An ad hoc committee under the auspices of the Committee on Science, Technology, and Law (CSTL) and the Board of Higher Education and Workforce (BHEW) will conduct a study of Federal regulations and reporting requirements with specific attention to those directed at research universities. In conducting its analyses the committee will be aware of (a) the context and intended benefits and circumstances under which a particular regulation was issued and may have evolved, and (b) whether those contexts or circumstances still remain of public concern. The committee will develop a new framework for Federal regulation of research universities in the 21st century that addresses the needs of Congress, Federal agencies, and the broader public while advancing to the maximum extent feasible the missions of research universities.

Specifically, the committee will:

· Identify by research agency and statutory authority the Federal regulations with significant impact, and the reporting requirements with which research universities must comply.

· Work with research universities and associations to gather and review information on personnel time and costs of compliance with Federal regulations and reporting requirements.

· Work with research universities and associations to gather and review information on methodologies for most efficiently and effectively estimating time, costs and resulting benefits.

· Work with federal research agencies to identify key regulations and requirements with significant impact that the committee should review.

· Work with professional staff of congressional committees with jurisdictional responsibility for regulatory oversight and research funding.

· Work with the stakeholders such as the Federal Demonstration Partnership to demonstrate methodologies for estimating the personnel time and costs of compliance for a subset of regulations and reporting requirements specific to research universities.

· Develop a framework and supporting principles for the Federal regulation of research universities in the 21st century, taking into account: (1) the purposes, costs, benefits, and reporting requirements of regulation, (2) the processes used to promulgate regulations and reporting requirements, (3) the roles of Congress, Offices of Inspectors General and Federal agencies, including the Office of Science and Technology Policy and the Office of Management and Budget, and (4) the missions of research universities.

· Recommend steps needed to implement the framework.

· Assess how a subset of regulations and reporting requirements fit within the framework, and offer suggestions for evaluating those regulations and reporting requirements that are outdated or redundant, or where compliance burdens have become disproportionate with expected benefits.

· Identify regulations and reporting requirements that will require additional analysis in order to assess their fit with the framework and to develop improved approaches.

The committee will issue an interim report with recommendations in late summer 2015 and then a final report in Spring 2016.

Although originally envisioned as a single document, the report has been divided into two parts. In response to a request from Congress for an expedited report,Optimizing the Nation's Investment in Academic Research: A New Regulatory Framework for the 21st Century: Part 1was issued in September 2015. Part 1 focused on those regulatory issues identified as of most pressing concern to the research community and upon which Congress might take immediate action. It addressed regulations along the continuum of research from proposal preparation and the conduct of research through to the final accounting of research funds and achievements. The report offered recommendations for Congress, federal agencies, Inspectors General, and universities. In addition, it articulated a new regulatory framework that includes the establishment of a Research Policy Board and the creation of a new position in the White House Office of Science and Technology Policy – Associate Director, Academic Research Enterprise. Finally, the committee offered a set of operational principles to undergird the new regulatory framework. Part 1 was issued with the understanding that other significant issues would be addressed in Part 2.

Part 2 of the report represents a continuation of the committee’s review of the federal regulation of the U.S. research enterprise. It focuses specifically on the impact of federal regulations on university technology transfer, human subjects research, research with select agents, and access to and use of technology (export controls). It also illustrates how the new regulatory framework articulated in Part 1 might be operationalized in the future.