Literature DB >> 17610447

Notes from the field: jumpstarting the IRB approval process in multicenter studies.

Jan Blustein1, Marsha Regenstein, Bruce Siegel, John Billings.   

Abstract

OBJECTIVE: To identify strategies that facilitate readiness for local Institutional Review Board (IRB) review, in multicenter studies. STUDY
SETTING: Eleven acute care hospitals, as they applied to participate in a foundation-sponsored quality improvement collaborative. STUDY
DESIGN: Case series. DATA COLLECTION/EXTRACTION: Participant observation, supplemented with review of written and oral communications. PRINCIPAL
FINDINGS: Applicant hospitals responded positively to efforts to engage them in early planning for the IRB review process. Strategies that were particularly effective were the provisions of application templates, a modular approach to study description, and reliance on conference calls to collectively engage prospective investigators, local IRB members, and the evaluation/national program office teams. Together, these strategies allowed early identification of problems, clarification of intent, and relatively timely completion of the local IRB review process, once hospitals were selected to participate in the learning collaborative.
CONCLUSIONS: Engaging potential collaborators in planning for IRB review may help expedite and facilitate review, without compromising the fairness of the grant-making process or the integrity of human subjects protection.

Entities:  

Mesh:

Year:  2007        PMID: 17610447      PMCID: PMC1955279          DOI: 10.1111/j.1475-6773.2006.00687.x

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


  5 in total

Review 1.  Institutional review boards and multisite studies in health services research: is there a better way?

Authors:  Jennifer L Gold; Carolyn S Dewa
Journal:  Health Serv Res       Date:  2005-02       Impact factor: 3.402

2.  Impact of institutional review board practice variation on observational health services research.

Authors:  Lee A Green; Julie C Lowery; Christine P Kowalski; Leon Wyszewianski
Journal:  Health Serv Res       Date:  2006-02       Impact factor: 3.402

3.  Variations among Institutional Review Board reviews in a multisite health services research study.

Authors:  Kathleen Dziak; Roger Anderson; Mary Ann Sevick; Carol S Weisman; Douglas W Levine; Sarah Hudson Scholle
Journal:  Health Serv Res       Date:  2005-02       Impact factor: 3.402

4.  Do patient consent procedures affect participation rates in health services research?

Authors:  Karin Nelson; Rosa Elena Garcia; Julie Brown; Carol M Mangione; Thomas A Louis; Emmett Keeler; Shan Cretin
Journal:  Med Care       Date:  2002-04       Impact factor: 2.983

5.  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

  5 in total
  5 in total

1.  Implications of the Revised Common Rule for Human Participant Research.

Authors:  Evan G DeRenzo; Joel Moss; Eric A Singer
Journal:  Chest       Date:  2018-10-09       Impact factor: 9.410

2.  Practice-Based Research Networks Ceding to a Single Institutional Review Board: A Report From the INSTTEPP Trial and Meta-LARC Consortium.

Authors:  Jeanette M Daly; Tabria Weiner Harrod; Kate Judge; LeAnn C Michaels; Barcey T Levy; David L Hahn; Lyle J Fagnan; Donald E Nease
Journal:  J Patient Cent Res Rev       Date:  2018-10-29

3.  Biobanking, consent, and commercialization in international genetics research: the Type 1 Diabetes Genetics Consortium.

Authors:  Mark A Hall; Nancy M P King; Letitia H Perdue; Joan E Hilner; Beena Akolkar; Carla J Greenbaum; Catherine McKeon
Journal:  Clin Trials       Date:  2010       Impact factor: 2.486

4.  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

5.  How variability in the institutional review board review process affects minimal-risk multisite health services research.

Authors:  Laura A Petersen; Kate Simpson; Richard Sorelle; Tracy Urech; Supicha Sookanan Chitwood
Journal:  Ann Intern Med       Date:  2012-05-15       Impact factor: 25.391

  5 in total

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