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Responsible Research: A Systems Approach to Protecting Research Participants
6.2 Initiate research programs and funding support for innovative research that would develop criteria for evaluating program performance and enhance the practice of quality improvement.
6.3 Include an accreditation standard directed at establishing and identifying accountability for specific protection functions.
6.4 Pilot test and evaluate voluntary accreditation as an approach to strengthening human research participant protections.
6.5 Ensure prospective, in-depth review of potential individual financial conflicts of interest.
42 CFR 50
21 CFR 54
45 CFR 46.116
6.6 Establish an external mechanism to review potential institutional conflicts of interest.
6.8 Compensate any research participant who is injured as a direct result of participating in research, without regard to fault. Include compensation for research-related injury as a requirement of accreditation.c