Summary of IOM recommendations according to the three implementation phases of an accreditation process
Development of an accreditation program:
Recommendation 1 — Pursue accreditation through pilot testing as one approach.
Recommendation 2 — Establish a nongovernmental accreditation organization(s).
Recommendation 5 — Accommodate distinct research methods and models within accreditation programs.
Recommendation 8 — Directly involve research participants in accreditation programs and human research participant protection programs.
Development of standards:
Recommendation 3 — Articulate sound goals within accreditation standards.
Recommendation 4 — Establish flexible, ethics-based, and meaningful standards.
Recommendation 6 — Base standards on existing regulations.
Recommendation 7 — Incorporate quality improvement mechanisms into standards.
Recommendation 9 — Use modified NCQA standards to initiate pilot programs.
Development of an evaluation process:
Recommendation 10 — Begin collecting data and assessing impacts of accreditation now.
Recommendation 11 — Initiate federal studies evaluating accreditation.
Source: Preserving Public Trust: Accreditation and Human Research Participant Protection Programs, Committee on Assessing the System for Protecting Human Research Subjects, Board on Health Sciences Policy, Institute of Medicine, Washington, DC, 2001.
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