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22 Impact of Regulations on the Conduct of Research

Most scientists acknowledge, respect and support regulations promulgated with the goal of protecting human subjects, animals, and the environment. Regardless of the inconvenience, cost, and burden, they abide by those regulations widely recognized as protecting the interests of society. Nonetheless, it must be recognized that scientists temperamentally and culturally are skeptical about the legitimacy of rules; instinctively they tend to oppose regulations as an unnecessary burden impeding research. Without question, scientists desire freedom to pursue their research devoid of encumbrances. Similarly, regulators want enlarged mandates as implied in the quip “Dogs bark, cows moo, and regulators regulate” attributed1 to Frank E. Young, former commissioner of the Food and Drug Administration. Public policy is not, and should not be, governed by extremists at either end of the spectrum—those opposing all regulations and those wanting to impose more and more regulations. Invariably scientists express frustration over those government regulations which are imposed as a result of political pressures, provide very little benefit, appear ill-advised or poorly crafted, are costly and do indeed impede scientific research. In his article,2 “Government Regulation of Research: The Good, The Bad, and The Ugly,” Robert Rich praised some regulatory efforts and their outcomes, questioned the value of other regulations, condemned still others, and expressed particular concern about a few impending regulations. Doubtless there are