By any other name: The many iterations of 'patient advocate' in clinical research

IRB Ethics and Human Research

Volumn 26, Issue 6, 2004, Pages 1-8

  Morreim, E Haavi ^a  

^a UNIVERSITY OF TENNESSEE HEALTH SCIENCE CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; CLINICAL TRIAL; ETHICS; HUMAN; HUMAN EXPERIMENT; INFORMED CONSENT; MENTAL CAPACITY; NOMENCLATURE; PATIENT ADVOCACY; PROFESSIONAL STANDARD; RESEARCH SUBJECT; RISK ASSESSMENT; STANDARD; VULNERABLE POPULATION;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

CLINICAL TRIALS; HUMAN EXPERIMENTATION; HUMANS; INFORMED CONSENT; MENTAL COMPETENCY; PATIENT ADVOCACY; PROFESSIONAL ROLE; RESEARCH SUBJECTS; RISK ASSESSMENT; TERMINOLOGY; VULNERABLE POPULATIONS;

EID: 13844309906     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3564096     Document Type: Review

References (53)

1. Milstein AC, Braslow DT. Memorandum of law in opposition to preliminary objections of defendant David Casarett, M.D.; http://www.sskrplaw.com.
2. See also the original complaint filed, Quinn v. ABIOMED et al.; http://www.sskrplaw.com. Count 69(d) alleged "patient advocate malpractice" via an alleged failure "to act with respect to billing issues," while Count 69(e) alleged patient advocate malpractice via alleging failure "to set up communications with the wives of other subjects."
3. As suggested by Dresser, "people enrolling in studies no longer bear the demeaning label 'subject'; instead, they are 'participants' or 'volunteers' contributing actively and significantly to the research process." Dresser R. When Science Offers Salvation. New York: Oxford University Press, 2001, p. 5.
4. To some prospective research enrollees, for instance, the word "subject" might refer to a topic, as in: "What was your favorite subject in school?"
5. Although the role may be called "patient advocate," "patient representative" or "ombudsman," these workers' umbrella organization is the National Society for Healthcare Consumer Advocacy - an arm of the American Hospital Association. See, e.g., http://www.tha.com/ all_aff/tnshca.htm
6. Thus, in Doe v. Travelers Ins. Co., the court noted that Travelers Insurance "covers only charges for services that are deemed to be 'medically necessary' by a patient advocate" Doe v. Travelers Ins. Co., 971 F.Supp. 623, 629 (D.Mass 1997). The court goes on to note that "the plan specifically excludes coverage for 'service or supplies which are not medically necessary'," per the patient advocate's determination.
7. Thus the "patient advocate Foundation" describes itself as "a national non-profit organization that serves as an active liaison between the patient and their insurer, employer and/or creditors." See http://www.patientadvocate.org/.
8. In California, the state's Office of the Patient Advocate likewise helps people enrolled in Health Maintenance Organizations (HMOs) to receive the care to which they are entitled under state law. See http://www.opa.ca.gov/
9. See, e.g., the Pennsylvania Medical Society's "Council on Patient Advocacy" at http://www.pamedsoc.org/Content/NavigationMenu/The_Society/ Membership_Groups/Councils-Commissions/Council_on_Patient_Advocacy/ Council_on_Patient_Advocacy.htm
10. See http://www.google.com Under the terms patient advocate and patient advocacy, over one million sites are identified.
11. See ref. 2, Dresser 2001, p. 18.
12. See http://www.pacirb.com/
13. Department of Health, Education, and Welfare. Research involving those institutionalized as mentally infirm. Report and recommendations of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. Federal Register. March 17, 1978; 43:11328-11358.
14. Bonnie RJ. Research with cognitively impaired subjects: Unfinished business in the regulation of human research. Archives of General Psychiatry 1997;54:105-111, p. 108.
15. See ref. 12, Bonnie 1997;
16. Hoffmann DE, Schwartz J, DeRenzo EG. Regulating research with decisionally impaired individuals: Are we making progress? DePaul Journal of Health Care Law 2000;3:547-608, p. 564.
17. See ref. 12, Bonnie 1997.
18. See ref. 12, Bonnie 1997, p. 109;
19. Berg JW. Legal and ethical complexities of consent with cognitively impaired research subjects: Proposed guidelines. Journal of Law, Medicine & Ethics 1996;24:18-35, p. 19;
20. see ref. 13, Hoffmann et al., 2000;
21. Michels R. Are research ethics bad for our mental health? NEJM 1999;340:1417-30, p. 1427.
