Using data to improve surrogate consent for clinical research with incapacitated adults

Journal of Empirical Research on Human Research Ethics

Volumn 7, Issue 2, 2012, Pages 37-50

  Abdoler, Emily ^a   Wendler, David ^a  

^a NATIONAL INSTITUTES OF HEALTH   (United States)

Author keywords

Capacity; Consent; Research

Indexed keywords

ADULT; ARTICLE; DECISION MAKING; ETHICS; FAMILY; HUMAN; INFORMED CONSENT; MEDICAL RESEARCH; MENTAL CAPACITY; PATIENT ATTITUDE; PATIENT SELECTION; RESEARCH SUBJECT;

ADULT; BIOMEDICAL RESEARCH; DECISION MAKING; FAMILY; HUMANS; INFORMED CONSENT; MENTAL COMPETENCY; PATIENT ACCEPTANCE OF HEALTH CARE; PATIENT SELECTION; RESEARCH SUBJECTS; THIRD-PARTY CONSENT;

EID: 84860740486     PISSN: 15562646     EISSN: 15562654     Source Type: Journal    
DOI: 10.1525/jer.2012.7.2.37     Document Type: Article

References (35)

1. Ali, K., Roffe, C., & Crome, P. (2006). What patients want: Consumer involvement in the design of a randomized controlled trial of routine oxygen supplementation after acute stroke. Stroke, 37(3), 865-871. (Pubitemid 43731923)
2. Alzheimer's Association. (2008). Alzheimer's disease facts and figures. Alzheimer's and Dementia, 4(2), 110-133.
3. Attorney General's Working Group. (1998). Final report on research involving decisionally incapacitated subjects. Baltimore, MD: Office of the Maryland Attorney General.
4. Ayalon, L. (2009). Willingness to participate in Alzheimer disease research and attitudes towards proxy-informed consent: Results from the health and retirement study. American Journal of Geriatric Psychiatry, 17(1), 65-74.
5. Berger, J. T. & Majerovitz, S. D. (2005). Do elderly persons' concerns for family burden influence their preferences for future participation in dementia research? Journal of Clinical Ethics, 16(2), 108-115. (Pubitemid 41139799)
6. Blixen, C. E. & Agich, G. J. (2005). Stroke patients' preferences and values about emergency research. Journal of Medical Ethics, 31(10), 608-611. (Pubitemid 41488942)
7. Bravo, G., Dubois, M. F., Pâquet, M., Langlois, F., & Bernier, J. P. (2004). Quebec physicians' knowledge and opinions regarding substitute consent for decisionally incapacitated older adults. IRB, 26(5), 12-17. (Pubitemid 43362253)
8. Bravo, G., Pâquet, M., & Dubois, M. F. (2003). Opinions regarding who should consent to research on behalf of an older adult suffering from dementia. Dementia, 2(1), 49-65.
9. Chen, D. T., Miller, F. G., & Rosenstein, D. L. (2002). Enrolling decisionally impaired adults in clinical research. Medical Care, 40(9 Suppl), V20-V29.
10. Chenaud, C., Merlani, P., Verdon, M., & Ricou, B. (2009). Who should consent for research in adult intensive care? Preferences of patients and their relatives: A pilot study. Journal of Medical Ethics, 35(11), 709-712.
11. Ciroldi, M., Cariou, A., Adrie, C., Annane, D., Castelain, V., Cohen, Y. et al. (2007). Ability of family members to predict patient's consent to critical care research. Intensive Care Medicine, 33(5), 807-813. (Pubitemid 46675320)
12. Coppolino, M. & Ackerson, L. (2001). Do surrogate decision makers provide accurate consent for intensive care research? Chest, 119(2), 603-612. (Pubitemid 32163776)
13. Council of Europe (Directorate of Legal Affairs). (1996). Convention for the protection of human rights and dignity of the human being with regard to the application of biology and medicine. Strasbourg, France: Council of Europe.
14. Del Giudice, A., Plaum, J., Maloney, E., Kasner, S. E., Le Roux, P. D., & Baren, J. M. (2009). Who will consent to emergency treatment trials for subarachnoid hemorrhage? Academy of Emergency Medicine, 16(4), 309-315.
15. Karlawish, J., Kim, S. Y. H., Knopman, D., van Dych, C. H., James, B. D., & Marson, D. (2008). The views of Alzheimer disease patients and their study partners on proxy consent for clinical trial enrollment. American Journal of Geriatric Psychiatry, 16(3), 240-247.
16. Karlawish, J., Rubright, J., Casarett, D., Cary, M., Ten Have, T., & Sankar, P. (2009). Older adults' attitudes toward enrollment of non-competent subjects participating in Alzheimer's research. American Journal of Psychiatry, 166(2), 182-188.
