OVERARCHING RECOMMENDATIONS | |
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RECOMMENDATION ONE: | The regulatory regime (comprising laws, regulations, rules, policies, guidances, and requirements) governing federally funded academic research should be critically reexamined and recalibrated. |
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 Board (see Recommendation 7.1 below) should collaborate with research institutions on the development of a policy to hold institutions accountable for such transgressions. |
RECOMMENDATION THREE: | Inspectors general responsibilities should be rebalanced so that appropriate consideration is given both to uncovering 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. |
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 Recommendations 7.1 and 7.2 below). |
SPECIFIC RECOMMENDATIONS | |
Topic: | Proposal Preparation |
Policy / Statute / Regulation(s): | Specific Agency Requirements |
Affected Parties: | Institutional Researchers Research Agencies |
Actors: |
Congress
White House Office of Management and Budget Federal Agencies Funding Research |
Relevant Report Section: | Part 1, Chapter 4 |
Recommended Actions: | 4.1. The committee recommends that Congress, in concert with the White House Office of Management and Budget, 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. |
4.2. The committee recommends that research proposal information should be limited 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/research team to carry out that research. For proposals demonstrating these characteristics, any supplementary information should, if requested, be provided just-in-time. 4.3. The committee recommends that research agencies develop a central repository to house assurances similar to the Single Audit Clearinghouse of the Federal Demonstration Partnership (FDP). 4.4. The committee recommends that Congress task a single agency with overseeing and unifying efforts to develop a central database of investigator information. |
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Topic: | Progress Reporting |
Policy / Statute / Regulation(s): | Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance) |
Affected Party: | Federal Agencies Funding Research |
Actor: | White House Office of Management and Budget |
Relevant Report Section: | Part 1, Chapter 4 |
Recommended Action: | 4.5. The committee recommends that the White House Office of Management and Budget require that research funding agencies use a uniform format for research progress reporting. |
Topic: | Subrecipient Monitoring |
Policy / Statute / Regulation(s): | Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance) |
Affected Party: | Institutional Administrators |
Actor: | White House Office of Management and Budget |
Relevant Report Section: | Part 1, Chapter 4 |
Recommended Action: | 4.6. The committee recommends that the White House Office of Management and Budget 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 statues, regulations, policies, and institution-wide business practices. |
As an immediate, interim measure, the committee recommends that the Office of Management and Budget permit 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. |
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Topic: | Conflicts of Interest |
Policy / Statute / Regulation(s): |
Public Health Service Regulations1: 42 CFR Part 50, Subpart F (2011)
NSF Grants Policy Manual, NSF 05-131 (2005)2 Uniform Guidance3: 2 CFR Part 200 (2013) |
Affected Parties: |
Institutional Researchers
Institutional Administrators |
Actors: |
Congress
White House Office of Science and Technology Policy Research Institutions Federal Agencies Funding Research |
Relevant Report Section: | Part 1, Chapter 5 |
Recommended Action: | 5.1. The committee recommends that Congress, in concert with the White House Office of Science and Technology Policy 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. |
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1Public Health Service Agencies include: National Institutes of Health (NIH), Food and Drug Administration (FDA), Centers for Disease Control (CDC), Substance Abuse and Mental Health Services Administration (SAMHSA), Agency for Healthcare Research & Quality (AHRQ), Agency for Toxic Substances and Disease Registry (ATSDR), Health Resources and Services Administration (HRSA), and Indian Health Service (IHS)
2While the NSF adopted the 1995 PHS FCOI regulations, the agency chose not to adopt the changes in the new 2012 PHS FCOI regulation. Thus the NSF’s policy is essentially identical to the former PHS policy.
3The Uniform Guidance applies to all federal agencies.
Topic: | Human Subjects Research |
Policy / Statute / Regulation(s): |
The Common Rule, codified at Protection of Human Subjects, 45 CFR 46 (2009).
