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Preserving Public Trust: Accreditation and Human Research Participant Protection Programs
Accreditation standards start from a base of regulations governing research with humans. The regulations, in turn, are based on a set of principles for the ethical conduct of research (see Recommendation 4). The standards proposed by NCQA are tightly coupled to the existing federal regulations, but they also incorporate quality improvement processes that could evolve into a different set of standards over time. The NCQA strategy will therefore focus first on facilitating compliance with existing regulations but, importantly, will provide a means to raise the quality of protection standards over time. By using standards that emphasize processes of continual quality improvement instead of an exclusive focus on regulatory compliance, the way may be open to the development of future standards that center on HRPPP performance, in addition to the current focus on documentation. For example, an HRPPP that demonstrates that it can ensure informed consent because it has data showing that participants understand the protocols in which they are enrolled could begin to supplant or augment paper audits of signed informed-consent forms. This strategy therefore has the potential to introduce the desired flexibility and focus on outcomes into the oversight system.
Accreditation will not be successful until it is widely accepted as a mark of excellence. It should also serve as an educational tool to raise the median overall performance. To do this, accreditation standards and the processes in which they will be used must incorporate consistent feedback from the parties involved in the various aspects of an HRPPP. Those who encounter problems in the research system —participants or people who care about them, investigators submitting research for review by an IRB, institutions negotiating agreements to perform sponsored research, anyone who notices something going awry in the course of a study, or data safety and monitoring boards that note a pattern in reported adverse events—need simple, consistent ways to bring their concerns to light. In addition, they need ways to bring relevant information into the procedure for the review of the process, including the functioning of both the HRPPP system and the accreditation process.
One of the chief advantages of a voluntary nongovernmental accreditation system over a mandatory government process is that it can evolve over time without requiring new federal regulations at each step. It took 10 years for 18 agencies to adopt the federal Common Rule governing human research (45 CFR 46, Subpart A), and at least 3 agencies that conduct human research remain outside of the rule.8 The current regulatory system is demonstrably unresponsive to dramatic changes in how research is conducted; a nongovernmental accreditation
OPRR noted three agencies that appeared to sponsor research with human participants but that were not signatories to the Common Rule: the National Endowment for the Humanities, the U.S. Department of Labor, and the Nuclear Regulatory Commission, as cited in a draft report forthcoming from the National Bioethics Advisory Committee (NBAC, forthcoming-b).