For nearly 70 years, the American people have considered fundamental research a national imperative. They have contributed, through an investment of federal funds, to a unique government–research university1 partnership built on the belief that each of the partners would fulfill its roles and obligations with honesty, integrity, and credibility and with the public good always in mind.
Through this partnership, research institutions, with federal government support, have been the principal source of a world-class labor force that has made fundamental discoveries that enhance our lives and the lives of others around the world. Research institutions help to create an educated citizenry capable of making informed and critical choices as engaged citizens in a democratic society. Through teaching, mentoring, research, and scholarship, research institutions train each succeeding generation of researchers, scholars, and leaders and thereby are uniquely responsible for both the creation and the transmission of new knowledge.
The result of this unique government–academic research partnership is a system of education, mentorship, and discovery that is renowned internationally, consistently attracts the best talent from around the world, and serves as a model for other nations determined to advance their leadership in science and engineering in pursuit of economic and social progress and prosperity.
Regrettably, the partnership is under stress. Concerns have been raised repeatedly that federal laws, regulations, rules, policies, guidances, and reporting requirements, while essential to a well-functioning, responsible system of research, have led over time to an environment wherein a significant percentage of an investigator’s time is spent complying with regulations,2 taking valuable time away from research, education, and scholarship.
1The terms research universities and research institutions, used interchangeably throughout this report, encompass not only research-focused universities but also other entities such as teaching hospitals (e.g., Massachusetts General Hospital) and other academic research institutes (e.g., The Scripps Research Institute) conducting federally funded research.
2Throughout this report, the term regulation is used not only to encompass laws, but also the “general and permanent rules published in the Federal Register by the executive departments and agencies of the federal government” [“About the CFR,” National Archives, accessed September 9, 2015, http://www.archives.gov/federal-register/cfr/about.html], agency policies, and policy guidance (including answers to FAQs), and executive actions.
When effective and well-coordinated, federal regulation protects the government, universities, investigators, and the public and helps prevent fraud, waste, and abuse. Today, however, there is growing concern that the unintended cumulative effect of federal regulations undercuts the productivity of the research enterprise and diminishes the return on the federal investment in research. Consequently, Congress called upon the National Academy of Sciences to examine the regulations and policies of all federal agencies that support basic and applied research and to recommend actions to: (1) assess the effectiveness of current regulations to achieve their intended purposes and modify those that are currently ineffective; (2) decrease redundancies of effort due to different government agencies utilizing different formats and requirements for receipt of similar information; and (3) develop new mechanisms for government agencies and academia to develop joint recommendations that best achieve regulatory intent and optimize the federal investment in research.
Although the study was originally planned for 18 months, 3 months after the committee’s first meeting, Senator Lamar Alexander, Chair, Senate Committee on Health, Education, Labor and Pensions, asked the committee to deliver an expedited report by summer’s end, 2015. As he explained in his remarks at the committee’s July 2015 meeting, Senator Alexander believed that fall 2015 presented a unique opportunity to reconsider, in a bipartisan manner, the regulatory environment governing federally funded research, as Congress would be considering several legislative actions involving higher education, research policy, and medical innovation where it would be appropriate to make changes to the current regulatory structure.
Within this new time frame, the committee reviewed extensive background materials and held four meetings and one regional workshop at the University of California, San Francisco, to hear from various stakeholders, including federal research and regulatory agencies, inspectors general, research administrators, accrediting bodies, higher education groups, and principal investigators. In the course of its study, the committee discovered, as have others, little rigorous analysis or supporting data precisely quantifying the total burden and cost to investigators and research institutions of complying with federal regulations specific to the conduct of federally funded research. In addition to the concerns voiced by the academic research community, the committee noted that numerous other organizations (e.g., the President’s Council of Advisors on Science and Technology, Congress, the White House, and the National Science Board) had observed that government regulations were directing investigators’ time away from research to the detriment of national interests (see Box 1-3). Nevertheless, the committee encountered difficulty finding data calculating the opportunity costs associated with diverting time, expertise, resources, and potential away from the conduct of basic and applied research to meet regulatory demands. This was not unexpected, as it is difficult to collect and synthesize this kind of data.
