Dean Stuart Shapiro served on a committee for a report titled “Simplifying Research Regulations and Policies” for the National Academies of Sciences, Engineering, and Medicine.
Executive Summary
The U.S. scientific enterprise has produced countless discoveries that have led to significant advances in technology, health, security, safety, and economic prosperity. However, concern exists that excessive, uncoordinated, and duplicative policies and regulations surrounding research are hampering progress and jeopardizing American scientific competitiveness. Estimates suggest the typical U.S. academic researcher spends more than 40 percent of their federally funded research time on administrative and regulatory matters, wasting intellectual capacity and taxpayer dollars. Although administrative and regulatory compliance work can be vital aspects of research, the time spent by researchers on such activities continues to increase because of a dramatic rise in regulations, policies, and requirements over time.
This is not a new problem. Although numerous studies and reports over the past decades have recommended solutions, there has been little progress in addressing this problem. However, increasing global competition in scientific discovery and innovation, coupled with a national priority to reduce unnecessary regulatory burdens, has set the stage for modifying current administrative and regulatory policies to better ensure that the research community is maximally productive while simultaneously ensuring the safety, accountability, security, and ethical conduct of publicly funded research.
In response to this imperative, the National Academies of Sciences, Engineering, and Medicine convened a committee to conduct an expedited study to examine federal research regulations and identify ways to improve regulatory processes and administrative tasks, reduce or eliminate unnecessary work, and modify and remove policies and regulations that have outlived their purpose while maintaining necessary and appropriate integrity, accountability, and oversight. In most cases, no single best way to achieve these goals exists, and therefore, the committee offers options in each area of research regulation rather than specific recommendations. Although the committee did not tier the options, some options presented may be quick to implement and acted on expeditiously, where others require congressional action and may take time. These considerations are noted in the pros and cons of each option.
Ultimately, the committee examined system-wide changes needed to address this problem in seven areas of academic research regulation:
- Grant Proposals and Management
- Research Misconduct
- Financial Conflict of Interest in Research
- Protecting Research Assets, which includes:
- Research Security
- Export Controls
- Cybersecurity and Data Management
- Research Involving Biological Agents
- Human Subjects Research
- Research Using Nonhuman Animals
For each area of regulation, the committee outlines the key problems researchers face navigating the current regulatory environment and provides a table detailing potential options for response. Within each table, the committee presents the goal of the option, the approach to implement it, and the pros and cons to consider before implementation (see the detailed options in the corresponding sections of Chapter 2). In total, the committee proposes 53 options. By addressing these critical challenges, the committee’s report provides a roadmap for establishing a more agile and resource-effective regulatory framework for federally funded research. Such a framework can liberate researchers from unnecessary administrative tasks, empower them to focus more on conducting research and training the next generation of scientists and engineers, and enable U.S. science and technology to thrive, unencumbered by unnecessary bureaucratic obstacles that rob the nation’s research enterprise of time and money.
The committee believes that progress can be made by implementing any of the options within a given area. However, the committee also identifies three overarching principles to guide future decision-making:
- Harmonize regulations and requirements across federal and state agencies and research institutions. This may require compromising in the name of harmonization on the type, specificity, and format of information that a given agency requests.
- Take an approach tiered to the nature, likelihood, and potential consequences of risks for a new regulation or requirement. Increased oversight may be needed for higher risk activities, but more flexibility should be allowed for projects less likely to present risks.
- Use technology to simplify the process of complying with regulations and requirements to the greatest extent possible, following the proven example of the financial industry in using artificial intelligence and machine learning to facilitate compliance activities.
Although the options outlined in this report will take varying degrees of effort and resources to implement, examples of recent reform success stories could serve as models of implementation and demonstrate the value of embracing new approaches. For example, federal agencies, working within the structure of the National Science and Technology Council and with oversight from the Office of Science and Technology Policy, developed coordinated research security policy, forms, guidance, and definitions to the extent possible and continue to work together on common agency implementation.
As administrative requirements adapt to the growing challenges faced by the research enterprise, the committee encourages policymakers to consider the three principles outlined above and in Chapter 2 of this report when adopting any new policies or approaches. The committee calls on all participants in the research enterprise to engage in this potentially transformative effort deliberately and thoughtfully, with energy, urgency, and a mindset that prioritizes results while preventing irreparable harm to U.S research. By doing so, the U.S. regulatory enterprise can accomplish its mission of ensuring that federally funded research is safe, is conducted with integrity, maximizes the value of taxpayer dollars, and protects the interests of the public without unnecessarily burdening the U.S. research ecosystem and inhibiting its contributions to national well-being, prosperity, and security.
Citation
National Academies of Sciences, Engineering, and Medicine. 2025. Simplifying Research Regulations and Policies: Optimizing American Science. Washington, DC: The National Academies Press. https://doi.org/10.17226/29231.