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Archive for Friday, March 19, 2010

Many medical schools update ethics policies

March 19, 2010

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— A sweeping conflict-of-interest policy that would apply to nearly all employees of the University of Minnesota crossed an important hurdle last week when the regents unanimously approved the plan’s outlines.

The regents policy, approved March 12, will cover more than 18,000 university employees and will allow enough flexibility to treat them differently depending on the risk of conflict-of-interest problems that go with their jobs.

University Vice President Kathryn F. Brown said that researchers working with human subjects would get the most scrutiny under the administration’s policy.

The administration’s draft is heavy on disclosure of outside business relationships, including asking some employees to disclose every dollar of outside income. The current policy calls for disclosure of amounts over $10,000.

Several regents spoke in favor of the new plan, but asked for regular updates on the development of the detailed policy and requested that they be consulted when it’s finished.

Regent John Frobenius urged administrators to find a balance in the need for disclosure without creating an overwhelming amount of paperwork. “This could be an enormous drag on the university,” he said.

Regent David Larson stressed the need for the new policy because he said that during stressful economic times, conflicts involving outside money tend to increase. “These are particularly risky times that we are in,” he said.

Many details of the Minnesota plan remain to be worked out. The not-quite-finished administrative policy doesn’t set penalties for violations, nor does it specify exactly which faculty must file the most detailed disclosures.

The new Minnesota policy grew out of concerns in the medical school in 2008 that industry money might unduly influence patient care, scientific research and medical education. As the new policy has developed, the university has suffered additional conflict-of-interest headaches.

The University of Minnesota is not alone in tackling conflict-of-interest issues. Allan Coukell, director of the Pew Prescription Project, which tracks such policies in medicine, has said that in the past two years, one-third of university medical schools have either approved new policies or are in the process of doing so.

At Kansas University Medical Center, ethics policies have become more stringent over the past couple of years, said Tom Field, associate vice chancellor for compliance at KUMC. While the Kansas Board of Regents requires that employees report business relationships of a more than $10,000 amount or a more than 5 percent ownership stake, KUMC has instituted stricter rules.

Today, employees at KUMC must report all such relationships, regardless of the amount of money or percentage of ownership involved, Field said, and potential conflicts are examined with an eye toward how they would impact research or patient care.

“The academic medical center research field is heading in that direction,” Field said.

— Reporter Andy Hyland contributed to this story.

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