FDA Regulations “Federal Policy for the Protection of Human Subjects,” Federal Register 80, no. 173 (September 8, 2015): 53933 |
Affected Parties: |
Institutional Researchers
Institutional Administrators Human Research Participants |
Actors: | Congress The 18 Federal Agencies Following the Common Rule4 |
Relevant Report Sections: | Part 1, Chapter 5 Part 2, Chapter 9 |
Recommended Actions: |
5.2. The committee recommends that Congress 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.
5.3. The committee recommends that Congress direct federal agencies following the Common Rule to require, for multisite research studies, that a single IRB with the necessary staff and infrastructure serve as the IRB of record for all domestic sites. 5.4. The committee recommends that Congress direct agencies, within a designated period of time, to align and harmonize their regulations (and definitions) concerning the protection of human subjects. 5.5. In instances of minimal-risk research where requiring informed consent would make the research impracticable, the committee recommends that Congress amend the FDA’s authority so as to allow the FDA to develop criteria for waiver or modification of the requirement of informed consent for minimal-risk research. 5.6. The committee recommends that Congress instruct HHS 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. |
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4These 18 agencies include: Departments of Agriculture, Defense, Education, Energy, Health & Human Services, Homeland Security, Housing & Urban Development, Justice, Transportation, Veterans Affairs, Consumer Product Safety Commission, Environmental Protection Agency, Agency for International Development, National Aeronautics & Space Administration, and the National Science Foundation.
9.1. The committee recommends that Congress authorize, and the President 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:
9.2. 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. |
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Topic: | Animal Research5 |
Policy / Statute / Regulation(s): | The Laboratory Animal Welfare Act. Pub. L. No. 89-544 (1966); Animal Welfare Act Amendments of 1976, 7 USC, 2131-2159 (1976); 9 CFR Chapter 1, subchapter A, part 2 (2016); Health Research Extension Act of 1985. Pub. L. No. 99-158 (1985); Plan for Use of Animals in Research, 42 USC § 283E (1999; and Animals in Research, 42 USC § 289D (2010) |
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5The policies and statutes listed here are just a sampling of the many that govern the use of animals in research. For a more complete listing of the statutes, policies, principles, agency directives, and reference manuals that govern the use of animals in research, see Table 5-1 on pages 107-109 on Part I of this report.
U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research and Training Public Health Service Policy on Humane Care and Use of Laboratory Animals |
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Affected Parties: |
Institutional Researchers
Institutional Administrators |
Actors: |
Congress
White House Office of Science and Technology Policy Federal Agencies Funding Animal Research Institutional Researchers Conducting Animal Research Research Institutions |
Relevant Report Section: | Part 1, Chapter 5 |
Recommended Actions: |
5.7. The committee recommends that Congress direct the White House Office of Science and Technology Policy 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.
5.8 The committee recommends that reporting, assurances, and verifications to agencies should be reduced and streamlined. Agencies should adjust their requirements for reporting 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 IACUC approval process, such as the Vertebrate Animal section of PHS grant applications and the DOD central administrative protocol review, should be eliminated. 5.9. The committee recommends that research institutions should 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. |
Topic: | Audits and Audit Climate |
Policy / Statute / Regulation(s): | Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance) |
Affected Parties: |
Inspectors General
Agency Heads Institutional Researchers Institutional Financial Officers |
Actors: |
Congress
Inspectors General Federal Agencies |
Relevant Report Section: | Part 1, Chapter 6 |
Recommended Actions: |
6.1. The committee recommends that Congress require inspectors general to:
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Topic: | Reporting of Compensation for Personnel Expenses |
Policy / Statute / Regulation(s): | Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance) |
Affected Parties: |
Institutional Researchers
Institutional Financial Officers |
Actors: |
Congress
White House Office of Management and Budget |
Relevant Report Section: | Part 1, Chapter 6 |
Recommended Action: | 6.2. The committee recommends that Congress and OMB affirm that research institutions may take advantage of the flexibility provided by the Uniform Guidance with regard to the documentation of personnel expenses. |
Topic: | Procurement Standards |
Policy / Statute / Regulation(s): | Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance) |
Affected Parties: |
Institutional Researchers
Institutional Financial Officers |
Actor: | White House Office of Management and Budget |
Relevant Report Section: | Part 1, Chapter 6 |
Recommended Action: |
6.3. The committee recommends that the White House Office of Management and Budget amend the Uniform Guidance as follows:
