Simplifying Research Regulations and Policies: Optimizing American Science (2025)
Chapter: 2 Options to Optimize the Research Enterprise
2
Options to Optimize the Research Enterprise
Despite the challenges to achieve greater regulatory efficiency outlined in Chapter 1, the time and environment are right to modify current administrative and regulatory policies to better ensure that the research community is maximally productive while simultaneously maintaining the safety, accountability, security, and ethical conduct of publicly funded research. Because there are many routes to accomplish these goals, the committee is presenting a menu of options for consideration in each area. The options the committee presents in this report offer multiple potential solutions to each problem, and policymakers can choose the approach they determine is best suited to their needs. The committee also acknowledges that the options presented here come at a time when the federal workforce is downsizing. While these options aim to reduce workload, many do incur upfront costs in time and other resources. However, these upfront investments, if implemented with intention, would ultimately reduce administrative workload for researchers and hopefully for federal agencies as well.
This chapter is divided into topical areas for categories of research policies that need to be addressed, and adopting any of the options presented in each section would make research more productive. Each topical area in this chapter can be read independent of the others, and common themes arise in the approaches presented in the options across different topical areas. There are many options presented in this chapter, and the committee does not place them in any order of preference. Instead, those looking to implement solutions to the problems outlined should consider the right
approach from the options presented. To inform decisions, the committee provides pros and cons for each option and potential timelines for implementation wherever applicable.
A NEW APPROACH TO RESEARCH REGULATIONS AND REQUIREMENTS
Historically, different federal agencies, each with its own mission, have supported a robust and world-leading U.S. scientific enterprise, creating a strong foundation of scientific knowledge and spurring technological innovation that has underpinned U.S. economic prosperity and national security. At the same time, this approach has led to a growing administrative burden, as Chapter 1 discussed. Solving the administrative challenges a researcher faces while navigating a decentralized U.S. research enterprise will require streamlining processes, establishing new coordinating functions, and regularly updating policies, requirements, guidance, and processes. Progress will require a new mindset from research funders and institutions, trust among the parties that everyone is acting in good faith toward a common good, and ongoing assessment of regulatory workload as changes are implemented.
Change should be made deliberately and thoughtfully, taking great care to not harm the U.S. research and innovation enterprise irreparably. Many of the options the report presents draw from those suggested by previous groups, and those groups have put significant and thoughtful analysis into them. At the same time, change is challenging to implement and has unintended consequences. It is important to acknowledge and address this whenever possible with utmost attention to preserving the strength of the U.S. research enterprise.
In developing the options for action, the committee found the same types of issues occurring in multiple oversight and regulatory areas. Although implementing any of the options within an area will lead to progress, three overarching principles should guide future decision-making. These principles, reflected in the 53 options presented in this chapter, represent a framework for developing additional options in the future.
- Harmonize regulations and requirements across federal and state agencies and research institutions. The U.S. government should reduce administrative workload for the researchers it supports by harmonizing policies to the greatest extent possible across
- all agencies. This may at times require compromising in the name of harmonization on the type, specificity, and format of information that a given agency requests. For example, a researcher should be able to prepare one standardized biographical statement for any federal grant proposal without deviation, with the same information required for all agency sponsors, and submit their application through one federal platform, such as the Science Experts Network Curriculum Vitae (SciENcv) system that the National Institutes of Health (NIH) hosts. When implementing a new regulation or requirement, it is important to consider whether any incremental gain in oversight that one agency might realize outweighs the cumulative costs to the U.S. research enterprise.
Federal requirements are not the sole source of increased burdens on researchers. Some states regulate research beyond what federal agencies require, which can create confusion and duplicative and additional requirements that may even conflict with federal requirements. Similarly, academic research institutions at times add unnecessary administrative work by implementing policies and procedures that go beyond the compliance requirements set by federal agencies. Along with necessary harmonization efforts at the federal level, states and institutions can also help reduce administrative burdens by harmonizing their policies and procedures to more closely adhere to federal requirements and not adopting additional compliance obligations. Coordinated community-based resources—such as those being developed by the research community via the U.S. National Science Foundation (NSF)-backed Safeguarding the Entire Community in the U.S. Research Ecosystem (SECURE) Center to address research security or the Compliance Unit Standard Procedures online repository for best practices in animal care and welfare—can help harmonize and enhance the quality of policies, procedures, guidance, and resources across the regulated community.
- Take an approach tiered to the risks involved when considering a new regulation or requirement. Regulatory requirements need to be sufficient to ensure the safety of human research participants, the public, and those conducting the research; safeguard the fiscal integrity of federally funded research; ensure the appropriate care of research animals; and protect intellectual property and national security. At the same time, they should be calibrated to
- the level of risk arising from noncompliance. Taking an approach to compliance that is tiered to risk—where the rigor of regulatory requirements aligns with the level of risk of an activity to society or regulatory objectives—can minimize the impact of federal requirements on researcher workload. State governments can also reduce regulatory requirements by taking a risk-tiered approach to research regulations and by being aware of U.S. government requirements.
Heavy workloads around research administration are largely a result of important efforts to manage risks, which include financial, reputational, and legal risks for institutions, safety and security issues, and ethics. While it is up to institutions to navigate risk management appropriately and ensure compliance with even low-risk work, agencies can help reduce administrative workload by allowing tolerances around smaller financial transactions and exempting research activities that present lower safety, security, or ethical risk from oversight, for example. Streamlining, rolling back, or reaching new compromises around consistent processes will likely mean that certain risks are managed differently or to a lesser degree than they are presently. However, processes that slow research and innovation unnecessarily are themselves a risk to the scientific enterprise and need to be reined in to better realize the benefits of the research enterprise.
In developing appropriate risk-tiering systems or models, government actors have multiple models to consider for the best approach, including those that already exist in the realm of scientific research. For example, Institutional Review Board (IRB) review of human subjects research is separated into three categories—exempt, expedited, and full review—with different requirements and levels of review based on potential risk to participants. The U.S. Environmental Protection Agency also relies on environmental risk assessments to understand and categorize human health and ecological risks of potential stressors through a scientific process that considers the amount of a stressor present, the exposure, and the effect (EPA, 2025). In addition, the government can look to examples in the financial industry and others that frequently model and tier risk and rely upon tools such as scorecards and decision trees to accomplish this (Kiritz et al.,
- 2019). Once tiered, consistent review is also needed to ensure no new information warrants a reassessment of risk.
- Use technology to simplify the process of complying with regulations and requirements to the greatest extent possible. Available technology that leverages artificial intelligence (AI) and machine learning can automate and may simplify regulatory compliance processes. By automating repetitive tasks, using cross-agency databases, and providing real-time data analysis through platforms like NSF SECURE, technology can minimize the risk of human error and ensure that compliance processes are both thorough and efficient. To ensure these efforts do not create burden in an attempt to reduce it, it is imperative to standardize requirements and implement appropriate safeguards for the use of technology and to ensure these tools are used ethically and are accessible to all who need them.
These three overarching principles are important guides for future decision-making. They will help realize the goal of reducing the burden of complying with the regulations and requirements while ensuring the safety, integrity, and efficiency of the U.S. research enterprise. To implement these principles, the committee suggests closely reviewing the options presented in the next section (System-Wide Change), which would allow for continuous monitoring of regulations and requirements across federal agencies to sustain a research ecosystem that is not overly burdensome.
SYSTEM-WIDE CHANGE
The following sections present key problems, and for each problem, the committee provides options with varying pros and cons. This first section addresses issues that cut across multiple domains. However, the sections that follow focus on specific regulatory areas and detail the key problems for researcher workload in each domain.
Problem: Insufficiently centralized U.S. government oversight of the regulatory environment has led to too many overly complex, duplicative, and occasionally contradictory regulations, requirements, and reporting processes across federal agencies.
Many agencies fund scientific research in the United States, enabling the government to support a broad spectrum of mission-specific funding and security postures. At the same time, this multiagency approach has resulted in tremendous variability in systems, policies, and processes across agencies. While some of this variance can be mission specific, much of it results from a lack of intentionality and harmonization in the absence of coordinating activities. Furthermore, in efforts to address research security, agencies such as the U.S. Department of Energy (DOE) and U.S. Department of Defense (DOD) have skirted oversight by the Office of Management and Budget’s (OMB’s) Office of Information and Regulatory Affairs (OIRA) by issuing internal policies that imposed criteria for assessing security risks resulting from potential conflicts driven by foreign talent recruitment programs (COGR, 2019; Crowell & Moring LLP, 2023). While well intentioned, the lack of oversight through typical OIRA processes prevents community feedback and the opportunity to streamline and harmonize new requirements.
A few coordinating bodies do exist that can enable a greater degree of harmonization across agencies. One such body is the National Science and Technology Council (NSTC), established by Executive Order (EO) 12881 in November 1993.1 The NSTC consists of cabinet members and agency heads and is led by the assistant to the president for science and technology at the president’s discretion. One of NSTC’s functions is to coordinate the science and technology policymaking process across agencies. According to the EO, the council may function through established or ad hoc committees, task forces, or interagency groups. In the area of research security, the NSTC interagency coordinating function led to the development of National Security Presidential Memorandum-33 (NSPM-33)2 and the subsequent development of implementation guidance and common definitions, along with the Common Current and Pending Support and Biosketch Forms and Research Security Program requirements. Federal agencies have continued to coordinate on implementing these measures outside of the NSTC process, working from the foundation laid there.
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1 Exec. Order No. 12881, Establishment of the National Science and Technology Council, C.F.R., title 3 (1993): 2450–2451. https://www.govinfo.gov/content/pkg/WCPD-1993-11-29/pdf/WCPD-1993-11-29-Pg2450.pdf.
2 National Security. Presidential Memorandum No. 33, United States Government-Supported Research & Development National Security Policy (Jan. 14, 2021). https://trumpwhitehouse.archives.gov/presidential-actions/presidential-memorandum-united-states-government-supported-research-development-national-security-policy/.
| Option 1: Establish a permanent function within the Office of Management and Budget (OMB) with the authority to coordinate cross-agency requirements | |
| Goal: To ensure strong leadership and strategic focus, establish a permanent career role in OMB that is charged with coordinating cross-agency requirements that affect federally funded academic research and has the authority to ensure agency coordination. |
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| Approach: OMB could create a permanent assistant director for institutional research coordination and community engagement position to collaborate with the Office of Information and Regulatory Affairs (OIRA) and the Office of Science and Technology Policy, and use the National Science and Technology Council to institute harmonization. This individual, a nonpolitical appointee, would serve as a resource that members of the research enterprise would turn to for assistance when inconsistencies arise or are anticipated between different funders or regulatory programs. The role would include overseeing the development of policies and requirements and how agencies implement them and identifying means to accelerate agency implementation when necessary. |
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| Option 2: Appoint a Federal Research Policy Board | |
| Goal: Increase harmonization across federal agencies. The committee sees value in having a board dedicated to facilitating agency coordination and reducing federally imposed administrative work rather than the current widespread practice of having each agency develop its own approach to regulatory compliance. |
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| Approach: One key recommendation from the National Academies’ 2016 reporta was for Congress to establish a Research Policy Board composed of representatives from federal funding agencies and academic research institutions to “make recommendations concerning the conception, development, and harmonization of policies having similar purposes across research funding agencies.” The year the report was released, Congress passed legislation through the 21st Century Cures Actb that required OMB to set up a Research Policy Board no more than a year after enactment. However, OMB never established the Research Policy Board, and congressional authority for the board ended on September 21, 2021. Congress can reauthorize the creation of a Research Policy Board within OIRA, granting it similar composition and authorities to those outlined in the 21st Century Cures Act. |
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| Option 3: Use the Federal Demonstration Partnership (FDP) to explore innovative ideas and practices through pilot programs | |
| Goal: Establish low-risk processes for testing innovative approaches to increase harmonization and use of approaches that are tiered to risk. |
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| Approach: FDP is “an association of federal agencies, research policy organizations, and academic research institutions with administrative, faculty, and technical representation.”c FDP has a track record of successfully implementing processes that improve regulatory efficiency and reduce administrative workload.d Its purpose is to streamline the administration of federally funded research grants and to do so through demonstration projects, where FDP identifies, tests, and advances new directions and practices. For example, guided by an interagency working group, FDP collaborated with the National Center for Biotechnology Information at the National Institutes of Health to build the Science Experts Network Curriculum Vitae (SciENcv) system to reduce the work required to develop biosketches for grant proposals.e As agencies develop new models and innovative approaches, they could work directly with FDP to test and refine these tools before formally launching them. This is currently taking place with a flexible risk-tiered approach to cybersecurity being developed cooperatively between federal agencies, research institutions, and faculty representatives via the FDP to meet federal research security program requirements. Piloted approaches to implementing new requirements can be evaluated and modified prior to broader implementation. |
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a National Academies of Sciences, Engineering, and Medicine. 2016. Optimizing the nation’s investment in academic research: A new regulatory framework for the 21st century. Washington, DC: The National Academies Press.
b 21st Century Cures Act, Public Law 114-255, 130 Stat. 1033 (December 13, 2016).
c FDP (Federal Demonstration Partnership). n.d. Who we are. https://thefdp.org/ (accessed July 11, 2025).
d FDP. 2025. Organization history. https://thefdp.org/organization/history/#tab-id-2 (accessed July 11, 2025).
e NIH (National Institutes of Health). 2025. SciENcv background. https://www.ncbi.nlm.nih.gov/sciencv/background/?hss_channel=lcp-9398777 (accessed August 11, 2025).
Given the broad reach of the federal regulatory environment and the vast number of regulations that affect researchers,3 the committee chose to focus on areas where regulatory reform could have the biggest effect on reducing the burden on the nation’s research community. The following sections identify specific problem areas and offer options to address those areas along with the pros and cons of each option where appropriate.
