scholarly journals What if Institutional Review Boards (IRBs) treated healthy volunteers in clinical trials as their clients?

2010 ◽  
pp. 767-771 ◽  
Author(s):  
Martin Tolich
Keyword(s):  
Clinical Trials ◽  
Healthy Volunteers ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
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 Informed Consent and Approval by Institutional Review Boards in Published Reports on Clinical Trials

1999 ◽  
Vol 340 (14) ◽  
pp. 1114-1115 ◽  
Author(s):  
Miguel Ruiz-Canela ◽  
Miguel Ángel Martínez-González ◽  
Enrique Gómez-Gracia ◽  
Joaquín Fernández-Crehuet
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Institutional Review Boards ◽  
Institutional Review ◽  
Review Boards

Defining and Describing Benefit Appropriately in Clinical Trials

2000 ◽  
Vol 28 (4) ◽  
pp. 332-343 ◽  
Author(s):  
Nancy M. P. King
Keyword(s):  
Clinical Trials ◽  
Healthy Volunteers ◽  
Potential Benefit ◽  
Consent Form ◽  
Institutional Review Boards ◽  
Risk Disclosure ◽  
Direct Benefit ◽  
Institutional Review ◽  
Great Harm ◽  
Effective Treatments

Institutional review boards (IRBs) and investigators are used to talking about risks of harm. Both low risks of great harm and high risks of small harm must be disclosed to prospective subjects and should be explained and categorized in ways that help potential subjects to understand and weigh them appropriately. Everyone on an IRB has probably spent time at meetings arguing over whether a three-page bulleted list of risk description is helpful or overkill for prospective subjects. Yet only a small fraction of all the time and attention lavished on risk disclosure has been devoted to discussing whether and when potential benefit to subjects can reasonably be claimed and, if so, how it should be described in the consent form and process.Traditionally, IRBs and regulators have worked to ensure that clear lines can be drawn between research that, by definition, carries no potential for direct benefit — because it uses healthy volunteers or because it is not foreseeably focused on the development of treatments — and research that does have the development of effective treatments as its goal.

scholarly journals The Challenges of First-in-Human Stem Cell Clinical Trials: What Does This Mean for Ethics and Institutional Review Boards?

2018 ◽  
Vol 10 (5) ◽  
pp. 1429-1431 ◽  
Author(s):  
Roger A. Barker ◽  
Melissa K. Carpenter ◽  
Stuart Forbes ◽  
Steven A. Goldman ◽  
Catriona Jamieson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Stem Cell ◽  
Institutional Review Boards ◽  
Human Stem Cell ◽  
Institutional Review ◽  
Review Boards

scholarly journals When and how to include vulnerable subjects in clinical trials

2020 ◽  
Vol 17 (6) ◽  
pp. 696-702
Author(s):  
David Wendler
Keyword(s):  
Clinical Trials ◽  
Pregnant Women ◽  
Negative Impact ◽  
Good Deal ◽  
Vulnerable Groups ◽  
Institutional Review Boards ◽  
Pragmatic Trials ◽  
Institutional Review ◽  
Vulnerable Subjects ◽  
Review Boards

There has been a good deal of discussion in the literature regarding which subjects are vulnerable in the context of clinical trials. There has been significantly less discussion regarding when and how to include vulnerable subjects in clinical trials. This lack of guidance is a particular problem for trials covered by the US regulations, which mandate strict requirements on the inclusion of three groups: pregnant women/fetuses, prisoners, and children. For the past 30 years, funders, investigators, and institutional review boards have frequently responded to these regulations by excluding pregnant women/fetuses, prisoners, and children from clinical trials. More recent work has emphasized the extent to which a default of exclusion can undermine the value of clinical trials, especially pragmatic trials. A default of exclusion also has the potential to undermine the interests of vulnerable groups, in both the short and the long term. These concerns raise the need for guidance on how to satisfy existing US regulations, while minimizing their negative impact on the value of clinical trials and the interests of vulnerable groups. The present manuscript thus describes a six-step decision procedure that institutional review boards can use to determine when and how to include vulnerable subjects in clinical trials, including pragmatic trials, that are covered by US regulations.

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.

Sign in / Sign up

Export Citation Format

Share Document