Washington, D.C., September 13, 2004 - A recent study by the Association of American Medical Colleges (AAMC) indicates that U.S. medical schools have made significant progress since 2001 in clarifying and strengthening their financial conflicts of interest (COI) standards in clinical research, with 95 percent now having a policy in place that applies to all human subjects research (HSR).

Following the publication in 2001 of the AAMC task force report, "Protecting Subjects, Preserving Trust, Promoting Progress: Policy and Guidelines for the Oversight of Individual Financial Interests in Human Subjects Research," the AAMC conducted a survey from May 2003 to February 2004 to assess the degree to which COI policies of the nation's accredited medical schools reflected the recommendations of the task force and responded to the changed circumstances of clinical research. Eighty-two percent of accredited U.S. allopathic medical schools responded to the AAMC survey. Among the key findings:

• Most medical schools have clarified the language in their COI standards and clearly identify to whom their COI policies apply:
  a) 95 percent of policies apply to all faculty engaged in HSR, regardless of the source of funding
  b) 77 percent include all non-faculty engaged in HSR, also regardless of the funding source

• Schools are moving toward processes that require full disclosure:
  a) 98 percent of the responding schools define a significant financial interest in their policies
  b) 95 percent use the federal government threshold of $10,000 or an even lower dollar standard
  c) 64 percent go beyond federal regulations and consider as significant financial interests all equity in non-publicly traded companies regardless of value, as well as non-royalty payments not directly related to reasonable costs of research, as recommended by the AAMC task force

• In addition, the study revealed that institutions are using a variety of safeguards to help manage COI in human subjects research:
  a) 85 percent require monitoring of the research
  b) 74 percent require disclosure of a significant financial interest to the human participants in the consent form, and the policies of 86 percent suggest or require disclosure
  c) 76 percent have established a standing committee on COI

The AAMC's 2001 COI task force recommended that institutions adopt the presumption that a researcher with a significant financial interest should not be permitted to conduct research on human subjects unless the researcher could demonstrate compelling circumstances to proceed. The survey results indicate that 81 percent of institutions permit a researcher with a significant financial interest to conduct human subjects research when they find that compelling circumstances exist.

Despite this substantial progress, the survey results also indicate that certain policies and procedures still need more attention from the academic medicine community. For example:

• 40 percent of medical schools that responded to the survey do not require researchers to disclose significant financial interests in oral presentations of research results

• 9 percent do not include outside representatives on standing COI committees

• 41 percent of schools with standing COI committees do not include within the committee's responsibilities the evaluation of significant financial interests prior to final IRB approval

In addition, many medical school policies do not suggest or require the involvement of patient representatives while recruiting or gaining the consent of human research participants; about half do not conduct regular audits of the consent and enrollment process and do not routinely use special committees established to monitor participants' safety during clinical trials. More consideration should be given to these safeguards to better protect research subjects, according to David Korn, M.D., senior vice president of AAMC's Division of Biomedical and Health Sciences Research.

"As calls increase for rapid translation of scientific discoveries into human benefit, the need to ensure that research on human subjects is conducted within an ethical framework that is rigorous, transparent and credible has never been more urgent," said Korn. "While this has been a challenging task for medical schools, and is still a work in progress, our study indicates that significant strides have been made in responding to the public's concerns."

To view the COI survey report, go to: www.aamc.org/members/coitf

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The Association of American Medical Colleges is a not-for-profit association representing all 129 accredited U.S. and 17 accredited Canadian medical schools; nearly 400 major teaching hospitals and health systems, including 68 Department of Veterans Affairs medical centers; and 94 academic and scientific societies. Through these institutions and organizations, the AAMC represents 109,000 faculty members, 67,000 medical students, and 104,000 resident physicians. Additional information about the AAMC and U.S. medical schools and teaching hospitals is available at www.aamc.org/newsroom.

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