Institutional Review Board (IRB) Shopping- Accessible for Public Comment

2021 ◽  
pp. 473-474
Author(s):  
Sampoornam. W ◽  
Jothilakshmi K.
Keyword(s):  
Clinical Research ◽  
Empirical Evidence ◽  
Research Methods ◽  
Ethical Issue ◽  
Institutional Review Board ◽  
Institutional Policy ◽  
Forum Shopping ◽  
Public Comment ◽  
Institutional Review ◽  
Standard Operating

Context: IRB Forum Shopping is an under-researched yet highly-relevant ethical issue in the context of clinical research. IRB members review the proposed research methods to ensure the ethical principles. The IRB has the authority to approve or disapprove the research proposals that fall within the institutional policy and adheres to SOP (Standard Operating Procedures). When the research project has obtained an unfavorable or conditional IRB review, the researcher bypass the process of addressing the IRB’s decision by deserting the IRB and selecting another forum that will provide favorable review. Currently, proposed regulations to prohibit IRB shopping are available for public comment. The FDA report made clear that no empirical evidence exists to support the widespread of IRB shopping.

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.

Empowering Clinicians to Effectively Engage in Research

2014 ◽  
Vol 24 (1) ◽  
pp. 9-14 ◽  
Author(s):  
Katherine McConville ◽  
Susan L. Thibeault
Keyword(s):  
Clinical Research ◽  
Research Program ◽  
Institutional Review Board ◽  
Speech Language Pathology ◽  
Research Engagement ◽  
University Of Wisconsin ◽  
Institutional Review ◽  
Language Pathology ◽  
The University ◽  
Common Barriers

In this article, we will discuss the need for clinician-driven clinical research in the field of speech-language pathology, identify common barriers to such research endeavors, and offer solutions for overcoming those barriers to increase effective clinician-initiated research engagement and output. Using the University of Wisconsin-Madison Voice and Swallow Clinics' developing clinical research program as an example, we will demonstrate how research can be incorporated into a busy clinical schedule with appropriate support and resources. Our own endeavors with this model have seen an increase in Institutional Review Board (IRB) submissions and approvals as well as publications from clinicians who had not previously considered themselves clinical investigators.

Applications for Research Concerning Fetal or Placental Tissue and Expected Institutional Review Board Responses

2017 ◽  
Vol 12 (3) ◽  
pp. 150-160
Author(s):  
Lynn Borgatta ◽  
David Kaufman ◽  
Judith Parsells Kelly ◽  
David Babaian ◽  
Mary Banks
Keyword(s):  
Placental Tissue ◽  
Diagnostic Procedures ◽  
Institutional Review Board ◽  
Institutional Policy ◽  
Research Projects ◽  
Electronic Survey ◽  
Institutional Review

Proposals for research concerning fetal and/or placental tissue may be refused institutional review board (IRB) review, effectively preventing the research from occurring. We conducted an anonymous electronic survey of IRB chairs to determine their assessment of the likely response to research projects using fetal/placental tissue obtained from various procedures. We found that proposals concerning tissue obtained from diagnostic procedures or miscarriage were anticipated to be considered at most institutions. Tissue obtained after abortion was likely to be refused consideration by more than 25% of respondents. Additional consultation during review was anticipated for up to 30% of scenarios. Responses for fetal and placental tissue were similar. The most frequently anticipated reason for refusal was institutional policy.

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