Human Subject Regulations Decision Charts
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.
- 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
- 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.
- 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?
OPRR February, 1998