University rolls out new steps to protect research participants

In the wake of heavy criticism, dozens of proposed changes to University research oversight were released Monday.

Christopher Aadland

The University of Minnesota unveiled proposed changes Monday to the way it protects human subjects in research.

A panel of outside experts, University faculty members and administrators formed in March outlined a beefed-up human research subjects protection program to the public after two recent reports criticized how the University conducts research on human enrollees.

Included in the 63 recommendations is hiring more staff for the school’s Institutional Review Board, increasing the number of the board’s review panels and paying review board members. The panel also recommended the creation of a new position to help educate researchers about ethical research standards.

“This is possibly the most robust policy I’ve ever seen,” Dr. Steven Miles, a University bioethics professor and committee member, said Monday. “It actually radically redistributes the power within the University in terms of making all parties accountable.”

The overhauled oversight measures are expected to cost the University about $5.5 million in the first year and $4.4 million each year after that. The school currently budgets $2.2 million annually for its Human Research Protection Program.

“This is the cost of doing research,” Dr. Brooks Jackson, Dean of the Medical School and panel member said Monday. ”We know it’s going to cost money and we are going to invest in this.”

Proposed changes to the University’s research practices come after more than a decade of criticism prompted the two latest investigations of the institution’s research.

Released in February, a report managed by the Association for the Accreditation of Human Research Protection Programs recommended dozens of changes to how the University conducts research on human subjects, especially those with diminished ability to consent to enrollment in a study, such as people with mental illness and dementia. It also revealed a “culture of fear” and intimidation in the Department of Psychiatry’s research.

The panel recommended ethics and leadership training for two researchers at the center of scrutiny. It also recommended psychiatric research at the University be transferred out of the Department of Psychiatry to the Clinical and Translational Science Institute.

Another report, released by the Minnesota Legislative Auditor in March, examined the circumstances around University research participant Dan Markingson’s death.

That report determined the University dismissed calls for reviews about the 2004 suicide of Markingson, who was enrolled in an antipsychotic drug study at the time of his death.

The March audit also found “serious ethical issues and numerous conflicts of interest,” which were also addressed in the panel’s recommendations. Under the reformed protocols, researchers participating in a study would not be able to receive any compensation from a company as long as that same company funds the study

While the new measures will add more steps for researchers to get a study approved, Jackson said he is confident the new measures won’t hinder research at the University.

“I’m not at all concerned that they would impair my ability to do research,” he said, adding that the revamped review process should reduce study review times.

Public comments on the plan will be accepted until June 1. A University Board of Regents committee will review the final report next month.