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July 22, 2003

Public Citizen Calls for Federal Investigation of Medical Schools That Conduct Unethical Research on Their Students

Coercive Tactics, Lack of Independent Review Plague

Annual 'Graduation Questionnaire'

WASHINGTON, D.C. - Many medical schools in the United States coerce their students to complete a research questionnaire that includes personal topics such as sexual harassment and personal debt - in violation of federal law and ethical standards, Public Citizen said today. In a letter to the Office for Human Research Protections, a division of the U.S. Department of Health and Human Services, Public Citizen urged the government to investigate these unethical and potentially illegal research practices.

Each year, the Association of American Medical Colleges (AAMC) coordinates the administration of the Graduation Questionnaire (GQ) to more than 15,000 final-year medical students. Individual universities are responsible for implementing the questionnaire, which is designed by the AAMC; in their eagerness to get students to complete the GQ, some schools overstep legal and ethical bounds.

Public Citizen has three main concerns. First, some schools threaten to withhold the student's medical degree or other benefits if the student does not complete the GQ - a clear breach of international ethical standards and federal law. Second, many schools ignore a federal requirement that research at federally funded institutions that use human subjects undergoes a formal ethics review. That review would ensure that the GQ's confidentiality procedures are adequate and should prevent coercion. Third, students are not told that their responses might become part of published journal articles.

"Rather than taking this opportunity to educate medical students on the importance of research ethics, the AAMC and the individual medical schools have taken the easy but unethical road," said Joshua Rising, M.D., a first-year resident at the University of California at San Francisco who took the GQ this year under coercive conditions at Boston University.

Public Citizen learned that at least 13 of 23 medical schools contacted penalize students unwilling to take the GQ (see table). Seven of these schools block the graduation of any student who refuses to take the GQ, while six withdraw benefits (such as the student's family's tickets to

graduation) if they do not comply.

"I'll simply say that we get every student to comply...because if they don't, then they don't get their diploma...It's just that simple. We get 100 percent cooperation," an administrator at the University of California at Los Angeles School of Medicine wrote in an e-mail to Rising.

Such coercive tactics violate the right of an individual to decide whether to participate in a research study and are never acceptable under standards established in the World Medical Association's Declaration of Helsinki, the Nuremberg Code and federal law for all institutions receiving federal funds.

Of nine institutions providing information about this topic, only one subjects the GQ to review by a federally mandated ethics board, called an Institutional Review Board (IRB). An IRB is required for any research, "including research development...and evaluation," that adds to "generalizable knowledge." As the information generated by the GQ has been published in almost two dozen peer-reviewed journal articles, the GQ is clearly performing a research function.

"We recognize that the GQ is an important resource and ask only that the data are collected ethically and legally," said Peter Lurie, M.D., deputy director of Public Citizen's Health Research Group. "It's time to stop the coercion of students and bring medical schools back in line with contemporary ethical standards."

A copy of the letter is available on the Web at: http://www.citizen.org/publications/release.cfm?ID=7268.

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Public Citizen is a nonprofit consumer advocacy organization based in Washington, D.C. For more information, please visit www.citizen.org.

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