Human Subject Federal Regulations
The Office for Protection from Research Risks (OPRR) provides the following graphic
aids to clarify portions of the Department of Health and Human Services (DHHS)
human subject regulations at
Title 45 Code of Federal Regulations Part 46 (45
CFR 46). These portions of the regulations are the subjects of frequent inquires
to OPRR.
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Chart 1: Definition of Human Subject at Section 46.102(f)
Is the definition of "human subject" at Section 46.102(f) met
in this research activity?
_________________________
1That is, the identity of the subject is or may readily be ascertained
or associated with information. OPRR 10/01/98
- Chart 2: Exemption at Section
46.101(b)(4) regarding research involving the collection or study of existing
data, documents, records, pathological specimens, or diagnostic specimens.
Is the research exempt in accordance with Section 46.101(b)(4)? The regulations at
45 CFR Part 46 do not apply if the criteria for exemption under Section 46.101(b)(4)
are met.
_________________________
1"Existing" means collected (i.e., on
the shelf) prior to the research for a purpose other than the proposed research.
It includes data or specimens collected in research and nonresearch activities.
OPRR 10/01/98
- Chart 3: Waiver or Alteration of Informed Consent under
Section 46.116(d).
Can the Institutional Review Board employ Section 46.116(d)
to waive informed consent or alter informed consent elements?
