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Harvard Medical School warned on lab animals

Harvard Medical School, including its troubled New England Primate Research Center, was put on probation in June by an international organization that accredits animal research programs at hundreds of universities, hospitals, companies, and government agencies.

Harvard retains its accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care International, but in response to questions from the Globe, disclosed that it was put on probationary status after a routine site visit. Four monkeys have died at Harvard’s Southborough primate center since 2010 in incidents related to animal care problems, and one monkey died at a medical school facility in Boston in 2011.

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The organization, a private nonprofit, visits participating institutions once every three years with a panel of specialists who review documents and facilities related to animal care and use in research.

“At the February site visit, we self-reported to AAALAC representatives issues that we had identified over past months and were in the process of correcting,” a statement released by the medical school said. “We continue to take aggressive actions to address the issues and to ensure that our internal systems, standards and procedures are strengthened, effective and sustainable.”

Christian Newcomer, executive director of the accrediting body, said that an organization is placed on probation when there is a finding “that is deemed necessary to correct to be accredited.”

Michele Cunneen, an animal research consultant in Natick who does work for biotech companies, said that it was significant for an institution to receive probationary accreditation.

“It is the only way that AAALAC has of getting your attention, because they’re not a federal regulatory authority; they can’t threaten to fine you, they can’t threaten to take away your research money,” Cunneen said. “For an institution of that size, it is a big concern and it hurts their research credibility, it hurts their collaborations, it hurts a lot of things.”

Although accreditation by the association is voluntary and probation does not affect an organization’s ability to do research or receive funding, Patricia Brown, director of the federal Office of Laboratory Animal Welfare at the National Institutes of Health, said institutions are asked to report whether or not they have the accreditation. If they do not have accreditation, she said, they are asked to submit additional information in their “assurance” — an agreement that details how their program of animal care, use, and oversight meets federal requirements.

“We do not require them to let us know about probation, but if they were to lose accreditation that is something they are supposed to inform us of,” Brown said.

Over the past year, the medical school has come under intense public scrutiny and made sweeping changes, after a flurry of citations by inspectors from the US Department of Agriculture for animal care problems, several of which have involved death or harm to primates. The medical school has replaced the leadership at the New England Primate Research Center in Southborough and worked to improve training, oversight, and animal-care procedures.

The Agriculture Department’s investigation into issues at the medical school’s animal research facilities is ongoing, a spokesman said. Harvard administrators declined to provide the Globe copies of documents from the accrediting association that detail the reasons for the probationary status, saying they were not intended to be made public. They also have declined to provide the full report of an independent panel that reviewed the primate center’s operations, although the executive summary has been made available.

Newcomer said it is left up to an institution’s discretion whether to disclose when they are put on probation. “AAALAC feels very strongly that when they have difficulties in their programs, those difficulties are matters that take a lot of diplomacy, even internally, to be able to resolve in a timely and effective way,” he said.

Although the information is not publicly posted by the association, some other institutions with laboratory animal programs have released information after being placed on probation.

For example, after the association visited the federal Centers for Disease Control and Prevention’s Atlanta site in 2005, it was put on probation for problems that ranged from administrative issues to infection control and animal safety problems. The animal care program was restructured and full accreditation was regained.

Harvard plans to make a progress report to the accrediting association by the year’s end, according to its statement.

“AAALAC accreditation is a voluntary process that we invite in order to further assess our standards of animal care,” the statement said.

Harvard was also visited in August by representatives of the National Institutes of Health’s Office of Laboratory Animal Welfare.

“We have a limited budget, so we select a number of institutions each year, and we have a variety of ways of deciding who we visit each year and Harvard came up on our list this year,” said Brown. She could not specify the reason that Harvard was chosen or comment on the site visit, because it is still under review.

“It may be based on funding. It may be based on ongoing issues we are aware of at the institution,” Brown said.

Carolyn Y. Johnson can be reached at cjohnson@globe.com. Follow her on Twitter @carolynyjohnson.
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