Hostname: page-component-cd9895bd7-q99xh Total loading time: 0 Render date: 2024-12-26T08:53:03.295Z Has data issue: false hasContentIssue false
  • English
  • Français

Currents in Contemporary Ethics

Lawsuits Against IRBs: Accountability or Incongruity?

Published online by Cambridge University Press:  01 January 2021

Mary R. Anderlik  and
Nanette Elster
Get access Rights & Permissions [Opens in a new window]

Extract

Pressure is mounting to hold researchers and research institutions accountable for the protection of human subjects. When subjects or their family members believe they have been injured, they are increasingly willing to file lawsuits. Recent cases indicate that institutional review boards (IREs) and their members may be pulled more and more into the legal fray.

On September 17, 1999, 18-year-old Jesse Gelsinger died while participating in research conducted by the University of Pennsylvania's Institute for Gene Therapy. Gelsinger was involved in a Phase I clinical trial testing a new approach to treatment of ornithine transcarbamylase deficiency (OTC), a rare metabolic disorder. Although infants affected by the severe form of OTC die shortly after birth, Gelsinger suffered from a relatively mild form. It appears undisputed that the cause of Gelsinger's death was not the disorder itself, but multiple organ system failure triggered by the virus used to carry new genetic material into his system.

Type
Article
Information
Journal of Law, Medicine & Ethics , Volume 29 , Issue 2 , Summer 2001 , pp. 220 - 228
Copyright
Copyright © American Society of Law, Medicine and Ethics 2001

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.)

Footnotes

Mark A. Rothstein serves as the section editor for “Currents in Contemporary Ethics.” Professor Rothstein is the Herbert F. Boehl Chair of Law and Medicine at the University of Louisville School of Medicine in Kentucky.

