AAMC Reporter: February 2007

Viewpoint:
"Accreditation Offers Assurance Against Conflicts of Interest"

Marjorie Speers, Ph.D., executive director, Association for the Accreditation of Human Research Protection Programs (AAHRPP)

In the five years since the AAMC issued its guidelines on investigator conflicts of interest in human subjects research, significant progress has been made, particularly by the nation's academic medical centers. According to an AAMC survey completed in 2004, 63 percent of 103 responding medical centers had revised their policies on individual financial conflicts of interest since December 2001. Of these, 52 percent had strengthened protections for research participants involved in studies in which a financial interest had been identified.

However, progress has been less obvious in other areas of the research enterprise. Some of the most recent evidence of this appears in the survey results published in the Nov. 30 issue of the New England Journal of Medicine. These data highlighted weaknesses in the oversight by institutional review boards (IRBs) of conflicts among their own members. Perhaps the most disturbing finding is that more than half of the 560 respondents indicated either that their IRB had no policy for disclosing conflicts of interest or that they were unaware of such a policy.

The federal regulation is clear: "No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB." Therefore, the findings reported in the New England Journal of Medicine raise the very real concern that more than 50 percent of the IRBs surveyed may not be in compliance with federal regulations. If there is no policy in place—or if the existence of a policy is not communicated—there can be no assurance that IRBs review research without influence from conflicts of interest. Additionally, if there is no assurance that decisions on approval were made objectively, without regard to financial interest, there is no assurance that research participants are adequately protected against those interests.

The first step in managing conflicts of interest to IRB members is to implement policies and procedures for defining, disclosing, and eliminating conflicts. The second, equally critical step is to ensure that IRB members follow the policies and procedures by providing the necessary education. Once those safeguards are in place, another challenge remains: publicizing the policies and procedures beyond the IRB to provide assurances to partners within the research enterprise and to research participants. On the surface, this may seem a daunting proposition. But for those who have earned accreditation from the AAHRPP, it is as simple as displaying the AAHRPP seal.

AAHRPP holds accredited organizations to the highest ethical principles by requiring adherence to standards that meet or exceed federal regulatory requirements for protection of research participants. Included in those standards are requirements that the research organization, its IRB members and consultants, and its investigators and research staff identify, manage, and minimize conflicts of interest. For IRBs, the AAHRPP standard is the same as the federal regulation, prohibiting IRB members and consultants from participating in the review of research studies in which they have a conflict, except to provide requested information.

To date, 46 organizations with 128 entities have attained AAHRPP accreditation. Included in this group are 32 of the nation's academic medical centers. All have demonstrated that they have and follow policies, procedures, and practices governing conflicts of interest. An additional 400 organizations are working toward accreditation and are expected, ultimately, to join their peers in providing tangible evidence that they, too, follow the highest standards and practices of research, including their management of conflicts of interest.

Accreditation has implications beyond conflicts of interest for academic medical centers and others engaged in research. Accredited organizations are more attractive to sponsors and other research partners because accreditation provides assurances that research is conducted ethically and that results are accurate. Since their human research protection programs have been meticulously reviewed by an objective third party, accredited organizations also can be confident that they have the systems in place to protect research participants and reduce their own exposure to risk. They need not worry about the findings of the next published study on faulty research policies or practices because they have already taken and documented the steps necessary to safeguard the public.

That, of course, is the most compelling reason to seek accreditation: the public. Accreditation was established to protect the public interest and assure the government that research organizations would hold themselves accountable to high ethical standards. It is the public that funds much of the scientific research taking place on U.S. soil, and it is the public that agrees to participate in research studies. By attaining accreditation, organizations acknowledge their obligation to the public and their commitment to earning—and maintaining—public trust.

Contact Us    © 1995-2008 AAMC    Terms and Conditions    Privacy Statement