Various federal regulations covering topics ranging from privacy of academic records to safety procedures for medical experiments and faculty training, will continue to increase University expenses in the next year as additional regulations are introduced.

According to Martha Pollack, the University vice provost for academic and budgetary affairs, the University expects to spend between $750,000 and $1 million more on compliance than last year due to new regulations from the National Institutes of Health and other government agencies in the next fiscal year. The increase is just the latest in a yearly cycle of spending more to meet new compliance standards.

According to a rough estimate provided by the University, the University currently spends between $22 million and $24 million annually on compliance issues — a figure that does not include athletics or the University of Michigan Health System, which are funded separately.

“No one ever wants to spend money on compliance,” Pollack said. “It’s not an area where you have to push us to be efficient. We will naturally be as efficient as we possibly can be.”

Pollack said other new compliance costs, such as augmented infection control systems in the Health Services Building, were accreditation compliance costs rather than research-related costs.

In a March 22 interview, University Provost Philip Hanlon said the new disclosure requirement from NIH would require the University to assemble an “elaborate” electronic database tracking conflicts of interest at a recurring cost of $700,000. He also cited new mandatory ethics training for researchers who work with human subjects as an additional compliance cost.

“We do north of a half-billion dollars in research for NIH, and this is a very big deal,” Pollack said. “They’ve changed the reporting requirements, they’ve changed how many people have to disclose (conflict of interest information), (and) the time in which you have to disclose.”

Pollack said the University consulted with peer institutions on how to minimize costs accrued by the new regulations, and it chose to focus on human resources rather than expensive software systems to comply with federal guidelines.

“Originally, we were going to put in place some permanent staff positions, but what we learned based on other people’s experience with workflow was that after a year or two, things settled out, so we can budget for some term-limited positions,” Pollack said.

Pollack emphasized that despite NIH’s focus on conflict of interest information in the most recent update to the federal guidelines, managed conflicts of interest pose no issue for the University.

“Conflicts of interest in (themselves are) not a bad thing. A bad thing is having a conflict of interest that’s not managed,” Pollack said. “You have to disclose it and make sure it’s properly managed, or if it can’t be managed, that you don’t act on it.”

According to a University report released last Friday, a snapshot of projects on Feb. 9 revealed that more than 5,200 projects at the University are under review by the Institutional Review Boards, among the leading compliance oversight bodies in University research which monitor research activities and protocols to be sure they meet regulations and ethical standards. IRBs are not the only compliance oversight bodies for research within the University, but they play a leading role especially where human subjects are involved. More than 4,000 of the projects are medically related, and they often require the strictest oversight.

Judy Nowack, associate vice president for research at the University, said despite the new regulations, the University has tried to increase the IRBs’ responsiveness to project petitions from faculty. Many non-medical projects are now exempt from the formal projects review or subject to an “expedited review.” In 2011, fewer than four new non-medical proposals went before a full IRB committee for review each month.

“We’re trying to take low risk determinations to educated staff, rather than taking faculty time to do it,” Nowack said. “It’s all a balance. We do it; we look at the effect … We don’t want to increase risk in the system.”

Nowack added that the University’s Office of Human Research Compliance Review independently oversees and educates the IRBs and faculty on protocols and compliance issues at the University. According to Nowack, the OHRCR also conducts surveys to measure risk in the research system. The University also accepts public comment on regulation compliance issues and how to minimize risk within the research system.

“We do subscribe that we provide protection to vulnerable groups,” Nowack said. “Our faculty members pretty well realize that if somebody gives us a bad reputation in the community, where we draw our subjects, then their own research is going to suffer.”

Nowack added that violations of compliance issues within the research unit seldom require direct response from the OHRCR.

“It’s very rare that we get really serious things that come all the way up to the top,” Nowack said. “We try to keep our fingers on the pulse.”

Fiona Linn, senior policy and projects adviser in the Office of the Vice President and General Counsel, said the University has not followed in the footsteps of many peer institutions in centralizing compliance operations under one office. She added that the complexity and large variety of University compliance operations prevented the University from pursuing that route.

“We made a deliberate choice at U of M not to centralize all of the compliance functions, which a number of universities have done,” Linn said. “They’ve done it following a very corporate model in which you have one senior vice president or similar role (who) is responsible for all issues in compliance.”

Linn helped oversee the creation of the
Compliance Resource Center website
, which is available for University students and staff. It currently serves as a launching point and information clearinghouse for compliance issues that allows users to access more detailed information and contacts.

“We like to think we’ve saved on duplication of effort,” Linn said. “Previously, you had people in various schools and colleges all trying to answer the same question (in) duplicative, and by coordinating these resources, we’re hoping that it saves time people spend across the University.”

Linn added that outside of research, the compliance website also deals with student rights and responsibilities, including links to privacy rights in disclosing grades and financial aid rights.

“That’s been one underlying assumption of all the work we’ve done … we’ve kept assuming that we’re dealing with a whole lot of smart people who want to do the right thing,” Linn said. “We want to give them information to help them know what the right thing looks like.”

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