REGULATORY AREA 1: GRANT PROPOSALS AND MANAGEMENT
Virtually every federal funding agency has its own set of requirements for submitting a research proposal. In addition, multiple grant submission portals exist, each requiring administrators and researchers to meet varying conditions, learn different systems, and keep current with agency-specific system requirements (COGR, 2025a). Then, once an investigator receives a research grant, each federal research agency requires different, often redundant reporting requirements for disclosing inventions throughout the lifetime of an award, filing progress reports, and detailing how funds were spent. Each agency also has its own closeout requirements at the end of the award lifecycle.
There has been some progress over time addressing these problems. For example, in response to the Uniform Guidance4,5 issued by OMB in December 2013, federal funding agencies began efforts to harmonize Notices of Funding Opportunities (NOFOs) and address the fact that federal agencies had developed different acronyms and formats to make funding announcements, such as Funding Opportunity Announcements, Requests for Applications, and Parent Announcements, which made it difficult for institutions to track and apply for these opportunities. The switch to NOFOs has eliminated confusion and a source of additional workload for research universities who notify their faculty of funding opportunities. The Grant Reporting Efficiency and Agreements Transparency Act of
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3 As part of its information gathering, the committee published a request for information seeking input from the research community on regulations that could be improved. The feedback ranged from requirements affecting a large number of researchers (like grant application processes) to regulations affecting a relatively small number of researchers (such as regulating zebrafish larvae).
4 Uniform Guidance refers to the set of federal regulations that govern the administration of federal grants and cooperative agreements.
5 Federal Financial Assistance, 2 C.F.R. Part 200 (April 22, 2024).
20196 sought to streamline federal grant reporting, but according to an analysis by the U.S. Government Accountability Office, OMB and the U.S. Department of Health and Human Services (HHS) have only partially met a statutory requirement to establish government-wide data standards for information reported by grant recipients and have not met the statutory requirement to jointly issue guidance to all agencies directing them to apply the data standards (GAO, 2024).
As the Council on Governmental Relations (COGR) and other professional associations have suggested, a single whole-of-government application process can eliminate the need for a large amount of duplicative, burdensome reporting requirements for researchers. The federal government can improve upon the compliance capabilities of existing databases such as SAM.gov (the government system for contracting, grants, loans, and other financial assistance), Research.gov (proposal and grant system for NSF awards), and ORCID.org (used to link funding and publication outputs to researcher identities) to facilitate development of a single whole-of-government portal (COGR, 2025a).
Instead of compounding training requirements for U.S. researchers, agencies could develop a unified set of skills and competencies across researchers and institutions and with adaptability for field- or method-specific needs. The government can also leverage a just-in-time approach, requesting additional action regarding training at the time of award. In addition, the committee offers the following pre- and post-award process structures to yield a more seamless experience between the government and the researcher.
In the pre-award stage, changes could include
- introducing a two-stage process to reduce time and effort for the initial submission;
- establishing a single portal as recommended by COGR; or
- reorganizing or reviewing the requirements to remove redundancy, prioritize consistency, and reduce researcher administrative workload (NASEM, 2016).
Currently, the process for reviewing and approving each agency’s application form and progress report form falls under the Paperwork Reduction
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6 Grant Reporting Efficiency and Agreements Transparency Act of 2019, H.R. 150, 116th Congress (June 6, 2019).
Act,7 which was amended most recently in 1995 to reduce the burden of government information collections on the American public. Under the act and its implementing regulations,8 agencies must submit any collection of information that applies to 10 or more individuals for public comment and for approval by OIRA. For any continuing collection, such as with grant applications and progress reports, agencies must renew this approval every 3 years, and at each renewal the agency must solicit public comment and submit the application to OIRA for approval.
The 2016 National Academies of Sciences, Engineering, and Medicine report noted that agency submissions to OIRA for grant applications and other information collections associated with required recordkeeping for grants were inconsistent and varied widely by federal agency, potentially underestimating the burden on universities to comply with different required submissions (NASEM, 2016). OIRA could use the authority granted to it through the Paperwork Reduction Act to encourage federal agencies to centralize and harmonize grant application and reporting requirements.
The committee provides options for a two-stage award process, harmonization across agencies, reduction of duplicative efforts, updated requirements, and clearer notifications of policy changes to address these issues.
Problem: Inconsistent, complex, and burdensome grant processes across federal agencies.
Current grant application processes differ widely across funding agencies, with agencies requesting information that varies in specificity, timelines, and length in initial grant proposals. While systems such as Grants.gov, for example, may provide a clearinghouse for funding announcements across the federal government, allowing for a single portal for submission, notice of policy changes, and submission of reporting requirements, other grant management systems require researchers and administrative officers to interface with platforms that are often disconnected, increasing time spent on submission and compliance. Onerous and disjointed research grant processes have increased the time individual researchers and institutional pre- and post-award staff must spend on administrative actions to satisfy
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7 Paperwork Reduction Act of 1980, H.R. 6410, 96th Congress (December 11, 1980).
8 Controlling Paperwork Burdens on the Public, 5 C.F.R. Part 320 (August 29, 2005).
TABLE 2-2 Options to Address the Burdensome Grant Processes (Regulatory Area 1)
| Option 1.1: Introduce a federal-wide, two-stage pre-award process | |
| Goal: This option would improve the efficiency of the pre-award process and harmonize the grant application process across funding agencies. |
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| Approach: To reduce the time spent by researchers on proposal preparation and submission, agencies could operationalize a common “letter of intent” (LOI) mechanism across funding opportunities that applies to single and multisite research, centers, instrumentation, training, and other grant mechanisms deemed appropriate by agency officials. LOIs could consist of five- to seven-page proposals focused on scientific merit, similar to the LOIs the U.S. National Science Foundation (NSF) uses. Subject-specific review panels would evaluate the LOIs to assess the merit of the proposed research. To ensure consistency across federal agencies, the Office of Information and Regulatory Affairs (OIRA) could review LOI proposal templates to reduce redundancies and harmonize formats, potentially through collaborative work with the Federal Demonstration Partnership. Researchers who submitted LOIs deemed high quality per the recommendation of the subject-specific review panel and identified as likely to be recommended for funding would then be invited to submit full-length proposals with detailed budget justifications and additional scientific detail, publication history, and other required documents to satisfy statutory and legal requirements. The expanded proposals would then undergo a final review to identify the most meritorious projects for final funding decisions. |
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| Option 1.2: Harmonize application and reporting systems including leveraging artificial intelligence (AI)–enabled tools | |
| Goal: Develop a single platform to minimize redundancy and leverage innovation to automate information gathering for reporting and generate common information needs for funding agencies. |
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Approach: All funding agencies could leverage and expand their use of existing platforms such as Research.gov, which is used by NSF; the Open Researcher and Contributor ID; and Science Experts Network Curriculum Vitae (SciENcv) system. Federal agencies could also use standard reporting formats consistent with the requested information on research goals, outcomes, societal benefits, and resources used. Developing and implementing machine-readable form standards across federal agencies, providing access to AI tools to institutions, and integrating AI into grant applications and reporting systems, with appropriate safeguards and policies, would enable AI to parse and automate grant materials. |
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| Option 1.3: Prioritize the reduction of duplication and unnecessary burden in the research enterprise in OIRA review of research agency information collections under the Paperwork Reduction Acta | |
| Goal: Use existing authority to require harmonization of grant application and reporting requirements across federal agencies. |
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| Approach: Given that agencies must resubmit their information collections to OIRA every 3 years, and that when submitted, the Office of Management and Budget (OMB) has a 30-day public comment period on the information collection, entities affected by these collections could submit public comments to the respective agency conducting information collections and OIRA about agency burden estimates and duplications across agencies. In response to these comments, OIRA could require that agencies respond before approval. OIRA could also condition approval of reporting and recordkeeping requirements on agency changes to the forms that would reduce burden and eliminate duplication. |
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| Option 1.4: Update cost accounting and financial compliance requirements | |
| Goal: Modernize existing overly complicated cost accounting and compliance requirements while maintaining adequate financial reporting. |
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| Approach: The 2016 report recommended that OMB update and amend the Uniform Guidance,d in consultation with research institutions, to eliminate institutional expectation for filing financial disclosure statements at every transaction in favor of periodic updates on a pre-determined schedule. Federal audit agencies could give due consideration to pre-existing commercial and university recordkeeping systems and generally accepted accounting principles to determine whether they can provide the government with the assurance it requires. In addition, OMB could propose a centralized disclosure system that satisfies financial reporting requirements across multiple grants and agencies. |
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| Option 1.5: Update SAM.gov with notifications when policy changes are made that impact award requirements | |
| Goal: Reduce confusion for grant managers and investigators and increase timely compliance with federal grant requirements. |
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Approach: As policies and regulations change, federal agencies update requirements for compliance in Grants.gov. However, it is difficult for grant managers and investigators to keep up with grant management requirements and their changes across federal agencies. To streamline registration and renewal processes, the General Services Administration could update the login and notification system in SAM.gov to facilitate a more user-friendly interface for major updates on policies and how they affect awards on an annual basis. |
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a Paperwork Reduction Act of 1980, H.R. 6410, 96th Congress (December 11, 1980).
b Rudalevige, A. 2018. Regulation beyond structure and process. National Affairs. https://www.nationalaffairs.com/publications/detail/regulation-beyond-structure-and-process (accessed July 2, 2025).
c ACUS (Administrative Conference of the United States). n.d. Improving the efficiency of the Paperwork Reduction Act. https://www.nationalaffairs.com/publications/detail/regulation-beyond-structure-and-process (accessed July 2, 2025).
d Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards, 89 Fed. Reg. 99695 (December 12, 2024).
often redundant requirements across funding sources, diverting time and resources from pursuing additional funding and conducting research. Researchers and institutions have to spend unnecessary resources and time addressing requirements that do not directly improve research quality or integrity. Lengthy grant submissions are especially challenging for researchers in an environment where success rates are low. In 2024, only 20 percent of NIH proposals were funded (NIH OER, 2024) and 26 percent of NSF proposals (NSF, 2025).
REGULATORY AREA 2: RESEARCH MISCONDUCT
The 2000 revision of the Federal Research Misconduct Policy9 establishes that federal agencies have authority over research misconduct, while research institutions bear the responsibility for preventing and detecting it. This policy defines research misconduct as falsification, fabrication, and plagiarism in proposing, performing, or reviewing research, or in reporting research results. Such oversight is vital to ensuring accurate and ethical conduct of federally funded research and maintaining trust with the public, policymakers, and the broader scientific community.
The committee found, however, that current regulations create challenges that do not further these important goals as effectively or efficiently as they could. When the Federal Research Misconduct Policy was revised in December 2000, many comments were received about ensuring uniform implementation of the policy across agencies (ORI, 2000). The reality of implementation, however, has not resulted in uniformity.
While some agencies rely entirely on the Federal Research Misconduct Policy, others have created their own detailed procedures (VA and VHA, 2017). The U.S. Department of Veterans Affairs (VA) Directive 1058.02, for example, has become increasingly detailed over time, losing much of the flexibility the Federal Research Misconduct Policy incorporates (Defino, 2025).
Agency variation can also result in inconsistency and differing standards for responding to misconduct. To modernize the existing research misconduct rule and provide better oversight, the HHS Office of Research Integrity (ORI) issued a “Final Rule” in 2024 that updated regulations established in 2005 (42 CFR Part 93; ORI, 2024). This update modern-
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9 Executive Office of the President, Office of Science and Technology Policy, Federal Policy on Research Misconduct; Preamble for Research Misconduct Policy, 65 Fed. Reg. 76260 (October 14, 1999).
ized definitions and procedures related to plagiarism and fabrication and falsification of data, streamlined certain parts of the investigatory process, and introduced new timelines and record-keeping standards. The Final Rule also aims to increase transparency by tasking institutions with maintaining detailed records of incidents of misconduct, submitting compliance reports by 2025, and prioritizing training and institutional accountability for ensuring reproducibility. ORI’s Final Rule, however, currently pertains only to HHS grantees and does not align with the corresponding rules of other federal funding agencies such as NSF, the U.S. Department of Agriculture (USDA), and others, which either use their own research misconduct regulations and frameworks or rely on the Federal Research Misconduct Policy released in 2000.10
Many researchers are funded by multiple agencies and therefore must adhere to their different requirements. The variation in misconduct policies and procedures, such as investigation timelines, the length of reviews by agencies such as ORI, and the increased burden on institutions to retain more information, makes it challenging for researchers, especially when an allegation of misconduct is received involving multiple funding agencies.
In such instances, agencies have to agree on which agency is the “lead” agency; otherwise, each involved agency may have to evaluate the allegation separately. The same is true of overlapping inspectors general, audit agencies, and investigative agencies that may compete for a role in the enforcement process, creating further variation and potential inconsistency across similar misconduct cases where a different set of agencies are involved. In addition, to manage funding agencies’ variations, institutions often adopt the strictest standard for responding to allegations of research misconduct, losing flexibility when a less strict but more appropriate standard could apply beyond research misconduct. HHS has recently introduced new guidelines to improve efficiency, but the effect of these is not yet known.
The committee also noted challenges in current reporting structures. At present, much of the infrastructure for managing and addressing research misconduct cases relies on email rather than secure and standardized online portals. This can lead to delays, lost communications, leaks, and issues with attorney-client privilege. In certain instances, submissions require specific formatting, which takes time to generate in personal emails; this format could be applied automatically via an online standardized form.
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10 Executive Office of the President, Office of Science and Technology Policy, Federal Policy on Research Misconduct; Preamble for Research Misconduct Policy, 65 Fed. Reg. 76260 (October 14, 1999).
The committee has heard of cases dragging on for months and even years as communication is bogged down by inefficient systems.
The committee provides options to address these issues through harmonization, assessment of new guidance, new systems, and more efficient approaches to managing misconduct cases.
Problem: Different standards for research misconduct proceedings across agencies.
