. "6 Improving Human Research Participant Protection Program Performance and Clarifying Roles." Responsible Research: A Systems Approach to Protecting Research Participants. Washington, DC: The National Academies Press, 2002.
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Responsible Research: A Systems Approach to Protecting Research Participants
BOX 6.4 Association for the Accreditation of Human Research Protection Programs: Principles for Accreditation of Human Research Protection Programs
Regulatory compliance is a minimal expectation for a Human Research Protection Program.
Protecting the rights and welfare of human research participants must be a research organization’s first priority. Beyond assessing compliance with applicable regulations, accreditation standards should promote a research environment where ethical, productive investigation is valued.
Accreditation must approach the Human Research Protection Program from a broad organizational perspective, moving beyond a narrow focus upon Institutional Review Board (IRB) operations to examine whether policies and procedures of the organization as a whole result in a coherent, effective scheme for the protection of human research participants.
The accreditation process should be flexible and responsive to changes in federal and state regulation of research. The accreditation process must also accommodate continuing evolution of the standards in response to growing experience in their application across the multiple disciplines and settings in which research involving human participants takes place.
Accreditation should primarily be an educational process involving collegial discussion and the provision of constructive feedback. The accreditation process must identify areas in which a Human Research Protection Program does not yet meet established standards, and it should afford inspected organizations the opportunity to discuss potential program improvements.
Standards should be performance-based, assessed through an evaluation scheme that is sufficiently detailed to support the accreditation process, yet capable of effective and efficient implementation. Program evaluation should result in a grade of pass or fail for each standard, but should also include commendations or recommendations for meeting standards, as appropriate.
Standards should be applicable to Human Research Protection Programs across the full range of settings (e.g., university-based biomedical, behavioral and social science research, independent review boards, government agencies, and others). Standards should address any special concerns (e.g., the use of vulnerable populations or heightened risk to privacy and confidentiality) that may arise in each setting.
The accreditation process should provide a clear, understandable pathway to accreditation, along with equally clear pathways for appeal and the remediation of identified shortcomings.
Standards should promote the development and implementation of outcome measures that can provide a basis for demonstrating quality improvement over time.