Ethical and Legal Issues of Informed Patient Consent: How to Avo id Mistakes
DOI:
https://doi.org/10.52692/1857-0011.2024.2-79.27Keywords:
nformed consent, medical ethics, legal liability, patient rights, medical errorsAbstract
The article examines ethical and legal issues of informed voluntary consent in medical practice, stressing the need to inform patients about treatments, risks, and alternatives. It highlights increasing patient rights litigation and the importance of accurate documentation to avoid legal issues. International standards, including the Helsinki Declaration and the Convention on Human Rights and Biomedicine, are discussed, with a recommendation to use checklists for compliance. This article emphasizes the protection of patient rights and the reduction of legal risks for medical professionals.
References
Akopov, V. I. On the State, Legal Significance, and Possibilities for Improving the Level of Quality Control of Medical Care at the Pre-Trial Stage. In Current Issues of Forensic Medicine and Expert Practice at the Present Stage, Moscow, 2006, pp. 307-309.
Alderson, P. Competent Children? Minors’ Consent to Health Care Treatment and Research. Social Science & Medicine, vol. 65, no. 11, 2007, pp. 2272-2283.
Appelbaum, Paul S. Assessment of Patients’ Competence to Consent to Treatment. NEJM, vol. 357, no. 18, 2007, pp. 1834-1840.
Brown, K., and Johnson, P. Deaf and Hard of Hearing Patients: A Medical Communication Guide. The Lancet, vol. 387, no. 10017, 2016, pp. 1976-1984.
Canterbury v. Spence, 464 F.2d 772, United States Court of Appeals for the District of Columbia Circuit, 1972.
Cheminava, R. V. On the Issue of Iatrogeny in Acute Surgical Diseases: Medical-Legal Qualification. In Theory and Practice of Forensic Medicine, St. Petersburg, 2006, pp. 121-122.
COD Nr. 985 din 18-04-2002 CODUL PENAL AL REPUBLICII MOLDOVA. Publicat: 14-04-2009 în Monitorul Oficial Nr. 72-74 art. 195.
Convenția privind drepturile persoanelor cu dizabilități a fost adoptată la New York de Adunarea Generală a Organizației Națiunilor Unite la 13 decembrie 2006.
Council of Europe. Convention on Human Rights and Biomedicine. Oviedo, 4 April 1997.
Dunn, L. B., Alici, Y., Roberts, L. W. Ethical Challenges in the Treatment of Cognitive Impairment in Aging. Current Behavioral Neuroscience Reports, vol. 2, 2015, pp. 226–233.
Dworkin, R. Life’s Dominion: An Argument About Abortion, Euthanasia, and Individual Freedom. New York: Alfred A. Knopf, 1994.
Erofeev, S. V., Timofeev, D. N. Adverse Outcome of Medical Care in Ophthalmological Practice. In Current Issues of Forensic Medicine and Expert Practice at the Present Stage, Moscow, 2006, pp. 303-304.
European Court of Human Rights. European Court of Human Rights. Council of Europe, https://www.echr.coe.int/.
Faden, R. R., and Beauchamp, T. L. A History and Theory of Informed Consent. New York: Oxford University Press, 1986.
Fields, Lisa M., and Julia D. Calvert. Informed Consent Procedures with Cognitively Impaired Patients: A Review of Ethics and Best Practices. Psychiatry and Clinical Neurosciences, vol. 69, no. 8, 2015, pp. 462- 471.
Fundamentals of the Legislation of the Russian Federation on the Protection of Citizens’ Health (approved by the Supreme Council of the Russian Federation on 22.07.1993 N 5487-1) (as amended on 07.12.2011). Article 34.
Gîlca, Boris, Rodica Gramma și Adriana Paladi. Ghid privind aplicarea procedurii de comunicare și consiliere a pacienților. Chișinău, 2018. 39 p.
Grisso, T., Appelbaum, P. S., Mulvey, E. P., and Fletcher, K. The MacArthur Treatment Competence Study. II: Measures of Abilities Related to Competence to Consent to Treatment. Law and Human Behavior, vol. 21, no. 2, 1997, pp. 127-140.
Grodin, M. A., and Glantz, L. H. Children as Research Subjects: Science, Ethics, and Law. Oxford University Press, 1994.
Hall, E. D. Language Barriers in Healthcare: Overcoming the Communication Gap. New England Journal of Medicine, vol. 376, no. 5, 2017, pp. 472- 475.
Lege Nr. 411 din 28-03-1995 ocrotirii sănătăţii. Publicat: 22-06-1995 în Monitorul Oficial Nr. 34 art. 373. Versiune în vigoare din 31.12.08 în baza modificărilor prin LP259-XVI din 05.12.08, MO237- 240/31.12.08 art. 862.
Manuals. Informed Consent – Professional Version.MSD Manual.
Markina, Nadezhda. In Russia, It’s Impossible to ‘Die Well.’ Gazeta.Ru, April 17, 2013, https://www.gazeta.ru/health/5258893.shtml.
O’Neill, O. Autonomy and Trust in Bioethics.Cambridge: Cambridge University Press, 2002.
Ordinul MS RM Nr. 303 din 06-05-2010 cu privire la asigurarea accesului la informația privind propriile date medicale şi lista intervențiilor medicale care necesită perfectarea acordului informat. Publicat: 29- 06-2010 în Monitorul Oficial Nr. 108-109 art. 382.
Pădure, Andrei, and Bondarev, Anatolii. Consimțământul informat al pacientului din perspectiva legislației europene și naționale. In Integrare prin cercetare si inovare: Științe juridice și economice, 10-11 November 2022, Chișinău. Chișinău, 2022, pp. 265-267.
Pădure, Andrei. Aspecte etice şi juridice ale consimțământului informat al pacientului. Sănătate Publică, Economie şi Management în Medicină, 2011, no. 1(36), pp. 57-60.
Pashinyan, G. A., Talalaev, V. N., and Anyutin, R.G. Expert Evaluation of Medical Care Defects in Otorhinolaryngology. Forensic Medical Examination, 2004, no. 4, pp. 3-6.
Pope, Thaddeus Mason. Capacity (Competence) and Incapacity. MSD Manual, Oct. 2023.
Scholten, M., Gather, J., and Vollmann, J. Ethical Considerations in Obtaining Informed Consent in Patients with Dementia. Journal of Medical Ethics, vol. 46, no. 9, 2020, pp. 619–625.
Smith, J., and Jones, M. Health Communication Strategies for Visually Impaired Patients. Journal of Medical Ethics, vol. 41, no. 4, 2015, pp. 234-240.
Stacey, Dawn, et al. Decision Aids for People Facing Health Treatment or Screening Decisions. The Cochrane Database of Systematic Reviews, vol. 4, 2017, CD001431.
Turner, N. R., and Williams, R. Cognitive Impairment and Informed Consent in Healthcare: Ethical and Practical Considerations. Journal of Clinical Ethics, vol. 30, no. 1, 2019, pp. 12-21.
World Health Organization. Patient safety rights charter, 2020. WHO, 2024. 12 p.
World Medical Association. Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects, 2013.
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