While a single Federal Research Misconduct Policy exists, agency variation continues, with particularly inflexible requirements from HHS and VA Directive 1058.02.11 This agency variation creates a number of problems, including potential inconsistencies in how misconduct cases are handled and a lack of flexibility to apply the most appropriate standard to the case at hand. There are increased challenges when multiple agencies are involved and need to determine a lead agency to oversee a case.
| Option 2.1: Agencies follow a single flexible federal misconduct policy | |
| Goal: Lower the administrative burden on institutions by simplifying and harmonizing research misconduct procedures across the federal funding agencies. Punitive standards could be applied consistently so that accused researchers are held to the same consequences. |
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| Approach: The Federal Research Misconduct Policy could be revised to provide a single set of flexible requirements to be followed for handling research misconduct allegations rather than vesting authority for research misconduct in each federal agency. Each federal funding agency can defer to the Federal Research Misconduct Policy and eliminate their separate procedures. |
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11 Research Misconduct, Veterans Health Administration Handbook 1058.02 (February 7, 2014).
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| Option 2.2: Ensure a single lead agency has jurisdiction over misconduct allegations for research with multiple funding agencies | |
| Goal: Increase clarity of which agency’s procedures apply for a given misconduct case and reduce duplicative oversight. |
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| Approach: Current Federal Research Misconduct Policy states that “if more than one federal agency has jurisdiction over allegations of research misconduct, those agencies could work together to designate a lead agency.”a While this intends to ensure a single agency has oversight over a misconduct case involving research funded by multiple agencies, it is not a requirement. The policy could be changed to require a lead agency and set clear criteria for how a lead agency would be determined. |
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a ORI (The Office of Research Integrity). 2000. Federal research misconduct policy. https://ori.hhs.gov/federal-research-misconduct-policy (accessed July 11, 2025).
Problem: Slow and ineffective digital infrastructure for handling misconduct cases.
Current communications with federal funding agencies for handling research misconduct proceedings rely heavily on an email system plagued by slow response times and communication issues. This introduces challenges for institutions and agencies tracking any single case and increases the time between reporting of research misconduct case decisions by institutions to determinations and corrective actions from the funding agency. In addition, certain reports, such as the separate inquiry and investigation reports for HHS, require incredibly specific formatting that is left to institutions to implement.12 These challenges are something that ORI is aware of and working actively to improve.
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12 For more information on the requirements of the HHS inquiry report, see 42 C.F.R. § 93.307(d).
| Option 2.3: Develop a new system for managing misconduct cases | |
| Goal: Improve infrastructure for reporting and managing research misconduct proceedings to ensure these proceedings move more effectively and efficiently. |
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| Approach: Rather than relying on email communication to share key reports and information during misconduct proceedings, an existing or newly built system could be used to ensure the organization of all key files. This system could also ensure consistent formatting of all reports by providing online forms that institutions can fill out and will automatically be structured as the agency desires. In the cases of a harmonized process, this could be a single government-wide system. If the current multiagency system remains, each agency could create its own system. |
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| Option 2.4: Continue efforts to improve response times | |
| Goal: Reduce the amount of time spent waiting for response to move misconduct cases forward. |
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| Approach: The U.S. Department of Health and Human Services’ Office of Research Integrity is already working to reduce the amount of time for responses to emails regarding research misconduct cases. These efforts could continue and increase with a clear target set for a timeline for accurate response. No new system would be built, but the old approach would be maintained with efforts to improve efficiency. |
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Pros:
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Cons:
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Problem: Uncertain impact of new HHS requirements.
HHS recently introduced new regulations to address and respond to research misconduct (ORI, 2025) in an effort to improve efficiency and streamline processes. These regulations will not be in full effect until 2026, so there is no available assessment of their effectiveness. Early reviews, however, suggest that while some updates represent welcome change and streamlining, other changes may not be consistent with improving efficiency (Green et al., 2023; Phillips and Earl, 2025). Some mechanism is needed to ensure these changes are in fact having the desired effect.
In addition, HHS has strict procedures for research misconduct, and because of the amount of funding for research from HHS, most institutions adopt its framework. Given this, even without harmonizing regulations across agencies, evaluating and streamlining HHS requirements would help reduce workload and burden.
TABLE 2-5 Option to Address the Uncertain Impact of New HHS Guidelines (Regulatory Area 2)
| Option 2.5: Assess new U.S. Department of Health and Human Services (HHS) misconduct regulations for efficiency and effectiveness | |
| Goal: Determine the effectiveness of new HHS guidelines and the impact of efforts to improve efficiency in the current HHS structure. |
|
| Approach: The HHS Office of Research Integrity could review the efficiency and effectiveness of the new regulations at a predetermined future time, ideally within 5 years of full implementation, and make adjustments based on feedback from key stakeholders. |
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Pros:
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Cons:
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REGULATORY AREA 3: FINANCIAL CONFLICT OF INTEREST IN RESEARCH
As with research misconduct policies, there is not a harmonized financial conflict of interest (FCOI) in research policy applied across funding agencies. FCOI is defined as a significant financial interest (SFI) that affects the design, conduct, or reporting of federally funded research (NIH, 2024a). Federal policies often provide monetary thresholds for what they determine to be an SFI that may affect a given research project. In response to a series of scientific misconduct and research harm cases in the 1970s and 1980s, Congress directed HHS to develop regulations addressing FCOIs. The Public Health Service (PHS) released the first FCOI regulation in 1995, with HHS revising it in 2011.
While most institutions have standardized their internal FCOI policies for awards to align with PHS requirements, each federal agency has developed its own FCOI policy and procedures, disclosure thresholds, and reporting requirements. In addition, the policies often conflict with each other, requiring institutions to create manual systems or use the most stringent requirements for disclosure, adding additional work for researchers and reviewers (COGR, 2025a). NSF’s policy, which it adopted from the original 1995 PHS policy, has a narrower definition of a reportable FCOI than the current PHS policy, is less burdensome than other reporting requirements, and has a different threshold than, for example, the U.S. Food and Drug Administration (FDA). The PHS threshold is $5,000, while the FDA threshold is $25,000, and neither are adjusted for inflation over time.
A survey by the Association of American Medical Colleges found that when PHS lowered its definition of an SFI from $10,000 to $5,000, 49 percent of the responding institutions reported an increase in the number of SFI disclosures (AAMC, 2020). However, there was only a 13 percent increase in the number of FCOIs reported to PHS and a decrease in the percentage of SFIs found to be FCOIs. This suggests that lowering the SFI threshold, with no indexing to inflation, may not be meeting the intended goal of protecting research integrity and that agencies could use an FCOI model with a higher SFI threshold, such as the NSF model (COGR, 2025a). Moreover, requiring actions such as conducting exhaustive retrospective reviews for determining bias, or reporting FCOIs through the eRA Commons platform, the online interface for NIH grant applicants, has not significantly addressed government concerns, with the former rarely identi-
fying bias but increasing workload significantly and the latter resulting in no action from the receiving agency (AAMC, 2020). The committee’s options, outlined below, focus on creating uniform policies, adjusting FCOI thresholds, and eliminating unnecessary reporting and requirements.
Problem: Inconsistent FCOI in research procedures and requirements.
Five federal agencies maintain FCOI regulations or policies that are inconsistent in terms of financial threshold for disclosure: PHS and DOE (DOE, 2021), which have a threshold of $5,000;13 FDA, which has a threshold of $25,000 (FDA, 2013); and NASA and NSF, which have a threshold of $10,000 (NASA, 2023; NSF, n.d.-a). The five agencies also have different reporting requirements. For example, PHS requires reporting of some FCOIs, while FDA requires reporting to the study sponsor. It is unclear what PHS does with these reported FCOIs, as agency guidance states only that program officers may request more information on a reported FCOI, but there is no guidance as to what might prompt such an inquiry (eRA, 2025). Multiple disclosure thresholds and reporting requirements, from these agencies as well as others with separate policies, increase the burden on researchers and administrative staff.
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13 Promoting Objectivity in Research, 42 C.F.R. 50 Subpart F (August 25, 2011).
TABLE 2-6 Options to Address the Inconsistent FCOI in Research Procedures (Regulatory Area 3)
| Option 3.1: Create a uniform financial conflict of interest (FCOI) in research policy | |
| Goal: Harmonize existing policies and procedures across federal funding agencies to provide for the consistent application of FCOI disclosures, identification, and management regardless of funding source. |
|
| Approach: Federal funding agencies can be directed to adopt one standard for FCOI in research, preferably the U.S. National Science Foundation (NSF) policy. Given NSF’s broad reach across disciplinary areas, adoption of NSF’s FCOI policies will ensure interagency alignment under a proven framework that maintains research integrity under a harmonized approach. |
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Pros:
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Cons:
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| Option 3.2: Revert to the earlier $10,000 Public Health Service (PHS) significant financial interest (SFI) threshold with periodic adjustments for inflation | |
| Goal: Increase the reporting threshold for financial conflicts to $10,000, as it was prior to 2011,a with annual adjustments made for inflation similar to the threshold for reporting in the Centers for Medicare & Medicaid Services Open Payments System. |
|
| Approach: PHS can increase the threshold for an SFI to $10,000 and publish an annual updated threshold amount, through the notice of opportunity to transition process, to account for inflation.b Alternately, PHS could maintain a lower SFI threshold but would update it periodically to account for inflation.a |
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Pros:
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Cons:
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| Option 3.3: Eliminate reporting of FCOIs for PHS-funded research | |
| Goal: Eliminate the reporting of FCOIs identified by academic research institutions to PHS. |
|
| Approach: Institutions are required to identify and manage FCOIs and report noncompliance to federal agencies, per regulation.a However, PHS goes beyond the regulation to require reporting of FCOIs. As PHS is the only federal agency to require reporting of FCOIs and it is unclear what is done with these reports, PHS can remove the requirement to report elements of management plans for PHS-supported researchers.a |
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Pros:
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Cons:
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| Option 3.4: Eliminate the requirement for a “determination of bias” | |
| Goal: Eliminate redundant requirements. |
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| Approach: PHS can eliminate the requirements around conducting a “determination of bias.”a As noted in the 2020 Association of American Medical Colleges report, out of more than 100 noncompliance reviews, it is extremely rare for an institution to find “bias.”d |
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Pros:
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Cons: |
a Promoting Objectivity in Research, 42 C.F.R. 50 Subpart F (August 25, 2011).
b Can be done by revising 42 C.F.R. Part 50, Subpart F.
c Responsibility of Applicants for Promoting Objectivity in Research for Which Public Health Service Funding Is Sought and Responsible Prospective Contractors, Fed. Reg. 76, no. 165 (August 25, 2011).
d AAMC (Association of American Medical Colleges). 2020. AAMC Conflicts of Interest Metrics Project - Measuring the impact of the Public Health Service regulations on conflicts of interest. https://www.aamc.org/media/50386/download (accessed July 2, 2025).
REGULATORY AREA 4: PROTECTING RESEARCH ASSETS
The United States has a vested interest in regulating research to ensure the protection of research assets. The policy options to improve the requirements for the protection of research assets are grouped under Research Security, Export Controls, and Cybersecurity and Data Management. The committee details options that implement federal government-wide consistent processes, revise legal limitations on training, update key definitions, adopt risk-based approaches, and renew previous initiatives intended to streamline key processes.
Research Security
Growing concerns about research security and foreign interference entered broad public discussion in 2018. This, in conjunction with the importance of research security to the full breadth of academic research, led Congress and the Executive Branch to take a number of actions, including the development of NSPM-3314 and the Creating Helpful Incentives to
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14 National Security Presidential Memorandum-33 (NSPM-33), United States Government-Supported Research & Development National Security Policy (January 14, 2021). https://trumpwhitehouse.archives.gov/presidential-actions/presidential-memorandum-united-states-government-supported-research-development-national-security-policy/.
Produce Semiconductors for America (CHIPS) and Science Act of 2022.15 NSPM-33, issued in January 2021, instituted broad requirements for disclosure and research security infrastructure for recipients of federal research and development funds that exceed $50 million annually.16 NSPM-33 directed federal agencies to create common forms for the disclosure of foreign affiliations, appointments, and funding sources and research organizations receiving over $50 million per year in federal research funding to implement a research security program that includes cybersecurity, foreign travel security, research security, and export control training (NSTC, 2022). The 2022 CHIPS and Science Act added additional mandates for training for personnel on federal awards and policy harmonization across agencies.
Despite efforts on the part of federal agencies and strong engagement with the research community, the U.S. research security landscape remains fragmented, requiring universities to reconcile overlapping or conflicting rules from multiple agencies. Researchers continue to confront inconsistent disclosure forms and systems—for example, often re-entering data already housed in SciENcv because agencies have not uniformly adopted the agreed upon “common forms” and SciENcv system. Another example is with “conflicts of commitment,” a new concept for institutions when first introduced (COGR, 2021). Conflicts of commitment occur when a researcher dedicates time to personal activities in excess of institutional policy or that may detract from their professional responsibilities (ORI, n.d.). This has led some institutions to develop and implement conflict of commitment programs. The ambiguity of some of the requirements has led to variation in how institutions are developing infrastructure to comply with the requirements and how internal policies affect researchers and trainees at different institutions. Foreign gift and contract reporting is also duplicative across federal agencies. Institutions also lack an authoritative, consolidated hub for information, communication, resources, FAQs, and training, requiring them to track and piece together guidance, a particular challenge for smaller institutions and research programs. The nascent NSF-funded SECURE Center, authorized in the CHIPS and Science Act of 2022, is poised to address some of these issues by working with the community to design and develop resources to meet their research security needs and providing “shared tools, best practices, training, analyses and
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15 CHIPS and Science Act, Division B, Title VI, Subtitle D (Pub. L. 117-167, §§ 10631-10638). 42 U.S.C. §§ 19231-19237.
16 All institutions that receive federal funding, regardless of funding threshold, are subject to certain aspects of NSPM-33, such as disclosure requirements.
other information, all delivered through a shared virtual environment” (NSF, 2024). The SECURE Center also has a mechanism for federal agency engagement through its U.S. Government (USG) Steering Committee, which is “composed of USG leaders and research security subject matter experts and chaired by NSF” (NSF, 2023). In tandem, NSF SECURE Analytics17 is designed to provide data-driven insight into actions needed for risk mitigation, decision-making, protecting integrity, and facilitating collaborations between institutions.
