Literature DB >> 21079221

Streamlining ethical review.

Joseph Millum1, Jerry Menikoff.   

Abstract

The review system for human subjects research in the United States has been widely criticized in recent years for requirements that delay research without improving human subject protections. Any major reformulation of regulations may take some time to implement. However, current regulations often allow for streamlined ethics review that does not jeopardize-and may improve-protections for research participants. The authors discuss underutilized options, including research that need not be classified as human subjects research, categories of studies that can be exempt from ethical review, studies that need only undergo expedited review by 1 institutional review board (IRB) member, and simplifying reviews of multicenter research by using the IRB of 1 institution. The authors speculate on multiple reasons for the underuse of these mechanisms and exhort IRBs and researchers to take advantage of these important opportunities to improve the review process.

Entities:  

Mesh:

Year:  2010        PMID: 21079221      PMCID: PMC4714763          DOI: 10.7326/0003-4819-153-10-201011160-00008

Source DB:  PubMed          Journal:  Ann Intern Med        ISSN: 0003-4819            Impact factor:   25.391


  7 in total

1.  Institutional review boards: a crisis in confidence.

Authors:  R J Levine
Journal:  Ann Intern Med       Date:  2001-01-16       Impact factor: 25.391

2.  Protection of human subjects: categories of research that may be reviewed by the Institutional Review Board (IRB) through an expedited review procedure--FDA. Notice.

Authors: 
Journal:  Fed Regist       Date:  1998-11-09

Review 3.  Ethical review of research involving human subjects: when and why is IRB review necessary?

Authors:  Richard M Wagner
Journal:  Muscle Nerve       Date:  2003-07       Impact factor: 3.217

4.  Variability in the costs of institutional review board oversight.

Authors:  Margaret M Byrne; Jeanne Speckman; Ken Getz; Jeremy Sugarman
Journal:  Acad Med       Date:  2006-08       Impact factor: 6.893

5.  The dysregulation of human subjects research.

Authors:  Norman Fost; Robert J Levine
Journal:  JAMA       Date:  2007-11-14       Impact factor: 56.272

Review 6.  Grinding to a halt: the effects of the increasing regulatory burden on research and quality improvement efforts.

Authors: 
Journal:  Clin Infect Dis       Date:  2009-08-01       Impact factor: 9.079

7.  A survey of IRB process in 68 U.S. hospitals.

Authors:  Elaine Larson; Tiffany Bratts; Jack Zwanziger; Patricia Stone
Journal:  J Nurs Scholarsh       Date:  2004       Impact factor: 3.176

  7 in total
  17 in total

1.  Canada's new ethical guidelines for research with humans: a critique and comparison with the United States.

Authors:  Joseph Millum
Journal:  CMAJ       Date:  2012-01-16       Impact factor: 8.262

2.  Education Research and Human Subject Protection: Crossing the IRB Quagmire.

Authors:  Gail M Sullivan
Journal:  J Grad Med Educ       Date:  2011-03

3.  Operational Characteristics of Institutional Review Boards (IRBs) in the United States.

Authors:  Genevieve L Nesom; Iraklis Petrof; Tyler M Moore
Journal:  AJOB Empir Bioeth       Date:  2019-10-16

4.  A Proposed Process for Reliably Updating the Common Rule.

Authors:  Benjamin E Berkman; David Wendler; Haley K Sullivan; Christine Grady
Journal:  Am J Bioeth       Date:  2017-07       Impact factor: 11.229

5.  Why Public Comments Matter: The Case of the National Institutes of Health Policy on Single Institutional Review Board Review of Multicenter Studies.

Authors:  Ann-Margret Ervin; Holly A Taylor; Stephan Ehrhardt; Curtis L Meinert
Journal:  Acad Med       Date:  2018-08       Impact factor: 6.893

6.  Expert Perspectives on Oversight for Unregulated mHealth Research: Empirical Data and Commentary.

Authors:  Laura M Beskow; Catherine M Hammack-Aviran; Kathleen M Brelsford; P Pearl O'Rourke
Journal:  J Law Med Ethics       Date:  2020-03       Impact factor: 1.718

7.  Increasing burden of institutional review in multicenter clinical trials of infertility: the Reproductive Medicine Network experience with the Pregnancy in Polycystic Ovary Syndrome (PPCOS) I and II studies.

Authors:  William D Schlaff; Heping Zhang; Michael P Diamond; Christos Coutifaris; Peter R Casson; Robert G Brzyski; Gregory M Christman; Kurt T Barnhart; J C Trussell; Stephen A Krawetz; Peter J Snyder; Dana Ohl; Nanette Santoro; Esther Eisenberg; Hao Huang; Richard S Legro
Journal:  Fertil Steril       Date:  2011-06-08       Impact factor: 7.329

8.  Navigating the institutional review board approval process in a multicenter observational critical care study.

Authors:  Carmen C Polito; Sushma K Cribbs; Greg S Martin; Terence O'Keeffe; Dan Herr; Todd W Rice; Jonathan E Sevransky
Journal:  Crit Care Med       Date:  2014-05       Impact factor: 7.598

9.  A national strategy to develop pragmatic clinical trials infrastructure.

Authors:  Thomas W Concannon; Jeanne-Marie Guise; Rowena J Dolor; Paul Meissner; Sean Tunis; Jerry A Krishnan; Wilson D Pace; Joel Saltz; William R Hersh; Lloyd Michener; Timothy S Carey
Journal:  Clin Transl Sci       Date:  2014-01-28       Impact factor: 4.689

10.  RESEARCH ETHICS. Evidence gaps and ethical review of multicenter studies.

Authors:  Ann-Margret Ervin; Holly A Taylor; Curtis L Meinert; Stephan Ehrhardt
Journal:  Science       Date:  2015-11-06       Impact factor: 47.728

View more

北京卡尤迪生物科技股份有限公司 © 2022-2023.