Correspondence

Institutional Review Board Reform

N Engl J Med 2002; 347:1285-1286October 17, 2002

Article

To the Editor:

A “central institutional review board,” as proposed by Christian et al. (May 2 issue),1 may be a national ethics review board or a central research ethics committee, but it cannot be an institutional review board (IRB). By definition, a central board “at the national level” transcends an institution.

The continued use of the term “institutional review board” may merely be the result of a habit that is hard to break, or it might reflect something deeper. The term does not contain the word “ethics,” implicitly elevating the institutional focus over the ethical focus. It also suggests that local IRBs should still have ultimate authority, despite the problems of duplicative reviews, dissipation of resources, delays, lack of experience and expertise, and conflicts of interest that are inherent in institution-based reviews. We should not continue to use inaccurate labels that also send the wrong message and impede acceptance of a more centralized review process.

Ezekiel J. Emanuel, M.D., Ph.D.
National Institutes of Health, Bethesda, MD 20892-1156

1 References

1
Christian MC, Goldberg JL, Killen J, et al. A central institutional review board for multi-institutional trials. N Engl J Med 2002;346:1405-1408
Full Text | Web of Science | Medline

To the Editor:

The articles by Steinbrook,1 Christian et al.,2 and Slater3 (May 2 issue) addressed IRB reform as a means of improving the protection of research subjects. On the basis of my experience as chairman of the IRBs at two major academic medical institutions for a total of 18 years, I would argue that serious risk to patients is more likely to be the result of human fallibility than of inadequate IRB procedures. Adequate IRB procedures could not have prevented the deaths of the student at the University of Rochester from an excessive dose of lidocaine, the volunteer at Johns Hopkins from the pulmonary damage inflicted by hexamethonium, the patient at the University of Pennsylvania from a genetically modified agent, or the nurse at Case Western Reserve from an overdose of methionine. These deaths were the result of a variety of human failings. The most zealous overhaul of IRB regulations and the expenditure of substantial sums to enforce them cannot avert the harm that results from unexpected events or is inflicted by an investigator's sociopathy, hubris, or carelessness.

However, I do believe that an increased emphasis on whistle-blower mechanisms can deal more effectively with the potential problems engendered by the character flaws of investigators. Members of the research community, at all levels, should be made aware of their responsibility to report deviations from protocol. Such mechanisms exist to deal with misconduct in science. They should be vigorously applied in medical research.

Donald S. Kornfeld, M.D.
Columbia University College of Physicians and Surgeons, New York, NY 10032
dsk3@columbia.edu

3 References

1
Steinbrook R. Improving protection for research subjects. N Engl J Med 2002;346:1425-1430[Erratum, N Engl J Med 2002;346:1838.]
Full Text | Web of Science | Medline

2
Christian MC, Goldberg JL, Killen J, et al. A central institutional review board for multi-institutional trials. N Engl J Med 2002;346:1405-1408
Full Text | Web of Science | Medline

3
Slater EE. IRB reform. N Engl J Med 2002;346:1402-1404
Full Text | Web of Science | Medline

To the Editor:

Christian and colleagues have provided an informative explication of the operations of a central institutional review board (CIRB) associated with the National Cancer Institute. The authors' statement that the “diverse perspectives and expertise of the board's members have resulted in a rich discussion of issues that is unmatched by many local IRBs” must be supported. I suggest that the board make public its deliberations. This action will permit the members of other IRBs, potential trial participants, and the general public to judge the manner in which the CIRB members evaluate whether the requirements for the ethical conduct of clinical research are met. Other IRBs may subsequently decide to adopt those features of the CIRB's review process that they deem meritorious or to acquire members with an equivalent range of expertise.

Making this material publicly accessible will also set an important precedent with respect to ending the traditional, but unjustified, secrecy surrounding the deliberations of IRBs.1 It will do so notwithstanding the fact that the minutes of the CIRB will be subject to public disclosure pursuant to an applicable law in the State of Maryland taking effect on October 1, 2002.2

Howard Mann, M.D.
University of Utah School of Medicine, Salt Lake City, UT 84132
howard.mann@hsc.utah.edu

2 References

1
Ashcroft R, Pfeffer N. Ethics behind closed doors: do research ethics committees need secrecy? BMJ 2001;322:1294-1296
CrossRef | Web of Science | Medline

2
Human Subject Research — Institutional Review Boards, House Bill 917, Md. (2002).

To the Editor:

The recent efforts detailed by Dr. Steinbrook toward “improving protection for research subjects” should not cause us to forget how the current system treats subjects who are, in fact, injured by virtue of their participation in research. Specifically, we must ensure that persons who suffer research-related injuries do not have to bear the additional indignity of having to pay for such injuries out of their own pockets. Unfortunately, they largely have to do so under the current system. This is ethically indefensible.

We all benefit from medical research. People who become research subjects are exposed to the small but real chance of being injured; we should all pay for these injuries. The President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research published a report in 1982 calling for a national policy for the compensation of subjects for research-related injuries.1 This theme was echoed by the Advisory Committee on Human Radiation Experiments.2 Despite these efforts, no national policy to protect human subjects from being stuck with a bill for expenses due to research-related injuries has been established. A number of other countries have such policies in place. It is time that the United States followed suit.

Michael K. Paasche-Orlow, M.D., M.P.H.
James C. Taggart, J.D.
Johns Hopkins University, Baltimore, MD 21205
mpaasche@jhmi.edu

2 References

1
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Compensating for research injuries: the ethical and legal implications of programs to redress injured subjects. Vol. 1. Washington, D.C.: Government Printing Office, 1982.

2
Advisory Committee on Human Radiation Experiments. ACHRE report. Washington, D.C.: Department of Energy, 2002. (Accessed September 26, 2002, at http://tis.eh.doe.gov/ohre/roadmap/achre/.)

Citing Articles (2)

Citing Articles

1
D. Buchanan, S. Sifunda, N. Naidoo, S. James, P. Reddy. (2008) Assuring Adequate Protections in International Health Research: A Principled Justification and Practical Recommendations for the Role of Community Oversight. Public Health Ethics 1:3, 246-257
CrossRef
2
Davina Ghersi. (2004) The future of institutional review boards. The Lancet Oncology 5:5, 325-329
CrossRef