Agencies implementing the CHIPS and Science Act training requirements currently require research security training requirements at the proposal stage, consistent with the statutory language, requiring even unfunded applicants to spend time addressing those requirements. Furthermore, reviews to identify research security risks associated with fundamental research proposals and requests for further clarification and mitigation are conducted with divergent risk-review criteria and mitigation rubrics across and within agencies, adding further unpredictability and confusion. This environment increases administrative workload, creates inefficiencies in the research process, and diverts resources from discovery and innovation. Coordinated federal leadership, harmonized agency implementation of research security requirements, just-in-time training, and common foundational principles for risk reviews that incorporate a tiered-risk approach to evaluations are needed to align protections with actual risk while minimizing unnecessary burden.
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17 For more information, see https://secure-analytics.org/.
TABLE 2-7 Options to Address Research Security Compliance Issues (Regulatory Area 4)
| Option 4.1: Implement the National Security Presidential Memorandum-33 (NSPM-33) common disclosure forms and disclosure table without deviation as the primary means to identify and address conflicts of commitment (COCs) and develop federal-wide FAQs via the interagency working group; in addition, use the Science Experts Network Curriculum Vitae (SciENcv) system, persistent identifiers (PIDs), and application programming interfaces (APIs) across research funding agencies | |
| Goal: Reduce duplication and deviation in common disclosure forms by adopting the interagency developed “common” forms and utilizing SciENcv and PIDs to enable prepopulation of forms, thereby further and significantly reducing researchers’ administrative workload. |
|
| Approach: Agencies are still in the process of implementing the common federal-wide current and pending support and biosketch disclosure forms, published in November 2023.a Full implementation and avoiding agency-specific deviations will reduce administrative workloads for researchers. Deviations are taking the form of separate, additional requirements outside of the common forms. Although several agencies have indicated they will not adopt SciENcv at this time, use of this system will significantly reduce researchers’ administrative workload and should be prioritized. Federal-wide use of the NSPM-33 pre- and post-award disclosure table, housed on the U.S. National Science Foundation (NSF) website,a will reduce the potential for differing agency interpretations that lead to stakeholder confusion and increased workloads. So, too, will the development of federal-wide, rather than independent agency, disclosure FAQs. Agency use and requirement of PIDs, as outlined in NSPM-33, to prepopulate forms with relevant information, as well as APIs to capture information from institutions and other sources, will further reduce workload. To avoid confusion and minimize administrative workload, the common forms could be uniformly used for identifying COCs that should not be addressed in conflict-of-interest (COI) policy, such as through the U.S. Department of Energy’s (DOE’s) draft COI/COC policy. |
|
Pros:
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Cons:
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| Option 4.2: Use the Safeguarding the Entire Community in the U.S. Research Ecosystem (SECURE) Center as an interactive research security information hub to keep the community current on the latest information and provide resources to facilitate consistent implementation of research security requirements across institutions | |
| Goal: Facilitate efficient navigation and implementation of evolving research security policies and subsequent compliance activities for all institutions, regardless of existing resources. |
|
| Approach: Leverage the NSF-funded SECURE Center and its shared virtual environment to provide resources codesigned and developed with the regulated community, to facilitate consistency across institutions in the implementation of federal requirements, and to serve as a hub for research security information, communications, and resources. This option proposes using the SECURE Center as a central information hub for research security information and resources for assessing and mitigating risks to research, addressing federal requirements, and adapting the shared virtual environment to provide a clearinghouse for federal and institutional research security-related policies and processes, checklists, FAQs, and training modules among other resources. Using innovations such as artificial intelligence, this clearinghouse would incorporate interactive dashboards and include querying tools to facilitate better navigation of the collected information and identify updates to policies and procedures. SECURE Analytics, also part of the SECURE Program, can be leveraged to assess risks and mitigate and prevent foreign interference in research. |
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Pros:
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Cons:
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| Option 4.3: Amend the CHIPS and Science Actb to allow for “just-in-time” research security training | |
| Goal: Reduce the administrative workload for researchers on unfunded proposals, increase efficiency during the early grant process, and harmonize training requirements across funding agencies. |
|
| Approach: DOE, the National Institutes of Health, and other Public Health Service federal funding agencies require that all principal investigators and other senior and key personnel complete COI training prior to expending project funds, and training is required every 4 years. Consistent with this, Congress could introduce amendments to the CHIPS and Science Act to allow for research security training at the time of award and to provide flexibility in the frequency of training. Clear guidance on training requirements could be communicated across federal agencies and the academic community to ensure the broad agency implementation of the just-in-time mechanism. To reduce the annual training hours required by current policies, agencies could subscribe to the SECURE Center’s condensed research security training module and broadly accept and apply an investigator’s completion of said module as satisfying the agency’s security training requirement. |
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Pros:
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Cons:
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| Option 4.4: Establish common principles for agency risk reviews | |
| Goal: Retain agency variance resulting from differences in mission—for example, basic fundamental research versus research involving critical technologies and military applications—while effectively reducing inconsistencies in the application of risk reviews and mitigation across the government, reducing uncertainty, and providing clarity to risk review determinations and broader international engagement. |
|
| Approach: Given the differing missions and research portfolios among federal research funding agencies, the procedures for risk reviews for fundamental research proposals result in inconsistent risk interpretation and mitigation. This leads to confusion among researchers and institutions with respect to international research engagement. To address these inconsistencies and the opacity of government actions, while also maintaining flexibility to account for their different missions and research portfolios, all agencies could adopt a standard set of fundamental principles and resources when conducting risk reviews and mitigation actions on federally funded research, both basic and applied. For example, agencies would use the same U.S. restricted party lists, assess use of education origins as a risk factor, assess a prohibition on use of non-U.S. risk tools, and use common principles and processes for risk mitigation. In addition, all agencies should develop a shared set of expectations for risk-mitigation issues identified in reviews with centralized tools to assist in harmonizing actions on areas of risk reviews. |
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Pros:
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Cons:
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a NSF (U.S. National Science Foundation). n.d.-b. NSPM-33 implementation guidance. https://www.nsf.gov/bfa/dias/policy/nspm-33-implementation-guidance (accessed July 15, 2025).
b Creating Helpful Incentives to Produce Semiconductors for America (CHIPS) and Science Act of 2022, Public Law 117-167 (August 9, 2022).
Export Controls
The federal government has an extensive export control regulatory regime to protect U.S. trade and national security (NASEM, 2009, 2022). Multiple federal departments oversee export control regulations, and this is an area that has long needed regulatory reform. Academic institutions have experienced significant challenges fully adopting existing federal export control framework requirements given the expansive research areas within academia that require a broad knowledge of regulations, compared to industry where organizations focus on a smaller number of technologies. To meet the demands of complying with both export controls and research security regulations and requirements, institutions have had to find ways to identify and coordinate resources needed to increase their efforts for coming into compliance and centralizing activities within the institution (COGR, 2022). The specialized staff, software, and legal services needed to ensure compliance may be difficult for less-resourced campuses to afford. Universities also navigate potential conflicts between open science practices for fundamental research and export controls. While the results of fundamental research are excluded from export controls, tangible items and software which are not intended for publication are subject to controls.
U.S. export control compliance for universities is characterized by both structural fragmentation and doctrinal ambiguity. Three primary regulators maintain separate country- and item-specific controls: the U.S. Department of State, which administers International Traffic in Arms Regulations and the United States Munitions List (USML); the U.S. Department of Commerce, which administers the Export Administration Regulations and the Commerce Control List (CCL); and the U.S. Department of the Treasury, which administers Office of Foreign Assets Control and the Specially Designated Nationals and Blocked Persons List. Other agencies can also impose additional or emergency measures, such as the Federal Emergency Management Agency’s pandemic-era restrictions on medical personal protective equipment (FEMA, 2021). Each agency follows distinct procedures for registrations, license determinations, exemptions, and end-use verifications, so an academic project containing multiple types of research may be subject to multiple overlapping requirements with no single point of harmonization.
Although the Fundamental Research Exclusion18,19 is meant to remove export controls when the results of research are intended for unrestricted publication and open use, physical tools, equipment, software, and proprietary data used in such research must be treated as controlled items as applicable. Universities, therefore, must operate comprehensive export control programs that include screening, licensing, training, and controls—including expensive modifications to facilities—even when the underlying scholarship is exempt. The interplay of multiple agency rules and the partial reach of the exclusion creates a complex, resource-intensive compliance environment that can delay collaborations, increase administrative costs, and discourage international partnerships essential to scientific progress.
Striving to stay compliant, institutions sometimes employ their own additional policies or processes to preemptively address federal concerns—such as export control policies related to foreign nationals—that may further increase administrative workloads without demonstrably improving protection. As an example, while most H-1B visa holders pursuing training as postdocs or positions as research personnel at U.S. institutions conduct fundamental research, which is exempt from export controls, universities have implemented additional reviews and are required to submit I-129 petitions to confirm that foreign nationals are, in fact, exempt (Decrappeo et al., 2011). This additional review requires not only coordination and processing through human resources and international affairs offices, which are typically engaged in H-1B applications, but also sponsored research offices, compliance officers, technology licensing, and sponsoring faculty to appropriately complete I-129 petitions. This level of extensive review and processing is both onerous and provides only a snapshot of the research connected to the individual, which may change and then require additional processing. This overcomplicates petitioning for administrative personnel, sponsoring faculty, and visa petitioners.
The federal government has attempted some broader efforts at reform of export controls, such as the Export Control Reform Initiative that ran from 2009 to 2016 (DOS, 2013). Of particular focus for this initiative was an effort to move appropriate items from the USML with its more stringent regulations to the CCL, which allows easier export of items that
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18 The U.S. White House. National Policy on the Transfer of Scientific, Technical and Engineering Information, National Security Decision Directive (NSDD) 189. Washington, DC: Office of the President, September 21, 1985. https://irp.fas.org/offdocs/nsdd/nsdd-189.htm.
19 “Technology” or “Software” That Arises During, or Results from, Fundamental Research, 15 C.F.R. Part 734.8 § 734.8 (March 25, 1996).
do not require greater control (Stricker and Albright, 2017). Over the course of the initiative, all categories in the USML were reviewed, except for firearms, ammunition, and artillery, to consider whether they could be moved to the CCL (Insinna, 2017). Other outcomes of this effort include a license exception called a Strategic Trade Authorization to facilitate export transfer to low-risk countries and the creation of an Export Enforcement Coordination Center to coordinate export control enforcement across agencies (CRS, 2020).
TABLE 2-8 Options to Address Export Controls (Regulatory Area 4)
| Option 4.5: Renew the Export Control Reform Initiativea with input from academia | |
| Goal: Continue prior efforts to streamline and clarify export controls and reduce associated administrative work with representation from the academic research community. |
|
| Approach: The Export Control Reform Initiative began in 2009 with the aim of streamlining export controls by simplifying processes and increasing coordination across agencies, enhancing the clarity of descriptions of controlled items, and transferring appropriate items from the United States Munitions List to the Commerce Control List to reduce the level of control for those items. Congress and the White House could initiate another reform campaign to continue and expand upon some previous successful efforts and include representation from the academic research community.b |
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Pros:
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Cons:
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| Option 4.6: Adopt a risk-tiered approach to export controls | |
| Goal: Reduce unnecessary work on low-risk research, transporting information, technology, or other research-related items of U.S. national interest overseas. |
|
| Approach: Export controls are broadly applied for industrial purposes, resulting in controls that are inconsistent with the academic research use of items, services, and technologies. Instead, barriers could be removed for those engaged in the lowest-risk work and appropriately tiered for others. The Fundamental Research Exclusionc does not include the technology or tools used to conduct research. The Departments of State and Commerce could allow for greater risk-tiered variation in requirements and regulations for their controlled items, particularly for research covered under the Fundamental Research Exclusion. |
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Pros:
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Cons:
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| Option 4.7: Expedited licensing processes for low-risk controlled research and transparency and clarity in Office of Foreign Assets Control (OFAC) license processes | |
| Goal: Expedite export-control licensing requests using a risk-tiered, fast-track licensing pathway for low-risk controlled research. |
|
| Approach: Lengthy licensing processes are a particular hindrance for low-risk but controlled research. Currently, the licensing process is not risk-tiered, but rather a first-come, first-served process, which can create delays to projects that present minimal security concerns, taking weeks or months to process and slowing the pace of research. Processes could be developed for low-risk research, similar to the ones undertaken in the voluntary self-disclosure program within the Department of Commerce, that reduce and fast-track licensing processes. In addition, OFAC licensing can take as long as a year. Greater transparency and clarity regarding the process would be beneficial. |
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Pros:
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Cons:
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a The White House. 2013. Fact sheet: implementation of export control reform. https://obamawhitehouse.archives.gov/the-press-office/2013/03/08/fact-sheet-implementation-export-control-reform (accessed August 12, 2025).
b CRS (Congressional Research Service). 2019. The U.S. export control system and the Export Control Reform Initiative. https://www.congress.gov/crs_external_products/R/PDF/R41916/R41916.46.pdf (accessed July 1, 2025).
c BIS (Department of Commerce Bureau of Industry and Security). 2011. Deemed exports and fundamental research for biological items. https://www.bis.doc.gov/index.php/2011-09-08-19-43-48 (accessed August 12, 2025).
Cybersecurity and Data Management
The federal data governance and cybersecurity landscape for academic research is a patchwork of overlapping and sometimes contradictory requirements. The National Institute of Standards and Technology is the technical backbone of federal cybersecurity policy and practice and has overall responsibility for developing cybersecurity standards, guidelines, best practices, and frameworks. Federal agencies use these policies, yet many, such as NIH, NSF, DOE, DOD, and USDA, impose agency-specific policies on data sharing, stewardship, privacy, and security. Application of the terms Controlled Unclassified Information (CUI), federal contract information, and fundamental research is not consistent across agencies, or, as in a recent NIH policy change, CUI data protection standards are implemented for data that the agency acknowledges are not CUI. CUI is often applied in agency agreements and contracts where the proposed work is fundamental research. Monitoring and enforcement are uneven, and many rules have not kept pace with evolving scientific practice.
