Informed consent in psychiatric research

Current Opinion in Psychiatry

Volumn 16, Issue 6, 2003, Pages 679-684

  Bloch, Sidney ^a   Salzberg, Michael ^a  

^a UNIVERSITY OF MELBOURNE   (Australia)

Author keywords

Competence; Informed consent; Privacy; Psychiatric research; Voluntarism

Indexed keywords

COMPETENCE; CULTURAL FACTOR; GENETICS; INFORMED CONSENT; LEGAL ASPECT; MANAGED CARE; MEDICAL ETHICS; PRIVACY; PSYCHIATRY; RESEARCH; REVIEW; SOCIAL ASPECT; SOCIOECONOMICS; VOLUNTEER;

EID: 0242392020     PISSN: 09517367     EISSN: None     Source Type: Journal    
DOI: 10.1097/00001504-200311000-00013     Document Type: Review

References (17)

1. Mitscherlich A, Mielke F. Doctors of infamy: the story of the Nazi medical crimes. New York: Schuman; 1949.
2. Appelbaum P, Roth L. Competency to consent to research: a psychiatric overview. Arch Gen Psychiatry 1982; 39:951-958.
3. O'Neill, O. Some limits of informed consent. J Med Ethics 2003; 29:4-7. This is a useful account of the limitations of the process of informed consent and ways to deal with them.
4. Roberts, L. Informed consent and the capacity for voluntarism. Am J Psychiatry 2002; 159:705-712. This is a comprehensive review of the concept of voluntarism in consenting to treatment and research in psychiatry, and gives helpful guidelines concerning its promotion.
5. Nelson R, Merz J. Voluntariness of consent for research. Medical care 2002; 40 (Suppl):V69-V80. This paper complements Roberts' [4••] review nicely by stressing characteristics of the researcher which may militate against free choice.
6. Guinn D. Mental competence, caregivers, and the process of consent: research involving Alzheimer's patients or others with decreasing mental capacity. Camb Q Healthc Ethics 2002; 11:230-245. The major focus of this paper is on the surrogate as a caring person who knows the research subject and can therefore act as 'facilitator'.
7. Yarborough M. Adults are not big children: examining surrogate consent to research using adults with dementia. Camb Q Healthc Ethics 2002; 11:160-168. This provides a clear account of three standards of substituted judgement, but argues for a position, influenced by Kantianism, which stresses the humanity and individuality of the subject.
8. Baier A. Postures of the mind. Minneapolis: University of Minnesota Press; 1985.
9. Cassell J, Young A. Why we should not seek individual informed consent for participation in health services research. J Med Ethics 2002; 28:313-317. This is a thoughtful, well-written paper exploring conflicts between the requirement for informed consent and other social 'goods' (particularly equity) in the conduct of health-services research. It covers the origins of the 'individualized' concept of informed consent in the Declaration of Helsinki, ways in which the informed consent requirement may exacerbate inequality, and offers a vision of citizens as members of a health service, rather than as consumers.
10. Karlawish JHT, Fox E, Pearlman R. How changes in health care practices, systems, and research challenge the practice of informed consent. Med Care 2002; 40 (Suppl):V12-V19. This is a useful exploration of the implications for informed consent of population-based perspectives, evidence-based medicine, managed care, research using existing clinical data, and research in emergency situations.
11. Petrila J. The emerging debate over the shape of informed consent: can the doctrine bear the weight? Behav Sci Law 2002; 21:121-133. Although mainly concerned with general medicine and with clinical practice, this paper is a valuable overview of recent legal developments concerning informed consent in the US. It examines pressures for a radical expansion of the kinds of information provided to patients (e.g. about physician's contractual arrangements with health-care plans) and explores the implications for trust in the doctor-patient relationship.
12. Parker LS. Ethical issues in bipolar disorders pedigree research: privacy concerns, informed consent, and grounds for waiver. Bipolar Disord 2002; 4:1-16. Pedigree research is an invaluable approach to the study of bipolar disorder. Conventionally, informed consent is sought from the proband only, who provides information about other family members; only when it is clear that the family is eligible is informed consent sought from them. Moves are afoot in the US to require researchers to seek informed consent from all family members at the outset. Parker, in a thoughtful review, argues that this will cause more harm than good, to probands, to families, and to the conduct of the research.
13. Kuczewski MG, Marshall P. The decision dynamics of clinical research: the context and process of informed consent. Med Care 2002; 40 (Suppl):V45-V54. This is a useful review of the role of self-health groups and primary-care physicians in informed consent. It also explores the relevance, to informed consent, of language barriers, socio-economic inequality, and gender and cultural differences.
14. Poythress NG. Obtaining informed consent for research: a model for use with participants who are mentally ill. J Law Med Ethics 2002; 30:367-374. When it comes to obtaining informed consent from the mentally ill to conduct research, the stakes are high for all concerned. The author offers the outline of an approach, applying the neuropsychological concept of 'recognition memory'. This is a practical suggestion which warrants consideration.
15. Kim SYH, Caine ED. Utility and limits of the Mini-Mental State Examination in evaluating consent capacity in Alzheimer's disease. Psychiatr Serv 2002; 53:1322-1324.
16. Moser DJ, Schultz SK, Arndt S, et al. Capacity to provide informed consent for participation in schizophrenia and HIV research. Am J Psychiatry 2002; 159:1201-1207.
17. Holmes-Rovner M, Wills CE. Improving informed consent: insights from behavioral decision research. Med Care 2002; 40 (Suppl):V30-V38. What you read in the title is what you get, i.e. a concise overview of several strands of psychological research on decision-making, with prima facie relevance to informed consent. Concepts such as heuristics and biases, order and framing effects, debiasing procedures and decision aids have been explored in general medicine, but only minimally in psychiatry.