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

Cohen L. P. , “To Screen New Drugs for Safety, Lilly Pays Homeless Alcoholics,” Wall Street Journal, November 14, 1996.

Jonas H. , “Philosophical Reflections on Experimenting with Human Subjects,” Daedalus 98, no. 2 (1969): 219–247.

Fethe C. , “Beyond Voluntary Consent: Hans Jonas on the Moral Requirements of Human Experimentation,” Journal of Medical Ethics 19, no. 2 (1993): 99–103.

Emanuel E. Wendler D. Grady C. , “What Makes Clinical Research Ethical?” JAMA 283, no. 20 (2000): 2701–2711.

Childress J. F. , “Compensating Injured Research Subjects: The Moral Argument,” Hastings Center Report 6, no. 6 (1976): 21–27.

Dietrich D. P. , “Legal Implications of Psychological Research with Human Subjects,” Duke Law Journal 265, no. 2 (1960): 265–274.

Ladimer I. , “Clinical Research Insurance,” Journal of Chronic Diseases 16, no. 12 (1963): 1229–1233.

Robertson J. A. , “Compensating Injured Research Subjects: The Law,” Hastings Center Report 6, no. 6 (1976): 29–31

Glass J. C. , “No-Fault Compensation for Human Subjects Injured in Biomedical Research: A Public Policy Conflict,” Pharos 48, no. 3 (1985): 2–7.

Calebresi G. , “Reflections on Medical Experimentation in Humans,” Daedalus 98, no. 2 (1969): 387–390.

Anonymous, Note, “Medical Experiment Insurance,” Columbia Law Review 70, no. 5 (1970): 965–979

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.

Havighurst C. , “Compensating Persons Injured in Human Experimentation,” Science 169, no. 941 (1970): 153–157.

Teff H. Munro C. , “Who Pays for Drug-Related Injuries?” New Scientist 72, no. 1025 (1976): 282–283.

See Glass , supra note 8

see Anonymous, supra note 10

see Havighurst , supra note 11.

See Robertson , supra note 8

see Glass , supra note 8

see Adams Shea-Stonum , supra note 10.

See Childress , supra note 5

see Adams Shea-Stonum , supra note 10.

See Childress , supra note 5.

Ackerman T. F. Mauer A. M. , “Compensation and Cancer Research,” New England Journal of Medicine 305, no. 13 (1981): 760–763, at 761.

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): 1–13.

Anonymous, “Harm to Research Subjects Will Now Lead to New Federal regulations,” Human Research Report 9, no. 12 (1994): 1–3.

See Havighurst , supra note 11.

Barber B. , Letter to the Editor, “Research on Injuries in Biomedical Research,” New England Journal of Medicine 295, no. 12 (1976): 673–674, at 674.

Curran W. J. , “Legal Liability in Clinical Investigations,” New England Journal of Medicine 298, no. 14 (1978): 778–779.

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): 650–654.

Zarafonetis C. J. D. Riley P. A. Jr. Willis P. W. III , “Clinically Significant Adverse Effects in a Phase I Testing Program,” Clinical Pharmacology and Therapeutics 24, no. 2 (1978): 127–132.

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.

See Robertson , supra note 8.

Amendment to 45 C.F.R. 46.103c (1978).

Curran W. J. , “Compensation for Human Research Subjects: Regulation by Informed Consent,” New England Journal of Medicine 301, no. 12 (1979): 648–649, at 648.

Levine R. J. , “Advice on Compensation: One IRB's Response to DHEW's ‘Interim Final Regulation,’” IRB 1, no. 1 (1979): 5.

See Cooper , supra note 18.

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.

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.

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): 183–193

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.

Angoff N. R. , “Disclosure of the Hidden Injury,” IRB 4, no. 9 (1982): 6–7.

Sandomire H. , “Women in Clinical Trials: Are Sponsors Liable for Fetal Injury?” Journal of Law, Medicine, & Ethics 21, no. 2 (1993): 217–230.

