Hostname: page-component-78c5997874-t5tsf Total loading time: 0 Render date: 2024-11-09T09:36:55.039Z Has data issue: false hasContentIssue false

Paying Human Subjects in Research: Where are We, How Did We Get Here, and Now What?

Published online by Cambridge University Press:  01 January 2021

Extract

On November 14, 1996, an in-depth report on the recruiting and testing practices of Lilly Pharmaceuticals appeared in the Wall Street Journal. Laurie Cohen reported that most pharmaceutical companies had difficulty recruiting healthy subjects to participate in testing of “untried and potentially dangerous” drugs. These companies often had to pay subjects up to $250 a day to ensure adequate enrollment, and some even gave referral bonuses to doctors who sent potential subjects their way. Cohen then exposed how Lilly was able to keep costs down: by recruiting homeless alcoholics to serve as research guinea pigs. “In many ways,” Cohen reported, “the practice is mutually beneficial. For Lilly, it is efficient and limits the risk that subjects will sue if harmed by an experiment or divulge particulars of a drug.” And the subjects “get several weeks or months of free room and board, and in interviews they express voluble gratitude for what they often call easy money.”

Type
Independent
Copyright
Copyright © American Society of Law, Medicine and Ethics 2011

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Cohen, L. P., “To Screen New Drugs for Safety, Lilly Pays Homeless Alcoholics,” Wall Street Journal, November 14, 1996.Google Scholar
Jonas, H., “Philosophical Reflections on Experimenting with Human Subjects,” Daedalus 98, no. 2 (1969): 219247.Google Scholar
Fethe, C., “Beyond Voluntary Consent: Hans Jonas on the Moral Requirements of Human Experimentation,” Journal of Medical Ethics 19, no. 2 (1993): 99103.CrossRefGoogle Scholar
Emanuel, E. Wendler, D. Grady, C., “What Makes Clinical Research Ethical?” JAMA 283, no. 20 (2000): 27012711.CrossRefGoogle Scholar
Childress, J. F., “Compensating Injured Research Subjects: The Moral Argument,” Hastings Center Report 6, no. 6 (1976): 2127.CrossRefGoogle Scholar
Dietrich, D. P., “Legal Implications of Psychological Research with Human Subjects,” Duke Law Journal 265, no. 2 (1960): 265274.Google Scholar
Ladimer, I., “Clinical Research Insurance,” Journal of Chronic Diseases 16, no. 12 (1963): 12291233.CrossRefGoogle Scholar
Robertson, J. A., “Compensating Injured Research Subjects: The Law,” Hastings Center Report 6, no. 6 (1976): 2931 Glass, J. C., “No-Fault Compensation for Human Subjects Injured in Biomedical Research: A Public Policy Conflict,” Pharos 48, no. 3 (1985): 2–7.CrossRefGoogle Scholar
Calebresi, G., “Reflections on Medical Experimentation in Humans,” Daedalus 98, no. 2 (1969): 387390.Google Scholar
Anonymous, Note, “Medical Experiment Insurance,” Columbia Law Review 70, no. 5 (1970): 965979; Adams, B. R. Shea-Stonum, M., “Toward a Theory of Control of Medical Experimentation with Human Subjects: The Role of Compensation,” Case Western Law Review 25, no. 3 (1975): 604–648.Google Scholar
Havighurst, C., “Compensating Persons Injured in Human Experimentation,” Science 169, no. 941 (1970): 153157.CrossRefGoogle Scholar
Teff, H. Munro, C., “Who Pays for Drug-Related Injuries?” New Scientist 72, no. 1025 (1976): 282283.Google Scholar
See Glass, , supra note 8; see Anonymous, supra note 10; see Havighurst, , supra note 11.Google Scholar
