of oil exposure and related health effects. We will test
samples for a variety of chemicals, hormones, markers of biological changes, and environmental agents.
We will also study effects on genes and if genetic factors interact with chemical exposures to increase or
decrease the chances of becoming sick. All research tests will not be done on all participants. We will not
test for illegal drugs.

7. Will I receive the results of my blood tests and other study procedures?
You will receive results from some clinic laboratory tests and procedures at the end of your visit. We will
report results from tests that are clinically relevant such as results from measurements of your blood
pressure, body mass index, lung function, and diabetes and cholesterol screening. We will let you know if

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U.S. Department of Health and Human Services  National Institutes of Health  National Institute of Environmental Health Sciences

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Answers to Your Questions
we think you should share your results with a doctor or clinic. Results from tests done in research
laboratories will not be shared because their meaning to your health will not be clear.
Results will not be shared with your employer, health insurance company, or health care provider unless
you ask us to in writing. We will not give study information to employers or insurance providers. Privacy
rules strictly prohibit sharing information about study participants with these groups. However, you are
allowed to share information with your employers and insurance provider. If an insurer or employer learns
from you that you are in the study and you consent in writing to have the information shared, we will give
out the information.

8. What should I do if I have questions about my exam results?
You should discuss your test results with your doctor. If you do not have a regular doctor, we will provide
referral to a local health care provider. We will be happy to answer general questions about the tests. We
will not provide medical care as part of this study. Your doctor will be in the best position to know what is
right for you.

9. How will you protect my privacy?
We will make every effort to protect your privacy and keep your data confidential. People in NIH studies
are not named in reports or presentations. Furthermore, a law called The Federal Privacy Act protects
your information. We will label the information from this interview with a special code number instead of
your name so you will not be identified. Only authorized staff will see your private information.

10. What should I do if…
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I want to find out if the exam is legitimate? You may contact the Public
Affairs/Communications Office at the NIEHS at 1-919-541-0073. You may also call the NIEHS Office
of Human Research Compliance, at 1-919-541-3852.
• I have questions about the exam or need to reschedule my appointment? If you have
questions about the exam, you may call the study toll-free number, 1-855-NIH-GULF (1-855-6444853), or visit the study website at www.gulfstudy.nih.gov.
• I have a problem or complaint about the clinic visit? Please call the GuLF STUDY toll-free
number, 1-855-NIH-GULF (1-855-644-4853), as soon as possible. Tell us about the problem and the
date and time that it occurred. We will relay your concern to the investigators and our study staff. We
will take any action that is necessary.

Version 2.0 (07/19/13)
U.S. Department of Health and Human Services  National Institutes of Health  National Institute of Environmental Health Sciences

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File Typeapplication/pdf
File TitleAppendix A:
Author[email protected]
File Modified2014-01-29
File Created2013-10-08

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