CIBA Foundation Study Group, “Medical Research: Civil Liability and Compensation for Personal Injury - A Discussion Paper,” BMJ 280, no. 6224 (1980): 1172–1175.

Anonymous, “Death of a Volunteer,” BMJ 290, no. 6479 (1985): 1369–1370.

Harvey I. Chadwick R. , “Compensation for Harm: The Implications for Medical Research,” Social Science & Medicine 34, no. 12 (1992): 1399–1404.

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): 225–228.

Barton J. M. Macmillan M. S. Sawyer L. , “The Compensation of Patients Injured in Clinical Trials,” Journal of Medical Ethics 21, no. 3 (1995): 166–169.

Wells F. , “Clinical Trial Compensation,” The Lancet 346, no. 8983 (1995): 1164.

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): 181–185

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.

Vere D. W. , “Payments to Healthy Volunteers: Ethical Problems,” British Journal of Clinical Pharmacology 32, no. 2 (1991): 141–142

Demarez J. P. , “Remuneration, Freedom of Choice, Professional Guinea Pig,” Fundamental & Clinical Pharmacology 4, S2 (1990): 189s-196s.

See Anonymous, supra note 10.

See Cooper , supra note 18.

McGee G. , “Subject to Payment?” JAMA 278, no. 3 (1997): 199–200.

Levine R. J. , “What Should Consent Forms Say about Cash Payments?” IRB 1, no. 1 (1979): 7–8.

Kolata G. , “The Death of A Research Subject,” Hastings Center Report 10, no. 4 (1980): 5–6.

45 C.F.R. 46.103.

Miller F. G. Wertheimer A. , “Facing up to Paternalism in Research Ethics,” Hastings Center Report 37, no. 3 (May-June 2007): 24–34.

Macklin R. , “Due and Undue Inducements: On Paying Money to Research Subjects,” IRB 3, no. 5 (1981): 1–6.

Palmer W. E. , “Monetary Inducement to Research Participation,” Pharos 48, no. 1 (1985): 26–30.

Holder A. R. , “Research on Unemployment: When Statutes Create Vulnerability,” IRB 6, no. 2 (1984): 6.

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): 500–506.

See Vere , supra note 43.

Newton L. , “Inducement, Due and Otherwise,” IRB 4, no. 3 (1982): 4–6, at 5.

Macklin R. , “Response: Beyond Paternalism,” IRB 4, no. 3 (1982): 6–7.

Macklin R. , “The Paradoxical Case of Payment as Benefit to Research Subjects,” IRB 11, no. 6 (1989): 1–3.

Wilkinson M. Moore A. , “Inducement in Research,” Bioethics 11, no. 5 (1997): 373–389.

Korn J. H. Hogan K. , “Effects of Incentives and Adversiveness of Treatment on Willingness to Participate in Research,” Teaching Psychology 19, no. 1 (1992): 21–24.

Giuffrida A. Torgerson D. J. , Letter, “Enhancing Patients' Compliance: Financial Inducements Are Equivalent to Coercion,” BMJ 316, no. 7128 (1998): 394.

Wilkinson M. J. Thornton J. G. , “When Is a Research Gift an Inducement?” Bulletin of Medical Ethics no. 151 (October 1999): 2.

Advisory Commission on Human Radiation Experiments, The Human Radiation Experiments (New York: Oxford University Press, 1996): At Introduction.

Moreno J. D. , “It's Not about the Money,” American Journal of Bioethics 1, no. 2 (2001): 46–47

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.

See Newton , supra note 56.

McNeill P. M. , “Paying People to Participate in Research: Why Not?” Bioethics 11, no. 5 (1997): 390–397.

Dresser R. , “Payments to Research Participants: The Importance of Context,” American Journal of Bioethics 1, no. 2 (2001): 47.

See Vere , supra note 43, at 141.

See Demarez , supra note 43.

See Wilkinson Moore , supra note 59.

45 C.F.R 46.103.

See Macklin , supra note 57.

See Cooper , supra note 18.

Warrington S. J. , “Ethics of Evaluation of New Drugs in Human Volunteers,” Annals of the Academy of Medicine, Singapore 20, no. 1 (1991): 101–105.

