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A framework for risk-benefit evaluations in biomedical research


Rid (Schulz-Baldes), A; Wendler, D (2011). A framework for risk-benefit evaluations in biomedical research. Kennedy Institute of Ethics Journal, 21(2):141-179.

Abstract

Essentially all guidelines and regulations require that biomedical research studies have an acceptable risk-benefit profile. However, these documents offer little concrete guidance for implementing this requirement and determining when it is satisfied. As a result, those charged with risk-benefit evaluations currently assess the risk-benefit profile of biomedical research studies in unsystematic ways, raising concern that some research participants are not being protected from excessive risks and that some valuable studies involving acceptable risk are being rejected. The present paper aims to address this situation by delineating the first comprehensive framework, which is based on existing guidelines and regulations as well as the relevant literature, for risk-benefit evaluations in biomedical research.

Essentially all guidelines and regulations require that biomedical research studies have an acceptable risk-benefit profile. However, these documents offer little concrete guidance for implementing this requirement and determining when it is satisfied. As a result, those charged with risk-benefit evaluations currently assess the risk-benefit profile of biomedical research studies in unsystematic ways, raising concern that some research participants are not being protected from excessive risks and that some valuable studies involving acceptable risk are being rejected. The present paper aims to address this situation by delineating the first comprehensive framework, which is based on existing guidelines and regulations as well as the relevant literature, for risk-benefit evaluations in biomedical research.

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21 citations in Web of Science®
25 citations in Scopus®
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Additional indexing

Item Type:Journal Article, refereed, original work
Communities & Collections:04 Faculty of Medicine > Institute of Biomedical Ethics and History of Medicine
Dewey Decimal Classification:610 Medicine & health
Language:English
Date:2011
Deposited On:13 Jan 2012 09:19
Last Modified:05 Apr 2016 15:22
Publisher:Johns Hopkins University Press
ISSN:1054-6863
Additional Information:Copyright © 2011 The Johns Hopkins University Press. This article first appeared in Kennedy Institute of Ethics Journal, 21(2):141-79
Publisher DOI:10.1353/ken.2011.0007
PubMed ID:21696094
Permanent URL: http://doi.org/10.5167/uzh-54897

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