Responsible Research A Systems Approach to Protecting Research Participants (2003) / Chapter Skim
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Appendix C: Clarifying Protocol Accountability
Appendix C: Clarifying Protocol Accountability
Pages 249-262
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From page 249... ...
to facilitate the tracking of human research participant protection in the context of the protocol-specific program unit. Such a template can be adapted to suit various research paradigms and institutional needs and may be most useful as an electronic, Web-based application that guides investigators preparing Research Ethics Review Boardi (Research ERB)
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Because it is not possible to include all possible collaborative arrangements among clinical investigators, private industry, and federal or private funding sources, these scenarios attempt to embrace a range of illustrative potential collaborative relationships. When an HRPPP is assembled to review and monitor any given protocol, accountability for the required participant protection functions must be clear.
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An external oversight committee established by MUA carries out a similar review examining potential institutional conflicts of interest. The ethical research review is performed by the MUA's Research ERB.
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NIH funding will cover patient care and travel costs as well as the cost of the investigators and their research staff to conduct the trial; the company will provide the drug and placebo free of charge. The company also is providing medical coverage for unanticipated AEs related to study conduct (indemnification)
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The pharmaceutical company initially conducts the scientific review, and subsequently, the independent Research ERB establishes an ad hoc scientific review board. Financial conflict of interest review of the investigators and their institutions is provided by the Conflict of Interest Office of the CRO, which requests financial disclosure statements from all investigators and relevant research organizations (i.e., the clinic through which an investigator will conduct the research)
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Each investigator must meet with his or her own institutional Research ERBs to ascertain whether he or she will accept the independent Research ERB review or will also conduct a subsequent review. Because the study involves computed tomography imaging, a separate Radiation Safety Committee is established by the independent Research ERB.
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C Protocol Review Process Scientific review of the study was conducted by NIH and the GAC at each participating academic institution.
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The ethical review was initially conducted by the Research ERB of the PI's institution. Most other participating institutions followed the recommendations of the primary Research ERB, although some institutions conducted their own reviews The investigator submitted the proposal to the Recombinant DNA Advisory Committee (RAC)
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APPENDIX C 257 ment expenses. The biotechnology company supported all vector production, laboratory assays, and indemnification of sites.
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PROTOCOL DEVELOPMENT Applicable? If yes, please identity responsible party.
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If yes, please identify responsible party. Internal (e.g., GCRC Advisory Committee, Scientific Review Committee)
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volunteer Y / N Y / N Y / N ONGOING MONITORING DURING STUDY CONDUCT Applicable? If yes, please identify responsible party.
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261 Y / N Y / N DATA MANAGEMENT AND ANALYSES/ DISSEMINATION OF STUDY REPORTS Please identify responsible party.
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SIGNATURES I have reviewed this Accountability Template and attest that the correct individuals are identified in each category. Signed, HRPPP Official (Head of research organization or sponsors, as applicable)
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