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Responsible Research A Systems Approach to Protecting Research Participants (2003) / Chapter Skim
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Appendix A: Data Sources and Methods
Pages 231-235

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From page 231...
... . In order to gather information for that report, the committee held several open meetings and invited public comment on the draft accreditation standards presented to the committee by Public Responsibility in Medicine and Research (PRIMER)
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From page 232...
... . During the August meeting, the presentations covered a variety of topics including the HRPPP system, the role of the pharmaceutical industry and of contract research organizations in protecting human research participants, federal regulations and their legal implications, informed consent processes, international research trials, National Bioethics Advisory Committee recommendations, Institutional Review Board (IRB)
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From page 234...
... The first call, held in January 2002, involved members of the IRB community, including IRB administrators and board members. The individual call participants were identified largely in consultation with the Applied Research Ethics National Association in order to gather a group representative of a variety of research organizations and disciplines.
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From page 235...
... The committee maintained information about the materials in a database that allowed the committee to search for items by keywords or other criteria. The materials provided to the committee addressed a large variety of topics including information about IRBs; informed consent procedures; federal regulations and compliance problems; the roles of industry, contract research organizations, participants, and other stakeholders in the research enterprise; the problems within the current protection system; the ethics of research involving humans; conflicts of interest; accreditation; regulatory costs; safety monitoring; multisite research; and a number of other topics.
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  • topics including

  • preserving public
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  • citizen advocacy
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  • bioethics advisory
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  • involving humans
  • fda policies

  • ohrp compliance
  • consent procedures
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  • november public
  • individual call


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