Will you be paid for participating?
You will be paid $20.00 for participating in the EPR.
Will it cost you anything to participate?
There will be no cost to you for any part of this study.
What if you want to withdraw from the EPR?
Your participation in the EPR is completely voluntary. You may withdraw from this study at any time without affecting your current or future treatment within the UNC Healthcare System. To withdraw, you should call or email Dr. Patricia Chulada (tel: 919-541-7736; email: chulada@niehs.nih.gov) at the National Institute of Environmental Health Sciences. If you are unable to reach Dr. Chulada within a reasonable amount of time, then contact Dr. Perry Blackshear (919-541-4899) at the National Institute of Environmental Health Sciences. Once notified, we will discard what blood or DNA samples may be remaining and make sure that you are not contacted in the future concerning follow-up studies. If your DNA has already been analyzed for certain DNA differences and the data have been statistically analyzed, we will not be able to remove the data from our databases, but we will not give your name and contact information to other scientists for future studies. If your name and contact information have already been passed on, we will contact those scientists and ask that your name be removed from their list.
What if you have questions about this study?
You have the right to ask, and have answered, any questions you may have about this research. If you have questions, you should call or email Dr. Patricia Chulada (tel: 919-541-7736; email: chulada@niehs.nih.gov). If you are unable to reach her within a reasonable amount of time, call Dr. Perry Blackshear at 919-541-4899.
How long will your participation last?
Unless you withdraw from this registry, we will keep your personal information and DNA for up to 25 years. During this time, you will be contacted once a year (by mail or phone) and asked to update your contact information. Also during this time, you might be contacted and asked to participate in a future follow-up study as described above. These future studies will most likely involve filling out a questionnaire or taking a telephone survey, but may involve being interviewed or having a physical examination or laboratory evaluation including blood tests. If you are re-contacted, we will not ask you to participate in more than one study per year.
Will I have to participate in future studies?
No. Future studies are separate from the EPR. If you are asked to participate in a follow-up research study and you voluntarily agree to do so, you will be asked at that time to sign a new consent form for that study.
What are the possible risks or discomforts?
The only known risk of this study is some minimal risk associated with maintaining your confidentiality. We will make every effort to keep your participation and study results confidential. For this study, we have obtained a Certificate of Confidentiality which legally protects your personal information and study data from third parties, e.g. insurance companies, employers, and others (see Confidentiality & Privacy(http://www.niehs.nih.gov/research/resources/databases/epr/participants/priv.cfm) page).
What are the possible benefits?
You will not benefit personally by joining the EPR. However, you may be helping scientists discover differences in our genetic material that make people more sensitive to environmental factors.
Will I be given my study results?
To date, none of the DNA differences we will be looking at have been associated with a condition or disease. Therefore, you will not receive any results from the initial DNA testing. However, the objective of some of the follow-up studies might be to look for an association of a particular DNA difference with a certain condition or disease. If you participate in this type of follow-up study, you may or may not be given the results. That will be decided by the principal investigator of that study. All results generated from the EPR are strictly for research purposes only and cannot be used to diagnose or predict a condition or disease.
What if you have questions about your rights as a subject?
Creation of the EPR has been reviewed and approved by the Office of Human Research Ethics (OHRE), the Biomedical Institutional Review Board at the University of North Carolina at Chapel Hill and the Institutional Review Board at the National Institute of Environmental Health Sciences, National Institutes of Health. If you have any questions or concerns regarding your rights as a research subject, you should first contact the Chairman of the NIEHS IRB committee, currently Marian Johnson-Thompson, Ph.D. (919) 541-4265. In addition, you may contact the chairman of the IRB at UNC who is currently Stephen A. Bernard, M.D. at (919) 966-1344.
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