scholarly journals Filling the Regulatory Gap: Potential Role of Institutional Review Boards in Promoting Consideration of Sex as a Biological Variable

2020 ◽  
Vol 29 (6) ◽  
pp. 868-875 ◽  
Author(s):  
Korrina A. Duffy ◽  
Tracy A. Ziolek ◽  
C. Neill Epperson
Keyword(s):  
Potential Role ◽  
Institutional Review Boards ◽  
Biological Variable ◽  
Institutional Review ◽  
Review Boards

Surgical innovation or surgical evolution: an ethical and practical guide to handling novel neurosurgical procedures

2004 ◽  
Vol 100 (1) ◽  
pp. 2-7 ◽  
Author(s):  
Mark Bernstein ◽  
Joseph Bampoe
Keyword(s):  
Personal Experience ◽  
Potential Role ◽  
Senior Author ◽  
Institutional Review Boards ◽  
Neurosurgical Procedures ◽  
Surgical Innovation ◽  
Content Type ◽  
Institutional Review ◽  
Fine Print

Object. Surgical innovation is an important driver of improvements in technique and technology, which ultimately translates into improvements in patients' outcomes. Nevertheless, patients may face new risks of morbidity and mortality when surgical innovation is used, and well-intentioned surgical “experimentation” on patients must be regulated and monitored. In this paper the authors examine the challenges of defining surgical innovation and briefly review the literature on this challenging subject. Methods. Using examples from the field of neurosurgery and in part from the personal experience of the senior author, the authors develop a model of levels of experimental acuity of surgical procedures and offer recommendations on how these procedures would best be regulated. Conclusions. The authors propose guidelines for determining the need for regulation of innovation. The potential role of institutional review boards in this process is highlighted.

Symposium on Human Subjects Research: Redux

2002 ◽  
Vol 30 (3) ◽  
pp. 358-360
Author(s):  
Jesse A. Goldner
Keyword(s):  
Quality Improvement ◽  
Human Subjects ◽  
Institutional Review Boards ◽  
Human Subjects Research ◽  
Institutional Review ◽  
New Directions ◽  
Short Run ◽  
Research Protections ◽  
Review Boards

Two years ago, the Journal of Law, Medicine & Ethics published volume 28, number 4, devoted to a symposium entitled Human Subjects Research and the Role of Institutional Review Boards - Conflicts and Challenges. I had the good fortune to be asked to serve as editor of that issue. In her introduction to the symposium, the then editor-in-chief of the journal, Ellen Wright Clayton, observed that the country is currently undergoing a major reexamination of how biomedical research is conducted. While that reexamination has continued in the interim, some very recent events raise questions about the extent to which this will continue, at least in the short run, with equal vigor. The intervening years have witnessed a variety of new directions and events. The federal Office of Human Research Protections (OHRP), directed by Dr. Greg Koski, who wrote a brief commentary for the last symposium,L has taken a new direction, strongly stressing the need for institutions and their institutional review boards ORBS) to engage in extensive educational and quality improvement efforts with both researchers and their own member.

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