Confidentiality & Privacy
Participants (How to Enroll)
Study staff for the EPR will take every effort possible to protect your privacy. All identifiers will be removed from your blood sample, and it will be encrypted with a personal identification number (PIN). The encryption system will be used on your blood and DNA samples and test results throughout the course of the study. Only the NIEHS investigator in charge of the registry, Dr. Shepherd H. Schurman, and other staff who are directly involved in the registry, will have the key that connects your identity and contact information to your samples and results.
Researchers who use your samples will not be able to identify you as your sample will only be identified by your PIN. Researchers will screen your samples to look for differences in your DNA sequence data (changes in your genetic code). Based on your study results, researchers might want to contact you (along with other people in the registry who have the same changes in their genetic code) and ask you to participate in follow-up studies. In that case, the researchers will develop a new study protocol and have this reviewed by multiple committees for scientific merit (scientific review) and to ensure that all research subjects who participate in the study are protected (Institutional Review Board, or IRB, review). If their study is approved by these review committees, we will then release your name and contact information to these researchers so they may contact you about their follow-up study. Participation in follow-up studies is always completely voluntary, and is separate from your enrollment in the EPR DNA registry.
No subjects will be identified by name in any report or publication resulting from this registry.
Information collected from the EPR is for research purposes only and will not be used for decisions concerning medical treatment and/or medical insurance payments.
DNA samples, the encryption key, and all accompanying personal identification and contact information will be kept for up to 25 years and will then be discarded. During this time, these samples and data are the property of the National Institute of Environmental Health Sciences (NIEHS).
Certificate of Confidentiality
To help us protect your privacy, we have obtained a Certificate of Confidentiality from the National Institutes of Health. With this Certificate, researchers cannot be forced to disclose information that may identify you, even by a court subpoena, in any federal, state, or local civil, criminal, administrative, legislative, or other proceedings. Researchers will use the Certificate to resist any demands for information that would identify you, except as explained below. The Certificate cannot be used to resist a demand for information from personnel of the United States Government that is used for auditing or evaluation of Federally funded projects or for information that must be disclosed in order to meet the requirements of the federal Food and Drug Administration (FDA).
You should understand that a Certificate of Confidentiality does not prevent you or a member of your family from voluntarily releasing information about yourself or your involvement in this research. If an insurer, employer, or other person obtains your written consent to receive research information, then the researchers may not use the Certificate to withhold that information. There are no conditions under which the researchers will make voluntary disclosures.
Last Reviewed: July 22, 2015