Ethical issues of the informed consent procedure in schizophrenia patients in view of cognitive dysfunction
https://doi.org/10.31363/2313-7053-2018-4-108-116
Abstract
Te procedure of obtaining the informed consent plays the crucial role in biomedical studies. Psychiatric patients refer to the vulnerable category of subjects, as there is an obvious conflict exists between the necessity of compliance to the subject’s autonomy rules and the restrictions of this autonomy caused by the illness. Schizophrenia patients suffer from cognitive dysfunction in different domains, which influence their ability to comprehend the information and to make decisions. From the other hand, arguing the appropriateness of informed consent obtaining in patients with severe mental disorders (e.g. with schizophrenia) and, thus, limitation of their ability to participate in clinical trials, can be considered as an equitable limitation of their access to the latest achievements of medical science. Potential difculties in obtaining informed consent in schizophrenia subjects can be divided into three categories: 1) subject related; 2) protocol related; 3) investigator/physician related; Both the investigators and the physicians must be acquainted with the potential ethical issues that can influence the decision making ability in schizophrenia subjects due cognitive dysfunction and the decline in subject’s autonomy level.
About the Authors
N. V. Semenova
V.M.Bekhterev National Research Medical Centre for Psychiatry and Neurology
Russian Federation
Russian Federation
M. G. Yanushko
V.M.Bekhterev National Research Medical Centre for Psychiatry and Neurology
Russian Federation
Russian Federation
A. Iu. Iakovleva
V.M.Bekhterev National Research Medical Centre for Psychiatry and Neurology
Russian Federation
Russian Federation
References
1. Ivanyushkin A.Ya., Tihonenko V.A. Ethical aspects of mental health care // Psihiatriya: nacional’noe rukovodstvo / pod red. T.B. Dmitrievoj. V.A. Krasnova, N.G. Neznanova, V.Ja. Semke, A.S. Tiganova. — M.: GEOTAR-Media, 2009: 64–72. (In Rus.)
2. KudryashovaV.Yu., SaraykinD.M., IvanovM.V. Copingsandself-regulationofehaviorinpatientswithschizophreniaandaffectivedisorders. Obozrenie psihiatriiimed icinskojpsihologiiimeniV.M. Bekhtereva. 2017; 2:33–39 (In Rus.).
3. Lutova N.B. Sorokin M.YU., Vid V.D. Stigma in patients with mental disorders — its manifestations and consequences. Obozrenie psihiatrii i medicinskoj psihologii imeni V.M. Bekhtereva. 2017; 3:41–45(In Rus.).
4. Semenova N.V. Te informed consent and borders of autonomy in clinical trials with participation of vulnerable groups of patients. Medicinskaja etika. 2018; 1:63–65. (In Rus.).
5. Stecenko S.G. Informed voluntary consent to medical intervention // Obespechenie i zashchita prav pacientov v RF / pod red. O.P. Shchepina. — M.: GRANT, 2003:70.
6. Beck J.C. Determining competency to assent to neuroleptic drug treatment. // Hosp Community Psychiatry. — 1988. — V. 39. — P.1106-1108.
7. Beck J.C., Stafn R.D. Patients’competency to give informed consent to medication. // Hosp Community Psychiatry. — 1986. — V.37. — P.400-402.
8. Bracken-Roche et al. Te concept of ‘vulnerability’ in research ethics: an in-depth analysis of policies and guidelines. // Health Research Policy and Systems. — 2017. — V.15. — P.8. DOI 10.1186/s12961-016-0164-6
9. Carpenter W.T., Gold J.M., Lahti A.C., Queern C.A., Conley R.R., Bartko J.J., et al. Decisional capacity for informed consent in schizophrenia research. — // Arch Gen Psychiatry. — 2000. –V.57. — P.533-538. DOI:/10.1111/1556-4029.13000
10. Casebook on ethical issues in international health research / edited by Richard Cash .et al. WHO, Geneva. — 2009. — 209p.
