Clinical Research From Proposal to Implementation

2008 ◽  
Vol 56 (8) ◽  
pp. 975-984 ◽  
Author(s):  
Suzanne M. Rivera
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Human Subject ◽  
Institutional Review Boards ◽  
Human Subject Protection ◽  
Institutional Review ◽  
The Us ◽  
Complicated Process ◽  
Study Participants ◽  
Review Boards

ABSTRACTThe conduct of clinical trials is a complicated process involving a myriad of regulations and enforcement entities. To protect the rights and welfare of study participants, a system of oversight bodies called institutional review boards has been established in the US. This article describes how institutional review boards work and explains what clinical researchers need to know about federally mandated human subject protection requirements.

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.

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.

Vulnerability as a Regulatory Category in Human Subject Research

2009 ◽  
Vol 37 (1) ◽  
pp. 12-18 ◽  
Author(s):  
Carl H. Coleman
Keyword(s):  
Research Ethics ◽  
Human Subject ◽  
Institutional Review Boards ◽  
Human Subject Research ◽  
Human Subject Protection ◽  
Research Ethics Review ◽  
Institutional Review ◽  
Research Regulations ◽  
Vulnerable Subjects ◽  
The Common

The concept of vulnerability has long played a central role in discussions of research ethics. In addition to its rhetorical use, vulnerability has become a term of art in U.S. and international research regulations and guidelines, many of which contain specific provisions applicable to research with vulnerable subjects. Yet, despite the frequency with which the term vulnerability is used, little consensus exists on what it actually means in the context of human subject protection or, more importantly, on how a finding of vulnerability should affect the process of research ethics review.The Common Rule, the centerpiece of the U.S. human subject protection regulations, uses the word vulnerable three times. First, it provides that institutional review boards (IRBs) that regularly review research involving a vulnerable category of subjects should consider including one or more individuals who are knowledgeable about and experienced in working with these subjects.

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 Assessing the Quality and Performance of Institutional Review Boards: Levels of Initial Reviews

2020 ◽  
Vol 15 (5) ◽  
pp. 407-414
Author(s):  
Min-Fu Tsan ◽  
Bruce Ling ◽  
Ulrike Feske ◽  
Susan Zickmund ◽  
Roslyn Stone ◽  
...  
Keyword(s):  
Human Subject ◽  
Institutional Review Boards ◽  
Human Research ◽  
Institutional Review ◽  
Review Procedure ◽  
Research Protections ◽  
And Performance ◽  
Board Review ◽  
Protocol Review ◽  
Review Boards

How well institutional review boards (IRBs) follow Common Rule criteria for levels of initial protocol review has not been systematically evaluated. We compared levels of review as determined using the Office for Human Research Protections (OHRP) human subject regulations decision charts of 313 protocols that had been approved by IRBs. There was a 97.8% agreement between 140 protocols that were reviewed by full board and the levels of review according to OHRP criteria. Likewise, there was a 93.8% agreement between 113 protocols that were reviewed using an expedited review procedure and OHRP criteria. However, there was only 75% agreement for exempt protocols. Specifically, 10 (16.7%) of the 60 exempt protocols were found to require IRB review, that is, six protocols requiring expedited review and four protocols requiring full board review. Conducting non-exempt research without prior IRB approval constitutes serious noncompliance. Our data suggest that exempt protocols need more scrutiny.

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