Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (2001)
Chapter: REVIEW OF AVAILABLE DRAFT STANDARDS
they review research protocols sponsored by external sources. The ICH-GCP guidelines provide a useful starting point, although they are narrowly focused on clinical trials.
Accreditation of HRPPPs could leave the responsibilities of research sponsors outside the accreditation framework but not necessarily outside the scope of regulation by the FDA or OHRP. FDA regulations, for example, place the mantle of responsibility for the ethical conduct of research on sponsors, and the ICH-GCP guidelines have a section devoted to sponsor responsibilities. For clinical trials of drugs, devices, and other products subject to FDA regulation, FDA staff would continue to hold sponsors accountable by site visits, audits, investigation, enforcement, and other activities already performed by agency staff. Sponsors may continue to be liable if they do not make reasonable efforts to determine whether participant protection systems are in place at research institutions where they are conducting research. Similarly, accreditation bodies should develop standards by which HRPPPs should determine the acceptability of funding from a given source.
The other alternative is to consider the research units within sponsoring organizations as the logical unit for accreditation, but this would require an entirely new framework and would entail accreditation of dozens of pharmaceutical firms, hundreds of biotechnology firms, and many federal agencies that directly sponsor research. This framework diverges sharply from the accreditation models proposed to the committee.
To address the role of sponsors, standards could include the following:
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The sponsor is responsible, where applicable, for implementing and maintaining quality assurance and control systems to ensure that studies are generated and documented in compliance with the protocol and applicable regulatory requirements.
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The sponsor should ensure that the peer review and design components of funded protocols meet the highest standards and that efforts are made to use the least number of participants possible while maintaining statistical relevance.
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The sponsor should ensure that the research team is appropriately trained and qualified to conduct the research.
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The sponsor should permit disclosure of the financial interests that investigators have in a research project as a result of the funding received for that project.
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The sponsor is responsible for reporting to all concerned investigators, institutions, and regulatory authorities any adverse events resulting from research studies.
REVIEW OF AVAILABLE DRAFT STANDARDS
The two draft sets of standards reviewed by the committee represent an initial step in constructing an accreditation system. However, standards are only as
