U. of Minn. adopts new ethics policy
University sought transparency in policies
In the wake of Sen. Charles Grassley's efforts to uncover and reduce conflicts of interest (COI) at academic medical institutions, some health care centers are re-examining their COI policies, and one of those is the University of Minnesota.
However, that institution is taking a "layered" approach to its COI policies, according to Mark B. Rotenberg, general counsel for the university.
On Aug. 3, the senior vice president for the academic medical center and the medical school administration adopted one of its multiple revised COI policies that will govern COI for clinical staff, or Appendix A, which is titled "Individual Conflicts of Interest: Clinical Care Patient Contact in the Academic Health Center."
The review of policies has been under way for about two years.
"The field of conflict of interest in major research universities is very dynamic . . . between research faculty and teaching faculty and businesses that fund research and fund other university activities; those relationships have become very complicated," Rotenberg tells Medical Ethics Advisor. "And the public's awareness of those relationships has increased dramatically over the past five to 10 years.
"Therefore, the need especially for a public land grant university to be transparent and assure integrity in its teaching and research activities has increased over time. And so, it's that dynamic situation of increased public awareness, increased sensitivity to COI issues, and the need for the university to deepen and expand its relationships with business, while maintaining integrity and transparency, that created a need to . . . look again at [our policies] . . . and then we decided to revise, our COI policies," Rotenberg says.
Previously, the university had COI policies at the Board of Regents level, since 1994. The system also has had administrative policies and administrative committees to evaluate and drive the agenda on conflict of interest at the institution for more than 15 years, he says.
Multiple policies will govern
"The new policies here are layered, so to speak," Rotenberg explains. "At the highest level at the broadest and most general level there's a new Board of Regents policy on individual conflicts of interest that was made effective in March; and that was a fairly comprehensive revision of the older conflict of interest policy. So, I would say, at that level, it's a substantial revision. It's not revolutionary, but it's a substantial evolution from the prior policy."
Geared toward implementing the Board of Regents policy is a "draft administrative policy, which is intended to cover the entire institution that covers dozens of our colleges from agriculture to medicine to engineering to business to our campuses in Rochester . . . and so on," Rotenberg says. "And that so-called wall-to-wall administrative policy is in the final stages of review and will probably be adopted by the end of this calendar year."
Leading up to the adoption of Appendix A, Rotenberg says there was a series of faculty meetings, allowing the faculty groups and administrators from those groups to review the draft language.
According to Rotenberg, in 2008, the medical school began its own process of reviewing the university's existing COI policies. The medical school dean established a task force, and in 2009, that task force issued a report with recommendations that would have been applied "solely in that context."
Ultimately, the central administration examined that process, and a decision was made that the medical school should not have its own, independent COI policy.
"That's what has taken so long, because we wanted to revise the institution's COI policies to promote interdisciplinary research, interdisciplinary teaching activity, interdisciplinary collaboration with business and industry . . . we didn't want to have a process that would silo COI policies," Rotenberg tells MEA.
The university wanted its COI policies to appear "seamless" and "user-friendly" to the business community, so as to avoid confusion for businesses and faculty who were collaborating.
"We didn't want to have the face of the university to business to be, 'Well, now, there's three different conflict of interest policies; you're going to have to fill out three different forms; and there are different limitations on what you can do and what kind of funding you take under which circumstances," Rotenberg explains.
Details of the policy for clinical staff
All individuals involved in clinical care are now required to complete annually a Report of External Professional Activities (REPA), which will be used to report "financial, equity, royalty and business interests that are related to the covered individual's University expertise or responsibilities . . ."
Some of the policy details include:
- All remuneration either received or anticipated during a calendar year must be reported on the form in amounts ranging from $1 to $1,000. Remuneration "includes salary and payment for services not otherwise identified as salary (e.g., consulting fees, honoraria, and paid authorship)."
- Equity interests includes both publicly traded and non-publicly traded entities, and they must be reported.
- Business interests "to include holding any executive position in a business or membership on a board of a business entity, whether or not such activities are compensated."
- Clinical staff "must complete a REPA within 30 days of a substantial change in a business interest . . . or in a financial interest . . . that relates to their university expertise or responsibilities."
- Clinical staff are considered responsible for the "accuracy and completeness" of the information reported in the REPA.
- Clinical staff whose consulting income "exceeds $100,000 in a calendar year will be forwarded by the Conflict of Interest Program to the individual's dean for a "Conflict of Commitment" review under the administrative policy."
"REPAs will be referred to the conflict of interest program for review when a financial interest in a business entity "annually exceeds $5,000..." Also, any clinical staff member who holds "an executive position in a business entity or membership on a board of a business entity" will be referred to the Conflict of Interest Program.
Regarding COI management, the policy states that, "When the Committee determines that a conflict of interest exists, it will determine whether the conflict must be eliminated or reduced or whether it can be effectively managed."
Among a long list of prohibitions for clinical staff is that they cannot "engage in ghostwriting."
For more information on the specifics of the clinical staff COI policy, visit the University of Minnesota Academic Health Center website.
Source
- Mark B. Rotenberg, JD, General Counsel, University of Minnesota.
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