CR82. Guidance for researchers and for research ethics committees on psychiatric research involving human participants


Price: £12.50

 

Approved: Jun 2000

 

Published: Jul 2001

 

Status: current

 

Review by: 2005

 

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Download Main Text of CR82 as a PDF file.  (The link above is for contents, working party membership, executive summary & acknowledgements only.)
 
Ethical issues in relation to research have come increasingly to the fore in recent years. This has happened as a result of both a growing public and professional awareness of the need to protect people (both patients and volunteers) who agree to participate in research, and a realization that research developments have raised new issues that have to be addressed. It is in everyone's interest that high quality research should be fostered and supported, but it is essential that this be conducted ethically in the context of appropriate risk-benefit analysis.
 
It was against this background that the Royal College of Psychiatrists set up an interdisciplinary working party to undertake a thorough reconsideration of the key issues with a special focus on concerns that apply particularly to psychiatry. Members of the working party reflected expertise in the difference branches in psychiatry (including its subspecialities), and in neurology, neurosurgery, psychology, social work, nursing, law, philosophy and consumer goods.
 
The topics covered in the report include: ethical responsibilities; the scope of ethics committees and varieties of research; research governance and clinical care; informed consent, capacity and competence; and the operation of ethics committees. The report notes the present state of the law but seeks to derive principles and to put forward practical guidelines for good practice.
 
An executive summary indicates the specifics of these guidelines, the body of the report provides a fuller background on the reasons for them, and appendices give more detailed considerations with respect to children's understanding of medical decisions; decision making and assessment of competence in individuals with a learning disability; and waived consent for research into acute grave illness, including unconscious patients, under emergency conditions.
 
The target audience for the report includes both researchers, with respect to their ethical and clinical responsibilities, and ethics committees, with respect to guidance on the issues that may be relevant in relation to applications dealing with mental health and illness issues.
 
© 2006 Royal College of Psychiatrists