Opening a medical school has made itespecially 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 CMUs need to update its human research protection program.

Im 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 dont 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 througha June 2013 external report done by HRP Consulting Inc., a New York-based firmthat focuses on improvingresearch 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 firmfound CMU lacks resources needed to have an effective humanresearch protection program, including staff, documentation, procedures, training and education.

It also found the university didnt 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 arent 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.

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CMED creates necessity for improved human research protection program