Agencies are applying different standards for handling and storing CUI, and some agencies struggle internally to apply applicable controls in a consistent manner. Research institutions must maintain parallel compliance programs, duplicate training, and multiple documentation streams to satisfy incompatible requirements, yet they still lack an authoritative source that reconciles definitions, risk categories, templates, and reporting formats. In the absence of a coordinated cross-agency framework, researchers and institutions face shifting guidance, redundant oversight, and significant administrative costs, while the nation falls short of delivering consistent and risk-appropriate protection for federally funded data. The sheer number of categories makes CUI an especially challenging issue.
TABLE 2-9 Options to Address Cybersecurity and Data Management (Regulatory Area 4)
| Option 4.8: Provide clarity for definitions on Controlled Unclassified Information (CUI) and fundamental research | |
| Goal: Increase clarity on policies related to CUI. |
|
| Approach: The White House could expand the definition of “fundamental research” beyond the scope of National Security Decision Directive 189 (NSDD-189)a to include all basic and applied research performed at U.S. institutions of higher education that is generally published and openly available for the scientific community.b In addition, the National Archives and Records Administration can provide clear guidelines for federal contract informationc and CUId with a definition of CUI to be used by all authoritative sources. |
|
Pros:
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Cons:
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| Option 4.9: Develop a coordinated cross-agency framework for research, data security, and governance | |
| Goal: Align and streamline federal data governance requirements across agencies. |
|
| Approach: The Office of Science and Technology Policy (OSTP) or National Institute of Standards and Technology (NIST) could coordinate a working group of the federal agencies with relevant policies to review and align existing data management, sharing, privacy, and security policies. The working group would develop a unified framework with standard definitions, risk categories, templates, and compliance expectations. Federal agencies could adopt the framework while allowing for mission-specific flexibility. |
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Pros:
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Cons:
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| Option 4.10: Adapt cybersecurity requirements for university settings | |
| Goal: Align cybersecurity requirements for institutions of higher education to reflect the current open science environment that underpins U.S. innovation. |
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| Approach: The secretary of commerce could direct the under secretary of commerce for standards and technology and director of NIST, in collaboration with OSTP and the broader research community, to undertake a comprehensive review of cybersecurity controls as they apply to institutions of higher education and make appropriate modifications to ensure alignment with the academic research environment with attention to the growing adoption of an open science framework. |
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Pros:
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Cons:
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a The White House. 1985. National Policy on the Transfer of Scientific, Technical, and Engineering Information. https://www.acq.osd.mil/dpap/dars/pgi/docs/National_Security_Decision_Directive_189.pdf (accessed July 11, 2025).
b COGR (Council on Governmental Relations). 2025. Actionable ideas to improve government efficiency affecting the performance of research. https://www.cogr.edu/sites/default/files/Actionable Ideas to Improve Gov Efficiency COGR_0.pdf (accessed July 8, 2025).
c Basic Safeguarding of Covered Contractor Information Systems, 48 C.F.R. Part 52, Subpart 52.2, § 52.204-21 (June 11, 2025).
d Controlled Unclassified Information, 32 C.F.R. Part 2002 (September 14, 2016).
REGULATORY AREA 5: RESEARCH INVOLVING BIOLOGICAL AGENTS
Multiple agencies oversee research involving biological agents, and there have been successful efforts to harmonize oversight over the years. Though these efforts are laudable, agencies continue to promulgate new requirements that continue to shift the burden of oversight to research institutions and individual principal investigators, often with insufficient guidance.
The U.S. Centers for Disease Control and Prevention (CDC)-NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) is generally accepted by federal agencies as the authoritative guidance document for biocontainment practices and laboratory safety (CDC, 2020). The NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) oversee recombinant pathogens and apply to research at NIH-funded entities. The NIH Guidelines govern research with synthetic and recombinant nucleic acid molecules and gene-drive modified organisms, establishing Institutional Biosafety Committees (IBCs) as the local-level oversight bodies that review and approve relevant research. While there are limits on the scope and applicability of the NIH Guidelines and BMBL, both are generally applied broadly and describe risk-tiered practices for safely conducting research with recombinant DNA and microbiological agents.
IBCs serve as the focal point for institutional biological safety oversight, and as new policies are issued, the work of IBCs has grown. The core function of IBCs is to oversee synthetic and recombinant nucleic acid molecule research, including gene-drive modified organisms, as described in the NIH Guidelines. However, IBCs at most institutions play a role in the oversight of a broader range of microbiological and recombinant DNA research than what is specifically articulated in the NIH Guidelines (Johnson and Dobos, 2019). They are also becoming increasingly involved in implementing policies around dual-use research of concern (DURC) and dangerous gain-of-function (GOF) research, representing an expansion of the scope of many IBCs from biosafety to biosecurity. DURC involves research that could be misused to threaten public health, agriculture, or national security. GOF studies, in this context, refer to research that enhances the pathogenicity or transmissibility of pathogens—particularly those with pandemic potential—to better understand their infectious nature. The May 5, 2025, EO Improving the Safety and Security of Biological Research directs agencies to revise or replace previous policies on DURC and GOF and aims to, among other things, stop dangerous GOF research, increase top-down oversight
and accountability, and manage risks associated with non-federally funded research (CRS, 2025; The White House, 2025). At the time of this writing, DURC and GOF policy outcomes are uncertain, but in implementing this recent EO, federal agencies have begun asking research institutions to identify and report any “dangerous gain-of-function” research they are conducting, providing no additional guidance outside of the broad descriptive language in the EO.
The Federal Select Agent Program, administered jointly by CDC and USDA, oversees the possession, use, and transfer of select agents and toxins that pose a threat to public, animal, or plant health. Using a list-based approach, these regulations require added safety and security measures, registration, security screenings of individuals enrolled in the program, inspections, and more to help ensure that research involving high consequence pathogens is conducted to the highest standards of safety and security.
Biological agents and toxins are also covered under export control regulations with certain agents requiring controls on their possession, use, and transfer. Taken together, the oversight of biological agents and toxins involves multiple federal agencies and policies, each with varying jurisdictions, scopes, and applicability, and all seeking to manage the same or similar risks of inadvertent or intentional release of pathogens that could endanger the health of those working with these organisms and the public. While new policies have been implemented, there continues to be multiple oversight frameworks, insufficient guidance, and an increased reliance on institutions and individual principal investigators to identify research with potential national security implications or potentially “significant societal consequences” (The White House, 2025).
The committee provides options to harmonize these overlapping regulations through centralization, simplified guidelines, and reducing duplicative efforts.
Problem: Complex and overlapping regulations for research involving biological agents.
There are a number of overlapping regulations, guidelines, and policies from multiple federal agencies for the oversight of research involving biological agents and toxins. These can be complex, be redundant, and require institutions to implement multiple sets of rules that could have been integrated. In addition, researchers must also navigate export controls for the transfer and communication of information about some pathogens. These policies are promulgated by multiple agencies, and their scopes and applicability vary.
| Option 5.1: Adopt a more centralized, more coordinated U.S. government-wide approach to regulating research involving biological agents and toxins | |
| Goal: Create a consistent and coordinated approach to reduce discrepancies and duplicative efforts across regulations of biological agents and toxins. |
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| Approach: The existing oversight frameworks provide a solid foundation for research involving biological agents and toxins but would benefit from a holistic effort to better centralize, coordinate, and clarify rules. A single agency, such as the National Institutes of Health (NIH) or another appropriate entity, could be charged with empowering and registering Institutional Biosafety Committees (IBCs) to provide oversight at the institutional level, regardless of the institution’s federal funding source. That agency or entity could be the focal point for communicating with IBCs and could coordinate with federal partners as needed. The Biosafety in Microbiological and Biomedical Laboratories (BMBL) documenta could remain as the authoritative guidance document describing containment and safety practices and gain wide adoption from federal agencies and research institutions. The Federal Select Agent Programb could continue to provide enhanced risk-tiered oversight of higher consequence pathogens and could work closely with the entity overseeing IBCs to harmonize guidance and requirements. |
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| Option 5.2: Simplify and harmonize current NIH/U.S. Department of Agriculture/U.S. Centers for Disease Control and Prevention guidelines, and exempt low-risk activities | |
| Goal: Ensure a risk-tiered, harmonized approach to guidelines for biological agents and toxins. |
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| Approach: The NIH Guidelines and BMBL provide risk-tiered guidance and oversight, but there are still examples of low-risk research that continue to require more stringent oversight, requiring researchers and institutions to devote unnecessary administrative time to activities that do not appreciably improve safety. NIH could review the current NIH Guidelinesc in an effort to improve clarity and remove unnecessary oversight requirements for low-risk recombinant and nonrecombinant activities. The Federal Select Agent Program could do likewise, continuing its periodic evaluations of the lists of covered agents. This approach would reduce administrative workload by removing review, approval, and reporting requirements for lower-risk research but would not be intended to increase safety risks as researchers would still be expected to follow general safety procedures such as wearing suitable personal protective equipment. |
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| Option 5.3: Largely remove biosecurity and national security oversight from the purview of IBCs and focus the oversight of dual-use research of concern (DURC) and dangerous gain-of-function (GOF) research at the federal level | |
| Goal: Streamline the oversight of DURC and GOF to ensure the most equipped bodies are focused on this. |
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| Approach: DURC and GOF policy efforts have focused on policy concerns around the potential misuse or inadvertent release of the highest-consequence pathogens. IBCs could continue to play a role in the local-level biosafety oversight of such work, but they are not well equipped to make determinations involving national security. Such determinations require expertise in national intelligence, security and vulnerability assessments, public health preparedness, and other areas that are within the purview of the federal government but not universities or research institutions. Rather than relying on IBCs and institutions to screen their portfolios or build new oversight mechanisms around research activities that are difficult to define or assess, federal funding agencies could identify, at the time of funding, whether any studies meet their definitions of DURC or dangerous GOF research. Then, the funding agency could enter into a dialogue with the institutions, prior to beginning the research, to collaboratively identify appropriate conditions and containment measures for safely conducting and communicating the research. Institutions could implement agreed-upon requirements for safely conducting the research. The Office of Science and Technology Policy (OSTP) could also serve as a coordinating function and a venue for sharing determinations by the agencies to ensure consistency. In cases where an agency may be unsure of whether to fund a certain study or is unclear on how best to manage risks, OSTP could convene experts from across the government to advise the agency. The federal government could continue to provide guidance to institutions about DURC and GOF, and could encourage communication in the event of questions, concerns, or unexpected research developments, but the primary oversight role would reside with the federal funders. |
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a HHS (U.S. Department of Health and Human Services), CDC (U.S. Centers for Disease Control and Prevention), and NIH (National Institutes of Health). 2020. Biosafety in microbiological and biomedical laboratories (BMBL), 6th Edition. https://www.cdc.gov/labs/pdf/SF__19_308133-A_BMBL6_00-BOOK-WEB-final-3.pdf. (accessed August 12, 2025).
b HHS and USDA (U.S. Department of Agriculture). n.d. Federal select agent program. https://www.selectagents.gov/ (accessed August 8, 2025).
c NIH (National Institutes of Health). 2024c. NIH guidelines for research involving recombinant or synthetic nucleic acid molecules. Office of Science Policy, U.S. Department of Health and Human Services. (Amendments effective September 30, 2024).
REGULATORY AREA 6: HUMAN SUBJECTS RESEARCH
There has been some progress in reforming the regulatory framework for overseeing human subjects research in the United States, but the system remains fragmented. While reforms over the past decade have aimed to modernize oversight, reduce administrative burden, and better align protections with current research practices, implementation has been inconsistent and has sometimes introduced new challenges. Many federal requirements remain siloed or are not well coordinated across agencies. As with other areas of regulations, these disconnects create inefficiencies in how institutions and agencies apply oversight requirements, which can undermine the ethical and scientific integrity the system is meant to support.
The principles and guidelines governing the protection of human research subjects in the United States date to the 1979 Belmont Report, issued under the National Research Act of 197420 to ensure all such research adhered to three basic ethnical principles: respect for persons, beneficence, and justice (HHS, 2018, 2024b). Today, human subjects research is more directly guided and regulated by the Federal Policy for the Protection of Human Subjects, also known as the Common Rule, because it is codified in separate regulations by each of its agency and department signatories.21 It is ultimately at the discretion of each federal agency as to whether or not the Common Rule applies. While 20 agencies are current signatories to the Common Rule (HHS, 2025), not every agency that funds human subjects research has signed on.
Adoption of the Common Rule across agencies created needed harmonization, but there remain challenges in creating and implementing a fully cohesive policy for protecting human subjects across the federal government. This is seen, for example, in inconsistent definitions across agencies for key terms such as “clinical trial,” “human subjects,” and “engagement in research,” as well as duplicative or inconsistently applied reporting requirements, such as variations in ClinicalTrials.gov registration or adverse event reporting.22
Another challenge is inconsistencies in implementation and interpre-
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20 National Research Act of 1974, Public Law 93-348, 93rd Congress, 2nd sess. (July 12, 1974).
21 Federal Policy for the Protection of Human Subjects, 82 Fed. Reg. 7149-7274 (January 19, 2017).
22 For more information about relevant human subjects research definitions (and differences between FDA and NIH), please see Comparison of FDA and HHS Human Subject Protection Regulations | FDA.
tation that contribute to regulatory fragmentation. For example, research funded by HHS is subject to additional regulatory protections for certain populations of research subjects beyond the Common Rule,23 while DOD adds additional unique restrictions on waivers of informed consent,24 and DOE has specific requirements for protecting personally identifiable information.25 These differences can increase administrative complexities, delay study start-up, and lead to variability in how regulatory requirements are applied by researchers and IRBs.
