Certificates of Confidentiality • Issued by the National Institutes of Health (NIH) • Protect investigators and institutions from being compelled to release information that could be used to identify research study participants • Allow the investigator and others who have access to research records to refuse to disclose identifying information in any • civil • criminal • administrative • legislative, or other proceeding, whether at the federal, state, or local level
Statutory Authority • Section 301(d) of the Public Health Service Act (42 U.S.C. 241(d)) • Secretary DHHS may authorize persons engaged in: • biomedical • behavioral • clinical • other research • to protect the privacy of individuals who are the subjects of that research. • Authority has been delegated to the NIH.
Identifying Information • Broadly defined • Not just name, address, social security number, etc. • Includes any item or combination of items that could lead directly or indirectly to the identification of a research participant.
Eligibility • For IRB-approved research collecting identifying information • If disclosure could have adverse consequences for subjects or damage: • financial standing • employability • insurability, or • reputation • NIH or PHS funding not required
Examples of research with potential adverse consequences for subjects • Collecting genetic information • Collecting information on psychological well-being of subjects • Collecting information on sexual attitudes, preferences or practices • Collecting data on substance abuse or other illegal risk behaviors • Studies where participants may be involved in litigation related to exposures under study (e.g., breast implants, environmental or occupational exposures)
Other issues • Issued for single, well-defined research projects • Certificates granted to Institutions based on PI’s application • Sometimes issued for cooperative multi-site projects • Must have a coordinating center or “lead” institution • Lead institution can apply on behalf of all institutions associated with the multi-site project. • Lead institution must ensure that all participating institutions conform to the application assurances
Projects Not Eligible for a Certificate • Not research • Not collecting personally identifiable information • Not reviewed and approved by the IRB as required by these guidelines • Collecting information, that if disclosed, would not significantly harm or damage the subject
Requirements • Must tell subjects that Certificate is in effect in Informed Consent form • Must provide fair and clear explanation of Certificate’s protection, including • limitations • exceptions • Must document IRB approval and IRB qualifications • Must provide a copy of the informed consent forms approved by the IRB • PI and Institutional Official must sign application
Assurances • Agree to protect against compelled disclosure and to support and defend the authority of the Certificate against legal challenges • Agree to comply with Federal regulations that protect human subjects • Agree to not represent Certificate as endorsement of project by DHHS or NIH or use to coerce participation • Agree to inform subjects about Certificate, its protections and limitations
Boundaries of Protection • Protects data maintained during any time the Certificate is in effect • Protects those data in perpetuity • Does not protect against voluntary disclosure: • child abuse • threat of harm to self or others • reportable communicable diseases • subject’s own disclosure • Must disclose information about subjects for DHHS audit or program evaluation or if required by the Federal Food, Drug, and Cosmetic Act
An Important Caveat • Certificates of Confidentiality do not obviate the need for data security • Data security is essential to the protection of research participants’ privacy • Researchers should safeguard research data and findings. • Unauthorized individuals must not access the research data or learn the identity of research participants
For Additional Information • Go to the Certificates of Confidentiality Kiosk at http://grants1.nih.gov/grants/policy/coc/index.htm • Kiosk includes: • background information and Instructions • application information for extramural investigators • application information of intramural investigators • FAQs • contact list • reportable communicable diseases policy