Proposed Revisions to the Common Rule Perspectives of Social and Behavioral Scientists: Workshop Summary (2013) / Chapter Skim
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Session 5: Multisite and Multidisciplinary Studies
Session 5: Multisite and Multidisciplinary Studies
Pages 61-72
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From page 61... ...
A SINGLE IRB FOR MULTISITE RESEARCH Pearl O'Rourke, of the Partners HealthCare System in Boston and Harvard Medical School, discussed the benefits and challenges of using a single IRB for multisite research and described her experience with such a 61
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From page 62... ...
The original National Cancer Institute IRB falls somewhere in the middle, she added, because the central IRB would do the initial review, but local IRBs reviewed local site amendments and local adverse events that were not too severe. In another type of share model, the IRBshare, there is "a sharing of documentation and review of what happened at the initial review, but basically everything reverts back to the local IRB once the protocol is up and running," she explained.
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From page 63... ...
In the nonshare model of a central IRB, the central IRB would be responsible for all IRB review tasks, including the initial review, continuing review, amendments, and so on, and might also be responsible for the Health Insurance Portability and Accountability Act (HIPAA) issues.
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From page 64... ...
NeuroNEXT uses a nonshare model, with the central IRB conducting all IRB reviews. Before any protocol, each network site had to sign a reliance agreement with the central IRB, which sets forth the process of the central IRB review and assigns legal, regulatory, and contractual responsibilities.
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From page 65... ...
In closing, O'Rourke said that mandating a single IRB for all multisite research would be "unconscionable." The ANPRM does not provide details about how the single-IRB approach would be carried out, she said, nor does it adequately suggest the complexities involved and the resources required both for being the central IRB and for relying on a central IRB. Those who play the role of a central IRB in a multisite study should not underestimate the time required for development, the startup and long-term costs of the central IRB infrastructure, the confusion that can result from differences in the ways institutions allocate responsibilities to the institution and the IRB, and the critical role that trust and familiarity play in the development and negotiation of IRB reliance relationships.
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From page 66... ...
They are practices that can improve review for social science research and research participants even if the proposed changes to the Common Rule are not carried out. Study Networks In the study network approach, large, well-funded organizations review all of the studies that are attached to common research initiatives.
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From page 67... ...
Two limitations affect study networks, Stark noted: liability and money. To reap the benefits of a network study, such as reduced administrative load and more consistent decisions, local boards must largely defer to the decisions made by study networks.
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From page 68... ...
Decision repositories can help widen the horizon of IRBs with low turnover rates and help remind IRBs with high turnover rates of what decisions have been made in the past. Publicly accessible decision repositories would also help researchers interact more
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From page 69... ...
The study received informed consent from approximately 200,000 people, using various forms of consent. Although international research is not addressed in the proposed changes to the Common Rule, Coates noted, the implications of these issues are vast, and they are in some ways similar to those of other issues addressed by the workshop speakers.
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From page 70... ...
Though most of his examples concerned biomedical research, Coates noted that many studies now blend behavioral, social, and biomedical research. The proposed changes in the Common Rule seem to be based on the assumption that the social and behavioral studies are completely separate from biomedical studies.
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From page 71... ...
He suggested that adverse event reporting systems, even for social and behavioral studies, should be designed to address issues arising in international studies and should be multinational. He also said that enhanced and simplified consent procedures would be useful and important, particularly for written consent.
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From page 72... ...
72 PROPOSED REVISIONS TO THE COMMON RULE REFERENCE Stark, L
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