Thursday, December 8, 2011

Regulation is a Four-Letter Word!

By Keith McDowell

Are you one of those people who insist on driving over the posted speed limit, no matter the circumstances? How do you feel about regulations prohibiting cell-phone use while driving – not to mention the obnoxious restaurant patron blathering away in a loud voice next to you about the inconsequential trivia of his life? And then we have Rick Perry and the Republican presidential candidates, all “fed up” and bothered by “regulations” they claim restrict the growth of business and the formation of startup companies. Has the American enterprise system indeed become so constipated by regulations that innovation is squelched and only a dose of Ex-Lax or “deregulation” will cure the problem?  Since when did “regulation” become a four-letter word!

And how about our universities, the ultimate innovation engines of America? Have they also become choked by rules and regulations? A simple, but true story from my own experience as a vice president for research at The University of Alabama reveals the truth. Believe me, even Snoopy in his effort to write the ultimate heroic novel couldn’t make this stuff up any better!

It was a Wednesday morning at the president’s staff meeting before the Alabama homecoming football game when the announcement was made that a fraternity planned to host several elephants as part of their weekend activities. Of course, elephants are the Alabama mascot. My heart stopped! Do we have a protocol I whispered? “No! What’s a protocol,” was the reply. I panicked and announced we had to have an IACUC-approved protocol for the display of animals. “Make it happen” became the order of the day.

With the help of Dr. Marianne Woods, we contacted Washington to determine the best protocol for elephants knowing full well that PETA had launched a national effort to protest the treatment of confined elephants. No one in Washington had a clue as to the proper care and feeding of elephants. And how could we possibly pull together the membership of the IACUC (animal use) committee?  It couldn’t be done by the weekend we informed the president that afternoon.

But then Alabama football supporters intervened overnight and we were back in business on Thursday morning. Suffice it to say that IACUC met that afternoon and reluctantly approved a protocol submitted by the fraternity. Finding a veterinarian to co-sign the protocol on Friday morning (both our regular veterinarians were out-of-town) was an adventure unto itself. Of course, we got our pound of flesh from the fraternity. On Friday afternoon at 5 pm, all the fraternity members and their dates, decked out in their ballroom finery, were subjected to a short lecture by a scruffy biology faculty member on the proper treatment of elephants.

But it didn’t end there. During photo-ops with the elephants on Saturday morning (if you don’t believe my story, see attached photo of myself and Dr. Woods with one of the elephants), a distinguished and prominent elderly alumnus of Alabama was knocked down and received scratches when a fraternity genius insisted on having pictures taken with the elephant holding a football by his curled up trunk. The football escaped and the elephant tried valiantly to “catch” the ball, thereby knocking down the alumnus. Arriving at the President’s Box with a torn shirt sleeve and bloodstained arm, the alumnus subsequently refused to participate in the required inquiry. All in all, Alabama personnel spent over two years bringing the case to a resolution with all parties including the federal government.

It’s a funny story. Hey, I was worried that the female elephants might charge the football stadium when the famous trumpeting of the male mating call at the start of the game echoed from the stadium! But it’s a story that displays in the microcosm what universities experience every day, every hour, every minute, and every second. I often claim that universities are the most regulated enterprises in America. You don’t believe me? Then test your knowledge against the following abbreviated list of regulatory activities and acronyms: IRB, IBC, HIPPA, TAL, ETRAC, conflict of interest monitoring, radiation safety committee, adverse lab events reporting, data and records retention, time and effort, trafficking in persons, export controls and dual-use technology, controlled substances and CFATS, MSDS, secondary chemical labeling, responsible conduct of research, misconduct in science, facilities security officer, … , and the list goes on. For every item in the list, I have funny stories to tell including the glacial acetic acid gift that kept on taking instead of giving, Babe the goldfish, and Ralph the turtle. But, unfortunately, it’s not a joke or a funny story. Regulations are an integral part of academe. And they affect research, discovery, and the ultimate goal of innovation.

First of all, compliance with regulations consumes an enormous amount of time. Witness the two years spent dealing with the Alabama elephant issue. Imagine how much time it takes for newly minted faculty members to come up-to-speed with the daunting list of regulatory activities presented above – not to mention the amount of time actually engaged in satisfying the regulations. Literally hundreds, if not over a thousand, IACUC and IRB protocols are reviewed every year on most campuses.

Second, compliance with regulations leads to bureaucracy and what many consider administrative bloat at universities as the price tag for tuition outpaces salary growth and inflation to pay for the costs. Every university these days has a Compliance Office and officer. But as Representative Barney Frank likes to say, it’s not fat in the form of gristle on the edge of our steaks that can easily be cut off, but more like marbling, firmly intertwined in the process of doing business. So how do you like your steaks?

Third, the regulatory environment has continued to morph and evolve into a set of regulations so hyper-technical that universities must hire content specialists to deal with them, often one for every major area such as human subjects versus animal care versus export controls. Does the federal government really believe that carrying the newest laptop with the latest software to China on university business is a violation, especially when the computer parts were likely made in China and the software development was out-sourced to foreign nations? Or must we prove and establish for audit purposes that no federal grant dollars on any federal grant were used for trafficking in people, usually for the sex trade market?

So, let’s cut to the chase! Should government, whether federal, state or local, regulate our activities and are we as a society, including universities, over-regulated to the point of stifling innovation, job, and business growth? It’s a great question for America and one that should not become politicized and made a slogan as it is in danger of becoming in our current dysfunctional environment. In the macro-sense, it’s easy to debase regulations and bemoan their impact, elephant stories notwithstanding. But in the micro-sense when a specific family of regulations is examined in detail – such as “informed consent” for “experiments” on human subjects or even the care and feeding of elephants, one faces the old “wait-a-minute” moment – that moment when we face the reality of the need for regulations for our own protection and the protection of society as a whole. Yes, we need regulatory reform, but not the wholesale purging suggested by some. Regulation is a difficult issue that will require the best of us, but it’s not a four-letter word – at least, not yet.

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