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Responsible Research: A Systems Approach to Protecting Research Participants
Continuously Improve Quality
To maximize the strength and efficiency of participant protection functions, the effectiveness and value of program policies and practices should be continuously assessed and improved. Protection programs can use systematic QI analysis tools to determine the underlying causes of shortfalls and develop procedures to eliminate them and improve work processes. The committee, in its first phase of deliberations regarding accreditation, emphasized the need to incorporate QI mechanisms into program performance assessment (IOM, 2001a).
The lack of empiric data on the performance of protection programs, the absence of defined measurable outcomes or other criteria for their ongoing evaluation, and the scant knowledge of approaches and methods by which programs have been improved have hindered efforts to initiate QI measures. Research sponsors should initiate programs and locate funding to develop criteria for evaluating program performance and enhancing QI practices. In doing so, specialists from many disciplines could contribute to a new empiric knowledge base that would inform both the leadership of individual HRPPPs and policy makers.
Recommendation: Research sponsors should initiate research programs and funding support for innovative research that would develop criteria for evaluating program performance and enhancing the practice of quality improvement.(Recommendation 6.2)
As observed in this committee’s first report, accreditation programs represent one promising approach to assessing the protection functions of research organizations in a uniform and independent manner, and may serve as a useful stimulus for QI programs (IOM, 2001a). The committee reiterates its support for pilot testing voluntary accreditation as an approach to strengthening participant protections, but repeats its recommendation that DHHS should arrange for a substantive, independent review and evaluation of HRPPP accreditation before determining its ultimate role in the participant protection system (see Recommendation 6.4).
Manage Potential Conflicts of Interest
Confidence about the current system of participant protection is undermined by the perception that harm to research participants may result from conflicts of interest involving the researcher, the research organization, and/ or the research sponsor. This concern is particularly acute regarding financial conflicts of interest, as the relationships between the academic and private research enterprises continue to evolve. Therefore, mechanisms for identifying, disclosing, and resolving conflicts of interest should be strengthened, especially those involving financial relationships (see Chapter 6).