Strangling the experimentalists: Opinion

Biomedical science as it is practiced today in the United States in academic institutions is largely an enterprise, and a very large enterprise, supported with public funds from the national government. Due to the real risks for lapses in safety or ethics and the appropriate expectation for some form of accountability, research supported by money from the National Institutes of Health (NIH) or other federal sources is expected to comply with rules and regulations intended to minimize the chances for breaches in safety or ethics or for inappropriate use of research funding. While many of these regulatory regimes are well-intentioned, collectively, they have come to represent an immense burden that stifles creativity and discourages timely implementation of research ideas resulting from new insights or inspirations.

Statues in a park in Prague Image: flickr/victoriapekham

The ever-growing list of annual re-training classes, forms to be filled out, and other requirements may vary from institution to institution or even from department to department, but I can give a sense of the scope of these strictures. As many faculty members engaged in research at American medical schools have both academic and clinical duties, I will first delineate research regulations and then briefly recount some of the similar requirements for individuals with clinical duties.

On the university side, many investigators have annual re-training for bloodborne pathogen exposure, hazardous chemicals, and general laboratory safety. Although I no longer use radioactive tracers in my research lab, investigators who do are also required to renew their certification for radioactive substances annually. Then, there are animal research protocols, which may be required for each different project even if they use similar methods and which may require annual renewal. There is also a special form for investigators using more dangerous pathogens and toxins. In addition, anyone interested in research with human subjects must obtain initial certification by reading a book and passing an exam and then maintaining a certain number of credits in relevant training over a period of three years. On an annual basis, active labs must also maintain and update lengthy plans that outline practices and procedures relating to bloodborne pathogen exposure, hazardous chemicals, and general laboratory safety and any of the other more specialized safety concerns that may apply. Legally, the principal investigator for a research laboratory is literally responsible for knowing every hazard associated with every chemical and procedure used in his or her lab. Finally, there are annual conflict-of-interest forms. I feel compelled to note that completing any of these forms is made more frustrating and time-consuming by virtue of the frequent occurrence of inadequately defined terms the definitions of which can determine how one should answer one or more questions contained therein.

Recently instituted policies emanating from the NIH mandate that every investigator fulfill the precise extent of effort, a term defined in a quite technical fashion, promised in the grant application. Therefore, the NIH now also requires completion of forms reporting on the distribution of effort to different NIH projects and non-NIH duties. My university requires that faculty members complete an online effort reporting form for every six-month period.

At my hospital, physicians must obtain four hours of risk management credits each year as mandated by the malpractice insurer for the clinical practice group. For the past few years, and for at least another year or two, my clinical colleagues and I are required to "earn" an hour of "compliance" credit. This latter requirement, by the way, resulted from the mistakes (committed more than five years ago) by a handful of hospital administrators and clinicians, some of whom had moved on before the so-called "compliance regime" was implemented by the federal Office of the Inspector General and imposed on hundreds of physicians who had committed no infractions whatsoever. The state of Ohio requires that licensed physicians obtain 100 hours of continuing medical education credits every two years and the American Society of Histocompatibility and Immunogenetics requires that clinical histocompatibility laboratory directors obtain 50 hours of CME pertaining to transplantation and immunogenetics. In the latter case, I actually have to list all of the different conferences, symposia, and journal clubs at which I obtained the continuing education. I believe that these sorts of CME requirements are common for re-licensing by many states as well as for membership renewal for many clinically-oriented professional societies. Like the NIH and my university, my hospital also requires effort reporting but with definitions of key terms that tend not to precisely match those of the NIH or the university.

What underlies this web of bureaucratic restraints is not solely the desire to limit mistakes affecting safety or ethics. Another factor first brought to my attention some years ago in a highly explicit way by my perceptive former faculty colleague, Scott Vande Pol, is burden and liability shifting. The university, hospital, and government basically "extort" from every aspiring investigator the promise to abide perfectly by a thicket of rules, regulations, and guidelines as the price to enter the lab, or clinic. Of course, it seems unlikely that the creators of all these rules would ever think to determine if they can be perfectly adhered to given the realities of human limitation and the demands of research, academic responsibility, and clinical service. The main point from the perspective of institutional representatives is that if any violation of the rules occurs, they have the documentation that permits them to transfer the blame onto the shoulders of the investigator or clinician

Furthermore, the generators of the regulations have apparently never considered the possibility (which is in fact reality) that the different rules are not entirely compatible. For example, while multiple institutions, organizations, and agencies only want to pay for what they define as directly relevant activities, thereby imposing the need to maintain ridiculously exhaustive records of how time is spent, no one wants to pay for the time devoted to creating, maintaining, and consulting those records.

The result of this state of affairs is that every investigator is maintained in a state of perpetual vulnerability because it is virtually impossible to fulfill fully all of the requirements and remain functional. In fact, it is frequently the case that the more conscientious the investigator, the greater the disadvantage from following the regulations. Therefore, at least in principle, given sufficient motivation, a chairman, administrator, or anyone with animus can potentially identify a lapse in someone's record and use it as a pretext to punish, or elicit punishment of, that targeted individual. Another perverse result of the inherent incompatibilities between regulations and the imprecise definitions of key terms is that it is virtually impossible to be absolutely honest, thereby institutionalizing the opposite behavior.

Before making suggestions on how to improve this situation, a final aspect of the current landscape needs to be highlighted. In the name of accountability, a nominally worthy goal, academics and clinicians are being asked to account for every minute of time and every penny of compensation. Unfortunately, the schemes put in place to achieve this objective are based on the profoundly misguided assumption that every moment of professional activity can be assigned to one or another absolutely distinct category, such as: research, teaching, clinical service, or administration. Such thinking is not only wrongheaded, it undercuts the very nature of creative intellectual activity that is, or at least should be, the essence of the academic endeavor. Modern academic medical centers are in fact founded in part on the synergies that are presumed to arise from combining the insights and experiences from different domains of inquiry and spheres of activity in individual brains.

So, what changes need to be implemented? For starters, reducing some of the safety renewals from annual to biannual would cut the burden in half with only a small chance of having any discernible adverse consequence. It is even arguable that having to devote less time to what can become perfunctory exercises might improve awareness of safety issues. It would be useful if the different definitions of terms used in independent regulatory schemes were reconciled. Eliminating or modifying regulations that do not actually (i.e., empirically) advance the nominal goals of the rules or that consume unwarranted amounts of time would also be valuable. I have no doubt that the members of the research and clinical communities could collectively generate a much longer list of proposed modifications to the current biomedical regulatory regime that would offer the prospect of simultaneously improving efficiency and sanity while maintaining or enhancing safety, ethics, and accountability.

Neil Greenspan is an immunologist and professor of pathology at the Case Western Reserve University School of Medicine and director of the Histocompatibility and Immunogenetics Laboratory of University Hospitals Case Medical Center. The opinions expressed above are solely his own and do not reflect official views of the institutions with which he is affiliated.


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