Operationalizing the New Regulatory Framework for the Federal Investment in Research Institutions
In Part 1 of this report, the committee called for a new regulatory framework for the government–academic research enterprise. As envisioned, the framework would include a new entity, the Research Policy Board (RPB), and the establishment of a new associate director position (Academic Research Enterprise) at the White House Office of Science and Technology Policy (OSTP). The committee also offered a set of principles to guide the recalibration and future development of federal research regulations.
The committee’s recommendations emanated from its assessment of the overall condition of the nation’s academic research enterprise. In the course of the committee’s investigation, analysis, and deliberations, it became clear that the absence of a body responsible for monitoring and optimizing the health and functioning of the nation’s $65 billion annual investment in basic and applied research causes serious problems. Congress, the Administration, funding and regulatory agencies, research institutions, and the public lack a means of communicating with one another about their concerns and expectations regarding the regulation of research. Also lacking are the data needed to assess whether the government–academic research enterprise is operating as well as it might and the extent to which existing and proposed regulations, guidance documents, and policies are aiding or hindering that end. In the current regulatory framework, agencies face barriers to harmonizing research regulations and policies for optimal effectiveness.
The committee concluded that steps can be taken to improve the operational status of the government–academic research enterprise so as to maximize the benefits to science and society. The RPB will provide an environment where key participants can have candid conversations about their concerns, develop a shared understanding of the problems to be addressed, gauge the costs of proposed solutions, and make realistic assessments of the benefits and unintended consequences that result from new regulations. This forum would also facilitate anticipatory discussions about emerging fields of research that may require new or revised regulations or policies. Another facet of the new framework, the
OSTP Associate Director, Academic Research Enterprise, can see to it that data about regulatory benefits and burdens are collected and evaluated and that conflicts and redundancies in regulations and reporting requirements are eliminated. The committee’s proposed framework thus provides the opportunity to create effective and proactive regulations geared to the needs of 21st century research.
The committee recognizes that creating and operationalizing a new regulatory framework will present challenges and that many questions must be answered in order to create an optimal model. Concerns of this type have been raised by readers of Part 1 of the committee’s report. The committee believes it is unwise for it to attempt to address every mechanistic function of the proposed framework. Nonetheless, the committee believes that some additional clarifying remarks are appropriate. Therefore, in the current chapter, the committee offers a discussion of how the RPB and the associate director at OSTP might engage with the White House Office of Management and Budget (OMB), Congress, funding and regulatory agencies, and research institutions and associated organizations to optimize the research partnership. As the committee noted in Part 1 of this report, the goal of the framework is not to increase bureaucracy, but rather to make the federal regulatory regime simpler, more effective, and more harmonized across research funding agencies. A high-level forum that facilitates substantive dialogue about and collects and analyzes data on existing and proposed regulations will ultimately result in less bureaucracy as the members of the partnership, working together, streamline and harmonize those regulations governing the conduct of research. The committee recognizes that the RPB will require dedicated staff, including a full-time director, to convene meetings of senior officials, conduct detailed examinations of rules and regulations, and to formulate appropriate responses for congressional and agency consideration.
In the context of the committee’s proposed regulatory framework, the committee envisions that the RPB will provide stakeholders with an opportunity to:
- Consider, in an anticipatory fashion, issues, policies, concerns, and regulations that affect the multiple agencies that support or regulate federally funded research.
- Consider, in an anticipatory fashion, new and emerging fields of research that may necessitate policy changes or new regulations.
- Evaluate and assess the effects of existing, new, or proposed policies, regulations, and guidance documents.
- Collect and evaluate appropriate data for the development of metrics that provide a quantitative assessment of the cost and benefit of specific regulations.1
1The importance of accurately estimating the costs of regulations cannot be overstated. As the committee noted in Chapter 2 of Part 1, while there are many ways to estimate the cost of regulations, there are no authoritative methodological approaches for calculating
Many of the recommendations in Parts 1 and 2 of the committee’s report could be advanced through engagement with the RPB. The RPB could, for example, provide both a venue for discussion and a vehicle for the assemblage and analysis of the data needed to facilitate the committee’s recommended consideration of, for example, a unified federal approach to the use and care of animals in research or select agent regulations.
