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Ethical lapses found in Harvard experiments

/ Source: The Associated Press

Federal health officials have found ethical lapses in eight Harvard Medical School experiments involving human subjects. The school said the audit should improve its research work.

No patients were injured in the experiments cited, but the mistakes found in a random government audit prompted officials to request increased protection for patients involved in clinical trials.

The Boston Globe obtained the audit by the Office of Human Research Protections, a branch of the U.S. Department of Health and Human Services, which reviewed 25 experiments conducted over the last four years. A spokeswoman for the office declined to comment.

Efforts to improve standards

Harvard’s institutional review board, a 12-member ethics panel that examines all planned experiments for patient security, mistakenly approved six in which patients were given inadequate or confusing consent forms. In other cases, the board did not conduct a necessary review.

The government said the Harvard review board was dominated by white males and lacked the racial and gender diversity reflective of the patients that participate.

Harvard acknowledged the lapses in a letter sent to the government and provided to the Globe. It contained plans for more aggressive reviews as well as adding black and Asian members to the board.

Federal officials said the audit was part of an effort to improve ethical standards in U.S. medical schools and hospitals. They have investigated the University of Alabama at Birmingham and the University of Texas at Austin, where they found similar errors at the medical schools.

“There’s no real controversy involved here,” said Dr. Raphael Dolin, Harvard Medical School’s dean for academic and clinical programs. “The recommendations they’ve made we think will strengthen our program.”

The experiments in question involved both national and international subjects, including a pilot study in Shanghai on improving treatment for depression, and a study on how villages in Tanzania cope with HIV.