Costs to subjects for research participation and the informed consent process: Regulatory and ethical considerations

IRB Ethics and Human Research

Volumn 26, Issue 6, 2004, Pages 9-13

  Iltis, Ana S ^a  

^a SAINT LOUIS UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; BIOMEDICAL AND BEHAVIORAL RESEARCH; COMPREHENSION; ECONOMICS; ETHICS; FINANCIAL MANAGEMENT; HEALTH CARE COST; HUMAN; INFORMED CONSENT; INSURANCE; INTERPERSONAL COMMUNICATION; LEGAL ASPECT; PATIENT ADVOCACY; PERSONAL AUTONOMY; PERSONNEL; PSYCHOLOGICAL ASPECT; RESEARCH SUBJECT; STANDARD;

BIOMEDICAL AND BEHAVIORAL RESEARCH;

COMPREHENSION; CONSENT FORMS; DISCLOSURE; FINANCING, PERSONAL; HEALTH CARE COSTS; HUMANS; INFORMED CONSENT; INSURANCE COVERAGE; PATIENT ADVOCACY; PERSONAL AUTONOMY; RESEARCH PERSONNEL; RESEARCH SUBJECTS;

EID: 13844311365     PISSN: 01937758     EISSN: None     Source Type: Journal    
DOI: 10.2307/3564097     Document Type: Review

References (44)

