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Preserving Public Trust Accreditation and Human Research Participant Protection Programs (2001) / Chapter Skim
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4 Evaluating HRPPP Pilot Accreditation Programs
Pages 89-94

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From page 89...
... , to affiliate with larger institutions that have operating HRPPPs, or to stop conducting research altogether. The cessation of research because of an inability to demonstrate that research practices respect the rights and interests of research participants is not necessarily an undesirable effect.
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From page 90...
... , monitor the accreditation pilot programs. Recommendation 10: Begin Collecting Data and Assessing Impacts of Accreditation Now DHHS should commission studies to gather baseline data on the current system of protections for human participants in the research that it oversees and to assess whether the system is improv· — sing over time.
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From page 91...
... Without such an evaluation, Congress and the executive branch will be positioned little better than they are today to make prudent choices about how to improve HRPPPs in 5 years. Research pursued under Recommendation 10 can provide some baseline information, but it cannot substitute for a thorough evaluation of the accreditation pilot projects themselves.
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From page 92...
... The HRPPP accreditation process should be evaluated not only according to whether it has improved protections for human research participants but also according to whether resources devoted to accreditation could be spent to equal or better effect on other ways to improve HRPPP oversight such as education, research monitoring, and improved feedback mechanisms. Evaluation should take into account both the costs of establishing a national accreditation system and the costs to applicant organizations (i.e., both direct and preparatory)
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From page 93...
... Another logical receptor for the OIG and GAO evaluations would be an independent agency to oversee the protection of human participants in research in both the public and the private sectors, if the recommendation of the National Bioethics Advisory Commission to create such an agency is carried out by Congress. In the event that NHRPAC's charter has expired and no independent oversight agency has been formed, then the synthesis of evaluations would have to be carried out by an independent advisory committee created for that purpose or delegated to an existing nongovernmental organization.
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Key Terms

  • accreditation process
  • accreditation pilot
  • accreditation bodies
  • pilot projects
  • human participants

  • site visit
  • accreditation programs
  • research protections
  • research participants
  • hrppp accreditation

  • research monitoring
  • clinical trials
  • protection programs
  • evaluation process
  • commission studies

  • research participant
  • pilot programs
  • national bioethics
  • cost data
  • science experiments

  • nongovernmental organization
  • initiated soon
  • larger institutions
  • independent agency
  • process outside

  • national committee
  • final evaluation
  • institutions conducting
  • similar fee
  • annual maintenance


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