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(Stroke. 2009;40:1555.)
© 2009 American Heart Association, Inc.

Editorials

Need for Ethics Approval and Patient Consent in Clinical Research

Philip M.W. Bath, MD, FRCP Alan R. Watson, FRCP

From the Stroke Trials Unit (P.M.W.B.), University of Nottingham; and Children’s Renal & Urology Unit (A.R.W.), Nottingham University Hospitals NHS Trust, Nottingham, UK.

Correspondence to Professor Philip Bath, Division of Stroke Medicine, University of Nottingham, City Hospital campus, Hucknall Road, Nottingham NG5 1PB, UK. E-mail philip.bath@nottingham.ac.uk

Key Words: ethics • consent

An extract of the first 250 words of the full text is provided, because this article has no abstract.

See related article, pages 1903–1906.

A key principle in clinical research is the need to obtain approval from a Research Ethics Committee before commencing a study, and then to obtain consent from each subject enrolled into the study. This tenet is highlighted in the Helsinki Declaration and reinforced in subsequent principles such as Good Clinical Practice/International Committee on Harmonisation. However, not all clinical studies need ethics approval and consent—the most obvious example is clinical audit, which aims to review patient care against predefined criteria and then implement change to improve care and outcomes. Hence, audit is about healthcare processes, which contrasts with clinical research where the aim is to understand human disease, its presentation, investigation, management, and outcome.

So, why this reminder about the need for ethics approval and consent in clinical research? I (P.B.) was one of three reviewers asked to assess the article of Steinhagen et al for the journal (and published in this issue) and consider its suitability for publication. One of the other reviewers and myself questioned the absence of any mention of ethics approval and patient consent in the manuscript. The authors modified the manuscript in light of the first set of comments and, in their response letter to the editor, responded that "Ethics approval was not needed because all investigations performed were part of standardized routine diagnostic workup." This statement made no sense, because the study was clearly clinical research; further, the authors did not claim the study was audit and it would . . . [Full Text of this Article]

Related Article:

Swallowing Disturbance Pattern Relates to Brain Lesion Location in Acute Stroke Patients

Volker Steinhagen, Annette Grossmann, Reiner Benecke, and Uwe Walter
Stroke 2009 40: 1903-1906. [Abstract] [Full Text] [PDF]