Ten Questions Institutional Review Boards Should Ask When Reviewing International Clinical Research Protocols

2003 ◽  
Vol 25 (2) ◽  
pp. 14 ◽  
Author(s):  
Daniel W. Fitzgerald ◽  
Angela Wasunna ◽  
Jean William Pape
Keyword(s):  
Clinical Research ◽  
Institutional Review Boards ◽  
Research Protocols ◽  
Institutional Review ◽  
International Clinical Research ◽  
Review Boards

scholarly journals The efficiency of single institutional review board review in National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network–initiated clinical trials

2018 ◽  
Vol 16 (1) ◽  
pp. 3-10 ◽  
Author(s):  
Michael P Diamond ◽  
Esther Eisenberg ◽  
Hao Huang ◽  
Christos Coutifaris ◽  
Richard S Legro ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Child Health ◽  
Clinical Research ◽  
Human Development ◽  
Reproductive Medicine ◽  
Institutional Review Board ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
The Impact ◽  
Review Boards

Background/aims: Timely review of research protocols by institutional review boards leads to more rapid initiation of clinical trials, which is critical to expeditious translation from bench to bedside. This observational study examined the impact of a single institutional review board on time and efforts required to initiate clinical trials by the National Institute of Child Health and Human Development Cooperative Reproductive Medicine Network. Methods: Collection of data from the same six main clinical sites for three current clinical trials and two past clinical trials, including time from institutional review board submission to approval, pages submitted, consent form length, number of required attachments, other regulatory requirements, order of review at central or local sites, and language in documents at individual participating sites. Results from two past clinical trials were also included. Results: While time required for actual institutional review board submission’s review and initial approval was reduced with use of a single institutional review board for multicenter trials (from a mean of 66.7–24.0 days), total time was increased (to a mean of 111.2 or 123.3 days). In addition to single institutional review board approval, all institutions required local approval of some components (commonly consent language and use of local language), which varied considerably. The single institutional review board relied on local institutions for adding or removing personnel, conflict of interest review, and auditing of activities. Conclusion: A single institutional review board reduced time for initial review and approval of protocols and informed consents, although time for the entire process was increased, as individual institutions retained oversight of components of required regulatory review. In order to best achieve the National Institute of Health’s goals for improved efficiency in initiation and conduct of multisite clinical research, greater coordination with local institutional review boards is key to streamlining and accelerating initiation of multisite clinical research.

scholarly journals Clinical Research in Vulnerable Populations: Variability and Focus of Institutional Review Boards’ Responses

PLoS ONE ◽  
2015 ◽  
Vol 10 (8) ◽  
pp. e0135997 ◽  
Author(s):  
Bärbel Kästner ◽  
Simone Behre ◽  
Nadine Lutz ◽  
Friederike Bürger ◽  
Steffen Luntz ◽  
...  
Keyword(s):  
Clinical Research ◽  
Vulnerable Populations ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
Review Boards

scholarly journals Time required to review research protocols at 10 Veterans Affairs Institutional Review Boards

2016 ◽  
Vol 204 (2) ◽  
pp. 481-489 ◽  
Author(s):  
Patrick R. Varley ◽  
Ulrike Feske ◽  
Shasha Gao ◽  
Roslyn A. Stone ◽  
Sijian Zhang ◽  
...  
Keyword(s):  
Veterans Affairs ◽  
Institutional Review Boards ◽  
Research Protocols ◽  
Institutional Review ◽  
Time Required ◽  
Review Boards

Differential payment to research participants in the same study: an ethical analysis

2019 ◽  
Vol 45 (5) ◽  
pp. 318-322 ◽  
Author(s):  
Govind Persad ◽  
Holly Fernandez Lynch ◽  
Emily Largent
Keyword(s):  
Clinical Research ◽  
Ethical Analysis ◽  
Institutional Review Boards ◽  
Research Participants ◽  
Institutional Review ◽  
Study Participants ◽  
Incentive Payments ◽  
Review Boards

Recognising that offers of payment to research participants can serve various purposes—reimbursement, compensation and incentive—helps uncover differences between participants, which can justify differential payment of participants within the same study. Participants with different study-related expenses will need different amounts of reimbursement to be restored to their preparticipation financial baseline. Differential compensation can be acceptable when some research participants commit more time or assume greater burdens than others, or if inter-site differences affect the value of compensation. Finally, it may be permissible to offer differential incentive payments if necessary to advance the goals of a study. We encourage investigators and Institutional Review Boards to think about whether to offer payment, in what amounts and for what purpose, and also to consider whether differential payment can help promote the scientific and ethical goals of clinical research.

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