Literature DB >> 28445582

Single IRBs in Multisite Trials: Questions Posed by the New NIH Policy.

Robert Klitzman1, Ekaterina Pivovarova2, Charles W Lidz2.   

Abstract

Entities:  

Mesh：

Year:  2017        PMID： 28445582      PMCID： PMC9009063          DOI： 10.1001/jama.2017.4624

Source DB:  PubMed          Journal:  JAMA        ISSN： 0098-7484            Impact factor:   56.272


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  4 in total

1.  How closely do institutional review boards follow the common rule?

Authors:  Charles W Lidz; Paul S Appelbaum; Robert Arnold; Philip Candilis; William Gardner; Suzanne Myers; Lorna Simon
Journal:  Acad Med       Date:  2012-07       Impact factor: 6.893

2.  Federal Policy for the Protection of Human Subjects. Final rule.

Authors: 
Journal:  Fed Regist       Date:  2017-01-19

3.  The ins and outs of independent IRBs.

Authors:  Janet M Lis; Melinda G Murray
Journal:  J Health Life Sci Law       Date:  2008-10

4.  Should society allow research ethics boards to be run as for-profit enterprises?

Authors:  Ezekiel J Emanuel; Trudo Lemmens; Carl Elliot
Journal:  PLoS Med       Date:  2006-07-25       Impact factor: 11.069
  4 in total
  10 in total

1.  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

2.  "You Really Do Have to Know the Local Context": IRB Administrators and Researchers on the Implications of the NIH Single IRB Mandate for Multisite Genomic Studies.

Authors:  Nora B Henrikson; Paula R Blasi; Jeremy J Corsmo; Emily Sheffer Serdoz; Aaron Scrol; Sarah M Greene; Tanya L Matthews; James D Ralston
Journal:  J Empir Res Hum Res Ethics       Date:  2019-05-22       Impact factor: 1.742

3.  A Study of Reliance Agreement Templates Used by U.S. Research Institutions.

Authors:  David B Resnik; Juliet Taylor; Kathryn Morris; Min Shi
Journal:  IRB       Date:  2018-05-01

4.  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

5.  How U.S. research institutions are responding to the single Institutional Review Board mandate.

Authors:  David B Resnik; Elise M Smith; Min Shi
Journal:  Account Res       Date:  2018-08-09       Impact factor: 2.622

6.  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

7.  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

8.  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

9.  Using single IRB consultations to meet the educational needs of investigative teams.

Authors:  Ann R Johnson; Mary Pautler; Jeri S Burr; Nael Abdelsamad; John M VanBuren; Lisa M Rigtrup; J Michael Dean; Erin Rothwell
Journal:  Contemp Clin Trials Commun       Date:  2022-08-11

10.  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
  10 in total

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