U’s human research protection program reaccredited

Following a decade of scrutiny and multiple investigations, the program has received reaccreditation

by Rilyn Eischens

Following dozens of changes prompted by a critical report, the University of Minnesota’s human research protection program has been reaccredited.

The University announced the reaccreditation of its Human Research Protection Program Jan. 11. The program was reaccredited by the Association for the Accreditation of Human Research Protection Programs, Inc. — the same group that managed a 2015 investigation that found the University inadequately protected human research participants.

That review was part of several investigations in 2015 that revealed a litany of ethical concerns with how the University conducted research, spurring 62 changes to how the school oversees research.

“The University has demonstrated its commitment to meeting, upholding and exceeding the highest ethical standards in research practices involving human participants,” said University President Eric Kaler in a press release announcing the reaccreditation. “This reaccreditation with special distinction provides strong recognition of the University faculty and staff who have committed considerable time and energy to improving our practices.”

While some faculty members say the changes put the University in a better place to continue important research, others still aren’t confident in the program.

The AAHRPP, an organization that ensures research institutions meet quality and protection standards, began the reaccreditation process in April 2015. The University was then required to make changes to meet certain criteria before regaining full accreditation status in December 2016.

Over $7 million was spent to overhaul the human research protection program, nearly doubling the office’s previous budget, said Dan Gilchrist, communications director for the University’s Office of the Vice President for Research.

Additionally, the University’s Institutional Review Board was expanded to include more panels, staff and meetings, he said.

The University also received a special distinction with its reaccreditation for its policy protecting adults who are unable to consent to research participation.

“As of now, there are no federal regulations that define that level of protection, so our bar is pretty high,” Gilchrist said.

The changes and reaccreditation come 12 years after the high-profile suicide of Dan Markingson, a participant in a University-run, anti-psychotic drug trial. Years of scrutiny prompted the internal and external reviews, which led to the changes. The Minnesota Legislature mandated last year that oversight of psychiatric drug trials be handled by the state.

A May 2016 review by the Minnesota Legislative Auditor — the office’s third look at University research since 2015 — found that concerns in previous reports were being addressed by the University.

“We are always looking for ways to improve our practices,” said Dr. Sophia Vinogradov, the Department of Psychiatry head. “This is how we establish trust, improve care and advance science all at the same time,” adding that the University is better able to complete important research as a result of the changes.

But despite the changes, some faculty still aren’t assured of the program’s effectiveness.

University bioethics professor Carl Elliott, an outspoken critic of the human research program and University’s response to criticism of its research practices since Markingson’s death in 2004, questioned AAHRPP’s support of the University’s bolstered program.

“AAHRPP accredited the U’s research protection program during its darkest period, when the Markingson scandal was playing out … The research protection program was a disaster,” he said in an email. “Now both the U and AAHRPP are saying again that all is well. Should we believe them? I have no idea.”