Work

A Delphi Study to Establish Important Aspects of Ethics Review

Year: 2011

Type: article

Abstract: Little research has been done to examine the cost-effectiveness of REC review, or the components of review that make the greatest contributions to the protection of human subjects. We describe a process used to obtain consensus on the important categories and outcomes of REC review using the Delphi method and an array of stakeholders in a limited domain of research (biomedical). Study participants recruited from the University of Michigan Medical School's RECs, REC council, and principal investigators identified the following six categories as being the most important aspects of REC review: (1) A favorable risk/benefit ratio; (2) minimization of risk to subjects; (3) clarity of consent; (4) protection of vulnerable populations; (5) protection of privacy and confidentiality; and (6) review time. We believe that this kind of information can be used to assist in the development of a metric to assess the effectiveness and efficiency of REC review in the various research domains.

Source: Journal of Empirical Research on Human Research Ethics

DOI: 10.1525/jer.2011.6.1.21

Authors: Michael E. Geisser, Kevin N. Alschuler, Raymond Hutchinson

Institutions: University of Michigan, Michigan Medicine

Language: English

Topic: Ethics in Clinical Research

Subfield: Public Health, Environmental and Occupational Health

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

Funders: University of Michigan, National Institutes of Health, National Center for Research Resources