CMED creates necessity for improved human research protection program

Opening a medical school has made it especially important that Central Michigan University returns its human research protection program to compliance with federal regulations.

Provost Michael Gealt said the potential risks that come with research done by the College of Medicine amplify CMU’s need to update its human research protection program.

“I’m looking, especially with the medical school, to make sure we get all the problems solved now before they really start increasing their research,” Gealt said. “We don’t want to mess with those problems where (we) potentially could be working with human (research) that could actually be life threatening.”

CMU discovered its non-compliance of university and federal regulations through a June 2013 external report done by HRP Consulting Inc., a New York-based firm that focuses on improving research policies.

“Changes are not necessarily being made because of the College of Medicine, but because CMU has taken a look at its overall program and will be dedicating its time and resources to the improvement of the program,” the report summarized.

The firm found CMU lacks resources needed to have an effective human research protection program, including staff, documentation, procedures, training and education.

It also found the university didn’t have a university-wide process for dealing with HIPAA, Health Insurance Portability and Accountability Act, allowing for possible violations when dealing with student medical records during research.

“The use of medical records for research purposes will only increase with the addition of the medical school,” according to the report. “Violations of HIPAA place the institution at significant regulatory and financial risk.”

HIPAA protects U.S. citizens’ medical records and ensures they aren’t excluded from insurance coverage based on health-status related factors.

At least two CMED faculty members have experienced "significant delays" in their research due to review board backups, said Ed McKee, chairman of foundational sciences and a biochemistry professor.

Though the first year medical students are just beginning to consider research areas they'd like to explore, McKee said having a working review board will be very important in the future.

"My sense is they're getting better," he said. "They're gradually getting through the backlog and with a little more time, things will get a lot better. We have several faculty on the IRB and they are working very hard to get the IRB caught up."

As more medical classes and faculty members interested in research come to Mount Pleasant, the importance of protecting human subjects will only increase.

“With the new medical school, the risks and the cost of not having a compliance program go up tremendously,” said Richard Backs, Institutional Review Board chairman and a psychology professor. “I think the breaking point was the medical school and the recognition that this is a whole new ball game; a whole new level of risk; a whole new level of expertise, and we really need to be prepared for it.”

CMED made up less than 3 percent of CMU's research protocols last year. The College of Humanities and Social and Behavioral Sciences made up 45 percent, followed by College of Health Professions with 23 percent and College of Education and Human Services with 16 percent.

John McGrath, CMU vice president of research, said the young medical school hasn’t begun to put much focus in research yet, but it will.

“I think sometimes CMED is seen as dominating and in some ways it’s true, but here it’s not,” he said. “Our challenge is supporting the faculty and students as growth occurs and as complexity is added.”

Earlier this month, McGrath published a progress report highlighting steps toward compliance in all 10 recommended areas.


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