Officials Find Ethical Lapses in HMS Labs

In a recently completed audit of research experimentation at the Harvard Medical School (HMS), federal health officials discovered a smattering of unethical procedures that members of the faculty had been employing in research involving human subjects.

The school’s own 12-member review board, an internal volunteer group responsible for making sure research proposals are scientifically and ethically sound, had apparently overlooked the transgressions during their initial investigations.

This group, known as an Institutional Review Board (IRB), follows the template of thousands of similarly directed efforts in other institutions, employing both scientists and laypeople to enforce certain standards of procedure for human subject research.

Any institution receiving federal funding for research is required to use an IRB, although many private pharmaceutical companies also employ similarly run third-party groups.

The Boston Globe reported that in addition to members of its own faculty, the HMS review board includes a rabbi, a former nurse, a lawyer and several other experts uninvolved in the sciences, all but two of whom are in some way affiliated with Harvard.

John Lacey, a spokesperson for HMS, wrote in an e-mail that the federal audit was “routine,” indicating that the Office of Human Research Protection (OHRP), the branch of the U.S. Department of Health and Human Services which launched the investigation in March, had not been prompted by any initial suspicions of procedural failures at HMS.

The routine nature of this recent audit is a marked departure from the last time Harvard was confronted by the OHRP two years ago, when the group was alerted by a third party that patients were being insufficiently protected during genetic research experimentation in China.

According to the Globe report, the OHRP reviewers came to campus in March and randomly selected 25 studies from a list of about 400 that HMS had conducted in the past four years. While the federal government was generally satisfied with the IRB’s work, it demanded a higher level of scrutiny in eight of the 25 experiments.

In his e-mail, Lacey denied that any “ethical lapses” had been identified during the review.

According to the Globe, the most serious ethical infraction that surfaced during the federal audit pertained to an anonymous gambling survey conducted without the IRB’s approval. The researcher in charge of the survey said he was not aware that research dealing with anonymous subjects was required to face the board’s scrutiny, but federal health officials at the OHRP were never informed of the incident.

Three of the other experiments in question were flagged during the OHRP’s audit for using inappropriately technical language in their consent forms—a fairly common problem among research scientists, according to HMS Assistant Professor of Medical Ethics Lisa S. Lehmann.

Lehmann, who serves on a joint IRB for Brigham Women’s Hospital and the Massachusetts General Hospital, said that researchers were too accustomed to using advanced language in their published work, and that more laypeople need to be brought into the IRBs to avoid confusing consent forms and information packets.

Lehmann stressed that Harvard’s infractions were minimal compared to recent occurrences at the University of Pennsylvania, Duke, and Johns Hopkins, where severe procedural carelessness had pushed the National Institute of Health to actually freeze research.

“I don’t think these are extreme,” Lehmann said about Harvard’s violations, “but at the same time, they’re concerning enough that we need to rethink how we’re approaching these issues.”

Lacey wrote that the OHRP also asked Harvard to assemble a more racially diverse group of reviewers on the IBR, which they said was dominated by white males. Lacey said that HMS is working to secure more black and Asian members for the board.

—Staff writer Leon Neyfakh can be reached at neyfakh@fas.harvard.edu.