References

E.g., Fox, J.L., “Gene Therapy Safety Issues Come to Fore,” Nature Biotechnology, 17 (1999): 1153; Fox, J.L., “Investigation of Gene Therapy Begins,” Nature Biotechnology, 18 (2000): 143; Fox, J.L., “Scrutiny of Gene Therapy Broadens, Intensifies,” Nature Biotechnology, 18 (2000): 377.Google Scholar
Stolberg, S.G., “The Biotech Death of Jesse Gelsinger,” New York Times Magazine, November 28, 1999, at 6.Google Scholar
Stolberg, S.G., “Scientists Defend Suspended Gene Therapy,” New York Times, Feb. 15, 2000, at A20; Stolberg, S.G., “Institute Restricted After Gene Therapy Death,” New York Times, May 25, 2000, at A20.Google Scholar
Gelsinger v. Trustees of the University of Pennsylvania (Phila. Cnty. Ct. of C.P. filed September 18, 2000), available at <http://www.sskrplaw.com/links/healthcare2.html>. Dr. Steven Raper, Dr. Mark Batshaw, the Children's Hospital of Philadelphia, and the Children's National Medical Center were also named as defendants..+Dr.+Steven+Raper,+Dr.+Mark+Batshaw,+the+Children's+Hospital+of+Philadelphia,+and+the+Children's+National+Medical+Center+were+also+named+as+defendants.>Google Scholar
The financial arrangements were complicated. According to the complaint, Wilson had founded Genovo, the private, for-profit biotechnology company that sponsored the research, and he controlled a significant share of its stock. The university received a 5 percent ownership stake in Genovo in lieu of up-front funding of the gene therapy (or, more accurately, gene transfer) research program. The University, Kelley, and Wilson held or had applied for patents in vectors of the kind employed in the research. Id. at 2–3.Google Scholar
Currently, federal regulations do not include financial conflicts of interest among the elements that must be addressed in consent forms. 45 C.F.R. § 46.116 (1990). 21 C.F.R. § 50.25 (1990). Disclosure may be required under state law. See Moore v. Regents of University of California, 793 P.2d 479 (Cal. 1989), cert. denied, 499 U.S. 936 (1991).Google Scholar
Gelsinger, supra note 4, at 5.Google Scholar
Id.Google Scholar
There may also have been problems with subject recruitment. According to Joanne Silberner, “volunteers had been recruited through an Internet site that presented overly optimistic information about the study.” Silberner, J., “A Gene Therapy Death,” Hastings Center Report, 30, no. 2 (2000): 6.Google Scholar
In an interview with a reporter, one of the plaintiffs' attorneys suggested that Caplan also helped write the informed-consent form. Nelson, D. and Weiss, R., “Penn Researchers Sued in Gene Therapy Death: Teen's Parents Also Name Ethicist as Defendant,” Washington Post, September 20, 2000, at A3. See also Gose, B., “Penn, Doctors, Ethicist Named in Suit Over Gene-Therapy Death,” Chronicle of Higher Education, September 29, 2000, at A34. Caplan's name was, however, omitted from the informed-consent-related counts in the complaint.Google Scholar
Weiss, R. and Nelson, D., “Penn Settles Gene Therapy Suit,” Washington Post, November 4, 2000, at A4.Google Scholar
Martin, J., “Patient Pleads for More Vaccine,” Tulsa World, July 24, 2000, at 1.Google Scholar
Kurt, K., “Officials Depart, Dismissed Amid Scandal at OU's Medical School,” Journal Record (Okla. City), July 24, 2000, 2000 WL 14297056.Google Scholar
Robertson v. McGee, No. 01CV00G0H(M) (N.D. Okla. filed January 29, 2001), available at <http://www.sskrplaw.com/gene/robertson/complaint.html>, at 2.,+at+2.>Google Scholar
Letter from N.K. Hausmann to M. McGee and T. Broughan, regarding GMP and GCP Audit of OU-Tulsa Melanoma Vaccine IND Sponsorship and Clinical Study Conduct (March 16, 2000) (on file with authors).Google Scholar
Letter from M.A. Carome to J.J. Ferritti, N.L. Nisbett, and J.W.E. Wortham, regarding Human Research Subject Protections Under Multiple Project Assurance (MPA) M-1448 (June 29, 2000) (on file with authors), at 10.Google Scholar
Id. at 13.Google Scholar
Robertson, supra note 14.Google Scholar
Martin, J. supra note 12. Anon., “OU to Help People in Canceled Cancer Study Resume Treatment,” Dallas Morning News, August 1, 2000, at 28A; Winslow, L., “Cancer Patients Denied Vaccine,” Tulsa World, August 9, 2000, at 1.Google Scholar
Robertson, supra note 1., at 7.Google Scholar
Wilson, D. and Heath, D., “The Blood Cancer Experiment,” Seattle Times, March 11, 2001, at A1.Google Scholar
