The Impact of Institutional Review Boards on Research

1980 ◽  
Vol 10 (1) ◽  
pp. 36 ◽  
Author(s):  
Bradford Gray ◽  
Robert A. Cooke
Keyword(s):  
Institutional Review Boards ◽  
Institutional Review ◽  
The Impact ◽  
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.

The Impact of Institutional Review Boards (IRBs) on Clinical Innovation

2015 ◽  
Vol 10 (5) ◽  
pp. 481-487 ◽  
Author(s):  
Tomasz P. Stryjewski ◽  
Brian T. Kalish ◽  
Benjamin Silverman ◽  
Lisa Soleymani Lehmann
Keyword(s):  
Institutional Review Boards ◽  
Institutional Review ◽  
Clinical Innovation ◽  
The Impact ◽  
Review Boards

Research ethics and Institutional Review Boards: The influence of moral constraints on emotion research

2012 ◽  
Vol 31 (1-2) ◽  
pp. 67-79 ◽  
Author(s):  
Michael Sontag
Keyword(s):  
Twentieth Century ◽  
Scientific Theory ◽  
Scientific Practice ◽  
First Century ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
Moral Standards ◽  
The 1960S ◽  
The Impact ◽  
Review Boards

Researchers in the twenty-first century face a set of challenges unknown to researchers a half century ago—the need to justify the moral acceptability of their research methods through formal review processes. However, the role that moral constraints play in the development and demise of scientific theories has largely gone unappreciated. The rise of Institutional Review Boards (IRB) in the 1960s compounded the impact of moral constraints on scientific research and on the theories that develop out of such highly monitored research. To demonstrate the effects of moral constraints on scientific theory and research, this paper offers a history and analysis of the interaction between evolving moral standards and twentieth century emotion theory. Recommendations regarding IRB reform are also reviewed. The paper concludes by arguing that, while appropriate IRB reform is important, it cannot eliminate the need for careful reflection on the broader forces that shape scientific practice and understanding.

Research ethics and Institutional Review Boards: The influence of moral constraints on emotion research

2012 ◽  
Vol 31 (1-2) ◽  
pp. 67-79 ◽  
Author(s):  
Michael Sontag
Keyword(s):  
Twentieth Century ◽  
Scientific Theory ◽  
Scientific Practice ◽  
First Century ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
Moral Standards ◽  
The 1960S ◽  
The Impact ◽  
Review Boards

Researchers in the twenty-first century face a set of challenges unknown to researchers a half century ago—the need to justify the moral acceptability of their research methods through formal review processes. However, the role that moral constraints play in the development and demise of scientific theories has largely gone unappreciated. The rise of Institutional Review Boards (IRB) in the 1960s compounded the impact of moral constraints on scientific research and on the theories that develop out of such highly monitored research. To demonstrate the effects of moral constraints on scientific theory and research, this paper offers a history and analysis of the interaction between evolving moral standards and twentieth century emotion theory. Recommendations regarding IRB reform are also reviewed. The paper concludes by arguing that, while appropriate IRB reform is important, it cannot eliminate the need for careful reflection on the broader forces that shape scientific practice and understanding.

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