. "Executive Summary." 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
5.4 Issue a yearly report summarizing the results of research monitoring activities in the United States, including OHRP and FDA findings from inspections conducted the previous year.
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56.108(b)
21 CFR
312.32
5.5 When potential risks to participants warrant high levels of scrutiny, NIH-funded studies should be monitored with the same rigor and scrutiny as trials carried out under an IND.
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21 CFR
312.23
21 CFR
312.53
6.1 Commission studies to gather baseline data on the current national system of protections for research participants.
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6.4 Pilot test and evaluate voluntary accreditation as an approach to strengthening human research participant protections.d
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6.7 Assemble data on the incidence of research injuries and conduct economic analyses of their costs to establish the potential magnitude of claims that would arise under a no-fault compensation system for such injuries.
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7.1 Authorize and appropriate support for a standing independent, multidisciplinary, nonpartisan committee on human research participant protections.
