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
  with information.
  
  OPRR 10/01/98

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• 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

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• 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