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.

 

X

 

X

X

 

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.

 

X

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.

 

X

 

6.4 Pilot test and evaluate voluntary accreditation as an approach to strengthening human research participant protections.d

 

X

 

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.

 

X

 

7.1 Authorize and appropriate support for a standing independent, multidisciplinary, nonpartisan committee on human research participant protections.

X

 



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