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A new report suggests a need to change regulations for federally funded research in the US.
According to the report, the current regulatory burden is diminishing the effectiveness of the US scientific enterprise and lowering the return on
the federal investment in research by directing investigators’ time away from research and toward administrative matters.
The report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century: Part 1 (2015), was
compiled by the National Academies of Sciences, Engineering, and Medicine.
“Federal regulations and reporting requirements, which began as a way to exercise responsible oversight, have increased dramatically in recent
decades and are now unduly encumbering the very research enterprise they were intended to facilitate,” said Larry Faulkner, chair of the committee that conducted the study and wrote the report, and president emeritus of the University of Texas, Austin.
“A significant amount of investigators’ time is now spent complying with regulations, taking valuable time from research, teaching, and scholarship.”
The report lists specific actions the government and research institutions should take to reduce the regulatory burden.
New framework needed
The report says a new framework is needed to approach regulation in a holistic, rather than piecemeal, way. Regulatory requirements should be harmonized across funding agencies, and we need a more effective and efficient partnership between funding agencies and research institutions.
Congress should create a Research Policy Board to serve as a public-private forum for discussions related to regulation of federally funded research programs. The board should be a government-enabled, private-sector entity that will foster more effective conception, development, and synchronization of research policies.
The board should be formally connected to government through a new associate director position at the White House Office of Science and Technology Policy (OSTP) and through the Office of Information and Regulatory Affairs at the White House Office of Management and Budget (OMB).
Strengthening the research partnership also requires that universities demand the highest standards in institutional and individual behavior, foster a culture of integrity, and mete out appropriate sanctions when behavior deviates from ethical and professional norms, the report says.
The Research Policy Board should collaborate with research institutions to develop a policy that holds universities accountable, sanctioning institutions that fail to enforce standards.
The report also recommends a number of specific actions—a sample of which are listed below—that are intended to improve the efficiency of federal regulation and reduce duplication.
Congress should:
- Work with OMB to conduct a review of agency research grant proposal documents for the purpose of developing a uniform format to be used by all funding agencies
- Work with OSTP and research institutions to develop a single financial conflict-of-interest policy to be used by all research funding agencies
- Task a single agency with overseeing and unifying efforts to develop a central database of investigators and their professional output
- Direct agencies to align and harmonize their regulations and definitions concerning the protection of human subjects
- Instruct OSTP to convene representatives from federal agencies that fund animal research and from the research community to assess and report back to Congress on the feasibility and usefulness of a unified federal approach to policies and regulations pertaining to the care and use of research animals.
The White House OMB should:
- Require that research funding agencies use a uniform format for research progress reporting
- Amend the new Uniform Guidance to improve the efficiency and consistency of procurement standards, financial reporting, and cost accounting.
Federal agencies should:
- Limit research proposals to the minimum 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 investigator to carry out that research. Any supplementary information—internal review board approval, conflict-of-interest disclosures, detailed budgets, etc.—should be provided “just in time,” after the research proposal is deemed likely to be funded
- Reduce and streamline reporting, assurances, and verifications. Agencies should also develop a central repository to house assurances.
Universities should:
- 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
- Revise self-imposed burdensome institutional policies that go beyond those necessary and sufficient to comply with federal, state, and local requirements.
The release of the report completes the first phase of the committee’s study, which was expedited at the request of Congress.
The committee will now continue its assessment and issue a spring 2016 addendum report addressing issues it has been unable to address in the first phase. 
Photo by Daniel Sone
A new report suggests a need to change regulations for federally funded research in the US.
According to the report, the current regulatory burden is diminishing the effectiveness of the US scientific enterprise and lowering the return on
the federal investment in research by directing investigators’ time away from research and toward administrative matters.
The report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century: Part 1 (2015), was
compiled by the National Academies of Sciences, Engineering, and Medicine.
“Federal regulations and reporting requirements, which began as a way to exercise responsible oversight, have increased dramatically in recent
decades and are now unduly encumbering the very research enterprise they were intended to facilitate,” said Larry Faulkner, chair of the committee that conducted the study and wrote the report, and president emeritus of the University of Texas, Austin.
“A significant amount of investigators’ time is now spent complying with regulations, taking valuable time from research, teaching, and scholarship.”
The report lists specific actions the government and research institutions should take to reduce the regulatory burden.
New framework needed
The report says a new framework is needed to approach regulation in a holistic, rather than piecemeal, way. Regulatory requirements should be harmonized across funding agencies, and we need a more effective and efficient partnership between funding agencies and research institutions.
Congress should create a Research Policy Board to serve as a public-private forum for discussions related to regulation of federally funded research programs. The board should be a government-enabled, private-sector entity that will foster more effective conception, development, and synchronization of research policies.
The board should be formally connected to government through a new associate director position at the White House Office of Science and Technology Policy (OSTP) and through the Office of Information and Regulatory Affairs at the White House Office of Management and Budget (OMB).
Strengthening the research partnership also requires that universities demand the highest standards in institutional and individual behavior, foster a culture of integrity, and mete out appropriate sanctions when behavior deviates from ethical and professional norms, the report says.
The Research Policy Board should collaborate with research institutions to develop a policy that holds universities accountable, sanctioning institutions that fail to enforce standards.