Clinical investigations provide another set of examples of human subjects research facing particular challenges under the Common Rule. Human subjects research encompasses a variety of different research, including social and behavioral research and medical or clinical research, with varying degrees of regulation based on risk. Clinical investigations understandably require greater oversight to ensure participant safety but are subject both to policies from agencies that have adopted the Common Rule, such as HHS, DOD, VA, and others, and FDA regulations that are similar but not identical to the Common Rule, resulting in unnecessary duplicative oversight. Clinical trials also face potential conflicting requirements between the Common Rule and the Health Insurance Portability and Accountability Act (HIPAA) regulations for protected health information (PHI). HIPAA protects the privacy and security of identifiable health information held by covered entities, requiring specific authorizations or waivers for its use, while the Common Rule governs the ethical conduct of human subjects research through informed consent, IRB oversight, and safeguards for vulnerable populations. Their requirements often diverge—including differing definitions of “identifiable” data and “de-identification” and slightly different criteria for waivers of consent or authorization. This means a dataset could be considered nonidentifiable under the Common Rule but still be PHI under HIPAA, which means that researchers are then required to meet two separate standards for the same project.
Another significant challenge for human subjects research exists for work conducted across multiple sites. The 2016 National Academies’ report recognized that additional work and burden is created in multisite studies when each site needs to get approval of their materials and procedures from their individual IRBs. To streamline the processes, that report recom-
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23 Protection of Human Subjects, 45 C.F.R. Part 46 (August 21, 2025).
24 Protection of Human Subjects and Adherence to Ethical Standards in DOD-Conducted and –Supported Research, DOD Instruction 3216.02 (June 29, 2022).
25 Protection of Human Research Subjects, DOE 0 443.1C Chg.1 (November 26, 2019).
mended creating a single IRB on which all sites would rely. NIH adopted this recommendation in 2016, with required implementation by 2018. Use of a single IRB for multisite studies was additionally adopted in the 2018 revisions to the Common Rule, with slated implementation by 2020.
The 2018 Common Rule revision introduced new exemption categories regarding benign behavioral interventions and secondary research involving identifiable private information or biospecimens when broad consent is obtained, as well as modernized consent forms (HHS, 2017). At the same time, the revised Common Rule now includes the concept of “limited IRB review” for some categories that were previously exempt, such as research involving surveys of benign behavioral interventions and storage or maintenance of identifiable private information or biospecimens for secondary research use.
While this broadened the type of research that qualifies for exemption, it also introduced a new category of review requiring the development of new forms and procedures for IRBs that increased burden. Since adoption, challenges and unintended consequences have arisen that have not reduced duplicative reviews and that need to be addressed to ensure the single IRB does in fact reduce burden (Cathrall, 2018). For example, while the single IRB was intended to prevent the need for IRB approval at each individual site, in practice, some institutions have been reluctant to rely on a single IRB of record or have faced challenges navigating this change, such as resistance to change as well as continuing institutional oversight responsibilities (Burr et al., 2022; Green, et al., 2023).
Similarly, Common Rule revisions that expanded the types of exempt studies should mean that such studies are not included in protocol data provided to the Office for Human Research Protections. However, IRBs have not implemented these revisions consistently, resulting in potential discrepancies and inaccuracies across institutions (GAO, 2023). With the lack of harmonization and hesitancy to centralize processes, IRB workloads in some cases have increased significantly, and Common Rule implementation has been slowed across agencies (Green et al., 2023).
Beyond the Common Rule itself, institutions must also navigate an expanding array of intersecting federal requirements not originally designed for human subjects research oversight but that intersect with this oversight, such as data security, research security, export controls, and privacy regulations. For example, export control and research security regulations might apply for a study involving human subjects that includes foreign collaborations, data sharing, or international travel. IRBs typically do not
have expertise in these areas, but decisions about study approval may hinge on whether potential risks have been properly assessed. The absence of an appropriate framework for integrating requirements like this into an existing research oversight structure such as a Human Research Protection Program adds further complexity to the research process and can lead to inconsistent or duplicative compliance approaches.
Finally, challenges in human subjects research occur as a result of a lack of practical flexibility in the regulatory framework and inadequate adaptation to evolving research methods and technology (Ehidiamen and Oladapo, 2024; Fleischman, 2005; Walch-Patterson, 2020). With limited flexibility in practice, requirements and regulations can face unnecessary delays and are still insufficiently calibrated to risk. Without appropriate adaptation to new methods and clear guidance on integrating outside requirements, there is uncertainty in how to ensure compliance when engaging new and innovative research practices as well as when dealing with intersecting regulations.
The committee proposes options to streamline regulations, consider revisions to the single IRB structure, and develop risk-based tiered and modernized approaches to human subjects research.
Problem 1: Continued variation across agencies in human subjects regulations, oversight, reporting, and definitions.
Even with the adoption of the Common Rule as the overarching framework for human subjects research, the complexity and overlap of multiple regulations and agency requirements can create significant administrative burdens for researchers and staff. Navigating state, federal, and agency requirements, as well as understanding which regulations apply to specific research, can lead to confusion and delays in the approval process. Specific challenges arise for clinical investigations, for which both regulations from agencies that have adopted the Common Rule and FDA regulations can apply, resulting in duplicative efforts. Problems also arise when HIPAA regulations and the Common Rule both apply but may conflict, such as in instances when differences in definitions lead data to be considered nonidentifiable under the Common Rule but PHI under HIPAA. In addition, variation in the definitions of key terms and reporting requirements creates unnecessary uncertainty and lack of clarity for researchers.
| Option 6.1: Establish a federal harmonization mechanism with joint agency guidance | |
| Goal: Provide consistent guidance, reduce regulatory duplication, and maintain alignment in human subjects research oversight. |
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| Approach: To address fragmentation and confusion in human subjects research oversight, the federal government could establish a mechanism, such as an interagency working group under the Office of Science and Technology Policy or the Office of Management and Budget’s Office of Information and Regulatory Affairs, and possibly using the National Science and Technology Council, with clear authority and accountability to align human subjects research policies, definitions, and review processes across agencies and maintain ongoing coordination. This body could be empowered to review proposed and existing regulations for consistency, recommend policy adjustments to reduce duplication, and monitor agency implementation. This body could also lead a coordinated effort to review and align key definitions relevant to human subjects research across federal agencies, including “clinical trials,” “human subjects,” and “engagement in research” with enforcement capability to ensure agency participation. As a first step, participating agencies could issue joint federal guidance clarifying the applicability of overlapping U.S. Food and Drug Administration (FDA) and Common Rulea requirements, including practical examples outlining when each framework applies and clear compliance pathways for dual-regulated studies. As an ongoing effort, this body could regularly solicit feedback from the regulated community to identify additional problem areas related to any joint agency guidance and effect solutions to address any issues. This approach provides immediate clarity to researchers while ensuring long-term consistency and enforceable alignment across agencies. |
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| Option 6.2: Lead a cross-agency review to streamline and align federal human subjects research requirements | |
| Goal: Reduce complexity and duplication in federal human subjects research regulations while maintaining necessary protections. |
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| Approach: The U.S. Department of Health and Human Services (HHS) and other federal agencies that conduct or support human subjects research could lead a comprehensive cross-agency review of federal human subjects research regulations to identify duplicative, outdated, or conflicting requirements. This review could engage all agencies that have signed on to the Common Rule, FDA, and relevant HHS offices and incorporate stakeholder input with the goal of developing a roadmap for regulatory alignment and simplification while maintaining participant protections. This effort could also examine agency-specific processes, including separate human subjects review and/or extra layers of oversight requirements imposed by some agencies, which have been cited by researchers and staff who support their work as duplicative. |
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| Option 6.3: Issue joint federal guidance clarifying definitions and application | |
| Goal: Provide immediate, actionable clarity while longer-term regulatory alignment efforts proceed. |
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| Approach: Federal agencies could collaboratively issue joint guidance clarifying the definitions and applications of key terms within human subjects research regulations and agency guidance. As an example, definitions of “identifiable” and “de-identification” differ between the Common Rule and Health Insurance Portability and Accountability Act (HIPAA) regulations, and this and other conflicts could be addressed through ensuring consistency in terms. This guidance could use practical examples and case studies to illustrate how definitions apply across various research contexts, reducing confusion and variability in interpretation while agencies work toward longer-term harmonization. |
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| Option 6.4: Develop a centralized federal reporting framework | |
| Goal: Reduce duplicative and inconsistent federal reporting burdens while maintaining transparency and accountability in human subjects research. |
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| Approach: Federal agencies, led by HHS along with other agencies that conduct or support human subjects research, could collaborate to establish a unified reporting framework that standardizes human subjects research reporting requirements across agencies while eliminating duplicative submissions. This could involve creating a shared reporting portal for investigator activities such as trial registration, results reporting, and adverse event submissions, enabling institutions to meet obligations across agencies through a single consistent process. This could also work to standardize systems across agencies for Institutional Review Board (IRB) reporting requirements such as determinations of suspension, termination, and unanticipated problems. |
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| Option 6.5: Conduct a federal review of reporting requirements and issue joint guidance | |
| Goal: Eliminate redundant reporting, reduce unnecessary administrative workload, and provide clear, consistent guidance while maintaining transparency and participant protections. |
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| Approach: HHS could lead a comprehensive review of human subjects research reporting requirements across federal agencies, including FDA, the U.S. Department of Defense, U.S. Department of Veterans Affairs, U.S. National Science Foundation, and others involved in overseeing human subjects research, to identify redundancies and opportunities for streamlining. Following this review, agencies could issue joint guidance clarifying which reporting requirements for investigators as well as for IRBs are necessary, aligning definitions and timelines, and providing clear examples to reduce duplicative reporting and compliance confusion. |
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| Option 6.6: Make FDA the sole regulatory agency for human subjects research for clinical investigationsb | |
| Goal: Streamline regulations for clinical investigations and reduce redundant and duplicative regulatory oversight. |
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| Approach: The FDA, which oversees clinical investigations, is not a Common Rule agency. While required to harmonize with the Common Rule to the extent possible by law, it ultimately has differing regulations.a Rather than continue duplicative efforts across both the Common Rule and FDA, FDA would be established as the sole regulatory agency for clinical investigations. Researchers conducting clinical investigations would be subject only to FDA rules and requirements.c |
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| Option 6.7: Centralize compliance information in one accessible platform | |
| Goal: Simplify access to regulatory information, making it easier for the various stakeholders to understand which regulations apply to their specific research projects and reduce time spent navigating multiple sources, and improve consistency in compliance across the institution. |
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| Approach: This solution involves creating a centralized digital platform where all relevant regulatory and agency requirements are stored in one place so that institutions and other organizations can access the most up-to-date requirements from a centralized location. Researchers and institutional staff could access these regulations through an intuitive search function or browse through categories specific to their type of research. HHS could lead this effort in partnership with other federal agencies and allow states and institutions to build out information on further regulations/requirements for researchers to be able to navigate. This effort could leverage work in the International Compilation of Human Research Standardsd as well as similar compilations in other areas, such as privacy and research security. The platform would feature a user-friendly interface where users can search for specific regulations by keywords, research type, or regulatory category. It could also include helpful links to guidance documents and FAQs. The system would be continuously updated as new regulations are released, ensuring that researchers always have access to the latest compliance information. |
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| Option 6.8: Implement an interactive decision-support tool or flowchart for determining applicable regulations | |
| Goal: Enable researchers and staff to more quickly and accurately identify compliance requirements earlier in the process. |
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| Approach: This solution involves creating an interactive decision-support tool or flowchart that guides researchers through a series of questions to determine which regulations apply to their specific research project. Researchers could input key details about their study, such as the study type, research methodology, participant population, and funding sources, and the tool would generate a list of relevant regulatory and compliance requirements. Spearheaded by HHS and in partnership with other federal agencies, the tool could function as an interactive, step-by-step decision tree. Researchers would answer a series of yes or no questions or select options that describe their study. Based on these inputs, the tool would suggest a list of applicable regulations, such as the Common Rule, HIPAA,e FDA regulations, or other relevant laws, regulations, and agency guidance. It could also provide links to regulatory documents or guidance materials that researchers can review for further details. This tool could draw on AI tools to aid in producing suggestions for applicable requirements. |
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a HHS (U.S. Department of Health and Human Services). 2025. Federal policy for the protection of human subjects (“common rule”). https://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html (accessed July 8, 2025).
b COGR (Council on Governmental Relations). 2025. Actionable ideas to improve government efficiency affecting the performance of research. https://www.cogr.edu/sites/default/files/Actionable Ideas to Improve Gov Efficiency COGR_0.pdf (accessed July 8, 2025).
c COGR. 2025b. Request for Information: “Ensuring Lawful Regulation and Unleashing Innovation to Make America Healthy Again” (Docket No. AHRQ-20250001). COGR Response to DHHS Deregulation RFI. https://www.cogr.edu/sites/default/files/Final%20letter%20responding%20to%20HHS%20deregulation%20RFI%20July%202025%20PDF.pdf (accessed July 16, 2025).
d HHS. 2024a. International compilation of human research standards. https://www.hhs.gov/ohrp/international/compilation-human-research-standards/index.html (accessed July 8, 2025).
e Health Insurance Portability and Accountability Act of 1996, Public Law No. 104-191, 110 Stat. 1936 (August 21, 1996).
Problem 2: Implementation challenges for the requirement of a single IRB for multisite studies.
When conducting human subjects research, an IRB—an independent committee that reviews research methods and plans to ensure the ethical conduct of human subjects research—must approve the study. In the case of collaborative research conducted across multiple sites, as is common in biomedical research, there could be multiple IRBs duplicating each other’s efforts. In 2016, NIH adopted a single IRB policy and in 2018, the Common Rule was also revised to align with the recommendation of the 2016 National Academies report (NASEM, 2016). These changes mandated the use of a single IRB for most federally funded, multisite research (NIH, 2024b).
