Managing local precedents Three models Challenges of multisite, - - PowerPoint PPT Presentation

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Mar 15, 2024 176 likes •303 views

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

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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

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Sander State IRB Greenly IRB Adams Medical Duration of observations 12 months 12 months 5 months Meeting(s) per month 1 1 2 New full-board protocols in period* 40 20 60 Number of IRB members Community members 2 2 2 Faculty and administrators 12 11 9 IRBs Observed

Behind Closed Doors: IRBs and the Making of Ethical Research University of Chicago Press, 2012

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Managing local precedents

Issue

Local precedents

Approaches

Three models

Questions

Merits of models; priorities in revising regulations

Laura Stark

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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…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

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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

Laura Stark

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Managing local precedents

Issue

Local precedents

Approaches

Three models

Laura Stark

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Approaches

Three models

Study networks

Laura Stark

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Approaches

Three models

Study networks
Collegial review

Laura Stark

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Approaches

Three models

Study networks
Collegial review
Decision repositories

Laura Stark

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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?

Laura Stark

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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