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Certificates of Confidentiality

Certificates of Confidentiality. David Forster. Basic Information. A Certificate of Confidentiality helps researchers protect the privacy of human research participants enrolled in sensitive research.

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Certificates of Confidentiality

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  1. Certificates of Confidentiality David Forster

  2. Basic Information • A Certificate of Confidentiality helps researchers protect the privacy of human research participants enrolled in sensitive research. • Certificates protect against compulsory legal demands, such as court orders and subpoenas, for identifying information or identifying characteristics of a research participant.

  3. How long does a Certificate's protection last? • Individuals who participate as research subjects (i.e., about whom the investigator maintains identifying information) in the specified research project during any time the Certificate is in effect are protected permanently- even if the subject gave the researcher data before the Certificate is issued.

  4. In what situations may information protected by a Certificate be disclosed? • Voluntary disclosure of information by study participants themselves or any disclosure that the study participant has consented to in writing. • Voluntary disclosure by the researcher of information on such things as child abuse, reportable communicable diseases, possible threat to self or others.

  5. In what situations may information protected by a Certificate be disclosed? • Voluntary compliance by the researcher with reporting requirements of state laws, such as knowledge of communicable disease, etc. • Release of information by researchers to DHHS as required for program evaluation or audits of research records or to the FDA.

  6. What is sensitive information? • sexual attitudes, preferences, or practices; • information relating to the use of alcohol, drugs, or other addictive products; • information pertaining to illegal conduct; • information that might be damaging to an individual's financial standing, employability, or reputation; • information pertaining to an individual's mental health; and • genetic information or tissue samples.

  7. Who Provides COCs? • NIH (FIC, NCCAM, NCI, NCATS, NEI, NHGRI, NHLBI, NIA, NIAAA, NIAID, NIAMS, NICHD, NIDA, NIDCD, NIDCR, NIDDK, NIEHS, NIGMS, NIMH, NINDS, NINR, NLM, Magnuson Clinical Center. • CDC • FDA (CDER, CBER, CDRH, more?) • HRSA • HIS • SAMHSA

  8. Can NIH give a COC to non-federally funded research? • Yes, but… • Ineligible studies include projects that are • not research based, • not approved by an IRB operating under a relevant agency, or • not involving a subject matter that is within a mission area of the National Institutes of Health.

  9. Difficulties • Sometimes the agencies/institutes decide not to issue a COC. • Limited history of legal cases.

  10. Difficulties • Which agency do you go to, especially if not federally funded and not involving an IND or IDE? • Hard to find the right people at some agencies/institutes. • Most agencies require IRB approval of research and consent prior to issuance, so adds another two weeks or up to 2 months after IRB approval. • (NB – The new OHRP guidance on conditional approvals eliminated the dilemma of giving a conditional IRB approval against OHRP policy in order to obtain a COC.)

  11. Difficulties • Multi-site research can be challenging. • For NIH, a coordinating center or lead institution can apply for and receive a Certificate on behalf of all member institutions.  In the application for a Certificate, multi-site applicants must list each participating unit, its address, and project director. New members can be added.

  12. Difficulties • For FDA, sponsor can hold a COC for all sites, but often the sponsors prefer that each site apply individually.

  13. Difficulties • Some agencies/institutes are very demanding as to the description of the COC in the consent form. • For instance, some institutes require removal of the statement “absolute confidentiality cannot be guaranteed,” and other such statements. The agencies/institutes are not consistent on what is unacceptable. • The back and forth between the IRB and agency on this issue can cause more delays.

  14. Difficulties • Some agencies have different processes, particularly DOJ and AHRQ. • DOJ requires a Privacy Certificate under 42 U.S.C. § 3789g for all research, even if minimal risk and not sensitive. • AHRQ has a statute protecting all identifiable information (42 U.S.C. § 299c-3(c)).

  15. Difficulties – Final Slide • COC’s are voluntary, not mandatory. • As a result, applied inconsistently to research where the extra protection is warranted. • Not applied as broadly as they could be. • Sometimes applied to research of low risk, such as tissue banks.

  16. More Information • The best source of information is the NIH “Certificate of Confidentiality Kiosk.” • On-line at http://grants.nih.gov/grants/policy/coc/. • Lots of great information.

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