Research organizations need to effectively embrace regulatory change

By Brian Herman, David Strauss and Claudia Neuhauser, Published June 8, 2017

With every new congressional and presidential election, researchers must be prepared for change. New federal research priorities may be announced and funding for research may be increased or reduced.

But as most every researcher knows, there is another area in which the government exerts influence: regulations governing research tied to federal budgets.

Although the current administration has yet to reveal a specific policy regarding the regulation of research, the President has stressed that reducing regulation overall is a high priority. How and when this might reach the realm of positive impact on research remains to be seen. But in thinking about the changes that may lie ahead, it is clear that those inside government and within the “regulated community” agree that the cost and administrative burden associated with regulation of research is a matter of concern.

The National Science Foundation’s National Science Board agrees. After examining the issue in 2014, they concluded:

“The past two decades have witnessed increasing recognition that the administrative workload placed on federally funded researchers at U.S. institutions is interfering with the conduct of science in a form and to an extent substantially out of proportion to the well-justified need to ensure accountability, transparency and safety,” report

Without question, many regulations impacting research are widely viewed as unnecessarily complicated, often burdensome and of uncertain merit.  For example, U.S. Public Health Service policies on financial conflict of interest are widely criticized for mandated processes to identify, and then eliminate or manage, an investigator’s outside financial interests even when there is little or no evidence that such interests have a significant impact on the conduct of research.  These efforts may address the “appearance of a problem with the appearance of a solution” but they do so at considerable administrative cost.

At the same time, institutions are left with little or no federal guidance as to how to effectively address genuine and commonly faced problems where the goals of discovery and entrepreneurship collide under the regulations, such as when an investigator with income related to intellectual property may continue to study the patented method or product.

What has evolved in many academic domains is a culture driven by avoidance of risk above all other priorities. The recently revised human subjects regulations, in contrast, offer a welcome opportunity for institutions to “recalibrate” human subjects research oversight to the degree of risk associated with the research at hand.  Time and resources saved by investigators and institutions by reducing the focus on low risk research translates to more appropriate attention to higher risk activities, and of course, the research itself.  Whether institutional cultures will take the opportunity to adapt to new concepts in research protections intended to reduce investigator burden remains to be seen.

With the potential for other significant regulatory change ahead, research organizations must be prepared to embrace other opportunities to enhance productivity while intelligently applying new rules.  The key will be in restoring balance at the institutional level, developing a culturally appropriate risk tolerance so that effort is refocused discovery, productivity and integrity, and on administrative compliance only to the extent that it support these goals..

As experienced research scientists and administrators, we at HSNA have a deep understanding of the inner architecture of research organizations. More importantly, we have extensive experience in managing the obstacles unique to research and bringing forth the best for researchers and for institutions.  Our areas of expertise include providing guidance on the strategic, financial, administrative and organizational operational aspects of research and research integrity.

This means we can help research organizations be more operationally effective amid a changing research landscape–that means, finding the right balance between regulatory compliance and research productivity.

Comments are closed.