Literature DB >> 25196592

The Harvard Catalyst Common Reciprocal IRB Reliance Agreement: an innovative approach to multisite IRB review and oversight.

Sabune J Winkler1, Elizabeth Witte, Barbara E Bierer.   

Abstract

Reduction of duplicative Institutional Review Board (IRB) review for multiinstitutional studies is a desirable goal to improve IRB efficiency while enhancing human subject protections. Here we describe the Harvard Catalyst Master Reciprocal Common IRB Reliance Agreement (MRA), a system that provides a legal framework for IRB reliance, with the potential to streamline IRB review processes and reduce administrative burden and barriers to collaborative, multiinstitutional research. The MRA respects the legal autonomy of the signatory institutions while offering a pathway to eliminate duplicative IRB review when appropriate. The Harvard Catalyst MRA provides a robust and flexible model for reciprocal reliance that is both adaptable and scalable.
© 2014 Wiley Periodicals, Inc.

Entities:  

Keywords:  IRB authorization agreement; bioethics; cede review; cooperative agreement; institutional review boards; master IRB agreements; multicenter clinical trials; reliance agreement; reliance agreement models; research ethics

Mesh:

Year:  2014        PMID: 25196592      PMCID: PMC4329026          DOI: 10.1111/cts.12202

Source DB:  PubMed          Journal:  Clin Transl Sci        ISSN: 1752-8054            Impact factor:   4.689


  4 in total

1.  The paradoxical problem with multiple-IRB review.

Authors:  Jerry Menikoff
Journal:  N Engl J Med       Date:  2010-10-13       Impact factor: 91.245

Review 2.  Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform.

Authors:  George Silberman; Katherine L Kahn
Journal:  Milbank Q       Date:  2011-12       Impact factor: 4.911

Review 3.  How do IRB members make decisions? A review and research agenda.

Authors:  Ivor A Pritchard
Journal:  J Empir Res Hum Res Ethics       Date:  2011-06       Impact factor: 1.742

4.  Oversight of human participants research: identifying problems to evaluate reform proposals.

Authors:  Ezekiel J Emanuel; Anne Wood; Alan Fleischman; Angela Bowen; Kenneth A Getz; Christine Grady; Carol Levine; Dale E Hammerschmidt; Ruth Faden; Lisa Eckenwiler; Carianne Tucker Muse; Jeremy Sugarman
Journal:  Ann Intern Med       Date:  2004-08-17       Impact factor: 25.391

  4 in total
  9 in total

1.  Public Comments on the Proposed Common Rule Mandate for Single-IRB Review of Multisite Research.

Authors:  Holly A Taylor; Stephan Ehrhardt; Ann-Margret Ervin
Journal:  Ethics Hum Res       Date:  2019-01

2.  Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study.

Authors:  Elisabeth De Smit; Lisa S Kearns; Linda Clarke; Jonathan Dick; Catherine L Hill; Alex W Hewitt
Journal:  Australas Med J       Date:  2016-02-29

3.  Convergence Despite Divergence: Views of Academic and Community Stakeholders about the Ethics of Community-Engaged Research.

Authors:  Stephanie M Hoover; Shristi Tiwari; Jimin Kim; Melissa Green; Al Richmond; Mysha Wynn; Kyle Simone Nisbeth; Stuart Rennie; Giselle Corbie-Smith
Journal:  Ethn Dis       Date:  2019-04-18       Impact factor: 1.847

4.  Roadmap to a Comprehensive Clinical Data Warehouse for Precision Medicine Applications in Oncology.

Authors:  David J Foran; Wenjin Chen; Huiqi Chu; Evita Sadimin; Doreen Loh; Gregory Riedlinger; Lauri A Goodell; Shridar Ganesan; Kim Hirshfield; Lorna Rodriguez; Robert S DiPaola
Journal:  Cancer Inform       Date:  2017-03-02

5.  Facilitating collaborative animal research: The development and implementation of a Master Reciprocal Institutional Agreement for Animal Care and Use.

Authors:  Kathryn Holthaus; David Goldberg; Carolyn Connelly; Brian Corning; Christina Nascimento; Elizabeth Witte; Barbara E Bierer
Journal:  J Clin Transl Sci       Date:  2020-02-26

6.  Innovation in biosafety oversight: The Harvard Catalyst Common Reciprocal IBC Reliance Authorization Agreement.

Authors:  Rebecca Caruso; Theodore Myatt; Barbara E Bierer
Journal:  J Clin Transl Sci       Date:  2020-02-26

7.  Conducting multicenter research in healthcare simulation: Lessons learned from the INSPIRE network.

Authors:  Adam Cheng; David Kessler; Ralph Mackinnon; Todd P Chang; Vinay M Nadkarni; Elizabeth A Hunt; Jordan Duval-Arnould; Yiqun Lin; Martin Pusic; Marc Auerbach
Journal:  Adv Simul (Lond)       Date:  2017-02-28

8.  The SMART IRB platform: A national resource for IRB review for multisite studies.

Authors:  Nichelle Cobb; Elizabeth Witte; Maria Cervone; Aaron Kirby; Douglas MacFadden; Lee Nadler; Barbara E Bierer
Journal:  J Clin Transl Sci       Date:  2019-07-29

9.  Getting Interdisciplinary Teams into the Field: Institutional Review Board Preapproval and Multi-Institution Authorization Agreements for Rapid Response Disaster Research.

Authors:  Lori Peek; Jennifer Tobin; John W van de Lindt; Anne Andrews
Journal:  Risk Anal       Date:  2021-05-07       Impact factor: 4.000

  9 in total

北京卡尤迪生物科技股份有限公司 © 2022-2023.