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University of Pittsburgh

May 16, 2013

Senate Matters: Echoes of exploding steamboats, Part 2

juhlIn the first part of this commentary on the regulatory burden in research (see May 2 University Times), I advanced the notion that beginning with the Steamship Act of 1838, governmental oversight has moved primarily in one direction, resulting in added complexity, reduced flexibility and incremental costs. This happens in large part because sentinel events signal a white-horse opportunity for regulators and legislators to do what they do: pass laws and write regulations (e.g. tax code reform, gun control legislation, immigration reform, etc.).

Thus, if the recommendation on “Regulatory Burden” in the National Research Council’s report, “Research Universities and the Future of America,”

“Reduce or eliminate regulations that increase administrative costs, impede research productivity, and deflect creative energy without substantially improving the research environment,”
is more hopeful than practical, what can we do locally to cope?

The University’s approach over the last decade has been two-fold.  First, we will follow the regulations. To do otherwise jeopardizes our research enterprise, both the good work that is done and the livelihood of the good people who do the work. Second, we are committed to conducting ethical and regulation-compliant research through integrated systems of research review, audit and educational programs implemented in a manner that maximizes investigator and institutional effectiveness.

Education

Based on the assumption that it is difficult to follow the regulations without knowing what they are or whom to ask, faculty, staff and students have countless opportunities for live and computer-based training in the rules of the road and, perhaps more important, whom to call if they have questions. In the past two years we have migrated away from producing our own online programming to employing a national provider used by many similar universities. However, schools, departments and research groups can request and will receive a live presentation from our staff on any aspect of regulatory compliance, structured to fit the needs of the group.

Audit

The various offices around the campus responsible to our funding agencies for research-related compliance would prefer to help you before you begin a new project rather than after you have winged it for a few months and then hear from Houston that you have a problem (although you will receive help in those cases, too). Most audits, whether of finances or of the conduct of research, are intended to correct problems before they happen and to be of assistance to researchers. Audits also are performed “for cause” when violations or complaints are received and, as you might expect, these exercises may become more summative than formative, especially when a federal agency decides to pay a visit.

Effectiveness

The burden of regulation formerly was proportional to the tonnage of paper required for compliance. As we have switched to IT systems, paper use has diminished and gains in efficiency have been realized to the benefit of the faculty, staff and students who must prepare applications and to the office staff and volunteer committee members who must read and assess those applications. Granted, some of the efficiencies of the web-based systems are cannibalized by the increasing regulatory demands, but I know we simply could not operate the Conflict of Interest, Institutional Review Board and Institutional Animal Care and Use Committee offices without the systems implemented over the past decade.  Last year the COI Superform web site received over 12,000 completed disclosure forms. OSIRIS and ARO, the IRB’s and IACUC’s protocol management systems, received 11,000 and 2,500 submissions respectively last year. Life has become measurably easier for all involved, especially the volunteer committee members and the office staff.

Many academic units have endeavored to make it easier for researchers to fulfill their regulatory responsibilities by having one or two staff members develop specialized expertise so they can assist faculty. These regulations are sufficiently complicated that investigators cannot maintain expertise in these moving targets and still focus on the primary mission of their projects. An additional strategy is to have faculty volunteers serve on oversight committees, so as to build a local repository of expertise at the faculty level.

I would like to tell you that relief is in sight, but even with all the talk of making government smaller, events of the day continue to incite the regulatory gods to rain bureaucracy down on our noble endeavors. We will continue to participate in the political process through our professional and institutional organizations to argue against reactive regulatory measures that add no benefit, only cost.  However, in light of the most recent news from Washington that a two-year effort to standardize the human-subject protection regulations among the federal agencies (which make the rules) has ground to an epic FAIL, I’m not optimistic. The best we can do is hope for, but not depend on, relief coming from Washington, while continuing to make improvements at home.

Randy P. Juhl is vice chancellor for research conduct and compliance and Distinguished Service Professor of Pharmacy.


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