U of M revises ethics policy

The policy applies to Academic Health Center employees.

U of M revises ethics policy

Katherine Lymn

Cautious collaboration is key for the University of Minnesota Medical School’s revised conflicts of interest policy, released last week.
The new policy places strict reporting requirements on external faculty compensation and regulates faculty consultations for outside companies and sponsored events on campus. The policy also aims to allow continued collaboration with these types of external entities, said Mark Rotenberg, general counsel for the University.
Conflicts of interest policies ensure the clinical care and research done by University employees is not swayed by sources of outside income.
Medical School Executive Vice Dean Mark Paller explained the policy prevents personal business decisions and financial welfare from taking precedence over a patient’s care.
The policy applies to individuals within the Academic Health Center — including the Schools of Nursing and Dentistry and the Colleges of Pharmacy and Veterinary Medicine — that come into contact with human or animal patients in clinical care and research, said Lynn Zentner, director of the University’s Office of Institutional Compliance.
The only students affected are those involved in clinical care, such as students serving medical residencies, Rotenberg said.
There was no policy specifically for those involved in clinical care before this document was released on Wednesday.
While in the form of an appendix to a yet-to-be-completed University-wide policy, the AHC policies are final and took effect Wednesday, Zentner said.
The overarching goal of the new policy was to prevent unethical activity while still allowing the necessary collaboration with outside entities, Rotenberg said.
“We want to make sure that the state of Minnesota and the public generally can benefit and take advantage of the expertise we have here,” Rotenberg said, while avoiding “the risk that the public may begin to believe that making money is more important than objective scholarship.”
A series of embarrassing situations led to the University revising its policies.
Among those investigated were David Polly, a University physician who had undisclosed relations with Medtronic, and Julie Jacko and Francois Sainfort, a married couple that worked simultaneously at both the University and Georgia Tech.
“[The] rules pretty much provide it so that the conflicts don’t exist,” Paller said, “which means that you know going into a project or going into a relationship … what you should and what you shouldn’t do.”
Restrictions on business relationships include the requirement that any outside income is reported, and that consulting fees given to a professor do not exceed their fair market value, Rotenberg said.
The threshold for reporting income was previously $10,000.
Now, all outside compensation must be reported and any exceeding $5,000 will be reviewed by a conflicts of interest committee.
The revisions may be in response to the Physician Payment Sunshine Act 2009, passed as part of the recent national health care reform. Starting in January 2010, the act requires pharmaceutical companies to disclose “financial gifts” given to physicians, said Tim Anderson of the American Medical Student Association. Schools are leaning toward stricter policies to ensure the public finds out about the relationships from the schools themselves, rather than the pharmaceutical companies, he said.
The Sunshine Act was sponsored by Sen. Charles Grassley, R-Iowa, who also wrote a letter to University President Bob Bruininks calling out Polly on his undisclosed relationship with Medtronic.
“That kind of political act has pushed most schools to start increasing their reporting requirements,” said Anderson, who heads AMSA’s 2010 to 2011 PharmFree Scorecard program, which grades medical schools’ conflict of interest policies.
In 2007 and 2008, the Scorecard program gave the University a D grade for its policies.
Anderson said the University’s new policy may be too complex but that there is a fine line between an overly-complicated and sufficiently comprehensive policy.
“The point of them isn’t to be used by lawyers,” Anderson said. “The point of them is for any faculty or resident or student to go back and be able to understand what they’re allowed and not allowed to do.”
The clarity and accessibility of the policy will affect how closely it is followed by faculty, Anderson said.
Because Minnesota Data Practice Act laws prohibit the University from requiring the conflict of interest information be public, the University will set up a public website where faculty and staff can voluntarily upload their data.
Rotenberg said he hopes University individuals will take advantage of this “opportunity to make their activities more transparent.”
The first conflict of interest policy of any kind was adopted by the University in the 1990s, Zentner said.
A University-wide policy, which will cover all faculty and staff, will be released in September, Rotenberg said.
Anderson said this type of omniscient policy is appropriate in an age of interdisciplinary activity by faculty.
Since this policy applies to every college, from the College of Science and Engineering to the College of Design, the procedure is extensive.
Various University affiliates have different views and different types of “interactions with the outside community,” Rotenberg said of the wall-to-wall policy.