The committee considered regulations (laws, regulations, rules, policies, guidances, and reporting requirements) along the continuum of research from proposal preparation and the conduct of research through to the final accounting of research funds and achievements (see Chapters 4–6). The committee directed detailed attention to those issues (see Box 1-2) repeatedly identified in presentations to the committee and in recent reports as encumbering the research enterprise, recognizing nevertheless the many attempts to address such issues at both the congressional and the agency level. It should be noted that because requirements are placed on research institutions through various means (e.g., laws, regulations, policies, guidance, FAQs, etc.), a “single fix” (e.g., deleting a single phrase in a particular piece of legislation) is generally not possible, as requirements are conveyed by various agencies using diverse mechanisms.
The committee’s expedited report was issued in September 2015 as Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century: Part 1. That report was published as a standalone volume and forms Chapters 1–7 and Appendixes A, D, E, F, G and the first part of Appendix C of this volume.3 It was published with the understanding that the committee would continue its assessment, seek additional data regarding the effects of regulations on the conduct of research, hold additional meetings (including a regional meeting at Rice University), and issue an addendum report addressing outstanding items from its charge not captured in the expedited report (e.g., assess a subset of regulations against the new proposed framework and identify regulations needing further analysis), and address other regulations (e.g., export controls and dual-use research of concern) that it had been unable to address comprehensively under the expedited time line.
Chapters 8–13 of this volume represent Part 2 of the committee’s review.4 In these chapters, the committee continues its discussion of human subjects research.5 The committee noted in Part 1 that it believed that a consideration of regulations governing human subjects research is critically important. As Part 1 of the committee’s report was going to press, the Department of Health and Human Services issued a Notice of Proposed Rulemaking (NPRM) that seeks to revise the Common Rule governing human subjects research. The committee had made initial comments on human subjects research regulations in its September 2015 report (see Chapter 5), but postponed additional analysis and recommendations so as to be able to incorporate a consideration of and response to the expected NPRM. It provides this analysis and additional recommendations
3In addition, the 2015 report is the source of the majority of the text in this summary and the first part of the text in the preface.
4The material in these chapters will not be published as an independent report.
5Throughout the report, the committee uses the traditional phrase human subject, as this is the phrasing typically used in regulatory language. The committee is, however, cognizant and appreciative of the shift from the use of the word subject to the use of the word participant.
on human subjects research in Chapter 9 of the current volume. Part 2 also discusses the impact of federal regulations on university technology transfer (see Chapter 10), select agent research (see Chapter 11), and access to and use of technology (export controls) (see Chapter 12); and in Chapter 13, the committee illustrates how the new regulatory framework articulated in the 2015 report might be operationalized in the future. Appendix B contains a table of the committee’s recommendations from Part 1 and Part 2 of its report.
Over the course of its study, the committee found that prior recommendations by others, though grounded in reality and practicality, had gained little traction. From stakeholders at every level and perspective, the committee heard how increasing federal regulations hinder the output of the remarkable research enterprise that arose from the government-academic partnership. Describing how and why this growth of regulations occurred, why a course correction is needed, and how the government-academic research partnership can be recalibrated and reinvigorated to best serve the nation in the 21st century are the objectives of this report.
Having benefited from the opportunity to brief numerous groups on Part 1 of our report, the committee has become even more convinced that the nation is far from optimizing its investment in academic research. We continue to believe that the only clear path to strengthening the U.S. research enterprise and preparing it for continued leadership in the 21st century is through the creation of a Research Policy Board as an analytical, anticipatory, and coordinating forum on research regulatory policy. We continue to believe further that the health of the academic research enterprise requires creation of a permanent position within the White House Office of Science Technology Policy established for the primary purpose of maintaining strong links to the research community, the Office of Management and Budget, federal research agencies, inspectors general, and the United States Congress.