While the federal single IRB policy for multisite research was intended to eliminate duplicative IRB reviews, it did not fully account for the distinct institutional oversight responsibilities that remain outside the IRB’s remit. Institutions retain obligations for compliance and risk management through separate oversight bodies and ancillary committees, such as those overseeing radiation safety, export controls, research security, and scientific review, which IRB review alone cannot replace. As a result, some institutions have their IRBs take on additional compliance responsibilities or conduct separate internal reviews, leading to delays, administrative burden, and variability across institutions. In addition, negotiations to establish a single IRB agreement are complex, and inconsistent implementation across institutions undermines the intended efficiencies of the single IRB policy.
TABLE 2-12 Options to Address Challenges with Implementing a Single IRB (Regulatory Area 6)
| Option 6.9: Develop federal guidance clarifying institutional responsibilities under the single Institutional Review Board (IRB) policy | |
| Goal: Increase clarity on institutional responsibilities under the single IRB policy, reduce duplicative IRB submissions, and streamline multisite research review. |
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| Approach: Federal agencies, led by the National Institutes of Health (NIH) and U.S. Department of Health and Human Services, could develop and disseminate clear guidance clarifying the distinct roles and responsibilities of single IRBs versus institutional oversight obligations.a This guidance could address common issues institutions encounter, such as managing “local context” requirements,b reporting mechanisms, and delineating what must remain under institutional purview while minimizing redundant IRB reviews. |
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| Option 6.10: Evaluate and refine the single IRB policy based on implementation data | |
| Goal: Ensure that the single IRB policy is achieving its intended goals while addressing unintended consequences. |
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| Approach: Federal agencies could collect and analyze implementation data from institutions and IRBs to evaluate the effectiveness of the single IRB policy, identify barriers, and refine policy requirements where necessary to improve efficiency while maintaining protections. Refinement may include identifying exceptions to requirements as well as considering revisions to submission pathways for exception requests. |
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| Option 6.11: Encourage adoption of SMART IRB recommendations and local context tools | |
| Goal: Promote consistent, efficient, and effective implementation of single IRB review across federally funded multisite research while reducing unnecessary duplication and variability. |
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| Approach: NIH has funded efforts at SMART IRB to develop recommendations and guidelines for harmonizing IRB processes and improving coordination for single IRB review.c This option would entail continuing and expanding federal support for the development, refinement, and dissemination of these harmonization guidelines, including tools for managing local context and institutional responsibilities under single IRB frameworks. All federal agencies requiring or supporting single IRB review could actively encourage and support institutions and IRBs in adopting these harmonization guidelines and tools to improve consistency and reduce unnecessary duplication. |
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a Johnson, A., M. Singleton, J. Ozier, E. Serdoz, J. Beadles, J. Maddox-Regis, S. Mumford, J. Burr, J. Dean, D. Ford, and G. Bernard. 2022. Key lessons and strategies for implementing single IRB review in the Trial Innovation Network. Journal of Clinical and Translational Science 6:1–16.
b Morain, S. R., J. Bollinger, M. K. Singleton, M. Terkowitz, C. Weston, and J. Sugarman. 2025. Local context review by single institutional review boards: Results from a modified Delphi process. Journal of Clinical and Translational Science 9(1):e2.
c SMART IRB. n.d. A roadmap to single IRB review. https://smartirb.org/ (accessed July 8, 2025).
Problem 3: Limited flexibility and timeliness within existing regulatory frameworks.
While exempt, expedited, and full board review pathways exist, federal regulations and guidance often lack practical flexibility, clear criteria, or timely processes to adjust oversight proportionally to the level of risk, public health urgency, or societal need. This can lead to unnecessary delays, hindering the rapid launch of lifesaving, rare disease, or other high-priority research when it is most needed.
| Option 6.12: Establish accelerated and flexible pathways for high-priority and emergency research | |
| Goal: Enable the rapid and responsible launch of critical high-impact research during emergencies and for high-priority scientific needs. |
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| Approach: Federal agencies led by the U.S. Department of Health and Human Services (HHS) along with other agencies that conduct or support human subjects research could develop accelerated regulatory pathways and guidance for research addressing life-saving interventions, rare diseases, and urgent public health needs. This could include rolling reviews, time-bound review commitments, prereview consultations, and the ability to activate flexibility through centralized review and streamlined documentation—for example, during public health emergencies or for high-priority research—while ensuring appropriate protections remain in place. |
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| Option 6.13: Establish a federal task force to identify and address bottlenecks in review timelines | |
| Goal: Reduce systemic delays in the regulatory review processes for all human subjects research. |
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| Approach: A dedicated federal task force led by HHS along with other agencies that conduct or support human subjects research could systematically review timelines across agencies to identify inefficiencies, duplicative processes, and other systemic barriers to timely research review. The task force would recommend specific process improvements and, where necessary, regulatory changes to streamline timelines while maintaining participant protections. |
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Problem 4: Inadequate adaptation to evolving research methods and technologies.
Federal regulations have not kept pace with evolving research practices, such as decentralized trials, use of digital health tools, and AI-driven protocols, leading to uncertainty regarding how to ensure compliance while supporting innovation. Though some federal agencies have issued guidance on specific topics, there is no comprehensive cross-agency framework clarifying how human subjects protections apply to emerging research methods and technologies. This creates confusion and inconsistent applications of requirements while potentially slowing the development of innovative participant-centered research approaches.
| Option 6.14: Establish a cross-agency initiative to align and consolidate guidance on emerging research methods | |
| Goal: Provide clear, consistent, and actionable federal guidance on how existing human subjects protections apply to evolving research methods, reducing confusion and supporting responsible innovation. |
| Approach: The federal government, through the U.S. Department of Health and Human Services and other agencies that conduct or support human subjects research, could establish a cross-agency initiative, led by an oversight body with authority and accountability, to review and consolidate existing agency guidance on emerging research methods and identify areas requiring further clarification. The goal would be to develop a clear, unified federal framework or compendium that aligns interpretations across agencies, fills critical gaps, and removes inconsistencies while preserving participant protections. |
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Problem 5: Lack of federal guidance on integrating nonhuman subjects requirements within human research protection programs.
Federal requirements outside of direct human subjects research oversight, such as data security, research security, export controls, and privacy regulations, often intersect with human subjects research without clear federal guidance on how these requirements should be integrated within a Human Research Protection Program, which includes IRB review processes, investigator responsibilities, and institutional oversight obligations. These intersecting requirements can directly affect protocol design, data collection, data sharing, and international collaboration within human subjects research, yet there is often no clear framework clarifying how institutions should interpret, prioritize, or operationalize these obligations alongside human subjects protections. This lack of integration guidance creates complexity and uncertainty for institutions, leading to duplicative or inconsistent compliance processes, increased administrative burden, and delays in study initiation without necessarily enhancing participant protections.
| Option 6.15: Establish a federal integration task force with clear authority and timelines | |
| Goal: Improve integration of human subjects oversight with nonhuman subjects regulation and increase clarity for institutions. |
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| Approach: The federal government could establish a cross-agency task force, coordinated by the Office of Science and Technology Policy and Office of Management and Budget, to systematically review the intersection of human subjects research regulations and oversight in data security, research security, export controls, and privacy regulations. The task force could clarify how intersecting nonhuman subjects regulations should integrate with human subjects oversight. It could engage stakeholders throughout the process to ensure practical implementation and to promote alignment with evolving research practices while maintaining participant protections. To ensure effectiveness, the task force could be explicitly charged with recommending and monitoring implementation timelines, with progress reports made public to enhance accountability and transparency. |
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| Option 6.16: Develop a federal interactive compliance integration tool | |
| Goal: Enable institutions and researchers to determine which intersecting federal requirements apply to their research and how to operationalize them within the Human Research Protection Program (HRPP) processes without unnecessary duplication. |
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| Approach: Federal agencies led by the U.S. Department of Health and Human Services and other agencies that conduct or support human subjects research could jointly develop an interactive, web-based, or application programming interface-enabled digital tool that helps institutions, Institutional Review Boards, and investigators determine which nonhuman subjects federal requirements regarding research security, export controls, data security, and privacy laws apply to specific human subjects research protocols. This tool would also provide advice on how to integrate them into HRPP workflows efficiently. Ideally, users would enter key project details, such as funding source, study type, data type, and any foreign collaborations, and receive customized output outlining applicable nonhuman subjects research requirements with clear action steps. |
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REGULATORY AREA 7: RESEARCH USING NONHUMAN ANIMALS
Research using nonhuman animals is governed by an expansive set of requirements and regulations intended to ensure the welfare of vertebrate animals used in research. These protections are important but have unfortunately faced challenges as they have grown in complexity over time in ways that can slow down research without adding significantly to animal welfare. Problems in the current system for regulating animal research include redundancies, contradictions,26 outdated or overly detailed requirements, and onerous paperwork and reporting that provide little if any benefit for animal welfare.27
One of the significant challenges in animal research is the multiagency structure for oversight including USDA Animal and Plant Health Inspection Service, NIH Office of Laboratory Animal Welfare (OLAW), VA, DOD, and others (DOD, 2025; NIH OLAW, 2015, 2024; VA, n.d.). This has created a regulatory framework of conflicting and duplicative require-
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26 One such contradiction involves policies regarding cage sizes for lab animals. USDA relies on its own regulations for cage sizes under 9 C.F.R., while PHS relies on minimum cage size recommendations in the Guide for the Care and Use of Laboratory Animals, which are not fully aligned with each other.
27 While the committee was preparing this report, NIH announced on July 18, 2025, that new funding opportunities will prioritize human-based technologies and models and will encourage alternatives to animal models. In addition, FDA has announced plans to reduce or phase out animal testing requirements for certain drugs and biologics.
ments. Minor efforts to harmonize and streamline regulations and policies have occurred. For example, USDA changed its annual review of animal activities by the Institutional Animal Care and Use Committee to align with PHS requirements. However, the changes that have occurred have not eliminated duplicative and at times contradictory oversight of animal research and, unlike human subjects research, animal research has not developed or implemented a Common Rule structure.
Other efforts have been made to address these challenges. In 2019, as required under Title II, Section 2034(d) of the 2016 21st Century Cures Act (NIH et al., 2019), NIH, USDA, and FDA convened a working group to review existing policies and regulations related to the care and use of laboratory animals and make recommendations to reduce administrative burden. The working group concentrated on reducing duplicative regulations and policies and improving coordination across agencies. The report focused mainly on actions to revise the existing structure and “reduce administrative burden on investigators while maintaining the integrity and credibility of research findings and protection of research animals” (FDA, n.d; NIH et al., 2019).
There have been some efforts by outside groups such as the Federal Demonstration Partnership (FDP) to help with streamlining management of regulations for research with nonhuman animals. In 2024, the FDP piloted an online repository called the Compliance Unit Standard Procedures where institutions can share best practices and standard procedures for animal care and welfare. This effort is intended to provide a database repository of consistent and compliant procedures (Bury and Cowell, 2024). The effort is still in early stages and at the time of writing was open only to FDP member institutions.
Inefficient structures and requirements for maintaining Animal Welfare Assurances also increase regulatory workload. Institutions must have a valid Animal Welfare Assurance to conduct PHS-funded research with animals. The current system relies on email correspondence to manage assurances rather than use of a digital platform, as is the case for human subjects research assurances through the HHS Office for Human Research Protections, HHS ORI, and the NIH Office of Science Policy. In addition, OLAW requires a substantially detailed description of institutional animal care and use programs, typically at least 20 pages long but often longer. This can result in processes that take months to review and often involves one or more rounds of revision by the institution.
Finally, challenges arise from unclear and overly strict guidance from OLAW. OLAW, while not a regulatory agency, creates policies, guidance, and recommendations. To this end, OLAW has created more than 150 documents outlining detailed paperwork and administrative requirements as well as guidance for research animal programs that in many instances provide no direct benefit to animal welfare but consume precious research resources. While guidance documents do not carry legal or regulatory power, this fact is often not communicated effectively. As a result, “guidance” documents become requirements imposed on researchers and institutions based on interpretation (COGR, 2017). Therefore, at times, researchers and institutions interpret guidance documents as official regulatory policy and adhere to recommendations that are not required (NASEM, 2016). Instead of a single, clear, and authoritative standard, institutions are left navigating a fragmented and ever-growing body of advisory material, contributing to regulatory creep and administrative burden.
In part, this has occurred because of an overly strict interpretation of the Guide for the Care and Use of Laboratory Animals (the Guide) (NRC, 2011). The Guide serves as a key document for all research with nonhuman animal subjects but was not intended to be interpreted as regulatory requirement. In addition, the Guide has not been sufficiently updated since 2011, leading to out-of-date guidance, and no new funding has been allocated for a present-day revision that would capture important advances in technology and improved knowledge of best practices (COGR, 2017).
The committee offers a number of options below to address these challenges, focusing on streamlining, harmonization, and ensuring clear and up-to-date guidance. The committee also provides options to enhance the digital infrastructure of agencies, streamline guidance, and provide regular updates to the Guide.
Problem 1: Lack of harmonization in regulation of research using nonhuman animals across federal agencies.