See Robertson, , supra note 8; see Glass, , supra note 8; see Adams, Shea-Stonum, , supra note 10.Google Scholar
See Childress, , supra note 5; see Adams, Shea-Stonum, , supra note 10.Google Scholar
See Childress, , supra note 5.Google Scholar
Ackerman, T. F. Mauer, A. M., “Compensation and Cancer Research,” New England Journal of Medicine 305, no. 13 (1981): 760763, at 761.CrossRefGoogle Scholar
See Robertson, , supra note 8; see Glass, , supra note 8; Id. (Ackerman, Mauer, ); Cooper, P. J., “Compensation for Human Subjects Research: Reform Ahead of Its Time?” Journal of Legal Medicine 2, no. 1 (1980): 113.Google Scholar
Anonymous, “Harm to Research Subjects Will Now Lead to New Federal regulations,” Human Research Report 9, no. 12 (1994): 13.Google Scholar
See Havighurst, , supra note 11.Google Scholar
Barber, B., Letter to the Editor, “Research on Injuries in Biomedical Research,” New England Journal of Medicine 295, no. 12 (1976): 673674, at 674.CrossRefGoogle Scholar
Curran, W. J., “Legal Liability in Clinical Investigations,” New England Journal of Medicine 298, no. 14 (1978): 778779.CrossRefGoogle Scholar
Cardon, P. V. Dommel, F. W. Trumble, R. R., “Injuries to Research Subjects: A Survey of Investigators,” New England Journal of Medicine 295, no. 12 (1976): 650654.CrossRefGoogle Scholar
Zarafonetis, C. J. D. Riley, P. A. Jr. Willis, P. W. III et al., “Clinically Significant Adverse Effects in a Phase I Testing Program,” Clinical Pharmacology and Therapeutics 24, no. 2 (1978): 127132.CrossRefGoogle Scholar
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, Compensation for Research Injuries: A Report on the Ethical and Legal Implications of Programs to Redress Injuries Caused by Biomedical and Behavioral Research, Rockville, MD, 1982.Google Scholar
See Robertson, , supra note 8.Google Scholar
Amendment to 45 C.F.R. 46.103c (1978).Google Scholar
Curran, W. J., “Compensation for Human Research Subjects: Regulation by Informed Consent,” New England Journal of Medicine 301, no. 12 (1979): 648649, at 648.CrossRefGoogle Scholar
Levine, R. J., “Advice on Compensation: One IRB's Response to DHEW's ‘Interim Final Regulation,’” IRB 1, no. 1 (1979): 5.Google Scholar
See Cooper, , supra note 18.Google Scholar
Josefson, D., “US Compensated Subjects of Radiation Experiments,” BMJ 313, no. 7070 (1996): 1421; Annas, G. J., “Burden of Proof: Judging Science and Protecting Public Health in (and out of) the Courtroom,” American Journal of Public Health 89, no. 4 (1999): 490–493; Wadman, M., “$100 Million Payout after Drug Data Withheld,” Nature 388, no. 6644 (1997): 703.CrossRefGoogle Scholar
Maloney, D. M., “Agency Will Pay for Care of Injured Research Subjects,” Human Research Report 11, no. 11 (1996): 3; Maloney, D. M., “First Federal Agency to Now Require Treatment for Injured Research Subjects,” Human Research Report 13, no. 4 (1998): 1–2.Google Scholar
Shore, J. J. M. Vardy, M., “The Government's Duty to Provide Financial Assistance to Persons Infected with HIV through Blood Transfusions and Blood Products,” Health Law Canada 10, no. 2 (1989): 183193; Stevens, D., “Negligence Liability for Transfusion-Associated AIDS Transmission: An Update and Proposal,” Journal of Legal Medicine 12, no. 2 (1991): 221–241; Breo, D. L., “Blood, Money, and Hemophiliacs – The Fatal Story of France's ‘AIDSgate,’” JAMA 266, no. 24 (1991): 3477–3482; Stein, R. E., “Vaccine Liability and Participant Compensation Incentives in HIV Vaccine Trials,” AIDS Research and Human Retroviruses 10, Supp. 2 (1994): S297–S300.Google Scholar