The research performed at research institutions by individual investigators and research teams, selected on the basis of scientific merit and capability, fuels economic growth; strengthens national security; enhances the overall health, education, and well-being of U.S. citizens, and often, of all humanity; and greatly contributes to U.S. leadership in science, technology, and social and behavioral sciences. Thus, federal investment in such research serves the interests of the nation. With the importance of this investment to the well-being of the nation as its backdrop, the committee noted nine overarching findings that characterize the current climate for federal support of research at academic research institutions:
- Effective regulation is essential to the overall health of the research enterprise, protecting both national investment and the various parties in the partnership (research participants, investigators, universities, and agencies).
- Continuing expansion of the federal regulatory system and its ever-growing requirements are diminishing the effectiveness of the nation’s research investment by directing investigators’ time away from research and training toward overlapping and incongruent administrative matters that do not take into consideration the environment under which research is conducted at academic institutions today. Our understanding of the cumulative effect of regulations is, however, constrained by a lack of empirical data.6
- Most federal regulations, policies, and guidance, in and of themselves, are efforts to address important issues of accountability and performance associated with scientific integrity, the stewardship of federal funds, and the well-being of the people and animals involved in research. But these well-intended efforts often result in unintended consequences that needlessly encumber the nation’s investment in research.
- Many regulations fail to recognize the significant diversity of academic research institutions (e.g., in geographic location, public or private, size, legal structure, missions, financial and physical resources, and research capability). This diversity translates into widely varying capabilities to respond to increasing and overlapping research regulations.
- When regulations are inconsistent, duplicative, or unclear, universities may place additional requirements on research investigators, thereby diminishing the effectiveness of the national investment in research.
- Academic research institutions often receive research funding from multiple federal agencies, but approaches to similar shared goals and requirements (formats of grant proposals and biosketches, animal care, financial conflicts of interest, etc.) are not harmonized across these agencies. Consequently, investigators and administrative staff spend unnecessary time, energy, and resources complying with different sets of rules, regulations, and policies that address common core issues and concerns.
- Some academic research institutions have failed to respond appropriately to investigators’ transgressions or failed to use effectively the range of tools available to create an environment that strongly discourages, at both the institutional and the individual level, behaviors in conflict with the standards and norms of the scientific community.
- Academic research institutions may be audited by any agency’s Office of Inspector General, many of which have very different ap
6Particularly quantitative data.
proaches that in some cases are incongruent with stated policies of their agency.
- The relationship between federal research funding agencies and academic research institutions has for the past seven decades been considered a partnership. Yet, there exists no formal entity, mechanism, or process by which senior stakeholders from both partners, dedicated to fostering, sustaining, and strengthening our nation’s unique research partnership, can consider the effectiveness of existing research policies and review proposed new policies needed to sustain a maximally dynamic, efficient, and effective research enterprise. Further, no entity exists that can collect the data necessary to provide a true measure of the effectiveness and unintended consequence of existing research regulations.
As the committee learned, stresses in the federal-academic partnership have diminished the effectiveness of the nation’s investment in academic research. To restore the health of the enterprise, the committee offers the following overarching recommendations and a new framework for the regulation of research at academic institutions. Recognizing the importance of regulation to the overall health of the research enterprise, the recommendations and framework are intended to achieve a more sensible regulatory structure that harmonizes and streamlines, where appropriate, federal regulations and policies addressing the same concerns and eliminates regulations that no longer benefit the nation’s investment in research. The goal of the framework is not to increase bureaucracy but rather to make the federal regulatory regime simpler and more effective for all those involved in the partnership. Additionally, moving forward, the recommendations, principles, and framework offer a chance to conduct analyses in advance of new regulations and to undertake retrospective review so that we adopt an evidence-based approach to future regulations.
Academic research is funded by diverse agencies with different missions and with different approaches to the implementation of regulations. Thus, the committee offers a number of recommendations directed at Congress with the expectation that Congress will work in concert with the various agencies to harmonize regulations affecting the academic research enterprise. When a recommendation is directed to a single federal agency, that is noted.
RECOMMENDATION ONE: The regulatory regime (comprising laws, regulations, rules, policies, guidances, and requirements) governing federally funded academic research should be critically reexamined and recalibrated.
