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The American Journal of Bioethics 4.1 (2004) 54-55



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A Step Toward Truly Protecting Human Subjects:

Reviewing the Review Boards

Grand Valley State University

Adil E. Shamoo and Jonathan D. Moreno (2004) provide an important, well-reasoned discussion of the SATURN (Student Athletic Testing Using Random Notification) study investigators' use of "vulnerable populations" (i.e., minors) as research subjects. Of particular concern are four procedural elements directly bearing on the ethicality of this research:

  1. informed consent;
  2. coercion;
  3. confidentiality; and
  4. equitable selection.

The mere assertion, however, that investigators pursuing multimillion dollar, high profile, government funding might run afoul of widely-held standards for ethical conduct is hardly a revelation. More intriguing—and disconcerting—is that the article implies that the very review boards established to protect participants from breaches in research ethics might have abdicated their responsibilities. Bluntly stated, I am less concerned with the actions of the SATURN investigators than with those trained and entrusted to protect research subjects. We must ask why the institutional review board (IRB) at the Oregon Health and Science University (OHSU) and the National Institute on Drug Abuse (NIDA) failed to enforce the most basic principles for ethical research set forth in the Belmont Report (U.S. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979) and the Nuremberg Code (1947).

When public outcry in the form of newspaper editorials, lawsuits, school board meetings, and so on reaches the point that a federal agency (the Office for Human Research Protections; OHRP) feels compelled to intervene, review, and ultimately suspend a previously approved project, we can only assume something in the oversight and approval process has gone terribly wrong. So egregious were the violations that even after submitting revisions in response to the initial OHRP suspension, the protocol still failed to adequately protect its research subjects to the extent that OHRP was obligated to indefinitely extend the suspension (Oregon Health and Science University 2003). When one further considers that beyond receiving local (OHSU) IRB approval, this research was federally funded to the tune of $3.6 million, serious question arise regarding the appropriateness of the review board's actions.

One thing of which we can be certain is that the errors in the approval process did not occur due to ignorance. The first sentence of the OHSU IRB policy and procedure manual states, "The OHSU IRB is guided by the ethical principles expressed in the Belmont Report" (Oregon Health and Science University 2002, 1). One assumes "being guided" includes an adherence to the three elements of informed consent required by the Belmont Report: information, comprehension, and voluntariness. The OHSU IRB manual also specifically states:

Parents or guardians must consent to research if participants are under 18 years of age (except in the case of emancipated minors). Nevertheless, the assent of children must be sought whenever the children are capable of understanding a lay language explanation of the purpose and procedures of the study. As this is within the capacity of most children between the ages of 7 and 17 years, the IRB requires assent forms to be used for children in this age range (except in cases of severe emotional or developmental impairment).... Note, however, that the ultimate decision about whether a child will participate in a study lies with the parents or legal guardians, regardless of whether the child assents to the research.
(36)

When systems designed to safeguard human health and welfare fail, we generally demand an inquiry to establish the reason. For example, several years ago I held a faculty appointment in a department of surgery. Every Monday morning we met to assess cases that did not go as well as anticipated. The purpose of these "morbidity and mortality" sessions was to explore where problems existed and—more important—where changes should be made for the betterment of the patients. When research proposals inconsistent with basic protections of human subjects are approved by both local and federal oversight committees there is a need for a complete—and public—examination...

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