On the need for improved protections of incapacitated and non-benefiting research subjects

Bioethics

Volumn 26, Issue 1, 2012, Pages 15-21

  Eriksson, Stefan ^a  

^a UPPSALA UNIVERSITY   (Sweden)

Author keywords

Incapacitated subjects; Minimal risk; Research ethics; Vulnerable subjects

Indexed keywords

ARTICLE; BENEFICENCE; DECISION MAKING; ETHICS; HUMAN; INFORMED CONSENT; MEDICAL RESEARCH; MENTAL CAPACITY; PSYCHOLOGICAL ASPECT; RESEARCH SUBJECT; RISK ASSESSMENT;

BENEFICENCE; BIOMEDICAL RESEARCH; DECISION MAKING; HUMANS; INFORMED CONSENT; MENTAL COMPETENCY; RESEARCH SUBJECTS; RISK ASSESSMENT;

EID: 83655191593     PISSN: 02699702     EISSN: 14678519     Source Type: Journal    
DOI: 10.1111/j.1467-8519.2010.01804.x     Document Type: Article

References (30)

1. C. Druml.Informed Consent of Incapable (ICU) Patients in Europe: Existing Laws and the EU Directive.Curr Opin Crit Care 2004; 10: 570-573.
2. Council of Europe. Additional Protocol to the Convention on Human Rights and Biomedicine Concerning Biomedical Research. Strasbourg: Council of Europe.2005
3. World Medical Association. 2008. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects, adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964, latest revision by the WMA General Assembly, Seoul Ferney-Voltaire, France: World Medical Association.2008
4. Council for International Organizations of Medical Sciences, CIOMS. International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva: WHO.2002
5. UNESCO. Universal Declaration on Bioethics and Human Rights, adopted by acclamation on 19 October 2005 by the 33rd session of the General Conference of UNESCO, Paris, Paris: UNESCO.2005
6. L.A. Eckenwiler et al. Hopes for Helsinki: Reconsidering 'Vulnerability'.J Med Ethics 2008 34: 765-66
7. R. Luebbert et al. IRB Member Judgments of Decisional Capacity, Coercion, and Risk in Medical and Psychiatric Studies. J Empir Res Hum Res Ethics2008315-24.
8. A.M. CapronEthical and Human-rights Issues in Research on Mental Disorders that May Affect Decision-making Capacity.N Eng J Med 1999; 340: 1430-1434
9. F. Lemaire.Patient Care versus Research: Does Clinical Research Provide Individual Benefit to Patients Enrolled in Trials? Curr Opin Crit Care200410: 565-569.
10. D. Wendler & K. PrasadCore Safeguards for Clinical Research with Adults who Are Unable to Consent.Ann Intern Med2001135514-523
11. R.A. O'Connell et al. Single-photon Emission Computed Tomography of the Brain in Acute Mania and Schizophrenia. J Neuroimaging 1995; 5(2): 101-104.
12. P. Lewis. Procedures that Are Against the Medical Interests of Incompetent Adults. Oxford Jour Leg Stud 2002; 22: 575-618.
13. G. Helgesson & S. Eriksson. Against the Principle that the Individual Shall Have Priority Over Science. J Med Ethics 2008; 34: 54-56.
14. Department of Health and Human Services. Code of Federal Regulations, 45 (i), (i), CFR46102(i), Protection of human subjects.
15. B. Freedman, A. Fuks & C. Weijer. In Loco Parentis: Minimal Risk as an Ethical Threshold for Research upon Children. Hast Cent Rep 1993; 23(2): 13-19.
16. Council for International Organizations of Medical Sciences, CIOMS2002
17. J.H.T. Karlawish. Conducting Research That Involves Subjects at the End of Life who Are Unable to Give Consent. J Pain Sympt Man 2003; 25: S14-S24.
18. Where a subject's medication is withdrawn in order to establish a baseline level of functioning without it.
19. Where a subject is exposed to some stimuli that provoke the symptoms one wishes to study or explain; for example, patients with agoraphobia have been asked to hyperventilate to investigate whether hyperventilation causes panic attacks, and African-American women have been subject to racist provocations from white opponents in order to measure the significant increase in heart rates and blood pressure. See L. Lum. Hyperventilation: The Tip and the Iceberg. J Psychosom Res 197519: 375-383
20. M.D. McNeilly et al. Effects of Racist Provocation and Social Support on Cardiovascular Reactivity in African American Women. Int J Behav Med 1995; 2: 321-338.
21. The National Bioethics Advisory Commission (NBAC). Research Involving Persons with Mental Disorders that May Affect Decisionmaking Capacity.Report and Recommendations of the NBAC. Rockville, Maryland: NBAC.19981
22. L.L. Emanuel et al. Advance Directives for Medical Care - A Case for Greater Use. N Engl J Med 1991; 324: 889-895.
23. P. Muthappan, H. Forster & D. Wendler. Research Advance Directives: Protection or Obstacle?. Am J Psychiatry 2005; 162: 2389-2391.
24. R. Michels. Editorial.Am J Psychiatry 2004; 161: 777-779.
25. Office of Inspector General. The Food and Drug Administration's Oversight of Clinical Trials. Washington, DC: Department of Health and Human Services.2007
26. Personal communication from the Swedish Medical Products Agency, October2007.
27. S. Kim, P. Ubel & R. De Vries. Pruning the Regulatory Tree. Nature2009457534-535.
28. The National Bioethics Advisory Commission
29. C.B. Stocking et al. Ethics Reporting in Publications about Research with Alzheimer's Disease Patients. J Am Ger Soc2004; 52: 305-310
30. D.L. Rosenstein & F.G. Miller. Ethical Considerations in Psychopharmacological Research Involving Decisionally Impaired Subjects. Psychopharmacology 200317192-97.