22. Bein PM. Surrogate consent and the incompetent experimental subject. Food, Drug and Cosmetic Law Journal 1991;46:739-777.
23. See ref. 15, Berg 1998.
24. See ref. 15, Berg 1998.
25. Posever TA, Chelmow T. Informed consent for research in schizophrenia. IRB: Ethics & Human Research 2001;23(1):10-15.
26. Keyserlingk EW, Glass K, Kogan S, Gauthier S. Proposed guidelines for the participation of persons with dementia as research subjects. Perspectives in Biology and Medicine 1995;38:319-62.
27. Appelbaum PS, Roth LH, Lidz CW, Benson P, Winslade W. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Center Report 1987;17(2):20-24;
28. Appelbaum PS, Roth LH, Lidz C. The therapeutic misconception: Informed consent in psychiatric research. International Journal of Law & Psychiatry 1981:5(3-4):319-329.
29. Of note, the "neutral discloser" idea has been endorsed in far more mundane kinds of research, such as that conducted in the offices of physicians in private practice. See, e.g., Klein JE, Fleischman AR. The private practicing physician-investigator: Ethical implications of clinical research in the office setting. Hastings Center Report 2002;32(4):22-26, p. 25.
30. Stroup S, Appelbaum P. The subject advocate: Protecting the interests of participants with fluctuating decisionmaking capacity. IRB: Ethics & Human Research 2003;25(3):9-11.
31. National Center for Research Resources. Guidelines for the General Clinical Research Centers Program. November, 2001. http://www.ncrr.nih.gov/ clinical/crguide2001/guidenov2001.pdf, p. 11.
32. O'Lonergan T. Creative solutions: Research subject advocates. Protecting Human Subjects Spring 2003, #8:10-11, p. 11.
33. See ref. 15, O'Lonergan 2003.
34. Steve Peckman, IRB Associate Director, University of California, Los Angeles; panel presentation, "The Role of 'patient advocates' in Medical Research." Fourth Annual Medical Research Summit. Baltimore, Maryland, April, 2004.
35. Jones M. Fetal surgery is a complicated procedure getting more so. New York Times, July 15, 2001. http://www.nytimes.com/2001/07/15/ magazine/15FETAL.html
36. Personal conversation with Mark J. Bliton, January 16, 2002; at the time Bliton was Assistant Professor of Medicine, Assistant Professor of Philosophy, Assistant Professor of Obstetrics and Gynecology, and Chief of Clinical Ethics Consultation Service, Vanderbilt University Medical Center.
37. Simmons PD. Ethical considerations in composite tissue allotransplantation. Microsurgery 2000;20:458-465, p. 462.
38. See ref. 30, Simmons 2000, p. 463.
39. See ref. 30, Simmons 2000, p. 463.
40. See ref. 23, Stroup and Appelbaum 2003, p. 9;
41. ref. 15, Berg 1996;
42. ref. 20, Keyserlingk 1995;
43. Levine RJ. Ethics and Regulation of Clinical Research. Baltimore: Urban & Schwarzenberg, 1986, p. 266.
44. Reiser SJ, Knudson P. Protecting research subjects after consent: The case for the "research intermediary." IRB: A Review of Human Subjects Research 1993;15(2):10-11.
45. The concept proposed in that discussion has been implemented at the University of Texas Health Science Center in Houston, Texas. The intermediary's role was discussed during the Annual IRB Conference, "Protecting Human Subjects: What's Best, What Works, What Doesn't?," sponsored by Public Responsibility in Medicine and Research (PRIM&R); San Diego, California; November, 2001; presentations by Paula Knudson.
46. The author chairs the IPAC.
47. The author chairs this group. See Morreim EH. Innovation in human research protection: The Independent Patient Advocacy Council. Law and Bioethics Report 2001;1:3-5.
48. See ref. 33, Levine 1986.
49. Sage WM. Physicians as advocates. Houston Law Review 1999;535:1519-1630.
50. "There is a large middle ground between regulatory silence and the highly intrusive regime of consent auditors, subject advocates, and judicial orders that seems to have been envisioned by some participants in the regulatory debate in 1981." See ref. 12, Bonnie 1997, p. 111.
51. Even impaired persons have profoundly differing needs. Hirschfeld RMA, Winslade W, Krause TL. Protecting subjects and fostering research: Striking the proper balance. Archives of General Psychiatry 1997;54:121-123.
52. Morin K, Rakatansky H, Riddick FA, Morse LJ, et al. Managing conflicts of interest in the conduct of clinical trials. JAMA 2001;187:78-84, at 78;
53. Noah L. Informed consent and the elusive dichotomy between standard and experimental therapy. American Journal of Law & Medicine 2002;28:361-408, p. 361.