Safeguards worry some researchers

by Christopher Aadland

Some researchers at the University of Minnesota fear new safeguards for human research subjects could stifle their work at the school.
New protections — approved by the Board of Regents last week — will toughen conflict of interest policies, create additional oversight boards and overhaul the school’s Institutional Review Board, among dozens of other changes. But some researchers at the University say the additional scrutiny is excessive and could suppress future investigations at the school.
Changes to how the University oversees human research participants and researchers were initiated after two reports criticized the school’s research oversight and response to ethical concerns.
“There is the very real risk that being overly prescriptive will stifle research,” three faculty members in the Division of Blood and Marrow Transplantation said in a letter sent to the University during the safeguards’ public comment period. “[The plan could] alienate the faculty rather than promulgate a culture of discovery, partnership and optimism.”
Associate professor of medicine Dr. Craig Weinert said he plans to enroll patients for his next study through Ohio State University because he is concerned the new regulations could make his research more difficult.
To help ease concerns over potentially burdensome regulations, the University tweaked some of the original recommendations after it received more than 70 public comments on the draft plan for the changes, which was released last month.
Dr. Joseph Neglia, head of the University’s Department of Pediatrics sent a letter to the University that expressed concern over some parts of the draft plan, but he said most concerns were eased in the final plan.
He said the new Institutional Review Board should help studies garner approval faster.
But the modified conflict of interest policies worried some researchers.
In the draft plan, researchers would have been prohibited from accepting any funds from companies that sponsored their research.

Some fields of study have few companies that have the capacity to fund studies, endocrinology professor Dr. Elizabeth Seaquist said in a June 1 letter to the
The school’s final plan allows researchers to receive reimbursements for travel and study-related expenses, but it still bars scientists from receiving financial benefits like consulting fees from a company that sponsors their research. Researchers can accept payments like consulting fees and work on the study if they are paid to the University.
“That’s going to be threatening to some,” Dr. William Tremaine, chair of the team in charge of implementing the changes, said at a Board of Regents committee meeting. “If you want the payments, then don’t do the research.”
The beefed-up measures come at a time when the Medical School hopes to lure first-class faculty members to the University to boost its ranking among other medical schools nationwide. Last month, the state Legislature gave the University $30 million, in part to hire new researchers.
Still, Brooks Jackson, dean of the Medical School, acknowledged that researchers will have to adapt to the new regulations.
“As a longtime clinical researcher myself, I’m supportive of the changes,” he said at the committee meeting Thursday. “I also think this will enhance our whole clinical research effort,” he said, noting that the new measures should make the University more reliable and attractive to industry investors.
The new measures are expected to cost nearly $10 million in the first year and $4.4 million each year after. It is expected to take up to a year to fully implement all of the safeguards.