Assessing research risks systematically: the net risks test

Dual-track assessment directs research ethics committees (RECs) to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and b...

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Bibliographic Details
Published inJournal of medical ethics Vol. 33; no. 8; pp. 481 - 486
Main Authors Wendler, D, Miller, F G
Format Journal Article
LanguageEnglish
Published England BMJ Publishing Group Ltd and Institute of Medical Ethics 01.08.2007
BMJ Publishing Group
BMJ Publishing Group Ltd
BMJ Publishing Group LTD
BMJ Group
Subjects
Alternatives
Analysis
Bioethics
Biomedical Research - ethics
Blood
Clinical research
Clinical Trials as Topic - adverse effects
Clinical Trials as Topic - ethics
Ethics
Ethics Committees, Research
Ethics, Research
Evaluation
Humans
Informed consent
Institutional review boards
Intervention
Medical treatment
Moral judgment
Nontherapeutic Human Experimentation - ethics
Palliative care
Research design
Research Ethics
Research studies
Research Subjects
Risk analysis
Risk Assessment
United States
Online AccessGet full text
ISSN0306-6800
1473-4257
DOI10.1136/jme.2005.014043

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Summary:Dual-track assessment directs research ethics committees (RECs) to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.
Bibliography:Correspondence to:
 D Wendler
 Building 10, Room 1C118, NIH, Bethesda, MD 20892, USA; dwendler@nih.gov
ark:/67375/NVC-V2P9CVNK-G
local:0330481
PMID:17664310
Dual-track assessment directs research ethics committees (RECs) to assess the risks of research interventions based on the unclear distinction between therapeutic and non-therapeutic interventions. The net risks test, in contrast, relies on the clinically familiar method of assessing the risks and benefits of interventions in comparison to the available alternatives and also focuses attention of the RECs on the central challenge of protecting research participants.
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ISSN:0306-6800
1473-4257
DOI:10.1136/jme.2005.014043