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CERTIFICATES OF CONFIDENTIALITY

CERTIFICATES OF CONFIDENTIALITY. 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

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CERTIFICATES OF CONFIDENTIALITY

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  1. CERTIFICATES OF CONFIDENTIALITY

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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)

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

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