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OHRP Guidance – Coded Private Information and Biological Specimens

Office for Human Research Protections (OHRP)

Department of Health and Human Services (HHS)

Guidance on Research Involving Coded Private Information or Biological Specimens

Date:

August 10, 2004

Scope:

This document applies to research involving coded private information or human biological specimens (hereafter referred to as “specimens”) that is conducted or supported by HHS. This document does the following:
(1) Provides guidance as to when research involving coded private information or specimens is or is not research involving human subjects, as defined under HHS regulations for the protection of human research subjects (45 CFR part 46).

(2) Reaffirms OHRP policy (see OHRP guidance on repository activities and research on human embryonic stem cells) that, under certain limited conditions, research involving only coded private information or specimens is not human subjects research.

(3) Clarifies the distinction between (a) research involving coded private information or specimens that does not involve human subjects and (b) human subjects research that is exempt from the requirements of the HHS regulations.

(4) References pertinent requirements of the HIPAA Privacy Rule that may be applicable to research involving coded private information or specimens.
NOTE: Some HHS conducted or supported research involving coded private information or specimens may be subject to Food and Drug Administration (FDA) regulations. The FDA regulatory definitions of human subject (21 CFR 50.3(g), 21 CFR 56.102(e)) and subject (21 CFR 312.3(b), 21 CFR 812.3(p)) differ from the definition of human subject under HHS regulations at 45 CFR 46.102(f). This guidance document does not apply to research regulated by FDA that involves coded private information or specimens. Anyone needing guidance on such FDA-regulated research should contact the FDA.

Target Audience:

Institutional review boards (IRBs), investigators, and funding agencies that may be responsible for review or oversight of human subjects research conducted or supported by HHS.

Background:

HHS regulations define research at 45 CFR 46.102(d) as follows:
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