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A delphi study to establish important aspects of ethics review.

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.

SUBMITTER: Geisser ME

PROVIDER: S-EPMC3253534 | biostudies-literature | 2011 Mar

REPOSITORIES: biostudies-literature

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A delphi study to establish important aspects of ethics review.

Geisser Michael E ME Alschuler Kevin N KN Hutchinson Raymond R

Journal of empirical research on human research ethics : JERHRE 20110301 1

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 investi ...[more]

PMID: 21460583

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Project description:BackgroundDemographical changes have stimulated a coordination reform in the Norwegian health care sector, creating new working practices and extending coordination within and between primary and hospital care, increasing the need for inter-municipal cooperation (IMC). This study aimed to identify challenges to coordination and IMC in the Norwegian health care sector as a basis for further theorizing and managerial advice in this growing area of research and practice.MethodsA Delphi study of consensus development was used. Experts in coordination and IMC in health care services were selected by the healthcare manager or the councillor in their respective municipalities. In the first round, an expert panel received open-ended questions addressing possible challenges, and their answers were categorized and consolidated as the basis for further validation in the second round. The expert panel members were then asked to point out important statements in the third round, before the most important statements ranked by a majority of the members were rated again in the fourth round, including the option to explain the ratings. The same procedure was used in round five, with the exception that the expert panel members could view the consolidated results of their previous rankings as the basis for a new and final rating. The statements reaching consensus in round five were abstracted and themed.ResultsNineteen experts consented to participate. Nine experts (47%) completed all of the five rounds. Eight statements concerning coordination reached consensus, resulting in four themes covering these challenges: different culture, uneven balance of power, lack of the possibility to communicate electronically, and demanding tasks in relation to resources. Three statements regarding challenges to IMC reached consensus, resulting in following themes: coopetition, complex leadership, and resistance to change.ConclusionsThis study identified several important challenges for coordination and it supports previous research. IMC in health care services deals with challenges other than coordination, and these must be addressed specifically. Our study contributes to extended knowledge of theoretical and practical implications in the field of coordination and IMC in health care sector.

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A delphi study to establish important aspects of ethics review.

Publications

A delphi study to establish important aspects of ethics review.

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