Angoff, N. R., “Disclosure of the Hidden Injury,” IRB 4, no. 9 (1982): 67.CrossRefGoogle Scholar
Sandomire, H., “Women in Clinical Trials: Are Sponsors Liable for Fetal Injury?” Journal of Law, Medicine, & Ethics 21, no. 2 (1993): 217230.CrossRefGoogle Scholar
CIBA Foundation Study Group, “Medical Research: Civil Liability and Compensation for Personal Injury - A Discussion Paper,” BMJ 280, no. 6224 (1980): 11721175.CrossRefGoogle Scholar
Anonymous, “Death of a Volunteer,” BMJ 290, no. 6479 (1985): 13691370.CrossRefGoogle Scholar
Harvey, I. Chadwick, R., “Compensation for Harm: The Implications for Medical Research,” Social Science & Medicine 34, no. 12 (1992): 13991404.CrossRefGoogle Scholar
Harth, S. C. Thong, Y. H., “Aftercare for Participants in Clinical Research: Ethical Considerations in an Asthma Drug Trial,” Journal of Medical Ethics 21, no. 4 (1995): 225228.CrossRefGoogle Scholar
Barton, J. M. Macmillan, M. S. Sawyer, L., “The Compensation of Patients Injured in Clinical Trials,” Journal of Medical Ethics 21, no. 3 (1995): 166169.CrossRefGoogle Scholar
Wells, F., “Clinical Trial Compensation,” The Lancet 346, no. 8983 (1995): 1164.CrossRefGoogle Scholar
Guest, S., “Compensation for Subjects of Medical Research: The Moral Rights of Patients and the Power of Research Ethics Committees,” Journal of Medical Ethics 23, no. 3 (1997): 181185; Hope, T., “Compensating Subjects of Medical Research,” Journal of Medical Ethics 23, no. 3 (1997): 131–132; Guest, S., “Compensation for the Subjects of Medical Research,” Journal of Medical Ethics 23, no. 5 (1997): 328.CrossRefGoogle Scholar
Vere, D. W., “Payments to Healthy Volunteers: Ethical Problems,” British Journal of Clinical Pharmacology 32, no. 2 (1991): 141142; Demarez, J. P., “Remuneration, Freedom of Choice, Professional Guinea Pig,” Fundamental & Clinical Pharmacology 4, S2 (1990): 189s-196s.CrossRefGoogle Scholar
See Anonymous, supra note 10.Google Scholar
See Cooper, , supra note 18.Google Scholar
McGee, G., “Subject to Payment?” JAMA 278, no. 3 (1997): 199200.CrossRefGoogle Scholar
Levine, R. J., “What Should Consent Forms Say about Cash Payments?” IRB 1, no. 1 (1979): 78.Google Scholar
Kolata, G., “The Death of A Research Subject,” Hastings Center Report 10, no. 4 (1980): 56.CrossRefGoogle Scholar
45 C.F.R. 46.103.Google Scholar
Miller, F. G. Wertheimer, A., “Facing up to Paternalism in Research Ethics,” Hastings Center Report 37, no. 3 (May-June 2007): 2434.CrossRefGoogle Scholar
Macklin, R., “Due and Undue Inducements: On Paying Money to Research Subjects,” IRB 3, no. 5 (1981): 16.CrossRefGoogle Scholar
Palmer, W. E., “Monetary Inducement to Research Participation,” Pharos 48, no. 1 (1985): 2630.Google Scholar
Holder, A. R., “Research on Unemployment: When Statutes Create Vulnerability,” IRB 6, no. 2 (1984): 6.CrossRefGoogle Scholar
Dunn, L. B. Palmer, B. W. Keehan, M. Jeste, D. V. Appelbaum, P., “Assessment of Therapeutic Misconception in Older Schizophrenia Patients with a Brief Instrument,” American Journal of Psychiatry 163, no. 3 (2006): 500506.CrossRefGoogle Scholar
See Vere, , supra note 43.Google Scholar
Newton, L., “Inducement, Due and Otherwise,” IRB 4, no. 3 (1982): 46, at 5.CrossRefGoogle Scholar
Macklin, R., “Response: Beyond Paternalism,” IRB 4, no. 3 (1982): 67.CrossRefGoogle Scholar
Macklin, R., “The Paradoxical Case of Payment as Benefit to Research Subjects,” IRB 11, no. 6 (1989): 13.CrossRefGoogle Scholar