Recognizing that the specific operational functionality of the RPB and the mandate of the proposed associate director will be defined through debate and negotiation, the committee provides, in the following section, a broad illustration of how the proposed framework might work.
The proposed OSTP-OMB annual report to Congress2 is a key component of this new framework, as it affords Congress the opportunity to review, on a yearly basis, the progress made in optimizing the functioning of the research enterprise. It would also highlight current challenges and identify prospective issues of regulatory concern. The importance of the annual report will be illustrated in the following text.
such costs. The American Council on Education, in its February 2015 report, Recalibrating Regulation of Colleges and Universities, observed that:
Calculating the precise benefits and costs of regulation is both difficult and time-consuming. One reason for this is that duties and functions associated with a new regulation are usually absorbed by staff who already perform other duties, simply adding to their workload. Similarly, estimates of the cost of complying with a new regulation may fail to take into account the complicated interplay between new and existing requirements. Regulations do not exist independently of each other, and the interplay of multiple requirements can add exponentially to the cost of compliance.
To take the example of one regulation, the National Institutes of Health estimated annualized burden hours for compliance with the 2011 Public Health Service financial conflict-of-interest rule at 676,130 hours at an estimated cost of $23 million across roughly 2,000 awardee institutions. In contrast, a survey undertaken by the Association of American Medical Colleges indicated that just 70 institutions spent $22.6 million to implement the rule (see Chapter 5, p. 91). For a further discussion of agency cost estimates, see Appendix F: A Brief Primer on the Paperwork Reduction Act.
2Given the nature and magnitude of the issues that affect the research enterprise, it is expected that, in addition to its annual report, the proposed Research Policy Board would issue supplementary reports to relevant congressional committees, including the U.S. Senate Committee on Health, Education, Labor and Pensions; U.S. Senate Committee On Commerce, Science, and Transportation; U.S. House Committee on Science, Space and Technology; and U.S. House Committee on Oversight and Government Reform.
HOW THE PROPOSED RESEARCH POLICY BOARD MIGHT SERVE AN ANTICIPATORY FUNCTION
As an anticipatory body, the RPB will convene representatives from the research funding and regulatory agencies, the White House Office of Information and Regulatory Affairs (OIRA), inspectors general, and the research community routinely, and not simply in response to agency actions. The purpose of these meetings would be to identify agenda items, set project priorities, and engage in horizon-scanning. Such meetings would provide an opportunity for research funding agencies to raise concerns. By enabling agencies to give early voice to their concerns, problematic issues could be addressed in a preemptive (rather than in a reactive) manner, and actions could be taken proportionate to the magnitude of the concern. Regulatory action need only be taken if an identified problem is found to be systemic and beyond the willingness or capacity of research institutions to manage.
Additionally, the RPB could convene meetings with legislative staff to discuss proposed legislative actions affecting federally funded research.
Regular meetings will be used to discuss advances in research so as to provide the RPB with information on emerging trends and disruptive technologies (e.g., gene editing, autonomous technologies, synthetic biology, massive data on social networks) that may require new thinking about the governance of research as well as reconsideration of existing and proposed regulations and policies.
Research institutions will be expected to raise issues of regulatory importance, that is, regarding laws, general and permanent rules published in the Federal Register, agency policies and policy guidance (including FAQs), and executive actions, and identify best practices for facilitating a strong government–research university partnership.
It may be desirable, on occasion, based upon discussions with stakeholders, for the RPB to recommend the initiation of rulemaking to correct problems in existing regulations. Existing mechanisms for retrospective review of regulations (e.g., Executive Order 135633) can be used for this purpose.
The RPB will explore mechanisms that would allow agencies to engage with the RPB prior to initiating a rulemaking. Issues that affect multiple agencies’ policies and programs (such as conflicts of interest, human subjects, or animal care) will be subject to particular consideration.
3Improving Regulation and Regulatory Review, Executive Order No. 13563, 2011.
HOW THE PROPOSED FRAMEWORK MIGHT WORK IN THE ISSUANCE OF A NEW REGULATION
Before a Notice of Proposed Rule Making
Prior to initiating rule making, a draft Advance Notice of Proposed Rulemaking (ANPRM) on a subject area of significant interest to the research community will be placed on the agenda of the RPB at the request of the Associate Director, Research Enterprise (ADRE), OSTP, a federal agency, or the leadership of the RPB.
