Literature DB >> 21871046

Views and experiences of IRBs concerning research integrity.

Robert Klitzman1.   

Abstract

Institutional Review Boards (IRBs) can play vital roles in observing, monitoring, and responding to research integrity (RI) issues among researchers, yet many questions remain concerning whether, when, and in what ways these boards adopt these roles. I contacted 60 IRBs (every fourth one in the list of the top 240 institutions by NIH funding), and interviewed leaders from 34 (response rate=55%), and an additional 12 members and administrators. IRBs become involved in a variety of RI problems, broadly defined, and face challenges in deciding how and when to do so. IRBs vary in how they define, discover, and respond to RI problems, and interact with other institutional offices concerning these issues; and what types of RI violations they encountered. While many institutions establish separate Compliance Offices, the boundaries and relationships between these entities and IRBs vary; and many IRBs discover and monitor RI violations, and struggle with how to respond. Larger questions arise of how IRBs decide whether to trust vs. closely monitor individual PIs. IRBs' roles are often indirect, and not fully systematic, raising questions of whether these functions should be enhanced, and if so, to what degree, and how. These areas require heightened investigation and discussion.
© 2011 American Society of Law, Medicine & Ethics, Inc.

Entities:  

Mesh:

Year:  2011        PMID: 21871046      PMCID: PMC3551536          DOI: 10.1111/j.1748-720X.2011.00618.x

Source DB:  PubMed          Journal:  J Law Med Ethics        ISSN: 1073-1105            Impact factor:   1.718


  17 in total

1.  The IRB's monitoring function: four concepts of monitoring.

Authors:  Erica J Heath
Journal:  IRB       Date:  1979 Aug-Sep

2.  Characteristics of medical school faculty members serving on institutional review boards: results of a national survey.

Authors:  Eric G Campbell; Joel S Weissman; Brian Clarridge; Recai Yucel; Nancyanne Causino; David Blumenthal
Journal:  Acad Med       Date:  2003-08       Impact factor: 6.893

3.  Scientists behaving badly.

Authors:  Brian C Martinson; Melissa S Anderson; Raymond de Vries
Journal:  Nature       Date:  2005-06-09       Impact factor: 49.962

Review 4.  A review finds that multicenter studies face substantial challenges but strategies exist to achieve Institutional Review Board approval.

Authors:  Sarah M Greene; Ann M Geiger
Journal:  J Clin Epidemiol       Date:  2006-03-15       Impact factor: 6.437

5.  The IRB paradox: could the protectors also encourage deceit?

Authors:  Patricia Keith-Spiegel; Gerald P Koocher
Journal:  Ethics Behav       Date:  2005

6.  Responding to fraud.

Authors:  Donald Kennedy
Journal:  Science       Date:  2006-12-01       Impact factor: 47.728

7.  Breaking the camel's back: multicenter clinical trials and local institutional review boards.

Authors:  W J Burman; R R Reves; D L Cohn; R T Schooley
Journal:  Ann Intern Med       Date:  2001-01-16       Impact factor: 25.391

8.  Evaluation of the research norms of scientists and administrators responsible for academic research integrity.

Authors:  S G Korenman; R Berk; N S Wenger; V Lew
Journal:  JAMA       Date:  1998-01-07       Impact factor: 56.272

9.  Updating protections for human subjects involved in research. Project on Informed Consent, Human Research Ethics Group.

Authors:  J Moreno; A L Caplan; P R Wolpe
Journal:  JAMA       Date:  1998-12-09       Impact factor: 56.272

10.  How local IRBs view central IRBs in the US.

Authors:  Robert Klitzman
Journal:  BMC Med Ethics       Date:  2011-06-23       Impact factor: 2.652

View more
  17 in total

1.  Institutional review board community members: who are they, what do they do, and whom do they represent?

Authors:  Robert Klitzman
Journal:  Acad Med       Date:  2012-07       Impact factor: 6.893

2.  How good does the science have to be in proposals submitted to Institutional Review Boards? An interview study of Institutional Review Board personnel.

Authors:  Robert Klitzman
Journal:  Clin Trials       Date:  2013-09-02       Impact factor: 2.486

3.  How IRB leaders view and approach challenges raised by industry-funded research.

Authors:  Robert Klitzman
Journal:  IRB       Date:  2013 May-Jun

4.  Views of IRBs Concerning their Local Ecologies: Perceptions of Relationships, Systems, and Tensions between IRBs and their Institutions.

Authors:  Robert Klitzman
Journal:  AJOB Prim Res       Date:  2013-01-01

5.  How IRBs view and make decisions about consent forms.

Authors:  Robert L Klitzman
Journal:  J Empir Res Hum Res Ethics       Date:  2013-02       Impact factor: 1.742

6.  Legal and ethical values in the resolution of research-related disputes: how can IRBS respond to participant complaints?

Authors:  Kristen Underhill
Journal:  J Empir Res Hum Res Ethics       Date:  2014-02       Impact factor: 1.742

7.  How US institutional review boards decide when researchers need to translate studies.

Authors:  Robert Klitzman
Journal:  J Med Ethics       Date:  2013-03-08       Impact factor: 2.903

8.  How IRBs view and make decisions about coercion and undue influence.

Authors:  Robert Klitzman
Journal:  J Med Ethics       Date:  2012-09-14       Impact factor: 2.903

9.  How IRBs view and make decisions about social risks.

Authors:  Robert L Klitzman
Journal:  J Empir Res Hum Res Ethics       Date:  2013-07       Impact factor: 1.742

10.  The Myth of Community Differences as the Cause of Variations Among IRBs.

Authors:  Robert Klitzman
Journal:  AJOB Prim Res       Date:  2011
View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.