IRB Manual
      5.2 Confidentiality Certificates

5.2.1 Department of Health & Human Services (42 CFR 2a)

DHHS has the authority to issue certificates which provide immunity from subpoena for biomedical, behavioral, clinical or other research (including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs). The research does not have to be funded by DHHS to be eligible.

Certificates will be granted only when the research is of a "sensitive nature where the protection is judged necessary to achieve the research objective".

More information can be found at the DHHS Certificates of Confidentiality Kiosk:

5.2.2 Department of Justice (21 CFR 1316.21)

The Department of Justice may issue certificates which authorize investigators to withhold the names and other identifying information of research subjects when the research relates to the use of drugs or other substances subject to control under the provisions of the Controlled Substances Act (21 CFR 1316.21). To be eligible, research projects do not need to be funded by the Department of Justice. However, they must be of a nature that the Department is authorized to conduct. Applications should be submitted to the Administrator, Drug Enforcement Administration (DEA), Department of Justice.

Department of Justice Law Enforcement Assistance Administration (LEAA) (28 CFR Part 22)

LEAA privacy certifications are restricted to recipients of funds from LEAA and differ from the two types of confidentiality certificates discussed above, in that they impose positive duties and obligations on recipients of funds from LEAA. According to the provisions of the Omnibus Crime Control and Safe Streets Act, no agent of the Federal government or any recipient of assistance under the provisions of the statute may use or reveal any research or statistical information furnished by any person or identifiable to any specific private person for any purpose not specified in the statute. This privacy certification provides immunity from subpoena and penalties for violations including fines of up to $10,000.

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