TABLE 3-1Elements in Three Sets of Standards and Guidelines

Organization Developing the Standard or Guideline
Key ElementsPRIM&RNCQAICH
Intended useStandardsStandardsGuidelines
Targeted sites or bodiesResearch institutions (U.S.)VA facilitiesOrganizations conducting clinical trials of drugs
Foundational principlesThe Belmont ReportaThe Belmont ReportDeclaration of Helsinkib
Regulatory relevanceImplied45 CFR46, 21 CFR 50 and 56, and VA regulations are the starting points (cross-referenced)Drug approval regulations in the European Union, Japan, and the United States
Components affected
  • Organizations
  • IRBs
  • Investigators and other personnel
  • HRPPs
  • Institutions
  • IRBs
  • Investigators
  • IRBs or ethics review committee
  • Investigators
  • Sponsors
Link to quality improvement program?NoYesNo
Standards for participant involvement (beyond consent)?NoNoNo
Standards for sponsors?NoNocYes
Standards for monitoring?Limited, one mention in one documentation standardYesYes
a
b
c

NCQA standards are written for research conducted in VA facilities. For research conducted at VA facilities but sponsored by external sources (e.g., National Institutes of Health; the U.S. Department of Defense; or pharmaceutical device, or biotechnology firms), additional sponsor provisions, such as written aggrement to abide by ICH-GCP guidelines would be needed.

From: 3, Standards for Accreditation

Cover of Preserving Public Trust
Preserving Public Trust: Accreditation and Human Research Participant Protection Programs.
Institute of Medicine (US) Committee on Assessing the System for Protecting Human Research Subjects.
Washington (DC): National Academies Press (US); 2001.
Copyright © 2001, National Academy of Sciences.

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