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Ethical issues in implementation research: a discussion of the problems in achieving informed consent

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Hutton, Jane (Statistician), Eccles, Martin P. and Grimshaw, Jeremy M.. (2008) Ethical issues in implementation research: a discussion of the problems in achieving informed consent. Implementation Science, Vol.3 (No.52). ISSN 1748-5908

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Official URL: http://dx.doi.org/10.1186/1748-5908-3-52

Abstract

Background: Improved quality of care is a policy objective of health care systems around the world. Implementation research is the scientific study of methods to promote the systematic uptake of clinical research findings into routine clinical practice, and hence to reduce inappropriate
care. It includes the study of influences on healthcare professionals' behaviour and methods to enable them to use research findings more effectively. Cluster randomized trials represent the optimal design for evaluating the effectiveness of implementation strategies. Various codes of
medical ethics, such as the Nuremberg Code and the Declaration of Helsinki inform medical research, but their relevance to cluster randomised trials in implementation research is unclear. This paper discusses the applicability of various ethical codes to obtaining consent in cluster trials in implementation research.
Discussion: The appropriate application of biomedical codes to implementation research is not obvious. Discussion of the nature and practice of informed consent in implementation research cluster trials must consider the levels at which consent can be sought, and for what purpose it can be sought. The level at which an intervention is delivered can render the idea of patient level
consent meaningless. Careful consideration of the ownership of information, and rights of access to and exploitation of data is required. For health care professionals and organizations, there is a balance between clinical freedom and responsibility to participate in research.
Summary: While ethical justification for clinical trials relies heavily on individual consent, for
implementation research aspects of distributive justice, economics, and political philosophy underlie the debate. Societies may need to trade off decisions on the choice between individualized consent and valid implementation research. We suggest that social sciences codes could usefully inform the consideration of implementation research by members of Research Ethics Committees.

Item Type:	Journal Article
Subjects:	R Medicine > R Medicine (General)
Divisions:	Faculty of Science > Statistics
Library of Congress Subject Headings (LCSH):	Informed consent (medical law), Clinical trials
Journal or Publication Title:	Implementation Science
Publisher:	BioMed Central Ltd.
ISSN:	1748-5908
Official Date:	17 December 2008
Volume:	Vol.3
Number:	No.52
Identification Number:	10.1186/1748-5908-3-52
Status:	Peer Reviewed
Access rights to Published version:	Open Access
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URI:	http://wrap.warwick.ac.uk/id/eprint/520