11. Dunn L.B. Ethical issues in schizophrenia: considerations for treatment and research. // Psychopharmacology Bull. — 2007. –V.40(4). — P.145- 155. DOI: 10.1093/schbul/sbj031
12. Dunn L.B., Jeste D.V. Enhancing informed consent for research and treatment. Neuropsychopharmacol. — 2001. — V.24. — P.595-607. DOI:10.1016/S0893-133X(00)00218-9
13. Dunn L.B., Lindamer L.A., Palmer B.W. Improving understanding of research consent in middle-aged and elderly patients with psychotic disorders. // Am J Geriatr Psychiatry. — 2002. V.10 (2). — P.142-150. DOI:10.1016/S0165-0327(03)00109-5
14. Falagas M.E., Korbila I.P., Giannopoulou K.P., Kondilis B.K., Peppas G. Informed consent: how much and what do patients understand? // Am J Surg. — 2009. — V. 198. — P. 420-435. DOI:/10.1016/j.amj surg.2009.02.010
15. Green M.F. Cognition, Drug Treatment, and Functional Outcome in Schizophrenia: A Tale of Two Transitions. // Am J Psychiatry. — 2007. — V. 6 (164). — P. 992-994. DOI:10.1176/ajp.2007.164.7.992
16. Green M.F., Kern R.S., Robertson M.J., et al. Relevance of neurocognitive defcits for functional outcome in schizophrenia // Cognition in Schizophrenia / ed. by T.Sharma, Ph.Harvey. — New York: Oxford University Press. — 2000. — P.178-192.
17. Grisso T., Appelbaum P.S., Mulvey E.P., Fletcher K. Te MacArthur Treatment Competence Study: II. Measures of abilities related to competence to consent to treatment. // Law Hum Beh. — 1995. — V.19. — P.127-148.
18. Grisso T., Appelbaum P.S. Te MacArthur Treatment Competence Study. III. Abilities of patients to consent to psychiatric and medical treatments. // Law Hum Beh. — 1995. — V 19. — P.149-174.
19. Grossman L., Summers F. A study of the capacity of schizophrenic patients to give informed consent. // Hosp Community Psychiatry. — 1980. — V.31. — P.205-206.
20. Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators. Department of Health and Human Services, Ofce of Secretary. 2011, FR Doc No: 2011–18792, July 26.
21. Irwin M., Lovitz A., Marder S.R., Mintz J., Winslade W.J., Van Putten T., et al. Psychotic patients’ understanding of informed consent // Am J Psychiatry. — 1984. — V. 142. — P. 1351-1354.
22. Manson N.C., O’Neill O. Rethinking Informed Consent in Bioethics. — UK: Cambridge University Pres. — 2007.
23. Mirza I., Phelan M. Managing physical illness in people with severe mental illness // Hosp Med. — 2002. — V.63. — P.535-539. DOI:10.12968/hosp.2002.63.9.1949
24. Nishimura A., Carey J., Erwin P.J., Tilburt J.C., Murad M.H., McCormick J.B. Improving understanding in the research informed consent process: a systematic review of 54 interventions tested in randomized control trials. // BMC Medical Ethics. — 2013. — V.14. — P.28. DOI: 10.1186/1472-6939-14-28.
25. Paasche-Orlow M.K., Taylor H.A., Brancati F.L. Readability standards for informed-consent forms as compared with actual readability. // N Eng J Med. — 2003. — V.348. — P.721-726. DOI:10.1056/NEJMsa021212
26. Research Involving Persons with Mental Disorders that May Affect Decision Making Capacity, Vol 1, Report and Recommendations of the National Bioethics Advisory Commission. — Rockville, MD: NBAC. — 1998. — 176p.
27. Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity, Vol 2, Commissioned Papers by the National Bioethics Advisory Commission. — Rockville, MD: National Bioethics Advisory Commission (NBAC). — 1999. — 79p.
28. Yanushko M., Semenova N. Local ethics committee role in resolving ethical cornerstones of clinical trials in psychiatry// European Psychiatry. — 2018. — V.48. — P.379. DOI: 10.1016/j.eurpsy.2017.12.016.
Review
For citations:
Semenova N.V., Yanushko M.G., Iakovleva A.I. Ethical issues of the informed consent procedure in schizophrenia patients in view of cognitive dysfunction. V.M. BEKHTEREV REVIEW OF PSYCHIATRY AND MEDICAL PSYCHOLOGY. 2018;(4):108-116. (In Russ.) https://doi.org/10.31363/2313-7053-2018-4-108-116
Views:
1176
Email this article 