Multiple federal agencies have regulations and requirements governing the use of vertebrate animals in research as noted previously. Each of these agencies have disparate or additive administrative requirements, regulations, and policies that at times conflict with or directly contradict each other, creating challenges for researchers.
| Option 7.1: Establish a single agency or office to oversee the use of animals in research | |
| Goal: Create a streamlined set of regulatory standards developed and implemented by a single body, allowing for efficient and expedient compliance with consistency for vertebrate animals used in research regardless of funding source. |
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| Approach: An act of Congress could create a new government agency or mandate the sole use of one existing agency. This centralized agency would be responsible for developing uniform and consistent regulations, standards, and administrative processes for all U.S. research institutions. |
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| Option 7.2: Eliminate the Animal Care and Use Review Office (ACURO) in the U.S. Department of Defense and establish the USDA as the sole regulatory agency for research of species covered by the Animal Welfare Act and the Office of Laboratory Animal Welfare (OLAW) as the sole oversight body for research funded by the U.S. Department of Health and Human Services involving all other vertebrate (non-USDA covered) species | |
| Goal: Reduce the number of agencies involved in the regulation of research animals while relying on existing agencies and structures to streamline the process. |
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| Approach: ACURO and other similar agency offices could be eliminated as they not only duplicate oversight by the USDA and OLAW but also re-review projects already approved by the federally mandated Institutional Animal Care and Use Committee. With this option, all oversight powers could be contained within USDA and OLAW. The overlapping oversight components for USDA and OLAW could be eliminated, but each group would maintain a different scope of oversight, clearly delineated by which vertebrate species are covered by the Animal Welfare Act and removing duplicative and contradictory compliance requirements for species that are both covered by the USDA and involved in Public Health Service- and U.S. National Science Foundation-funded research.a |
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| Option 7.3: Increase coordination between agencies to provide for consistency between all federal agencies involved in oversight of animal research | |
| Goal: Increase interagency coordination and consistency. |
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| Approach: Improved interagency coordination could be undertaken by establishing a new or empowering an existing National Science and Technology Council subcommittee or working group that includes representatives from USDA, NIH OLAW, ACURO, as well as animal research offices in the U.S. Department of Veterans Affairs, NASA, and National Institute of Standards and Technology. |
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a COGR (Council on Governmental Relations). 2025b. Request for Information: “Ensuring Lawful Regulation and Unleashing Innovation to Make America Healthy Again” (Docket No. AHRQ-2025-0001). COGR Response to DHHS Deregulation RFI. https://www.cogr.edu/sites/default/files/Final%20letter%20responding%20to%20HHS%20deregulation%20RFI%20July%202025%20PDF.pdf (accessed July 16, 2025).
Problem 2: Previously identified burdensome and overly detailed NIH OLAW requirements.
OLAW has developed overly detailed administrative and reporting requirements that significantly increase researcher administrative workload through additional paperwork with little direct benefit to animal welfare. PHS Policy allows for Animal Welfare Assurance approval of up to 5 years, yet OLAW requires renewal every 4 years, along with annual reports, documentation of semi-annual reviews, and in instances where a protocol deviation occurs, in-time reports of noncompliance regardless of the degree to which the deviation affects animal welfare (NASEM, 2016). This stems in part from an overly stringent interpretation of the Guide, well beyond what was intended by the authors and research community at the time of the latest version’s publication (COGR, 2017; NRC, 2011). Further compounding the burden is the over-reliance on email and lack of online submission portals, which are used by other offices within HHS for analogous purposes.
| Option 7.4: OLAW can streamline guidance to only the Public Health Service (PHS) Policy and the Guide for the Care and Use of Laboratory Animalsa and interpret the Guide as it was intended | |
| Goal: Avoid unnecessary and time-intensive compliance with additional suggestions that are not found in OLAW’s foundational documents and do not help researchers or improve the welfare of research animals. |
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| Approach: Use the two required documents, PHS Policy and the Guide, as the main guidance from OLAW and eliminate multiple paperwork-based requirements. OLAW could eliminate most, if not all, of its guidance requirements that fall outside the direct scope of the PHS Policy and the Guide and, moving forward, could provide institutions the flexibility to interpret and use the Guide as it was intended.b OLAW could also clarify any guidance that remains does not have legal or regulatory authority.c |
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| Option 7.5: Update digital infrastructure and Animal Welfare Assurance processes for OLAW in alignment with analogous U.S. Department of Health and Human Services (HHS) oversight offices | |
| Goal: Use an existing model of assurance and registration approvals to significantly improve the effectiveness and efficiency of the NIH Assurance approval and renewal process. |
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| Approach: The OLAW Assurance process could be streamlined by aligning it with other HHS office entities that also require assurances or registrations, including HHS Office for Human Research Protections, HHS Office of Research Integrity (ORI), and NIH Office of Science Policy. Not only do the other offices use digital platforms for registration and assurance reviews, they also have streamlined such information to approximately two pages, eliminating the need for dozens of text-heavy pages that must be reviewed and critiqued. OLAW Assurance renewal can take months. In contrast, with a more streamlined process, the renewal process for HHS ORI can be completed within days. Given the successful implementation of such efficient, effective, and time-saving workflows at analogous offices, NIH OLAW can leverage an already existing model of enhanced productivity and consistency. |
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a NRC (National Research Council). 2011. Guide for the care and use of laboratory animals: Eighth edition. Washington, DC: The National Academies Press.
b COGR (Council on Governmental Relations). 2025b. Request for Information: “Ensuring Lawful Regulation and Unleashing Innovation to Make America Healthy Again” (Docket No. AHRQ-2025-0001). COGR Response to DHHS Deregulation RFI. https://www.cogr.edu/sites/default/files/Final%20letter%20responding%20to%20HHS%20deregulation%20RFI%20July%202025%20PDF.pdf (accessed July 16, 2025).
c COGR. 2017. Reforming animal research regulations: Workshop recommendations to reduce regulatory burden. https://www.cogr.edu/sites/default/files/Animal-Regulatory-Report-October2017.pdf (accessed June 24, 2025).
Problem 3: Lack of a sustainable mechanism for revising the Guide for the Care and Use of Laboratory Animals.
The Guide, originally published in 1963 and last revised in 2011, is a fundamental document used as guidance throughout the global research community working with laboratory animals. The Guide was updated with some regularity following its initial publication in 1963, with NIH issuing revisions in 1965, 1968, 1972, 1978, 1985, 1996, and 2011. Information in the current Guide does not reflect the most recent scientific advances, and research practices for many laboratory settings, and does not always offer guidance on nontraditional research applications and animal models. As a result, some requirements in the Guide are outdated and may lead to unnecessary efforts, given the availability of new knowledge and best practices. In the absence of updated guidance, NIH OLAW has issued more than 150 commentaries, FAQs, and guidance documents aimed at clarifying expectations. Although these materials are presented as recommendations, unless
| Option 7.6: The National Institutes of Health, NASA, U.S. Department of Veterans Affairs, U.S. Department of Defense, and other federal agencies that require extramurally funded institutions to follow the Guide for the Care and Use of Laboratory Animals (the Guide)a would financially sponsor regular revisions | |
| Goal: Ensure the Guide is reflective of current laboratory animal science knowledge and standards. |
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| Approach: Agencies that require adherence to the Guide could financially sponsor revisions to the Guide on a predetermined periodic basis. |
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| Option 7.7: Congress mandates that the Guide be updated and revisited periodically | |
| Goal: Ensure the Guide is reflective of current laboratory animal science knowledge and standards. |
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| Approach: Congress can require that the Guide be updated periodically and appropriate funds for the effort. |
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a NRC (National Research Council). 2011. Guide for the care and use of laboratory animals: Eighth edition. Washington, DC: The National Academies Press.
specifically mandated, they often function as de facto requirements across academic institutions. NIH OLAW has attempted to provide some flexibility by allowing institutions to use an alternative approach if they satisfy the requirements of the PHS Policy. Revisions of the Guide have been supported by funding from NIH and other governmental and nongovernmental entities, but no dedicated funding has been allocated for updates in recent years.
CONCLUDING THOUGHTS
The U.S scientific, engineering, and biomedical enterprise has long been the envy of the world, driving innovation and discovery across sectors that has benefited and shaped society. Ensuring that federally funded science is safe, is conducted with integrity, and protects the interests of the public requires federal oversight and regulation. However, over time, these regulations and requirements have proliferated without sufficient checks, resulting in duplicative agency requirements and disjointed, outdated systems that add heavy workload to implement and hinder innovation. In many cases, a lack of alignment or harmonization, overlapping requirements, and inconsistent implementation have contributed to a fragmented and complex oversight environment, where multiple regulatory demands may apply simultaneously, creating inefficiencies and diverting resources from research itself. A comprehensive reexamination is needed to ensure that regulations and policies continue to support the integrity, security, transparency, and ethical conduct of research while promoting coordination, clarity, and flexibility across the research enterprise.
For years, researchers, groups representing higher education institutions, policymakers, and others have called for reforms to the oversight of federally funded research that provide clear and actionable methods for decreasing burden. However, little progress has been made in implementing these reforms. The U.S. scientific enterprise continues to experience domestic challenges (NASEM, 2023) while competition from other countries is increasing, making it essential that American science advances without unnecessary hindrance. Therefore, it is critical that the federal government take action to revise federal research requirements and oversight processes.
Although the reform options outlined in this report take varying degrees of effort and resources to implement, there is at least one recent example of a potentially promising reform effort that could serve as a model of implementation and demonstrate the value of embracing new approaches. In response to growing concerns about foreign threats to the
security and integrity of U.S. research, the CHIPS and Science Act of 202228 directed NSF to establish an organization to help researchers meet federal research security requirements. This organization, established in September 2024 and now known as the SECURE Program, including the SECURE Center and SECURE Analytics, serves to connect the research community and collectively design and develop resources and tools to address research security risks and federal agency research security requirements. Although it is relatively new and its evaluation is ongoing, the SECURE Center could be a model for community codesigned resources that facilitate coordinated implementation across institutions. Realization of the SECURE Program stemmed from significant federal-wide interest and concerns from Congress, the White House, national security agencies, and research funding and other agencies and offices about malign foreign influence. Absent this kind of intense focus in other areas, achieving progress and coordination has proved to be incredibly challenging.
Furthermore, leveraging emerging technologies, such as AI, as several options in this chapter propose, may ensure that researchers and regulators both incorporate technology appropriately to increase efficiency. As new technologies such as AI are developed and operationalized, they have the potential to substantially reduce the time, energy, and resources spent across various stages of the research timeline. Special care should be taken to ensure that all institutions have access to these new technologies. Smaller Emerging Research Institutions29 and traditionally under-resourced institutions (NASFAA, 2021) often struggle with having the necessary resources to utilize technologies such as AI across their institutions. Widening the use of innovations may require targeted funding for infrastructure development to ensure that both small and large institutions can benefit from the potential of burden reduction tools like AI. Integrating novel tools into current and future regulatory activities can significantly reduce the time researchers spend navigating compliance, particularly when coupled with the options for streamlining, harmonization, and reduction detailed previously.
At the same time, as new transformative technologies arise, they will likely require their own regulations and guidance to ensure ethical use in research as well as alignment across agencies. For example, as new technologies such as computational modeling of complex systems, organ-on-a-chip
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28 Creating Helpful Incentives to Produce Semiconductors for America (CHIPS) and Science Act of 2022, Public Law 117-167 (August 9, 2022).
29 Definitions, 42 U.S.C. § 18901 (August 11, 2025).
systems, and other new approach methodologies are developed, federal agencies are crafting guidance for use of these new technologies and need to coordinate these efforts (FDA, 2025). In addition, developing appropriate AI models requires substantial time and resources. While these technologies have the possibility to produce transformative change, there is still work and cost attached to getting them there.
As various actors work to ensure a more efficient and streamlined regulatory environment, the committee once again encourages policymakers to consider the three principles detailed in this chapter: harmonize research requirements across agencies, take a risk-tiered approach to new requirements, and use technology to simplify requirements and their implementation to the extent possible. Adhering to these principles can ensure an appropriate balance between the oversight needed to ensure federally funded science is safe, ethical, and responsive to the interests of the public,
BOX 2-1
Illustrative Case of a Possible Future in the Regulatory Environment
Dr. Linh Tran, an associate professor of robotics at an emerging research university, had always known what she wanted to do. As a child, she watched her sister struggle after losing the use of her arm in an accident. Dr. Tran dreamed of building prosthetics that could restore both motion and dignity—devices as intuitive as a natural limb.
Now, years later, Dr. Tran was on the brink of realizing that vision. Her lab had made major advances in brain-computer interfaces, and her newest prototypes—infused with artificial intelligence—showed the potential to respond to human thought with lifelike precision. With support from the U.S. National Science Foundation (NSF), the U.S. Department of Defense (DOD), and an industry partner, her team was ready to scale. And unlike years past, the process to get there had not been a bureaucratic marathon.
Thanks to recent reforms, NSF and DOD had adopted a shared administrative platform. Dr. Tran submitted her proposal packages to each agency through a unified research portal. To her surprise, both agencies had adopted the same two-step proposal process. Her initial proposals were only five pages long, and upon learning they were to be
and reducing administrative workloads that can liberate and catalyze needed scientific discovery and innovation to advance the well-being, prosperity, and security of the nation.
In Chapter 1, the committee laid out an example of the types of burdens the current research requirements impose on researchers. In Box 2-1, the committee describes the same researcher described in Chapter 1 but in a world where research regulations and requirements have been reformed. This world is a possibility when the principles of harmonization, risk-tiered regulation, and user-friendly technology guide changes to federal research regulation and oversight.
funded, she was asked for more detailed documentation. In this process, budget templates, biosketches, and compliance documentation were harmonized, and redundant questions about team composition and institutional approvals were eliminated.
As her projects launched, she completed one annual conflict of interest disclosure as agencies had aligned their definitions of “significant financial interest” and other requirements. At the same time, her postdoc, a brilliant biosystems engineer from South Korea, was cleared to work on the project through a streamlined vetting process for foreign collaborators. Questions about export controls and research security were addressed easily because the federal government had significantly harmonized and clarified its screening criteria.
Dr. Tran’s postdoc arrived within months and hit the ground running. DOD no longer required its own Institutional Review Board (IRB) approval, so when the university IRB approved the study, the postdoc was ready to begin recruiting subjects.
By the end of the first year, Dr. Tran’s lab had published a major paper, filed a provisional patent, and started to develop plans for a pilot clinical study with volunteers. She still worked long hours, but they were spent mentoring students, analyzing data, and pushing science forward with far fewer hours on administrative requirements. The barriers were lower, the systems were smarter, and Dr. Tran finally felt like the pace of discovery matched the urgency of the need.
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