Managing Local Precedents in Multisite Studies: Challenges and Approaches
Explore the challenges faced in managing local precedents in multisite, multidisciplinary studies, as discussed by Professor Laura Stark. Issues such as variations in IRB reviews and the importance of local precedents are examined, alongside three models for study networks and collegial review. The focus is on understanding the merits of different models and priorities in revising regulations under 45CFR46.
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Managing local precedents Three models Challenges of multisite, multidisciplinary studies National Academies of Science 22 March 2013 Professor Laura Stark Center for Medicine, Health & Society Vanderbilt University laura-stark.com laura.stark@vanderbilt.edu
Managing local precedents Issue Local precedents Approaches Three models Questions Merits of models; priorities in revising regulations
The issue ANPRM In many cases, a local IRB for each institution does independently review the research protocol, informed consent documents and other materials, sometimes resulting in hundreds of reviews for one study. When any one of these IRBs requires changes to the research protocol that are adopted for the entire study, investigators must resubmit the revised protocol to all of the reviewing IRBs. This process can take many months and can significantly delay the initiation of research projects. Separately, there are reports showing that there can be widely differing outcomes regarding the level of review required from IRB to IRB, even for identical studies. HHS, 2011
The issue Local precedents Definition Past decisions that guide board members evaluations of subsequent research (Stark 2012) Consequences Faster decisions, internal consistency Board-specific idiosyncracies
Managing local precedents Issue Local precedents Approaches Three models
Approaches Three models Study networks
Approaches Three models Study networks Collegial review
Approaches Three models Study networks Collegial review Decision repositories
Managing local precedents Issue Local precedents Approaches Three models Study networks Collegial review Decision repositories Questions What are the relative merits of the three models? What are highest priorities in revising in 45CFR46?
Managing local precedents Three models Challenges of multisite, multidisciplinary studies National Academies of Science 22 March 2013 Professor Laura Stark Center for Medicine, Health & Society Vanderbilt University laura-stark.com laura.stark@vanderbilt.edu
