Ethical and legal issues regarding consent in research with adult stroke patients: case study in the ethics of mental health research.

Journal: The Journal of nervous and mental disease

Volume: 200

Issue: 3

Year of Publication: 2012

Affiliated Institutions:  Department of Private Law, Law Faculty, University of Cape Town, Cape Town, South Africa. Anne.pope@uct.ac.za

Abstract summary 

This case study describes research into interventions to enhance stroke patients' ability to communicate. Because patients' cognitive abilities are compromised, it is argued that they may lack the capacity to consent and that surrogate consent should be required. In South Africa, this would make conducting the research difficult because only court-appointed curators are "legally appropriate" substitutes for research enrolment. Here, the research ethics committee must balance legal requirements and ethical concerns. It must also balance protection and respect for autonomy, even for cognitively compromised participants. First, incapacity should not simply be assumed but should be individually assessed. However, stroke patients present a further complication for capacity assessment because they may retain the capacity to reason but have lost the ability to communicate effectively. Second, the research ethics committee must decide whether recruitment should be restricted or whether incapacitated participants may be enrolled. Given the low risk of harm, incapacitated persons could be enrolled by proxies.

Authors & Co-authors:  Pope Anne A

Study Outcome 

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Statistics
Citations : 
Authors :  1
Identifiers
Doi : 10.1097/NMD.0b013e318247d22b
SSN : 1539-736X
Study Population
Male,Female
Mesh Terms
Adult
Other Terms
Study Design
Case Study,Cross Sectional Study
Study Approach
Country of Study
South Africa
Publication Country
United States