17. Kim, S. Y. H., Cox, C., & Caine, E. D. (2002). Impaired decision-making ability in subjects with Alzheimer's disease and willingness to participate in research. American Journal of Psychiatry, 159(5), 797-802. (Pubitemid 34465054)
18. Kim, S. Y. H., Kim, H. M., Langa, K. M., Karlawish, J. H. T., Knopman, D. S., & Appelbaum, P. S. (2009). Surrogate consent for dementia research: A national survey of older Americans. Neurology, 72(2), 149-155.
19. Kim, S. Y. H., Kim, H. M., McCallum, C., & Tariot, P. N. (2005). What do people at risk for Alzheimer disease think about surrogate consent for research? Neurology, 65(9), 1395-1401. (Pubitemid 41552768)
20. Medical Research Council of Canada, Natural Sciences and Engineering Research Council of Canada, and Social Sciences and Humanities Research Council of Canada. (1998). Tri-council policy statement. Ottawa, Ontario: Public Works and Government.
21. Muncie, H. L., Magaziner, J., Hebel, J. R., & Warren, J. W. (1997). Proxies' decisions about clinical research participation for their charges. Journal of the American Geriatric Society, 45(8), 929-933. (Pubitemid 27330121)
22. Muthappan, P., Forster, H., & Wendler, D. (2005). Research advance directives: Protection or obstacle? American Journal of Psychiatry, 162(12), 2389-2391. (Pubitemid 41740223)
23. National Bioethics Advisory Commission (NBAC). (1998). Research involving persons with mental disorders that may affect decisionmaking capacity. Washington, DC: U.S. Government Printing Office.
24. National Human Research Protections Advisory Committee. (2002). Report from NHRPAC on informed consent and the decisionally impaired. Washington, DC: U.S. Department of Health and Human Services, Office for Human Research Protections.
25. National Institutes of Health Clinical Center. (2008). Medical Administrative Series: Research involving adults who are or may be unable to consent. Available from the corresponding author upon request.
26. New York State Advisory Work Group. (1998). Recommendations on the oversight of human subjects research involving the protected classes. Albany, NY: New York State Department of Health.
27. Nuremberg Code. (1996). Journal of the American Medical Association, 276(20), 1691.
28. Sachs, G. A., Stocking, C. B., Stern, R., Cox, D. M., Houghman, G., & Sachs, R. S. (1994). Ethical aspects of dementia research: Informed consent and proxy consent. Clinical Research, 42(3), 403-412.
29. Secretary's Advisory Committee on Human Research Protections (SACHRP). (2009a). Recommendation 5. In: Recommendations from the subcommittee for the inclusion of individuals with impaired decision making in research. Washington, DC: U.S. Department of Health and Human Services, Office for Human Research Protections.
30. Secretary's Advisory Committee on Human Research Protections. (2009b). Recommendation 9. In: Recommendations from the subcommittee for the inclusion of individuals with impaired decision making in research. Washington, DC: U.S. Department of Health and Human Services, Office for Human Research Protections.
31. Shalowitz, D. I., Garrett-Mayer, E., & Wendler D. (2006). The accuracy of surrogate decision makers: A systematic review. Archives of Internal Medicine, 166(5), 493-497.
32. Stephenson, A. C., Baker, S., & Zeps, N. (2007). Attitudes of relatives of patients in intensive care and emergency departments to surrogate consent to research on incapacitated participants. Critical Care and Resuscitation, 9(1), 40-50.
33. Stocking, C. B., Hougham, G. W., Danner, D. D., Patterson, M. B., Whitehouse, P. J., & Sachs, G. A. (2006). Speaking of research advance directives: Planning for future research participation. Neurology, 66(9), 1361-1366. (Pubitemid 43739645)
34. U.S. Department of Health and Human Services. (1991). Protections of human subjects. 45 CFR § 46.
35. Wendler, D., Martinez, R.A., Fairclough, D., Sunderland, T., & Emanuel, E. (2002). Views of potential subjects toward proposed regulations for clinical research with adults unable to consent. American Journal of Psychiatry, 159(4), 585-591. (Pubitemid 34274940)