The National Institutes of Health (NIH) and the Food and Drug Administration (FDA) issue Certificates of Confidentiality (CoC) to protect identifiable research information from forced disclosure. A CoC allows an investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.
Certificates can be used for biomedical, behavioral, clinical, or other types of research that are sensitive. In sensitive research, disclosure of identifying information could have adverse consequences for research participants or damage their financial standing, employability, insurability, or reputation.
Examples of sensitive research activities include, but are not limited to, collection of the following:
· Genetic information
· Information on psychological well-being of participants
· Information on participants' sexual attitudes, preferences or practices
· Data on substance abuse or other illegal risk behaviors
In general, CoCs are issued for single, well-defined research projects, rather than groups or classes of projects. In some instances, they can be issued for cooperative multi-site projects. A coordinating center or "lead" institution designated by the NIH program officer may apply on behalf of all institutions associated with the multi-site project. The lead institution must ensure that all participating institutions conform to the application assurances and inform participants appropriately about the CoC, its protections, and the circumstances in which voluntary disclosures would be made.
Information on COC is available on the NIH web site at the COC Kiosk. The Kiosk includes background information on Certificates, application instructions, frequently asked questions, information on communicable disease reporting policies, and a list of contacts.
The Food and Drug Administration handles requests for Certificate of Confidentiality protection for studies that obtain an Investigational New Drug (IND) authorization or other FDA authorization. The FDA’s certificate of confidentiality application form asks some questions not asked in the NIH form and requires different assurances. For more information, see, http://www.grad.wisc.edu/hrpp/10245.doc.
Projects with INDs or IDEs should apply to the FDA (Kevin Prohaska, D.O., M.P.H., Captain, U.S. Public Health Service Corps, Medical Officer, Division of Scientific Investigations, kevin.prohaska@fda.hhs.gov, 301-796-3707 OR Patricia Holobaugh, Bioresearch Monitoring Branch, HFM-664, Center for Biologics Evaluation and Research, patricia.holobaugh@fda.hhs.gov, 301-827-6347).
The following are links to Microsoft Word documents: