Journal of Medical Ethics 34 (3):167-170 (2008)
Background: Many people participating in dementia research may lack capacity to give informed consent and the relationship between cognitive function and capacity remains unclear. Recent changes in the law reinforce the need for robust and reproducible methods of assessing capacity when recruiting people for research.Aims: To identify numbers of capacitous participants in a pragmatic randomised trial of dementia treatment; to assess characteristics associated with capacity; to describe a legally acceptable consent process for research.Methods: As part of a pragmatic randomised controlled trial of Ginkgo biloba for mild-moderate dementia, we used a consenting algorithm that met the requirements of existing case law and the exigencies of the new Mental Capacity Act. We decided who had capacity to give informed consent for participation in the trial using this algorithm and sought predictors of capacity.Results: Most participants with mild-moderate dementia in this trial were unable to give informed consent according to the legal criteria. When adjusted for confounding, the Mini Mental State examination did not predict the presence of capacity.Conclusion: Cognitive testing alone is insufficient to assess the presence of capacity. Researchers and clinicians need to be aware of the challenging processes regarding capacity assessment. We outline a procedure which we believe meets the ethical and legal requirements
|Keywords||No keywords specified (fix it)|
|Categories||categorize this paper)|
References found in this work BETA
No references found.
Citations of this work BETA
Research Ethics Review: Social Care and Social Science Research and the Mental Capacity Act 2005.Jonathan Parker, Bridget Penhale & David Stanley - 2011 - Ethics and Social Welfare 5 (4):380-400.
Research Involving Subjects with Alzheimer’s Disease in Italy: The Possible Role of Family Members.Corinna Porteri & Carlo Petrini - 2015 - BMC Medical Ethics 16 (1):12.
Similar books and articles
Research Without Consent: Exception From and Waiver of Informed Consent in Resuscitation Research.Michelle H. Biros - 2007 - Science and Engineering Ethics 13 (3):361-369.
Correlates of Parental Participation During Informed Consent for Randomized Clinical Trials in the Treatment of Childhood Leukemia.Dennis Drotar, Victoria Miller, Victoria Willard, Kyle Anthony & Eric Kodish - 2004 - Ethics and Behavior 14 (1):1 – 15.
Children's Capacity to Agree to Psychological Research: Knowledge of Risks and Benefits and Voluntariness.Rona Abramovitch, Jonathan L. Freedman, Kate Henry & Michelle Van Brunschot - 1995 - Ethics and Behavior 5 (1):25 – 48.
Effectively Obtaining Informed Consent for Child and Adolescent Participation in Mental Health Research.Benedetto Vitiello - 2008 - Ethics and Behavior 18 (2 & 3):182 – 198.
Informed Consent: A Primer for Clinical Practice.Deborah Bowman - 2011 - Cambridge University Press.
Genetic Research, Adolescents, and Informed Consent.Robert F. Weir & Jay R. Horton - 1995 - Theoretical Medicine and Bioethics 16 (4).
Informed Consent and Anonymous Tissue Samples: The Case of Hiv Seroprevalence Studies.Loretta M. Kopelman - 1994 - Journal of Medicine and Philosophy 19 (6):525-552.
Which Benefits of Research Participation Count as 'Direct'?Alexander Friedman, Emily Robbins & David Wendler - 2012 - Bioethics 26 (2):60-67.
The Neuroscience of Decision Making and Our Standards for Assessing Competence to Consent.Steve Clarke - 2013 - Neuroethics 6 (1):189-196.
Money for Research Participation: Does It Jeopardize Informed Consent?Christine Grady - 2001 - American Journal of Bioethics 1 (2):40 – 44.
Emergency Research Without Consent Under Polish Law.Joanna Różyńska & Marek Czarkowski - 2007 - Science and Engineering Ethics 13 (3):337-350.
Participants' Understanding of the Process of Psychological Research: Informed Consent.Janet L. Brody, John P. Cluck & Alfredo S. Aragon - 1997 - Ethics and Behavior 7 (4):285 – 298.
Added to index2010-08-24
Total downloads6 ( #563,676 of 2,178,178 )
Recent downloads (6 months)1 ( #316,504 of 2,178,178 )
How can I increase my downloads?