Specifically, the committee recommends that Congress take the following actions:
- In concert with the White House Office of Management and Budget (OMB), conduct a transparent and comprehensive review of agency research grant proposal documents for the purpose of developing a uniform format to be used by all research funding agencies (Recommendation 4.1).
- Task a single agency with overseeing and unifying efforts to develop a central database of investigator information (Recommendation 4.4).
- In concert with the White House Office of Science and Technology Policy (OSTP), and in partnership with research institutions, develop, within the upcoming fiscal year, a federal-wide financial conflicts-of-interest policy to be used by all research funding agencies (Recommendation 5.1).
- Direct federal agencies following the Common Rule to institute a risk-stratified system of human subjects protections that substantially reduces regulatory burden on minimal-risk research while reserving more intensive regulatory oversight for higher-risk research (Recommendation 5.2).
- Direct federal agencies following the Common Rule to require, for multisite research studies, that a single institutional review board (IRB) with the necessary staff and infrastructure serve as the IRB of record for all domestic sites (Recommendation 5.3).
- Direct agencies, within a designated period of time, to align and harmonize their regulations (and definitions) concerning the protection of human subjects (Recommendation 5.4).
- In instances of minimal-risk research where requiring informed consent would make the research impracticable, amend the Food and Drug Administration’s (FDA) authority so as to allow the FDA to develop criteria for waiver or modification of the requirement of informed consent for minimal-risk research (Recommendation 5.5).
- Instruct the Department of Health and Human Services to work with other agencies to ensure that research involving biospecimens is eligible for a waiver or modification of informed consent, so long as the proposed research meets the conditions for waiver or modification of informed consent as specified in the Common Rule (Recommendation 5.6).
- Instruct the White House OSTP to convene within one fiscal year representatives from federal agencies that fund animal research and representatives from the research community to assess and report back to Congress on the feasibility and utility of developing a unified federal approach for the development, promulgation, and management of policies and regulations pertaining to the care and use of research animals (Recommendation 5.7).
Require inspectors general to:
- Resolve issues regarding their interpretation of agency policies and priorities with the agency before conducting formal audits of research institutions; this should not apply in those situations in which the audit itself is directed toward inconsistent agency policy interpretations.
- Include in their semiannual reports, publish on their websites, and highlight in their presentations to Congress examples of effective, innovative, and cost-saving initiatives undertaken by research institutions and federal research agencies that both advance and protect the research enterprise.
- Provide to Congress and make publicly available information generated each year on the total costs (agency and institutional) of inspectors general audits of research institutions, the total amounts of initial findings, the total amounts paid by institutions after audit resolution, and any significant management, technology, personnel, and accountability steps taken by research institutions as the result of a completed audit.
- Reexamine the risk-based methodology in identifying institutions as candidates for Offices of Inspectors General audits to take into account the existing compliance environment and oversight on campuses, recognizing that many research institutions have clean Single Audits, are well managed, and have had long-standing relationships with the federal government.
- Encourage all federal inspectors general to report only final audit resolution findings on their websites and in their semiannual reports to Congress (Recommendation 6.1).
- In concert with the White House OMB, affirm that research institutions may take advantage of the flexibility provided by the Uniform Guidance8 for the documentation of personnel expenses (Recommendation 6.2).
- Transfer responsibility for the operation of the invention report system (currently iEdison) to the Department of Commerce (DOC) and allocate appropriate resources to the department for upgrading the invention reporting system so as to create a user-friendly interface for the input of data on inventions (Recommendation 10.1).
- Authorize the DOC to require that the invention data-reporting obligations imposed on recipients of federal funding by all agencies are aligned with agreed-upon reporting requirements (Recommendation 10.3).
Specifically, the committee recommends that the White House Office of Management and Budget take the following actions:
- Conduct a transparent and comprehensive review of agency research grant proposal documents for the purpose of developing a uniform format to be used by all agencies (Recommendation 4.1).
- Require that research funding agencies use a uniform format for research progress reporting (Recommendation 4.5).
