Literature DB >> 27974026

NIH Policy on Single-IRB Review - A New Era in Multicenter Studies.

Ann-Margret Ervin1, Holly A Taylor1, Stephan Ehrhardt1.   

Abstract

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Year:  2016        PMID： 27974026      PMCID： PMC5234329          DOI： 10.1056/NEJMp1608766

Source DB:  PubMed          Journal:  N Engl J Med        ISSN： 0028-4793            Impact factor:   91.245


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  3 in total

1.  Central institutional review board review for an academic trial network.

Authors:  Petra Kaufmann; P Pearl O'Rourke
Journal:  Acad Med       Date:  2015-03       Impact factor: 6.893

Review 2.  A systematic review of the empirical literature evaluating IRBs: what we know and what we still need to learn.

Authors:  Lura Abbott; Christine Grady
Journal:  J Empir Res Hum Res Ethics       Date:  2011-03       Impact factor: 1.742

3.  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
  3 in total
  12 in total

Review 1.  Efficient design of clinical trials and epidemiological research: is it possible?

Authors:  Michael S Lauer; David Gordon; Gina Wei; Gail Pearson
Journal:  Nat Rev Cardiol       Date:  2017-04-27       Impact factor: 32.419

2.  A Measure of Effectiveness Is Key to the Success of sIRB Policy.

Authors:  Holly A Taylor; Ann Margret Ervin
Journal:  Am J Bioeth       Date:  2017-07       Impact factor: 11.229

3.  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

4.  Transitioning to the National Institutes of Health single institutional review board model: Piloting the use of the Streamlined, Multi-site, Accelerated Resources for Trials IRB Reliance.

Authors:  Orly Vardeny; Adrian F Hernandez; Lauren W Cohen; Amy Franklin; Mina Baqai; Sarah Palmer; Barbara E Bierer; Nichelle Cobb
Journal:  Clin Trials       Date:  2019-03-13       Impact factor: 2.486

Review 5.  "Choice of law" in precision medicine research.

Authors:  Laura M Beskow; Leslie E Wolf
Journal:  Am J Hum Genet       Date:  2022-08-04       Impact factor: 11.043

6.  Type 1 Diabetes TrialNet: A Multifaceted Approach to Bringing Disease-Modifying Therapy to Clinical Use in Type 1 Diabetes.

Authors:  Polly J Bingley; Diane K Wherrett; Ann Shultz; Lisa E Rafkin; Mark A Atkinson; Carla J Greenbaum
Journal:  Diabetes Care       Date:  2018-04       Impact factor: 19.112

7.  The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network-initiated clinical trials.

Authors:  Michael P Diamond; Esther Eisenberg; Hao Huang; Christos Coutifaris; Richard S Legro; Karl R Hansen; Anne Z Steiner; Marcelle Cedars; Kurt Barnhart; Tracy Ziolek; Tracey R Thomas; Kate Maurer; Stephen A Krawetz; Robert A Wild; J C Trussell; Nanette Santoro; Heping Zhang
Journal:  Clin Trials       Date:  2018-10-24       Impact factor: 2.486

8.  Reducing the Single IRB Burden: Streamlining Electronic IRB Systems.

Authors:  Alexandra Murray; Ekaterina Pivovarova; Robert Klitzman; Deborah F Stiles; Paul Appelbaum; Charles W Lidz
Journal:  AJOB Empir Bioeth       Date:  2020-09-25

9.  Escitalopram for agitation in Alzheimer's disease (S-CitAD): Methods and design of an investigator-initiated, randomized, controlled, multicenter clinical trial.

Authors:  Stephan Ehrhardt; Anton P Porsteinsson; Cynthia A Munro; Paul B Rosenberg; Bruce G Pollock; Davangere P Devanand; Jacobo Mintzer; Tarek K Rajji; Zahinoor Ismail; Lon S Schneider; Sheriza N Baksh; Lea T Drye; Dimitri Avramopoulos; David M Shade; Constantine G Lyketsos
Journal:  Alzheimers Dement       Date:  2019-10-03       Impact factor: 16.655

10.  Hospital recruitment for a pragmatic cluster-randomized clinical trial: Lessons learned from the COMPASS study.

Authors:  Anna M Johnson; Sara B Jones; Pamela W Duncan; Cheryl D Bushnell; Sylvia W Coleman; Laurie H Mettam; Anna M Kucharska-Newton; Mysha E Sissine; Wayne D Rosamond
Journal:  Trials       Date:  2018-01-26       Impact factor: 2.279
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