scholarly journals Review of Ethical and Scientific Aspects of Acupuncture Clinical Trials Pointed Out by Institutional Review Board a Part of Development Process of the Acupuncture and Moxibustion Clinical Research Guideline

2015 ◽  
Vol 32 (2) ◽  
pp. 11-21
Author(s):  
Jung Tae Leem ◽  
Seung Hoon Lee ◽  
Ga Jin Han ◽  
Eun Jung Kim ◽  
Byung Kwan Seo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Development Process ◽  
Institutional Review Board ◽  
Acupuncture And Moxibustion ◽  
Institutional Review

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.

Intelligent Drug Development

2014 ◽  
Author(s):  
Michael Tansey
Keyword(s):  
Clinical Trials ◽  
Cost Effectiveness ◽  
Drug Development ◽  
Clinical Research ◽  
Development Process ◽  
Drug Development Process ◽  
Individual Trial ◽  
Specific Technology

Clinical research is heavily regulated and involves coordination of numerous pharmaceutical-related disciplines. Each individual trial involves contractual, regulatory, and ethics approval at each site and in each country. Clinical trials have become so complex and government requirements so stringent that researchers often approach trials too cautiously, convinced that the process is bound to be insurmountably complicated and riddled with roadblocks. A step back is needed, an objective examination of the drug development process as a whole, and recommendations made for streamlining the process at all stages. With Intelligent Drug Development, Michael Tansey systematically addresses the key elements that affect the quality, timeliness, and cost-effectiveness of the drug-development process, and identifies steps that can be adjusted and made more efficient. Tansey uses his own experiences conducting clinical trials to create a guide that provides flexible, adaptable ways of implementing the necessary processes of development. Moreover, the processes described in the book are not dependent either on a particular company structure or on any specific technology; thus, Tansey's approach can be implemented at any company, regardless of size. The book includes specific examples that illustrate some of the ways in which the principles can be applied, as well as suggestions for providing a better context in which the changes can be implemented. The protocols for drug development and clinical research have grown increasingly complex in recent years, making Intelligent Drug Development a needed examination of the pharmaceutical process.

Reviews in Medical Ethics

2008 ◽  
Vol 36 (2) ◽  
pp. 419-424
Author(s):  
Ana S. Iltis
Keyword(s):  
Clinical Trials ◽  
Medical Ethics ◽  
Clinical Research ◽  
Intended Audience ◽  
Institutional Review ◽  
Law And Ethics ◽  
Ethics Research ◽  
Depth Study ◽  
The Relationship ◽  
Shed Light

What the Doctor Didn’t Say, by Jerry Menikoff and Edward P. Richards, is a courageous and well-written volume that examines some of the fundamental debates pertaining to the ethics of clinical research. The volume deserves a careful reading by anyone with a potential role in clinical research: clinicians who might serve as investigators or refer patients to clinical trials; research staff; Institutional Review Board (IRB) members and administrators; sponsors who design clinical trials; and the book’s intended audience, namely, potential research participants and their families. A cursory reading of this volume might lead one to think that Menikoff and Richards have declared war on clinical research. They have not. Instead, they offer an in-depth study of the conduct and oversight of clinical research through the lens of law and ethics. They shed light on old issues and initiate discussion of new questions, challenging readers to think critically about the relationship between medical ethics, research ethics, the law, and the conduct of clinical research.

scholarly journals When are clinical trials beneficial for study patients and future patients? A factorial vignette-based survey of institutional review board members

BMJ Open ◽  
2016 ◽  
Vol 6 (9) ◽  
pp. e011150
Author(s):  
Rahul Mhaskar ◽  
Branko Miladinovic ◽  
Thomas M Guterbock ◽  
Benjamin Djulbegovic
Keyword(s):  
Clinical Trials ◽  
Institutional Review Board ◽  
Board Members ◽  
Institutional Review
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