- Amend the Uniform Guidance to clarify that subrecipient monitoring requirements apply to institutions of higher education only to the extent necessary for prudent project and performance monitoring, and do not require more extensive monitoring of subrecipients’ institutional compliance with all federal statutes, regulations, policies, and institution-wide business practices. Permit, as an immediate, interim measure, research institutions to use subrecipients’ publicly available Single Audit Reports to verify that subrecipients have not been otherwise debarred or suspended with respect to the receipt of federal funds. For those with a clean Single Audit Report, the prime institution should be allowed to rely on the Single Audit Act oversight process as an alternative to conducting a review of the adequacy of the subrecipient’s institutional systems and business practices (Recommendation 4.6).
- Amend the Uniform Guidance to establish a mandatory 120-day timetable for the submission of all financial reports for all federal research funding agencies (Recommendation 6.4).
- Amend the Uniform Guidance so that research universities are not required to submit a revised Cost Accounting Disclosure Statement (DS-2) each time they change their accounting practices, as long as those practices are in compliance with the Uniform Guidance and are posted promptly on the universities’ websites. Rather, the initial disclosure statement and revisions to it should be submitted to the research institution’s cognizant agency in coordination with the institution’s Facilities and Administrative proposal (Recommendation 6.5).
- Further amend the Uniform Guidance as follows:
- Amend Section 200.329 to read: Procurement by micro-purchases. Procurement by micro-purchase is the acquisition of supplies or services on a purchase order from a single vendor, the aggregate dollar amount of which does not exceed $10,000 (or $2,000 in the case of acquisitions for construction subject to the Davis-Bacon Act).9
9Reporting on Real Property, 2 CFR § 200.329 (2014). The Uniform Guidance currently reads, “Procurement by micro-purchases. Procurement by micro-purchase is the acquisition of supplies or services, the aggregate dollar amount of which does not exceed the micro-purchase threshold (§ 200.67 Micro-purchase).”
OMB shall periodically revisit and adjust the $10,000 threshold to account for escalating costs of supplies and services.
- Amend the list of criteria for the permissible purchase of supplies and services through noncompetitive bids in Section 200.320 to include: “The procurement is necessary for research, scientific, or other programmatic reasons, such as instances where the purchase is for a specialized service or of a necessary quality that is available only from a single vendor or if only one vendor can deliver in the required time frame” (Recommendation 6.3).10
Specifically, the committee recommends that Congress and the Administration take the following actions:
- Congress should authorize, and the President should appoint, an independent, free-standing national commission modeled on the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. This commission was authorized by Congress under Public Law 95-622 in 1978, appointed by the President in 1979, and existed outside the structure of federal departments and agencies. The commission had a direct line-item appropriation from Congress, appointed its own staff, and set its own agenda.
Congress should charge the proposed commission with examining and updating as necessary the ethical, legal, and institutional frameworks governing human subjects research. The commission should make recommendations to the President, Congress, and relevant federal agencies regarding how the basic ethical principles governing human subjects research should be applied to unresolved human research questions and novel human research contexts.
The commission should have two broad charges:
- Recommend to the President and Congress ethically sound regulatory approaches for unresolved questions in human subjects research; and
10This criterion should be added as an additional item in Methods of Procurement to be Followed, 2 CFR § 200.320(f) (2014), which currently reads as follows:
“Procurement by noncompetitive proposals. Procurement by noncompetitive proposals is procurement through solicitation of a proposal from only one source and may be used only when one or more of the following circumstances apply:
(1) The item is available only from a single source;
(2) The public exigency or emergency for the requirement will not permit a delay resulting from competitive solicitation;
(3) The Federal awarding agency or pass-through entity expressly authorizes noncompetitive proposals in response to a written request from the non-Federal entity; or
(4) After solicitation of a number of sources, competition is determined inadequate.”
- Recommend to the President and Congress revisions in the legal and institutional structures for regulating research with human subjects (Recommendation 9.1).
- To ensure that the proposed national commission can address the full range of unanswered questions regarding the protection of human subjects in federally funded research, the committee recommends that the executive branch withdraw the Notice of Proposed Rulemaking on the Federal Policy for the Protection of Human Subjects. The committee further recommends that the regulatory structure protecting human research subjects not be revised until the national commission has issued its report and the research community, patient groups, the public, and others have had an opportunity to consider and respond to the commission’s recommendations (Recommendation 9.2).