The report also recommends a number of specific actions—a sample of which are listed below—that are intended to improve the efficiency of federal regulation and reduce duplication.
Congress should:
- Work with OMB to conduct a review of agency research grant proposal documents for the purpose of developing a uniform format to be used by all funding agencies
- Work with OSTP and research institutions to develop a single financial conflict-of-interest policy to be used by all research funding agencies
- Task a single agency with overseeing and unifying efforts to develop a central database of investigators and their professional output
- Direct agencies to align and harmonize their regulations and definitions concerning the protection of human subjects
- Instruct OSTP to convene representatives from federal agencies that fund animal research and from the research community to assess and report back to Congress on the feasibility and usefulness of a unified federal approach to policies and regulations pertaining to the care and use of research animals.
The White House OMB should:
- Require that research funding agencies use a uniform format for research progress reporting
- Amend the new Uniform Guidance to improve the efficiency and consistency of procurement standards, financial reporting, and cost accounting.
Federal agencies should:
- Limit research proposals to the minimum 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 investigator to carry out that research. Any supplementary information—internal review board approval, conflict-of-interest disclosures, detailed budgets, etc.—should be provided “just in time,” after the research proposal is deemed likely to be funded
- Reduce and streamline reporting, assurances, and verifications. Agencies should also develop a central repository to house assurances.
Universities should:
- 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
- Revise self-imposed burdensome institutional policies that go beyond those necessary and sufficient to comply with federal, state, and local requirements.
The release of the report completes the first phase of the committee’s study, which was expedited at the request of Congress.
The committee will now continue its assessment and issue a spring 2016 addendum report addressing issues it has been unable to address in the first phase.
Photo by Daniel Sone
A new report suggests a need to change regulations for federally funded research in the US.
According to the report, the current regulatory burden is diminishing the effectiveness of the US scientific enterprise and lowering the return on
the federal investment in research by directing investigators’ time away from research and toward administrative matters.
The report, Optimizing the Nation’s Investment in Academic Research: A New Regulatory Framework for the 21st Century: Part 1 (2015), was
compiled by the National Academies of Sciences, Engineering, and Medicine.
“Federal regulations and reporting requirements, which began as a way to exercise responsible oversight, have increased dramatically in recent
decades and are now unduly encumbering the very research enterprise they were intended to facilitate,” said Larry Faulkner, chair of the committee that conducted the study and wrote the report, and president emeritus of the University of Texas, Austin.
“A significant amount of investigators’ time is now spent complying with regulations, taking valuable time from research, teaching, and scholarship.”
The report lists specific actions the government and research institutions should take to reduce the regulatory burden.
New framework needed
The report says a new framework is needed to approach regulation in a holistic, rather than piecemeal, way. Regulatory requirements should be harmonized across funding agencies, and we need a more effective and efficient partnership between funding agencies and research institutions.
Congress should create a Research Policy Board to serve as a public-private forum for discussions related to regulation of federally funded research programs. The board should be a government-enabled, private-sector entity that will foster more effective conception, development, and synchronization of research policies.
The board should be formally connected to government through a new associate director position at the White House Office of Science and Technology Policy (OSTP) and through the Office of Information and Regulatory Affairs at the White House Office of Management and Budget (OMB).
Strengthening the research partnership also requires that universities demand the highest standards in institutional and individual behavior, foster a culture of integrity, and mete out appropriate sanctions when behavior deviates from ethical and professional norms, the report says.
The Research Policy Board should collaborate with research institutions to develop a policy that holds universities accountable, sanctioning institutions that fail to enforce standards.
The report also recommends a number of specific actions—a sample of which are listed below—that are intended to improve the efficiency of federal regulation and reduce duplication.
Congress should:
- Work with OMB to conduct a review of agency research grant proposal documents for the purpose of developing a uniform format to be used by all funding agencies
- Work with OSTP and research institutions to develop a single financial conflict-of-interest policy to be used by all research funding agencies
- Task a single agency with overseeing and unifying efforts to develop a central database of investigators and their professional output
- Direct agencies to align and harmonize their regulations and definitions concerning the protection of human subjects
- Instruct OSTP to convene representatives from federal agencies that fund animal research and from the research community to assess and report back to Congress on the feasibility and usefulness of a unified federal approach to policies and regulations pertaining to the care and use of research animals.
The White House OMB should:
- Require that research funding agencies use a uniform format for research progress reporting
- Amend the new Uniform Guidance to improve the efficiency and consistency of procurement standards, financial reporting, and cost accounting.
Federal agencies should:
- Limit research proposals to the minimum 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 investigator to carry out that research. Any supplementary information—internal review board approval, conflict-of-interest disclosures, detailed budgets, etc.—should be provided “just in time,” after the research proposal is deemed likely to be funded
- Reduce and streamline reporting, assurances, and verifications. Agencies should also develop a central repository to house assurances.
Universities should:
- 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
- Revise self-imposed burdensome institutional policies that go beyond those necessary and sufficient to comply with federal, state, and local requirements.
The release of the report completes the first phase of the committee’s study, which was expedited at the request of Congress.
The committee will now continue its assessment and issue a spring 2016 addendum report addressing issues it has been unable to address in the first phase.