Literature DB >> 30744311

Local Knowledge and Single IRBs for Multisite Studies: Challenges and Solutions.

Robert Klitzman1, Ekaterina Pivovarova2, Alexandra Murray3, Paul S Appelbaum4, Deborah F Stiles5, Charles W Lidz6.   

Abstract

New federal policies require single IRB review for multisite studies, but many questions remain about how these IRBs will use local knowledge. The findings from our study, the first to examine how single IRBs perceive needs for local knowledge, reveal several challenges. Study respondents identified four potentially relevant types of local knowledge: about culture and linguistics, about geography and socioeconomics, about the researchers, and about the institutions. Such knowledge can potentially be obtained through local sites, but single IRBs may be unaware of potentially relevant local information, and lack of informal relationships may impede single IRBs' reviews and interactions with researchers. While a recent, commonly used, standardized single-IRB form asks three basic questions about local information, our findings suggest potential needs for additional information and, thus, have important implications for practice, policy, and research.
© 2019 by The Hastings Center. All rights reserved.

Entities:  

Keywords:  Common Rule; human subjects research; local IRBs; multisite studies; research ethics; single IRBs

Mesh:

Year:  2019        PMID: 30744311      PMCID: PMC9205159          DOI: 10.1002/eahr.500003

Source DB:  PubMed          Journal:  Ethics Hum Res        ISSN: 2578-2355


  6 in total

1.  Scientists behaving badly.

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

2.  Normal Misbehavior: Scientists Talk about the Ethics of Research.

Authors:  Raymond de Vries; Melissa S Anderson; Brian C Martinson
Journal:  J Empir Res Hum Res Ethics       Date:  2006-03       Impact factor: 1.742

3.  Learning health care systems and justice.

Authors:  Ruth R Faden; Tom L Beauchamp; Nancy E Kass
Journal:  Hastings Cent Rep       Date:  2011 Jul-Aug       Impact factor: 2.683

Review 4.  Use of central institutional review boards for multicenter clinical trials in the United States: a review of the literature.

Authors:  Devon K Check; Kevin P Weinfurt; Carrie B Dombeck; Judith M Kramer; Kathryn E Flynn
Journal:  Clin Trials       Date:  2013-05-10       Impact factor: 2.486

5.  The participation of community members on medical institutional review boards.

Authors:  Charles W Lidz; Lorna J Simon; Antonia V Seligowski; Suzanne Myers; William Gardner; Philip J Candilis; Robert Arnold; Paul S Appelbaum
Journal:  J Empir Res Hum Res Ethics       Date:  2012-02       Impact factor: 1.742

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

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

  6 in total
  5 in total

1.  Key lessons and strategies for implementing single IRB review in the Trial Innovation Network.

Authors:  Ann R Johnson; Megan Kasimatis Singleton; Julie Ozier; Emily Serdoz; Jennifer G Beadles; Janelle Maddox-Regis; Sarah Mumford; Jeri Burr; J Michael Dean; Daniel E Ford; Gordon R Bernard
Journal:  J Clin Transl Sci       Date:  2022-04-19

2.  The IRB Reliance Exchange (IREx): A national web-based platform for operationalizing single IRB review.

Authors:  Emily Sheffer Serdoz; Terri Edwards; Jill Pulley; Jenni Beadles; Julie Ozier; Paul Harris; Gordon R Bernard; Todd W Rice
Journal:  J Clin Transl Sci       Date:  2022-03-23

3.  When IRBs Say No to Participating in Research about Single IRBs.

Authors:  Robert Klitzman; Paul S Appelbaum; Alexandra Murray; Ekaterina Pivovarova; Deborah F Stiles; Charles W Lidz
Journal:  Ethics Hum Res       Date:  2020-01

4.  Pediatric specific challenges of the single institutional review board mandate.

Authors:  Andrew Hu; Jane L Holl; Mehul V Raval
Journal:  Trials       Date:  2022-03-21       Impact factor: 2.279

5.  The status of central ethical reviewing and challenges regarding its introduction to non-interventional studies in Japan.

Authors:  Yoshihiko Iijima; Tadao Takano; Toshinori Murayama
Journal:  Nagoya J Med Sci       Date:  2021-05       Impact factor: 1.131

  5 in total

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