Food and Drug Administration, IRB Information Sheets, Department of Health and Human Services, 1989, at 83.

See, supra note 57.

See Palmer , supra note 52

Ackerman T. F. , “An Ethical Framework for the Practice of Paying Research Subjects,” IRB 11, no. 4 (1989): 1–4.

Emanuel E. , “Ending Concerns about Undue Inducement,” Journal of Law, Medicine, & Ethics 32, no. 1 (2004): 100–105.

See Menikoff Thornton , supra note 62.

See, supra note 78.

Day R. O. Chalmers D. R. Williams K. M. , “The Death of a Healthy Volunteer in a Human Research Project: Implications for Australian Clinical Research,” Medical Journal of Australia 168, no. 9 (1998): 449–451, at 450.

Larkin M. , “Clinical Trials: What Price Progress?” The Lancet 354, no. 9189 (1999): 1534.

Adler M. W. , “Human Subjects Issues in Drug Abuse Research,” Drug & Alcohol Dependence 37, no. 2 (1995): 167–175.

See Wilkinson and Moore, supra note 59.

Murray T. H. , “Gifts of the Body and the Needs of Strangers,” Hastings Center Report 17, no. 2 (1987): 30–38.

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.

Grady C. , “Money for Research Participation: Does It Jeopardize Informed Consent?” American Journal of Bioethics 1, no. 2 (2001): 40–44.

Wilkinson M. Moore A. , “Inducements Revisited,” Bioethics 13, no. 2 (1999): 114–130.

Resnick D. B. , “Research Participation and Financial Inducements,” American Journal of Bioethics 1, no. 2 (2001): 54–56.

Pan-American Health Organization, Investigación en Sujetos Humanos: Experiencia Internacional, 1st International Assessor Committee on Bioethics Meeting, Washington, D.C., May, 1999.

See Wilkinson and Moore, supra note 88.

Id.

Resnick D. B. , “The Commodification of Human Reproductive Materials,” Journal of Medical Ethics 24, no. 6 (1998): 388–393.

See Newton , supra note 56.

See Resnick , supra note 89.

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): 141–145.

See Ackerman , supra note 77.

Ashcroft R. E. , “Money, Consent, and Exploitation in Research,” American Journal of Bioethics 1, no. 2 (2001): 62–63.

See, supra note 66

see Wilkinson and Moore, supra note 88.

Savalescu J. , Letter, “On the Commercial Exploitation of Participants of Research,” Journal of Medical Ethics 23, no. 6 (1997): 392.

Lemmens T. , “Guinea Pigs on the Payroll: The Ethics of Paying Research Subjects,” Accountability in Research 7, no. 1 (1999): 3–20.

See Adams Shea-Stonum , supra note 10.

See Macklin , supra note 51.

See Newton , supra note 56.

See Ackerman , supra note 77.

Lawson C. , “Research Participation as a Contract,” Ethics & Behavior 5, no. 3 (1995): 205–215.

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): 198–203.

See, supra note 66.

See Chambers , supra note 86.

Grady C. Levmore P. , “Point/Counterpoint: Is It Ethical to Pay Research Subjects Large Sums?” Physician's Weekly, November 15, 1999.

See Wilkinson and Moore, supra note 88

see Wilkinson and Moore, supra note 59.

Lemmens T. Elliott C. , “Justice for the Professional Guinea Pig,” American Journal of Bioethics 1, no. 2 (2001): 51–53

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.

Id. ( Anderson Weijer [2001]).

See Lemmens Elliott , supra note 112.

See Anderson Weijer (2002), supra note 112.

See Vere , supra note 43.

Latterman J. Merz J. F. , “How Much Are Subjects Paid to Participate in Research?” American Journal of Bioethics 1, no. 2 (2001): 45–46.

Dickert N. Emanuel E. Grady C. , “Paying Research Subjects: An Analysis of Current Policies,” Annals of Internal Medicine 136, no. 5 (2002): 368–373.

See Cohen , supra note 1.

See Emanuel , supra note 78.