Wilkinson, M. Moore, A., “Inducement in Research,” Bioethics 11, no. 5 (1997): 373389.CrossRefGoogle Scholar
Korn, J. H. Hogan, K., “Effects of Incentives and Adversiveness of Treatment on Willingness to Participate in Research,” Teaching Psychology 19, no. 1 (1992): 2124.CrossRefGoogle Scholar
Giuffrida, A. Torgerson, D. J., Letter, “Enhancing Patients' Compliance: Financial Inducements Are Equivalent to Coercion,” BMJ 316, no. 7128 (1998): 394.Google Scholar
Wilkinson, M. J. Thornton, J. G., “When Is a Research Gift an Inducement?” Bulletin of Medical Ethics no. 151 (October 1999): 2.Google Scholar
Advisory Commission on Human Radiation Experiments, The Human Radiation Experiments (New York: Oxford University Press, 1996): At Introduction.Google Scholar
Moreno, J. D., “It's Not about the Money,” American Journal of Bioethics 1, no. 2 (2001): 4647; Menikoff, J., “Just Compensation: Paying Research Subjects Relative to the Risks They Bear,” American Journal of Bioethics 1, no. 2 (2001): 56–58; Simonoff, L. A., “Money and the Research Subject: A Response to Grady,” American Journal of Bioethics 1, no. 2 (2001): 65–66.CrossRefGoogle Scholar
See Newton, , supra note 56.Google Scholar
McNeill, P. M., “Paying People to Participate in Research: Why Not?” Bioethics 11, no. 5 (1997): 390397.CrossRefGoogle Scholar
Dresser, R., “Payments to Research Participants: The Importance of Context,” American Journal of Bioethics 1, no. 2 (2001): 47.CrossRefGoogle Scholar
See Vere, , supra note 43, at 141.Google Scholar
See Demarez, , supra note 43.Google Scholar
See Wilkinson, Moore, , supra note 59.Google Scholar
45 C.F.R 46.103.Google Scholar
See Macklin, , supra note 57.Google Scholar
See Cooper, , supra note 18.Google Scholar
Warrington, S. J., “Ethics of Evaluation of New Drugs in Human Volunteers,” Annals of the Academy of Medicine, Singapore 20, no. 1 (1991): 101105.Google Scholar
Food and Drug Administration, IRB Information Sheets, Department of Health and Human Services, 1989, at 83.Google Scholar
See, supra note 57.Google Scholar
See Palmer, , supra note 52; Ackerman, T. F., “An Ethical Framework for the Practice of Paying Research Subjects,” IRB 11, no. 4 (1989): 14.Google Scholar
Emanuel, E., “Ending Concerns about Undue Inducement,” Journal of Law, Medicine, & Ethics 32, no. 1 (2004): 100105.CrossRefGoogle Scholar
See Menikoff, Thornton, , supra note 62.Google Scholar
See, supra note 78.Google Scholar
Day, R. O. Chalmers, D. R. Williams, K. M. et al., “The Death of a Healthy Volunteer in a Human Research Project: Implications for Australian Clinical Research,” Medical Journal of Australia 168, no. 9 (1998): 449451, at 450.CrossRefGoogle Scholar
Larkin, M., “Clinical Trials: What Price Progress?” The Lancet 354, no. 9189 (1999): 1534.CrossRefGoogle Scholar
Adler, M. W., “Human Subjects Issues in Drug Abuse Research,” Drug & Alcohol Dependence 37, no. 2 (1995): 167175.Google Scholar
See Wilkinson, and Moore, supra note 59.Google Scholar
Murray, T. H., “Gifts of the Body and the Needs of Strangers,” Hastings Center Report 17, no. 2 (1987): 3038.CrossRefGoogle Scholar
Sears, J. M., “Payment of Research Subjects: A Broader Perspective,” American Journal of Bioethics 1, no. 2 (2001): 47; Chambers, T., “Participation as Commodity, Participation as Gift,” American Journal of Bioethics 1, no. 2 (2001): 48.CrossRefGoogle Scholar
Grady, C., “Money for Research Participation: Does It Jeopardize Informed Consent?” American Journal of Bioethics 1, no. 2 (2001): 4044.CrossRefGoogle Scholar
