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Government Agrees to Investigate Unethical Research on Medical Students

Sept. 26, 2003

Government Agrees to Investigate Unethical Research on Medical Students

Public Citizen Letter Spurs Inquiry Into Coercive Administration,Lack of Ethical Oversight of Graduation Questionnaire

WASHINGTON, D.C. – In response to a complaint from Public Citizen, a government agency responsible for protecting human research subjects has opened an investigation into the administration of a research questionnaire given to all graduating medical students. The way many universities administer the questionnaire may violate federal law and ethical standards. The Office for Human Research Protections (OHRP), part of the U.S. Department of Health and Human Services, notified Public Citizen of its investigation on Thursday.

Public Citizen sent a letter this summer to the government after it learned that some universities were coercing students to complete the questionnaire, which covers topics such as sexual harassment and personal debt, and often making completion of the questionnaire a requirement for graduation. The tactics undercut a student’s right to decide whether to participate in research, violating the World Medical Association’s Declaration of Helsinki and federal law, Public Citizen said. Additionally, most universities on which Public Citizen had information were ignoring a federal requirement that research using human subjects conducted at federally funded institutions undergo a formal ethics review.

“Coercing subjects to participate in research and eluding ethical review are serious abrogations of medical ethics,” said Peter Lurie, M.D., deputy director of Public Citizen’s Health Research Group. “Medical schools should be held to the highest ethical standards, particularly because they are training future researchers.”

Each year, the Association of American Medical Colleges (AAMC) coordinates the administration of the questionnaire given to more than 15,000 final-year medical students. Individual universities are responsible for maximizing the response rates to the questionnaire, which is designed by the AAMC. The government indicated that it would also be contacting the AAMC, which also did not run the research study through an ethics committee.

Thirteen of 23 schools Public Citizen contacted penalize students unwilling to complete the questionnaire by blocking the students from graduating or by withdrawing benefits such as tickets to graduation ceremonies for the graduates’ families. The OHRP sent letters of inquiry to the seven schools that made completion of the questionnaire a graduation requirement, as well as the AAMC.

The schools receiving letters are Albany Medical College, Chicago Medical School, The George Washington University, University of California (Los Angeles), University of Massachusetts, University of Miami and New Jersey Medical School.

“We would have preferred that the government investigate all potentially violating medical schools,” said Joshua Rising, M.D., a first-year resident at the University of California at San Francisco who took the questionnaire this year under coercive conditions at Boston University. “Presumably if OHRP finds ethical and legal violations, as we believe it will, the other schools will have to modify their practices as well.”

To view Public Citizen’s July 22 letter, which includes information on other schools’ administration of the questionnaire, click here.