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MODELS OF ACCREDITATION 57 An accreditation process should directly involve the kinds of institutions and research expertise being accredited, but an accreditation organization should not be beholden to any particular stakeholder or interest group. Accreditation bodies for HRPPPs will require input from academic health centers, organizations representing research sponsors, nongovernmental research organizations, private firms developing products and services tested in studies with humans, participants, IRB members and staff from both academic and nonacademic institutions, research administrators in both academic and nonacademic institutions, and individuals from a range of research fields appropriate to the intended range of applicant institutions. SOME ISSUES THAT ACCREDITATION ALONE CANNOT ADDRESS Some elements important to the protection of the rights and interests of those participating in research are not directly addressed in proposed programs for HRPPP accreditation. In most cases, an accreditation process could be used as an indirect means to improvement; however, further actions would be needed in parallel with the establishment of an accreditation process. The committee expects to come back to many of these topics in its second report and has discussed how to integrate some elements not currently emphasized into the accreditation process. The discussion below includes some suggestions to that effect. Accreditation is not a short-term fix. It must be viewed as one element of a long-term strategy. The VA-NCQA accreditation program will operate in a relatively circumscribed system, but it will take several years to implement the system and several more to evaluate it. The national voluntary system being developed under AAHRPP may take even longer to establish. Before a program could be granted deemed status it would need to be given time to develop and mature. Turning over regulatory authority to an untested program would be very risky, reinforcing the need for pilot testing as a first step. Identifying, Investigating, and Sanctioning Violations Accreditation cannot totally replace federal regulation. Accreditation is rarely effective in dealing with bad actorsâthose who intentionally flout or ignore requirements. Monitoring, investigation, and enforcement are necessary to augment an accreditation system, and under the current regulatory framework these will remain functions of OHRP and the FDA.11 The main cause of error in many prominent controversies in research ethics lies with investigators who diverge from an agreed- upon protocol. Review of protocols cannot fix the 11 One recommendation of NBAC is to consolidate these functions into a single agency, as noted above.
MODELS OF ACCREDITATION 58 problem when investigators deviate from the protocols, although a more robust research monitoring capacity could reduce such deviations. Some of the most conspicuous cases in the past two decadesâMartin Cline's 1980 gene transfer experiments in Israel and Italy (Thompson, 1994) and the death of Jesse Gelsinger in gene transfer experiments at the University of Pennsylvania in 1999, for example12 âappear to be attributable to the conduct of principal investigators and their collaborators or to institutional decisions unrelated to the IRB, so it is not clear how accreditation of an HRPPP could prevent such cases. An accreditation body should not be expected to be the original source responsible for uncovering violations or the main body responsible for investigating or sanctioning them. Accreditation could, over time, reduce the likelihood that violations would occur as a result of changes in norms and behaviors. Accreditation could, moreover, be withdrawn or made probationary on the basis of the disclosure of infractions at an accredited institution. Reports of infractions would surely increase scrutiny by an accreditation body. An accreditation organization could also be used as part of the strategy to bring an institution back into compliance with federal regulations after infractions were detected and investigated. Therefore, accreditation is relevant to the problem of bad actors, but 12 In 1980, Martin Cline administered recombinant DNA with the hope of effecting gene transfer in two patients with thalassemia, one in Israel and one in Italy. His IRB had not approved his protocol and, indeed, rejected it just days after Cline conducted the experiments. The IRB had reviewed the protocol several times and had enlisted external expert reviewers who uniformly judged the experiment premature. Cline also deliberately misled a review panel in Israel and his collaborator in Italy, who identified the patient who was treated. The experiments had no known adverse health consequences for the patients, and after an NIH investigation, Cline had several grants terminated and was barred from seeking NIH funds for 4 years; he also resigned from his division chairmanship at the University of California at Los Angeles. IRB action in connection with this protocol was not at fault in the infractions. This case was reviewed in Larry Thompson's Correcting the Code (Thompson, 1994) and in a background paper for NBAC (Cook-Deegan, 1997). IRB action was similarly a relatively minor concern in the 1999 death of Jesse Gelsinger. The lawsuit brought by his family focuses on the actions of the principal investigator and two research institutions: James Wilson, a private company (Genovo), and the Institute for Human Gene Therapy at the University of Pennsylvania. Arthur Caplan, a bioethicist who gave advice about the trial design, was initially also named in the suit, but he was not on the IRB. Actions named in the suit, which was settled out of court on terms that have not been publicly disclosed, focus mainly on deviations from the protocol approved by the IRB and not on IRB actions. The only mention of the IRB is that it approved the protocol (for more information, see http:// www.sskrplaw.com/links/healthcare2.html). The broader definition of an HRPPP could reduce the likelihood of similar events, particularly if the committee's recommendations about incorporating research monitoring were adopted.
