Plan outlines safeguards for research subjects

Christopher Aadland

The University of Minnesota unveiled proposed changes last week to the way it protects human subjects in research.
 
An “implementation team” formed in March — made up of outside experts, University faculty members and administrators —  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. 
 
The 63 recommendations include 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  creating 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 last 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 last Monday. ”We know it’s going to cost money, and we are going to invest in this.”
 
The proposed changes to the University’s research practices come after more than a decade of criticism which eventually prompted two recent investigations into 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. Another report, released by the Minnesota Legislative Auditor in March, examined the circumstances around University research participant Dan Markingson’s death.
 
The March audit found “serious ethical issues and numerous conflicts of interest,” which were also addressed in the panel’s recommendations. 
 
Under the recently released 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. 
 
The school’s Institutional Review Board would also lose the ability to review alleged research misconduct.
 
The panel also 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. 
 
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.