Human research protection program making progress, still in non-compliance with university, federal guidelines

Central Michigan University remains out of compliance with federal regulations for its human research protection program, despite making recent strides to address the issue.

The university has had a faulty program, including its institutional review board, for more than 20 years, said Richard Backs, IRB board chairman and a CMU psychology professor.

“It’s always been under-funded. It’s always been under-staffed,” Backs said. “That’s part of what the (2013) consultant’s report was trying to get the provost and president to recognize. The infrastructure has never been in place at the level we need.”

Failing to abide by federal regulations could result in the loss of more than just federal dollars, according to a 2013 external report done by HRP Consulting, Inc.

“The university is at stake for losing grants and faculty to other institutions who can provide better quality IRB review of their research,” the report reads.

Provost Michael Gealt said he understands the importance of a successful institutional review board for students of all departments.

“It’s very important that (students) get research experience while they’re undergraduates,” Gealt said. “The only reason they get that research experience while they’re undergraduates is if our committees are functioning properly.”

Some faculty and staff are conducting their research in partnership with other universities’ institutional review boards without a formal process. In doing so, those universities receive grant funds CMU is missing out on.

Courses that used to assign projects involving human subject research have been altered to avoid using the difficult review board process, which results in a lesser scholarly experience for students.

A human research protection program ensures the protection of rights and welfare of human research subjects and of institutional liability. The institutional review board follows ethical standards, as well as university, state and federal regulations to approve human subject research requests, known as protocols.

In June 2013, HRP Consulting visited CMU per the university’s request.

The New York-based consulting firm provided the university with a 12-page report documenting areas of non-compliance and recommendations to improve human subject research.

HRP consultants expressed many concerns, including insufficient staffing, a lack of available documentation, minimal training and education programs for both researchers and review board members.

Earlier this month, Vice President for Research John McGrath published his progress report on steps being made toward compliance. Improvements include additional review board representation and training for board members.

“That progress report shows significant progress on all 10 recommendations,” McGrath said. “There are still things that need to be done, but there is a lot of progress that has been made.”

McGrath outlined a few necessary steps the program must take to be in compliance again. These steps involve completing current research requests, updating standard operating procedures, preparing checklists for requests and training faculty.

He hopes to have the research program in compliance with university and federal guidelines by Fall 2014.

“We want to be there as soon as we can,” McGrath said. “But the reality is … it’s complicated and we want to do it right.”

As far as faculty members are concerned, those interviewed by HRP in June reported little trust in the administration’s ability to fix the problems.

“HRP found throughout the interview process that there was an overall sense that although higher administration is making the effort to evaluate and asses (concerns), (faculty members feel) that administration will not follow through in making any changes or improvements that are recommended,” the report reads.

In response, Gealt said improving the human research portion of the issue is a top priority.

“The problem is going to be fixed,” he said. “We’re just working our way through as fast as we can. Hopefully we’ll do a lot of catching up over the summer.”

Of the four universities Gealt has been employed at, the provost said CMU has the worst institutional review board issues in terms of quantity, though other universities’ struggles have often been more severe.

Shortfalls

A large portion of the consultant’s recommendations stemmed from a lack of necessary personnel to run an efficient human research protection program.

“We’re really, really understaffed and have been for many, many years,” Backs said. “Dr. McGrath is trying to address that, but it’s going slowly.”

Consultants insisted CMU add a research compliance officer separate from the Office of Research and Sponsored Programs.

As a result, CMU hired Bob Bienkowski and created the Office of Research Compliance. He will officially begin in May.

“(Bienkowski is) very experienced, very passionate and I think this is going to be a really significant and positive step forward for CMU,” McGrath said. “Each position provides complimentary expertise and capabilities, and it spreads the load, so things will be stronger in that sense.”

Consultants also recommend adding two full-time administrative staff support positions for the review boards, as well as a human research protection program director.

A second institutional review board is also suggested to divide the health sciences from the social and behavioral sciences. A summer review board was created in 2013, and Gealt said he is trying to prepare funds for the committee to work through the summer.

“(Two IRBs) would be the goal, but again, we don’t have enough resources to run one IRB right now,” Backs said. “There’s no way to institute a second IRB without additional resources and that’s up to the president and provost to do.”

McGrath is hopeful of the creation of a second IRB and has prepared a group to be ready if endorsement is granted in May.

Requests for these additional positions have been submitted to Gealt and University President George Ross.

The consultants’ report found a lack of effective training and review systems for board members and investigators.

Backs and McGrath said training for IRB staff has increased “tremendously” since the report was released, though faculty members still need to be brought up to speed.

“There’s actually been a lot of progress trying to build infrastructure on the research office side that hasn’t necessarily been apparent to the faculty members and the users of the IRB,” Backs said.

Other problem areas include a poor documentation system, which allowed research to be carried out without approval and protocols to fall through the cracks.

CMU’s standard operating procedures are out of date as well. McGrath hopes to have the university-specific procedures in place this summer.

Although the additional positions, increased training and an IRBNet software update have added costs for the university, Gealt said they are worthwhile expenses.

“If it solves problems, it will actually in the long run save us money,” he said. “It’s going to cost some money because everything we do costs money.”

Progress

Per the June report’s advice, CMU reported its non-compliance to the U.S. Department of Health and Human Services. It also published HRP’s report to the CMU website to ensure transparency.

“If you self-report and come up with a plan to correct those deficiencies, what they’re interested in at the federal level is that you’re doing what you’re supposed to be doing,” Backs said.

Backs suggested the report’s findings are nothing new to faculty who have been using the IRB and complaining about it for years.

“It’s really, in many respects, stating the obvious, but it’s now not just the faculty that’s complaining,” Backs said.

McGrath understands faculty, staff and student frustrations and asks only for patience.

“Our role is to do the best we can to support them and so it’s important to listen to them,” McGrath said. “I apologize for where we are right now, but (I’m) asking for their understanding that we’re doing the best we can to get us from where we were to where we will be soon.”