Regulatory Challenges in University Research

DAVID L. WYNES

GRAINNE MARTIN

DAVID J. SKORTON

Regulatory Challenges in University Research

Federal regulations must be streamlined and coordinated so that society’s values can be upheld without impeding science.

The body of federal regulations designed to ensure that university research adheres to generally accepted societal values and ethics has grown rapidly in recent years, creating an administrative burden and a potential impediment to research. As publicly supported and publicly accountable institutions, universities are expected by force of regulation to develop effective procedures to deal with a number of research-related issues. Some of the most challenging sets of issues, which we focus on here, involve protecting human and animal research subjects, and detecting and managing scholarly misconduct. Other important issues include dealing with conflicts of interest among researchers and protecting the research environment for the benefit of both scientific workers and research subjects. The university research community has long accepted responsibility for these various tasks and recognized that reasonable regulations to achieve these goals are worthwhile and necessary, but the requirements imposed by the regulatory system are reaching the point where they may no longer be called reasonable.

The university community now finds itself trying to resolve the tension that has developed between two missions: fostering a robust research program and monitoring and regulating the activities that constitute this program. To demonstrate their accountability to the public trust for funding the research, universities must demonstrate that their adherence to regulations is unequivocal and visible. However, badly designed or poorly coordinated regulations can create an unnecessary problem for universities. We outline some key issues in the regulation of research and point to possible national strategies to achieve compliance with these regulations without unduly hampering scholarly inquiry.