Thomas never served as principal investigator, however.Google Scholar
E.g., “I know that we are not constituted to review substantive research issues, but we should be sure that such a review has taken place. … In terms of the consent form, I think if the purpose of the Human Subjects Review Committee is to actually make sure the patient is fully informed, it should include in the consent the risk of GVHD [graft-versus-host disease] in the patients.” Minutes of the Fred Hutchinson Cancer Research Center, Human Subjects Review Committee (January 20, 1981) (on file with authors).Google Scholar
Wilson, D. and Heath, D., “The Whistleblower,” Seattle Times, March 12, 2001, at A1.Google Scholar
Letter from R.W. Day to K.K. Mittal (Oct. 18, 1993), available at <http://www.fhcrc.org/response/document2.html>..>Google Scholar
Wilson, and Heath, supra note 24.Google Scholar
Letter from J. Puglisi to R.W. Day, regarding Conclusion of Evaluation of Compliance with Assurance M-1008 with Regard to the Complaint Filed by John M. Pesando, M.D., Ph.D. (September 5, 1995) (on file with authors). According to the Seattle Times, the OPRR failed to interview IRB members, study investigators, Hutch officials, subjects, subjects' families, or outside experts. Wilson and Heath, supra note 24.Google Scholar
Faden, R. and Beauchamp, T., “Removing ‘Deficiencies’ in Human Research,” Baltimore Sun, March 5, 2000, at 3C.Google Scholar
“Nuremberg Code: Directives for Human Experimentation,” Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10, 2 (Washington, D.C.: U.S. Government Printing Office, 1949): 181–82.Google Scholar
Bell, J., Whiton, J., and Connelly, S., Final Report: Evaluation of NIH Implementation of Section 491 of the Public Health Service Act, Mandating a Program of Protection for Research Subjects (Washington, D.C.: NIH Office of Extramural Research, 1998).Google Scholar
World Medical Association, Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects (Helsinki: World Medical Association, 1964).Google Scholar
Beecher, H.K., “Ethics and Clinical Research,” N. Engl. J. Med., 274 (1966):1354–60.Google Scholar
Bell, , Whiton, , and Connelly, supra note 3., at 12.Google Scholar
See, e.g., Jones, J.H., Bad Blood: The Tuskegee Syphilis Experiment (New York: Free Press, 1993).Google Scholar
See, e.g., Wolf, S.M., “Quality Assessment of Ethics in Health Care: The Accountability Revolution,” American Journal of Law & Medicine, 20 (1994): 105–28, at 105–6.Google Scholar
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, U.S. Dep't of Health Education and Welfare Pub. No. (OS) 78–0012 (Washington, D.C.: U.S. Gov't Printing Office, 1978).Google Scholar
Advisory Committee on Human Radiation Experiments, Updating Protection for Human Subjects Involved in Research (New York: Oxford University Press, 1996).Google Scholar
Office of Inspector General, Institutional Review Boards: A Time for Reform, U.S. Dep't of Health and Human Services Pub. No. OEI-01-97-00193 (Washington, D.C.: U.S. Gov't Printing Office, 1998).Google Scholar
Id.Google Scholar
See, e.g., Phillips, D.F., “IRBs Search for Answers and Support During a Time of Institutional Change,” JAMA, 283 (2000): 729–30.Google Scholar
Bayh-Dole Act, 35 U.S.C. §§ 200–11, followed by the Stevenson Wydler Act, 15 U.S.C. §§ 3701–14, as amended by the Federal Technology Transfer Act.Google Scholar
Statement of George Grob, Deputy Inspector General before the Committee on Gov't Reform and Oversight, “Institutional Review Boards: A Time for Reform,” U.S. Dep't of Health and Human Services (1998).Google Scholar
See, e.g., Human Subject Research Protections: Hearing Before the Criminal Justice, Drug Policy and Human Resources Subcommittee of the House Government Reform Comm., 106th Cong. (2000).Google Scholar
Snyderman, R. and Holmes, E., “Oversight Mechanisms for Clinical Research,” Science, 287 (2000): 595, 597.Google Scholar
Finn, R., “Reports Bring Several Changes to IRBs,” Journal of the National Cancer Institute, 92 (2000): 1287–90.Google Scholar
Office of the Inspector General, Protecting Human Research Subjects: Status of Recommendations, U.S. Department of Health and Human Services Pub. No. OEI-01-97-00197 (2000).Google Scholar
Id. at 8.Google Scholar
Manier, J. and Peres, J., “Rush Asks U.S. to Lift Research Suspension; Hospital Takes Steps to Correct Violations of Oversight Rules,” Chicago Tribune, October 28, 1998, at 8, quoting Richard Rawlins.Google Scholar