1. On payments to subjects, see Grady C. Money for research participation: Does it jeopardize informed consent? American Journal of Bioethics 2001;1(2):40-44;
2. Lemmens T, Miller PB. The human subjects trade: Ethical and legal issues surrounding recruitment incentives. Journal of Law, Medicine & Ethics 2003;31:398-418;
3. Wilkinson M, Moore A. Inducement in research. Bioethics 1997;11(5):373-389.
4. On conflicts of interest, see Brody BA, Anderson C, McCrary SV, et al. Expanding disclosure of conflicts of interest: The views of stakeholders. IRB:Ethics & Human Research 2003;25(1):1-8;
5. Goldner JA. Dealing with conflicts of interest in biomedical research: IRB oversight as the next best solution to the abolitionist approach. Journal of Law, Medicine & Ethics 2000;28(4):379-404.
6. For further discussion of compensation for research related injury, see Scott LD. Research-related injury: Problems and solutions. Journal of Law, Medicine, & Ethics. 2003;31(3):419-428.
7. U.S. Food and Drug Administration. Information Sheets: Guidance for Institutional Review Boards and Clinical Investigators. 1998 Update: Charging for Investigational Products, www.fda.gov/oc/ohrt/irbs/toc4.html Accessed April 19, 2004.
8. 45 CFR 46.116b; 21 CFR 50.25b.
9. This is to be expected given the variation in judgment among IRBs. Numerous studies have documented cases of different IRBs responding differently to identical protocols or circumstances. See, for example, Kavanagh C, Matthews D, Sorenson JR, Swazey JP. We shall overcome: Multi-institutional review of a genetic counseling study. IRB: A Review of Human Subjects Research 1979;1(2):1-3,12;
10. Silverman H, Chandros S, Sugarman J. Variability among institutional review boards' decisions within the context of a multicenter trial. Critical Care Medicine 2001;29(2):235-241;
11. Stair TO, Reed CR, Radeos MS, et al. Variation in institutional review board responses to a standard protocol for a multicenter trial. Academic Emergency Medicine 2001;8(6):636-641;
12. McWilliams R, Hoover-Fong J, Hamosh A, et al. Problematic variation in local institutional review of a multicenter genetic epidemiology study. JAMA 2003;290(3):360-366.
13. See, for example, the policy of the Wayne State University IRB. http://www.hic.wayne.edu/hicpol/costs.htm Accessed March 1, 2004.
14. One exception to this is in the OPRR Guidebook discussion of research involving terminally ill persons. It is recommended that the IRB "consider" whether "all costs to subjects of receiving a drug or device under an expanded availability mechanism [are] clearly specified" (Office for Protection from Research Risks. OPRR Guidebook. Washington, D.C.: Government Printing Office, 1993, chapter 6, section G). The Guidebook, it should be noted, is not a regulatory document and offers only guidance. Moreover, it is not clear that the IRB ought to disapprove the use of drugs or devices when the costs are not clearly spelled out. The guidance is merely that the IRB consider this issue. In their deliberations, the IRB should recognize that costs borne by terminally ill persons may become the responsibility of their heirs, posing a risk to persons who are not subjects but who nevertheless may be affected by a protocol.
15. Until recently, "routine care" expenses were not always covered by third party payers if the services were delivered within research trials and thus represented additional health system related costs borne by research subjects. This was especially true for patients enrolled in cancer trials. Antman K. Reimbursement issues facing patients, providers, and payers. Cancer 1993;72:9supp:2842-2845.
16. This has changed since 2000 when Medicare began covering the costs of routine care delivered within the context of clinical trials and numerous states began requiring that private third party payers cover routine care costs for cancer patients enrolled in clinical trials. Ault A. Insurers agree to cover cancer trial costs voluntarily. Nature Medicine 2000;6:121;
17. White House, Office of the Press Secretary. President Clinton takes new action to encourage participation in clinical trials. White House Press Release. June 7, 2000;
18. National Cancer Institute. States that require health plans to cover patient care costs in clinical trials. April 25, 2003; Available on-line: www.cancer.gov/clinicaltrials/developments/laws-about-clinical-trial-costs Accessed July 31, 2003.
19. For further discussion of silent cerebral infarcts in children with sickle cell disease, see Schatz J, Brown RT, Pascual JM, et al. Poor school and cognitive functioning with silent cerebral infarcts and sickle cell disease. Neurology 2001;56(8):1109-1111;
20. Steen RG, Miles MA, Helton KJ, et al. Cognitive impairment in children with hemoglobin SS sickle cell disease: Relationship to MR imaging findings and hematocrit. American Journal of Neuroradiology 2003;14(3)382-389.
21. Hochhauser M. Informed consent and patient's rights documents: A right, a rite, or a rewrite? Ethics and Behavior 1999;9:1-20;
22. Montgomery C, Lydon A, Lloyd K. Patients may not understand enough to give their informed consent [letter]. BMJ 1997;314:1482.;
23. Ogloff JRP, Otto RK. Are research participants truly informed? Readability of informed consent forms used in research. Ethics and Behavior 2001:1:239-252;
24. Paasche-Orlow MK, Taylor HA, Brancati FL. Readability standards for informed-consent forms as compared with actual readability. NEJM 2003;348(8):721-726;
25. Titus SL, Keane MA. Do you understand? An ethical assessment of researchers' description of the consenting process. Journal of Clinical Ethics 1996;7(1):60-68.
26. Bane E. The duty to fully explain trial-linked costs in the informed consent process. Medical Research Law & Policy Report Banner 2003;2:19:7;
27. Moreno J, Caplan AL, Wolpe PR. Updating protections for human subjects involved in research. JAMA 1998;280(22):1951-1958.
28. Appelbaum PS, Roth LH, Lidz CW. The therapeutic misconception: Informed consent in psychiatric research. International Journal of Law and Psychiatry 1982;5:319-329;
29. Appelbaum PS, Roth LH, Lidz CW, et al. False hopes and best data: Consent to research and the therapeutic misconception. Hastings Center Report 1987;12(2):20-24.
30. Having third-party payers cover the costs of research participation may have a similar effect. Persons are not accustomed to having their health insurance cover services not considered medically necessary.
31. 45 CFR 46.111a; 21 CFR 56.111a.
32. See ref. 7, OPRR Guidebook 1993, chapter 3, section A.
33. Katz J. The Silent World of Doctor and Patient. New York: The Free Press, 1984.
34. See ref. 11, Moreno et al. 1998.
35. Alexander GC, Casalino LP, Meltzer DO. Patient-physician communication about out-of-pocket costs. JAMA 2003;290(7):953-958;
36. Eddy DM. Connecting value and costs: Whom do we ask, and what do we ask them? JAMA 1990;264(13):1737-1739;
37. Huskamp HA, Deverka PA, Epstein AM, et al. The effect of incentive-based formularies on prescription-drug utilization and spending. NEJM 2003;349(23):2224-2232;
38. Morreim EH. Economic disclosure and economic advocacy. Journal of Legal Medicine 1991;12:275-319;
39. Wilkes MS, Schriger, DL. Caution: The meter is running: Informing patients about health care costs. Western Journal of Medicine 1996;165:74-49.
40. See ref. 18, Wilkes and Schriger 1996.
41. See ref. 18, Wilkes and Schriger 1996.
42. Bane E. The duty to fully explain trial-linked costs in the informed consent process. Medical Research Law & Policy Report Banner 2000;2(19):7.
43. Martel CL, Li Y, Beckett K, et al. Cancer clinical trial (CCT) accrual patterns: A prospective re-evaluation of barriers to enrollment following passage of legislation requiring third-party coverage of CCT costs in California. American Society of Clinical Oncology Abstracts, www.asco.org Accessed August, 27, 2003.
44. This differential charge may strike some as unfair, yet it is standard practice in healthcare today that not everyone pays the same amount of money for the same services. An alternative to the price differences for study-related procedures would be for the investigator to negotiate a discounted rate with the hospital and charge all subjects a uniform fee.