Wilkinson, M. Moore, A., “Inducements Revisited,” Bioethics 13, no. 2 (1999): 114130.CrossRefGoogle Scholar
Resnick, D. B., “Research Participation and Financial Inducements,” American Journal of Bioethics 1, no. 2 (2001): 5456.CrossRefGoogle Scholar
Pan-American Health Organization, Investigación en Sujetos Humanos: Experiencia Internacional, 1st International Assessor Committee on Bioethics Meeting, Washington, D.C., May, 1999.Google Scholar
See Wilkinson, and Moore, supra note 88.Google Scholar
Resnick, D. B., “The Commodification of Human Reproductive Materials,” Journal of Medical Ethics 24, no. 6 (1998): 388393.CrossRefGoogle Scholar
See Newton, , supra note 56.Google Scholar
See Resnick, , supra note 89.Google Scholar
Gorelick, P. B. Harris, Y. Burnett, B. Bonecutter, F. W., “The Recruitment Triangle: Reasons Why African Americans Enroll, Refuse to Enroll, or Voluntarily Withdraw From a Clinical Trial,” Journal of the National Medical Association 90, no. 3 (1998): 141145.Google Scholar
See Ackerman, , supra note 77.Google Scholar
Ashcroft, R. E., “Money, Consent, and Exploitation in Research,” American Journal of Bioethics 1, no. 2 (2001): 6263.CrossRefGoogle Scholar
See, supra note 66; see Wilkinson, and Moore, supra note 88.Google Scholar
Savalescu, J., Letter, “On the Commercial Exploitation of Participants of Research,” Journal of Medical Ethics 23, no. 6 (1997): 392.CrossRefGoogle Scholar
Lemmens, T., “Guinea Pigs on the Payroll: The Ethics of Paying Research Subjects,” Accountability in Research 7, no. 1 (1999): 320.CrossRefGoogle Scholar
See Adams, Shea-Stonum, , supra note 10.Google Scholar
See Macklin, , supra note 51.Google Scholar
See Newton, , supra note 56.Google Scholar
See Ackerman, , supra note 77.Google Scholar
Lawson, C., “Research Participation as a Contract,” Ethics & Behavior 5, no. 3 (1995): 205215.CrossRefGoogle Scholar
Dickert, N. Grady, C., “What's the Price of a Research Subject? Approaches to Payment for Research Participation,” New England Journal of Medicine 341, no. 3 (1999): 198203.CrossRefGoogle Scholar
See, supra note 66.Google Scholar
See Chambers, , supra note 86.Google Scholar
Grady, C. Levmore, P., “Point/Counterpoint: Is It Ethical to Pay Research Subjects Large Sums?” Physician's Weekly, November 15, 1999.Google Scholar
See Wilkinson, and Moore, supra note 88; see Wilkinson, and Moore, supra note 59.Google Scholar
Lemmens, T. Elliott, C., “Justice for the Professional Guinea Pig,” American Journal of Bioethics 1, no. 2 (2001): 5153; Anderson, J. A. Weijer, C., “The Research Subject as Entrepreneur,” American Journal of Bioethics 1, no. 2 (2001): 67–68; Anderson, J. A. Weijer, C., “The Research Subject as Wage Earner,” Theoretical Medicine and Bioethics 23, no. 4–5 (2002): 359–376.CrossRefGoogle Scholar
Id. (Anderson, Weijer, [2001]).Google Scholar
See Lemmens, Elliott, , supra note 112.Google Scholar
See Anderson, Weijer, (2002), supra note 112.Google Scholar
See Vere, , supra note 43.Google Scholar
Latterman, J. Merz, J. F., “How Much Are Subjects Paid to Participate in Research?” American Journal of Bioethics 1, no. 2 (2001): 4546.CrossRefGoogle Scholar
Dickert, N. Emanuel, E. Grady, C., “Paying Research Subjects: An Analysis of Current Policies,” Annals of Internal Medicine 136, no. 5 (2002): 368373.CrossRefGoogle Scholar
See Cohen, , supra note 1.Google Scholar
See Emanuel, , supra note 78.Google Scholar