Literature DB >> 15663714

Institutional review boards and multisite studies in health services research: is there a better way?

Jennifer L Gold1, Carolyn S Dewa.   

Abstract

OBJECTIVE: The following paper examines the issue of whether the current system for ethics review of multisite health services research protocols is adequate, or whether there exist alternative methods that should be considered. PRINCIPAL
FINDINGS: (1) Investigators at different sites in a multisite project often have very different experiences with respect to the requirements and requests of the review board. Other problems include the waste of time and resources spent on document preparation for review boards, and delays in the commencement of research activities. (2) There are several possible reasons why there is variability in ethics review. These include the absence of standardized forms, differences in the background and experiences of board members, the influence of institutional or professional culture, and regional thinking. (3) Given the limited benefits derived from the variability in recommendations of multiple boards and the numerous problems encountered in seeking ethics approval from multiple boards suggest that some sort of reform is in order.
CONCLUSIONS: The increasing number of multisite, health services research studies calls for a centralized system of ethics review. The local review model is simply not conducive to multisite studies, and jeopardizes the integrity of the research process. Centralized multisite review boards, together with standardized documents and procedure, electronic access to documentation, and training for board members are all possible solutions. Changes to the current system are necessary not only to facilitate the conduct of multisite research, but also to preserve the integrity of the ethics approval process in general.

Keywords:  Biomedical and Behavioral Research

Mesh:

Year:  2005        PMID: 15663714      PMCID: PMC1361138          DOI: 10.1111/j.1475-6773.2005.00354.x

Source DB:  PubMed          Journal:  Health Serv Res        ISSN: 0017-9124            Impact factor:   3.402


  13 in total

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Authors:  K G Alberti
Journal:  BMJ       Date:  2000-04-29

2.  The new system of review by multicentre research ethics committees: prospective study.

Authors:  J Tully; N Ninis; R Booy; R Viner
Journal:  BMJ       Date:  2000-04-29

3.  Responses of local research ethics committees to a study with approval from a multicentre research ethics committee.

Authors:  A L Lux; S W Edwards; J P Osborne
Journal:  BMJ       Date:  2000-04-29

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Authors:  K Jamrozik; M Kolybaba
Journal:  Med J Aust       Date:  1999-01-04       Impact factor: 7.738

5.  Costs of seeking ethics approval before and after the introduction of multicentre research ethics committees.

Authors:  N R Dunn; A Arscott; R D Mann
Journal:  J R Soc Med       Date:  2000-10       Impact factor: 5.344

6.  Multisite randomized controlled trials in health services research: scientific challenges and operational issues.

Authors:  M Weinberger; E Z Oddone; W G Henderson; D M Smith; J Huey; A Giobbie-Hurder; J R Feussner
Journal:  Med Care       Date:  2001-06       Impact factor: 2.983

7.  The effects of local review on informed consent documents from a multicenter clinical trials consortium.

Authors:  William Burman; Peter Breese; Stephen Weis; Naomi Bock; John Bernardo; Andrew Vernon
Journal:  Control Clin Trials       Date:  2003-06

8.  Variability among institutional review boards' decisions within the context of a multicenter trial.

Authors:  H Silverman; S C Hull; J Sugarman
Journal:  Crit Care Med       Date:  2001-02       Impact factor: 7.598

9.  Isn't one institutional ethics committee's approval enough?

Authors:  M A Smith; B Jalaludin; S R Leeder; W T Smith
Journal:  Med J Aust       Date:  1994-05-16       Impact factor: 7.738

10.  Problematic variation in local institutional review of a multicenter genetic epidemiology study.

Authors:  Rita McWilliams; Julie Hoover-Fong; Ada Hamosh; Suzanne Beck; Terri Beaty; Garry Cutting
Journal:  JAMA       Date:  2003-07-16       Impact factor: 56.272

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  23 in total

1.  Ethics and privacy issues of a practice-based surveillance system: need for a national-level institutional research ethics board and consent standards.

Authors:  Jyoti A Kotecha; Donna Manca; Anita Lambert-Lanning; Karim Keshavjee; Neil Drummond; Marshall Godwin; Michelle Greiver; Wayne Putnam; Marie-Thérèse Lussier; Richard Birtwhistle
Journal:  Can Fam Physician       Date:  2011-10       Impact factor: 3.275

2.  Ethics review as a component of institutional approval for a multicentre continuous quality improvement project: the investigator's perspective.

Authors:  Hanna Ezzat; Sue Ross; Peter von Dadelszen; Tara Morris; Robert Liston; Laura A Magee
Journal:  BMC Health Serv Res       Date:  2010-07-30       Impact factor: 2.655

3.  Variability in obtaining institutional review board approval for quality improvement activities in residency programs.

Authors:  Lisa N Conforti; Brian J Hess; Kathryn M Ross; Lorna A Lynn; Eric S Holmboe
Journal:  J Grad Med Educ       Date:  2012-03

4.  Integrating a Federated Healthcare Data Query Platform With Electronic IRB Information Systems.

Authors:  Shan He; John F Hurdle; Jeffrey R Botkin; Scott P Narus
Journal:  AMIA Annu Symp Proc       Date:  2010-11-13

5.  Effects of local institutional review board review on participation in national practice-based research network studies.

Authors:  Stacia A Finch; Shari L Barkin; Richard C Wasserman; Niramol Dhepyasuwan; Eric J Slora; Robert D Sege
Journal:  Arch Pediatr Adolesc Med       Date:  2009-12

6.  Regulatory Issues Encountered when Conducting Longitudinal Substance Abuse Research.

Authors:  Elizabeth Evans; Debra A Murphy; Christine E Grella; Michele Mouttapa; Yih-Ing Hser
Journal:  J Drug Issues       Date:  2008-10-01

7.  A domain analysis model for eIRB systems: addressing the weak link in clinical research informatics.

Authors:  Shan He; Scott P Narus; Julio C Facelli; Lee Min Lau; Jefferey R Botkin; John F Hurdle
Journal:  J Biomed Inform       Date:  2014-06-11       Impact factor: 6.317

8.  Harmonization and streamlining of research oversight for pragmatic clinical trials.

Authors:  P Pearl O'Rourke; Judith Carrithers; Bray Patrick-Lake; Todd W Rice; Jeremy Corsmo; Raffaella Hart; Marc K Drezner; John D Lantos
Journal:  Clin Trials       Date:  2015-09-15       Impact factor: 2.486

9.  Practice-based research networks, part I: clinical laboratories to generate and translate research findings into effective patient care.

Authors:  Eric L Sauers; Tamara C Valovich McLeod; R Curtis Bay
Journal:  J Athl Train       Date:  2012 Sep-Oct       Impact factor: 2.860

10.  Institutional review board and regulatory solutions in the dental PBRN.

Authors:  Gregg H Gilbert; Vibeke Qvist; Sheila D Moore; D Brad Rindal; Jeffrey L Fellows; Valeria V Gordan; O Dale Williams
Journal:  J Public Health Dent       Date:  2010       Impact factor: 1.821

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