The RPB will convene a meeting to hear from the research community and invite the Associate Director, OSTP; OMB-OIRA administrator; issuing agency staff, and other relevant agency staff to informally discuss with the research community concerns about the draft ANPRM.4
OIRA would review subsequent revisions to the draft ANPRM to assess whether an agency has been responsive to concerns raised and meet with the RPB to hear any remaining concerns about the revised ANPRM so as to assure that these concerns had been appropriately considered before the proposal would be opened to public comment.
Following the OIRA-RPB meeting, in collaboration with the ADRE, the RPB will issue a report to the OSTP director and the OMB-OIRA administrator, identifying remaining unresolved issues of concern to the research community. Such reports will be included as an appendix in the annual OSTP-OMB report to Congress.
Between a Notice of Proposed Rulemaking and a Final Rule
If an agency issues a Notice of Proposed Rulemaking (NPRM)5 that has not responded to the concerns raised by the academic research community through the process described above, then the following will occur.
The RPB will convene a meeting to discuss the agency response with the participants described above while ensuring that agency policies on ex parte communication during the rulemaking process are not violated.
Following the meeting, the RPB will issue a report describing problematic issues remaining in the NPRM and highlighting, as appropriate, that the issues with the NPRM were raised at the ANPRM stage. If, in the preamble to the NPRM, the responsible agency explains why it did not make changes, the RPB will detail, in its report to OSTP and OMB-OIRA, the reasons why the research community believes that the responses given are insufficient.
4The committee recognizes that Federal Advisory Committee Act issues will need to be considered with regard to such discussions.
5If an NPRM is not preceded by an ANPRM, then the NPRM would be subject to review in a manner consistent with the process described above for an ANPRM.
OMB-OIRA would be expected to take into account the concerns raised in this report during its review of the agency final rule.
The RPB report will be included as an appendix in the OSTP-OMB annual report to Congress. The report will identify problematic final rules and document solutions offered by the research community to redress these concerns and, in so doing, provide Congress with an opportunity to conduct additional necessary information gathering.
After a Final Rule
The RPB will evaluate and comment on:
- Guidance documents interpreting regulations and the associated burden that such documents might impose on research institutions.
- Requests for new information collections, the associated burdens that such collections might create for universities, and the application of the Paperwork Reduction Act to minimize such burdens.
- The enforcement of regulatory provisions by agencies and their inspectors general.
- Internal retrospective reviews of current agency regulations.
Following the issuance of a final rule, the RPB will engage in ongoing communications about the implementation of the associated regulations with agency liaisons and the research community.
HOW THE PROPOSED RESEARCH POLICY BOARD MIGH ASSIST IN THE DEVELOPMENT OF METRICS, THE COLLECTION OF DATA, AND IN EVALUATING AND ASSESSING DATA
The RPB will work with the research community, research policy organizations, and federal agencies to identify and, as necessary, develop appropriate metrics to be used to assess the impact of regulations on the conduct of research. This should include defining appropriate methodologies for assessing the costs, benefits, and burdens associated with regulations.
The RPB will routinely request, in collaboration with organizations such as the Federal Demonstration Partnership, the Council on Governmental Relations, the American Association of Universities, the Association of Public and Land-grant Universities, the Association of American Medical Colleges, and the Federation of American Societies for Experimental Biology, data from research institutions regarding regulations currently under review as part of retrospective reviews of agency regulations required under Executive Order 13563. This information would be provided to the government.
The RPB will compile data on the costs of proposed and actual regulations. This information would be provided in the OSTP-OMB annual report to
Congress. For any significant new proposed regulations where the agency and research community’s calculations of the costs, benefits, and burdens of the regulation significantly diverge, the RPB will convene a meeting with OIRA, the research community, and the issuing agency. Information regarding these meetings and the data collected should be included in the OSTP-OMB annual report to Congress.
Ultimately, the strength of the RPB will be its ability to contribute, through the vital role it will play in creating and shaping a meaningful dialogue among all stakeholders in the government–academic research partnership, to a more responsive and efficient regulatory structure that optimizes the nation’s investment in academic research by better serving the interests of government, universities, investigators, and the public.
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