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Preserving Public Trust Accreditation and Human Research Participant Protection Programs (2001) / Chapter Skim
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Pages 53-56

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From page 53...
... Accreditation as a mark of excellence of achievement well beyond regulatory compliance might offer an HRPPP a competitive advantage over nonaccredited competitors in seeking support from sponsors or access to participants, researchers, or students. That is, NIH or other funding review committees might look more favorably on research proposals from accredited institutions than on those from nonaccredited ones, those recruiting participants might advertise accreditation as a hallmark of quality and safety, or private drug and device firms might preferentially site clinical trials that they sponsor at accredited research institutions (or have them reviewed by accredited IRBs)
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From page 54...
... and independent investigation and enforcement capacity if violations are alleged or documented and would periodically need to "accredit the accreditors," as in other deemedstatus accreditation models. However, before the usefulness of this approach can be assessed in the case of HRPPP accreditation, an accreditation programs will need to be much further along in its development.
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From page 55...
... of such a program. Testimony that the committee heard from representatives of the FDA and OHRP left it uncertain about whether the draft accreditation standards are seen as supplementing a regulatory program that will continue largely as is or as providing an alternative means of oversight, with federal agencies "deeming" accredited HRPPPs to be in compliance and thus reducing federal inspections and audits of accredited institutions.
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From page 56...
... The regulations are demonstrably unresponsive to dramatic changes in how research is conducted; a nongovernmental accreditation system may be more responsive by comparison and would comport with Circular A-119 of the Office of Management and Budget, which urges the use of nongovernmental "voluntary consensus standards" where possible (OMB, 1998~.~° The committee envisions an accreditation process that will continually evolve to update standards over time and to incorporate the variety of organizational structures through which human research programs are reviewed and carried out. The operations of organizations seeking accreditation will also evolve.
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Key Terms

  • human research
  • accreditation process
  • accreditation standards
  • research participants
  • clinical trials

  • research proposals
  • human participants
  • accreditation programs
  • research proposal
  • pilot testing

  • nongovernmental accreditation
  • dhhs oig
  • subsequent report
  • accredited institutions
  • regulatory framework

  • research institution
  • seeking accreditation
  • organizations formulating
  • research participant
  • organizations seeking

  • participant protection
  • accreditation processes
  • clinical trial
  • accreditation organizations
  • accreditation organization

  • common rule
  • national accreditation
  • appeals process
  • regulatory minimum
  • regulatory program


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