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May 2, 2013

University Senate Matters: The regulatory burden


Echoes of exploding steamboats:  Part 1

Shortly after I was asked to comment on the “Regulatory Burden” section of the National Research Council’s report, “Research Universities and the Future of America,” I stumbled upon a article about exploding steamboats. The combination of competition among steamboat operators to have the fastest boat on the Mississippi and unreliable methods of predicting boiler wall failures led to frequent, spectacular and catastrophic events.  Between 1814 and 1848, according to author Robert Gudmestad of Colorado State University, 1,433 souls reportedly were lost to steamboat accidents.

In a scenario of tragedy-begets-politicking, well-intentioned citizens (and citizen-victims) petitioned elected officials demanding safety provisions, and then butted heads with private sector steamboat owners who did not want the government, or anyone else, interfering with their enterprise. (I imagine the push and shove of fracking in the Marcellus Shale fields is the most recent verse of this oft-sung hymn.)

Thus was born the Steamboat Act of 1838 and the Steamship Inspection Service, which is said to be the first time the federal government regulated private enterprise.

Attention-grabbing tragedies are the seed corn of bureaucracy. Think of the headlines over the past 50 years that spawned laws and regulations: airplane hijackings, drunk driving, house fires, asbestos insulation, toxic waste disposal, falling school achievement measures, workplace safety, discriminatory practices, etc.

Research universities are a repository for bureaucratic responsibilities arising via the aforementioned formula, beginning with the Nuremberg trials and the Tuskegee syphilis study. Our research enterprise is burdened with a raft of individually well-intentioned, but collectively stifling, requirements that confuse, frustrate and delay the important work of our faculty. OMB Circular A-21 and A-110, IRB, IACUC, COI, IBC/rDNA, EH&S, RDRC, HIPAA, IND/IDE, hSCRO, BSL3 and MTA are but a few of the alphabet soup that investigators must navigate before getting to the actual research. Unfortunately, recent, well-publicized misbehaviors by colleagues in the academy have catalyzed heightened public accountability, especially in conflicts of interest (COI).

Now back to the NRC report’s recommendation on “Regulatory Burden.” The common-sense suggestion from the report is for regulatory authorities to “Reduce or eliminate regulations that increase administrative costs, impede research productivity, and deflect creative energy without substantially improving the research environment.”

Although I sincerely hope that research-related agencies will lighten the regulatory burden, I believe the probability approximates the likelihood of smithereens of an exploding steamboat magically reassembling into a seaworthy vessel as if a video clip were run in reverse. Both happenings appear to violate natural laws. Let me provide a recent example.

Congressional investigation revealed improper relationships between biomedical researchers/clinicians and drug and device manufacturers. Improprieties included sham consulting agreements, ghostwriting, unethical gifts and remunerations and illegal marketing of yet-to-be-approved drugs and devices. The practices have lowered the public’s trust in biomedical research, added billions of dollars to the nation’s annual health-care costs, endangered the reputations of the individuals and their universities and in some cases resulted in harm to patients.

The attention-grabbing cases involved some payments in the millions of dollars. However, in its efforts to “tighten up” the COI regulations, the National Institutes of Health (NIH) chose to take a page from the Transportation Security Administration’s (TSA) manual. (TSA has yet to return my mother’s fingernail clipper, confiscated at the Minneapolis airport some years ago, although I must admit there have been precious few terrorist attacks by elderly Norwegian women wielding manicure utensils.)

Rather than revise the COI regulations to focus on the high-dollar offenders (of which Pitt thankfully has no experience), NIH decided to focus on the other end of the scale by lowering the limit for disclosure from $10,000 to $5,000 — this in spite of major initiatives at virtually all academic medical centers, including Pitt/UPMC. In addition, reimbursement for travel expenses now is included in the de minimus amount of $5,000. The net impacts at Pitt are more paperwork for faculty and departments, an increase from 963 individuals who disclosed outside interests a year ago to 1,465 and counting, and a huge increase in workload for our valiant but overwhelmed COI office staff and COI committee members. There is no convincing evidence that the world is a better place as a result of these changes.

Unfortunately, most regulatory reform follows this pathway; the outcomes are in stark contrast to the sensible, but unrealistic, recommendation in the NRC Report. Although steamboats have been replaced by those giant cruise ships that function flawlessly.

In the May 16 issue: Homeland strategies for dealing with the regulatory burden.

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

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