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?
No, you will not receive any results from the initial DNA testing. For this first part of this study, we will be examining DNA differences anonymously. That means we won’t know whose DNA we are examining because the identity of the person donating the DNA will be blinded. 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 the identity of your sample is unblinded so that a researcher can ask you to participate in this type of follow-up study, that researcher will tell you the significance of the gene they are looking at and if it has been associated with any human conditions or disease. 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 Compliance (OHRC) at the National Institute of Environmental Health Sciences, and the Biomedical Institutional Review Boards (IRBs) at the University of North Carolina at Chapel Hill and Integrated Laboratory Systems, Inc. (contract laboratory helping with this study). If you have any questions or concerns regarding your rights as a research subject, you can contact the UNC IRB at (919) 966-3113 or by email (IRB_subjects@unc.edu), or the NIEHS OHRC (919) 541-3852. You may contact any of these IRBs anonymously, if you wish.
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