See, e.g., Weiss, R., “N.Y. Research Centers Faulted in Child Study: Patient Protection is Found Lacking,” Washington Post, June 1, 1999, at A02.Google Scholar
See, e.g., Shamp, J., “Agency Halts Federally Funded Duke Research on New Patients,” The Herald-Sun, May 12, 1999, at A1.Google Scholar
65 Fed. Reg. 37,136 (June 13, 2000).Google Scholar
See OHRP's website at <http://ohrp.osophs.dhhs.gov> (last visited May 8, 2001). (last visited May 8, 2001).' href=https://scholar.google.com/scholar?q=See+OHRP's+website+at++(last+visited+May+8,+2001).>Google Scholar
Id.Google Scholar
Office of the Inspector General, Protecting Human Research Subjects: Status of Recommendations, supra note 4., at 18.Google Scholar
Foubister, V., “Clinical Trial Patients Sue IRB Members,” American Medical News, February 26, 2001. Lawsuits have been brought against IRBs as entities before, albeit rarely. For example, the Boston University institutional review board, among others, was sued in connection with an experimental surgical procedure. The case eventually settled. See Saltus, R., “BU Medical Center Sued for $3.25M Over Surgery,” Boston Globe, May 12, 1994, at 26.Google Scholar
Foubister, supra note 55.Google Scholar
Id., quoting Leonard Glantz.Google Scholar
See, e.g., Gregg v. Kane, 1997 WL 570909 (E.D. Pa. 1997). Kus v. Sherman Hospital, 268 Ill. App. 3d 771 (Ill. App. Ct. 1995).Google Scholar
21 C.F.R. § 56.102(g) (1990).Google Scholar
Restatement (Second) of Torts § 285.Google Scholar
State laws and regulations concerning protection of human subjects in research may also be cited as evidence of a standard of care where federal regulations do not apply. See, e.g., Protection of Human Subjects in Medical Experimentation Act, Cal. Health & Safety Code § 24170 et seq. (West 2000).Google Scholar
See, e.g., Bragdon v. Abbott, 524 U.S. 624 (1998).Google Scholar
Doe v. Illinois Masonic Medical Center, 297 Ill. App. 3d 240 (Ill. App. Ct. 1998). For a different outcome, under a Minnesota statute, see Konrady v. Oesterling, 149 F.R.D. 592 (D. Minn. 1993).Google Scholar
Savulescu, J., Chalmers, I., and Blunt, J., “Does Setting Good Practice Standards for Research Ethics Committees Increase Their Legal Liability?,” British Medical Journal, 314 (1997): 1833.Google Scholar
“Preface your statement that this is what UCLA is in trouble for so be careful. … Unfortunately, these protocols are a hot potato in terms of what is happening at UCLA. It would behoove the investigators to have a meeting with this committee to answer some of the questions raised. So if there are any questions from the public in the future, we will have looked into the matter. …” Minutes of the Fred Hutchinson Cancer Research Center, Human Subjects Review Committee, supra note 23.Google Scholar
Merritt, A.L., “The Tort Liability of Hospital Ethics Committees,” Southern California Law Review, 60 (1987): 1297.Google Scholar
See Finn, R., “Reports Bring Several Changes to IRBs,” Journal of the National Cancer Institute, 92 (2000): 1287–90, quoting Emil C. Gotschlich, M.D., vice president for medical sciences at Rockefeller University.Google Scholar
See, e.g., Studdert, D.M. et al., “Negligent Care and Malpractice Claiming Behavior in Utah and Colorado,” Medical Care, 38 (2000): 250–60.Google Scholar
Foubister, supra note 5., quoting Gary Chadwick, executive director of the institutional review board at the University of Rochester.Google Scholar
Institute of Medicine, Preserving Public Trust: Accreditation and Human Research Participant Programs (Washington, D.C.: National Academy Press, 2001).Google Scholar
The FDA, for example, plans to disseminate extensive safety data to the public for the subset of clinical studies involving gene therapy or xenotransplantation. See 66 Fed. Reg. 4688–706 (January 18, 2001).Google Scholar
Foubister, supra note 5., quoting David Korn, senior vice president for biomedical and health sciences of the Association of American Medical Colleges.Google Scholar
Simply being named as a defendant in a lawsuit is always a negative. In addition, usually by policy and sometimes by law, beneficiaries are not protected against personal liability for actions taken with malicious purpose, in bad faith, or in a reckless manner.Google Scholar
Foubister, supra note 55.Google Scholar