- Support a robust continuation and renewal of the Export Control Reform Initiative. Even under current statutes, the initiative has the potential to make further, marked improvements (e.g., to the regulations, oversight process, and ease of compliance) that would bring significant benefits to national security, to commerce, and to the economy, as well as to federally funded university research. The lessons learned in the initiative over the past 5 years could help participants in the process accelerate the rate at which needed regulatory revisions are proposed and adopted (Recommendation 12.1).
Specifically, the committee recommends that the Administration take the following action:
- The President should assign the responsibility for regulating all microbes and toxins on the select agents and toxins list to a single agency (Recommendation 11.3).11
Specifically, the committee recommends that federal research agencies take the following actions:
- Limit research proposals to the minimal information necessary to permit peer evaluation of the merit of the scientific questions being asked, the feasibility of answering those questions, and the ability of the researcher or research team to carry out that research. For proposals demonstrating these characteristics, any supplementary information should, if requested, be provided just-in-time (Recommendation 4.2).
11The proposed Research Policy Board could take a leadership role in discussions about which agency should have responsibility for the regulation of the microbes and toxins on the select agents and toxins list.
- Develop a central repository to house assurances similar to the Single Audit Clearinghouse of the Federal Demonstration Partnership (Recommendation 4.3).
- Reporting, assurances, and verifications to agencies should be reduced and streamlined. Requirements for reporting should be adjusted such that animal-related noncompliance reports are tiered to the level of significance or impact on animals and included in an annual report rather than submitted on an individual event basis. Annual reports to individual agencies about animal care programs should be replaced by a single annual report under the proposed Federalwide Assurance mechanism. Processes that are redundant to the institutional animal care and use committee approval process, such as the Vertebrate Animal section of Public Health Service grant applications and the Department of Defense central administrative protocol review, should be eliminated (Recommendation 5.8).
Specifically, the committee recommends that other federal agencies take the following actions:
- The Department of Commerce, in consultation with the proposed Research Policy Board, should develop a uniform set of requirements regarding the frequency and type of data to be submitted to federal agencies regarding invention reporting, ensuring that these do not exceed what is required by the Bayh-Dole Act (Recommendation 10.2).
- The Federal Select Agent Program should develop and promulgate a reasonable inventory management system for biological select agents and toxins that takes account of the living, self-replicating nature of biological agents (Recommendation 11.2).
- The regulations12 governing select agents and toxins should be amended to:
- Allow researchers to more readily access relevant select agents in times of public health emergencies;
- Increase the number of lower-virulence strains of select biological agents available to researchers; and
- Make more transparent the process by which materials are added to and removed from the select agents and toxins list (Recommendation 11.3).
- The Export Control Reform Initiative should seek university input at all stages of the process. The Research Policy Board proposed in Part 1 of
12Possession, Use and Transfer of Select Agents and Toxins, 7 CFR 331 (2005); Possession, Use and Transfer of Select Agents and Toxins, 9 CFR 121 (2005); and Select Agents and Toxins, 42 CFR 73 (2005).
this committee’s report would be an ideal vehicle for providing such input (Recommendation 12.2).
- The Export Control Reform Initiative should work closely with universities and other stakeholders to specifically address the deemed export provisions13 and vigorously support the spirit and letter of the fundamental research exclusion (Recommendation 12.3).
Specifically, the committee recommends that research institutions take the following actions:
- Assess their own regulatory processes to determine where their compliance activities can be streamlined to ensure effective use of indirect research recovery costs, while still meeting the requirements of federal regulations (Recommendation 5.9).
- Conduct a review of institutional policies developed to comply with federal regulations of research to determine whether the institution itself has created excessive or unnecessary self-imposed burden. (Chapter 7).
- Revise self-imposed burdensome institutional policies that go beyond those necessary and sufficient to comply with federal, state, and local requirements (Chapter 7).