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Topic: | Financial Reporting |
Policy / Statute / Regulation(s): | Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance) |
Affected Parties: |
Institutional Researchers
Institutional Financial Officers |
Actor: | White House Office of Management and Budget |
Relevant Report Section: | Part 1, Chapter 6 |
Recommended Action: | 6.4. The committee recommends that White House Office of Management and Budget amend the Uniform Guidance to establish a mandatory 120 day timetable for the submission of all financial reports for all federal research funding agencies. |
Topic: | Cost Accounting Standards |
Policy / Statute / Regulation(s): | Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance) |
Affected Parties: |
Institutional Researchers
Institutional Financial Officers |
Actor: | White House Office of Management and Budget |
Relevant Report Section: | Part 1, Chapter 6 |
Recommended Action: | 6.5. The committee recommends that the White House Office of Management and Budget 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’ web sites. 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 F&A proposal. |
Topic: | Intellectual Property and Technology Transfer |
Policy / Statute / Regulation(s): | Reporting on Utilization of Subject Inventions, 37 CFR 401.8 |
Affected Parties: | Institutional Researchers Federal Agencies Funding Research |
Actors: | Congress National Institute of Standards and Technology |
Relevant Report Section: | Part 2, Chapter 10 |
Recommended Actions: |
The committee recommends that Congress:
10.1 Congress transfer responsibility for the operation of the invention report system (currently iEdison) to the Department of Commerce 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. 10.2 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. 10.3. Authorize the Department of Commerce to require that the invention data reporting obligations imposed on recipients of federal funding by all agencies are aligned with agreed upon reporting requirements. |
Topic: | Select Agents and Toxins and Dual-Use Research of Concern |
Policy / Statute / Regulation(s): |
Possession, 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) Select Agents and Toxins, 42 CFR 73 (2005) |
Affected Parties: |
Institutional Researchers
Federal Agencies Funding Research |
Actors: |
Executive Branch
Federal Select Agent Program Federal Agencies Funding Research |
Relevant Report Section: | Part 2, Chapter 11 |
Recommended Actions: |
11.1. The committee recommends that the President assign the responsibility for regulating all microbes and toxins on the select agents and toxins list to a single agency.6 11.2. The committee recommends that the Federal Select Agent Program 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. 11.3. The committee recommends that the regulations7 governing select agents and toxins be amended to:
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Topic: | Export Controls |
Policy / Statute / Regulation(s): | Export Control Reform Initiative |
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6The 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.
7Possession, 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).
Affected Parties: |
Institutional Researchers
Department of Commerce Department of State |
Actors: | Congress Executive Branch |
Relevant Report Section: | Part 2, Chapter 12 |
Recommended Actions: |
12.1. The committee recommends that Congress and the Administration 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 five years could help participants in the process accelerate the rate at which needed regulatory revisions are proposed and adopted.
12.2. The committee recommends that the Export Control Reform Initiative seek university input at all stages of the process. The Research Policy Board proposed in Part 1 of this committee’s report would be an ideal vehicle for providing such input. 12.3. The committee recommends that the Export Control Reform Initiative work closely with universities and other stakeholders to specifically address the deemed export provisions8 and vigorously support the spirit and letter of the fundamental research exclusion. |
Topic: | Regulatory Framework |
Policy / Statute / Regulation(s): | Requires New Legislation / Executive Action |
Affected Parties: | Office of Information and Regulatory Affairs, White House Office of Management and Budget White House Office of Science and Technology Policy |
Actor: | Congress |
Relevant Report Section: | Part 1, Chapter 7 |
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8As 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: U.S. Department of Commerce, 2007)].
Recommended Action: |
7.1. 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 regulations of similar purposes across agencies.
Specifically, the committee recommends that Congress take the following actions:
7.2. The committee recommends that participants in the government-academic research partnership adopt the…set of operational principles [articulated on pp. 14-15 of this report] as a part of the new regulatory framework for federally funded academic research. The committee recommends that research institutions 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 (see Chapter 7). The committee recommends that research institutions revise self-imposed burdensome institutional policies that go beyond those necessary and sufficient to comply with federal, state, and local requirements (see Chapter 7). |
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