RECOMMENDATION TWO: To advance the government-academic research partnership, research institutions must demand the highest standards in institutional and individual behavior. This can only be achieved if universities foster a culture of integrity among academic leaders, faculty, postdoctoral trainees, students, and staff, and institutional administrators, and mete out appropriate sanctions in instances where behavior deviates from the ethical and professional norms of the institution and of the academic research community. Universities that deviate from or fail to enforce the norms of behavior should be sanctioned. The committee recommends that a newly established Research Policy Board14 should collaborate with research institutions on the development of a policy to hold institutions accountable for such transgressions (see Chapter 7).
RECOMMENDATION THREE: Inspectors general responsibilities should be rebalanced so that appropriate consideration is given both to uncovering
13As recommended by the report The Deemed Export Rule in the Era of Globalization [U.S. Deemed Export Advisory Committee, The Deemed Export Rule in the Era of Globalization (Washington, DC: Department of Commerce, 2007)].
14See Recommendation Four below.
waste, fraud, and abuse and to advising on economy, efficiency, and effectiveness. The relationship between inspectors general and research institutions should be based on a shared commitment to advancing the nation’s interest through a dynamic and productive research enterprise (see Chapter 6).
RECOMMENDATION FOUR: The committee recommends the creation of a new mechanism, to include an active public-private forum and a designated official within government, to foster a more effective conception, development, and harmonization of research policies (see Chapters 7 and 13).
Specifically, the committee recommends that Congress take the following actions:15
- Establish a new entity, a Research Policy Board. The Research Policy Board would be a self-funded, government-linked entity serving as the primary policy forum for discussions relating to the regulation of federally funded research programs in academic research institutions
- Establish a new Associate Director, Academic Research Enterprise, in the White House OSTP, having responsibilities to (a) serve as one of two principal federal contact points for the Research Policy Board; (b) oversee and facilitate the general health of the government–academic research partnership; (c) work in partnership with the Office of Information and Regulatory Affairs (OIRA) of the White House OMB to manage the overall regulatory burden; and (d) jointly with the Administrator of OIRA issue an annual report to Congress on regulatory issues and actions affecting the research partnership (Recommendation 7.1).
Specifically, the committee recommends that participants in the government–academic research partnership adopt a set of operational principles as a part of the new regulatory framework for federally funded academic research:
- Regulations should reflect the shared commitment of academic research institutions and federal agencies to the effective and efficient conduct of research and the maintenance of research integrity.
- Regulations should be harmonized across all federal research funding agencies. To the extent that agency-specific missions require agencies to depart from a uniform approach, agency-based deviations should be reviewed and approved by OIRA in consultation with the Associate Director, Academic Research Enterprise, OSTP.
- Regulations should be written with the input of the Research Policy Board.
- Regulations and their enforcement should take into account the risk of malfeasance and the overall cost of compliance. Before proposing any new regulation, an agency should determine whether the problem that the regulation is intended to address is systemic. Actions need to be targeted where transgressions occur. Minor issues should not become cause for disproportionate regulatory response. Egregious transgressions that are found to be isolated events should not trigger disproportionate responses.
- Regulations should be framed with the recognition that risk levels will never be reduced to zero.
- Regulations should be reviewed periodically to determine their effectiveness. If a regulation is deemed to be ineffective or excessively burdensome, it should be repealed or reformed.
- Wherever practical and appropriate, new regulations should be piloted at a small number of institutions to determine whether they efficiently accomplish the intent of regulation, and funds should be provided to pilot institutions for related personnel expenses.
- Academic research institutions must take timely and appropriate action against members of their communities who violate the values of trust and integrity to which community standards and federal funding of research, as well as academic responsibilities, require strict adherence. (Recommendation 7.2).
For nearly 70 years, research universities in partnership with the federal government have advanced fundamental and applied research to improve the health, economic well-being, and security of our citizens. This partnership has yielded tremendous benefit for the American people. It behooves us to be watchful and to make every reasonable effort to ensure that the partnership continues to flourish. Targeted revisions to regulations affecting research institutions, combined with a new framework of structures and principles to coordinate and nurture the government–academic research partnership, will serve the nation as it confronts the scientific and technological challenges of the 21st century.
This page intentionally left blank.
This page intentionally left blank.