Regulatory Alerts

The Division of Research provides timely updates about changing regulations and policies affecting your research program and compiles them on the Regulatory Alerts webpage. Current Regulatory Alerts provide updates on new Responsible Conduct of Research training requirements, safe and inclusive workplace requirements, data management plans, and support disclosure and biosketch requirements.

Scroll down or use the navigation bar at the right to view articles. The articles provide synopses with links to additional details.

As new articles are added, past editions of Regulatory Alerts will be available on the archived page, where you can also search topics by keyword.

NIH award recipients should report foreign co-authorship to the funding Institute or Center as soon as they become aware of it, so NIH can determine whether additional steps are needed. Faculty should also ensure NIH-funded publications accurately acknowledge federal support, avoid attributing publications to awards that did not support the work, and review NOFO restrictions carefully because some NIH programs do not permit foreign components.  NIH also emphasizes that foreign co-authorship does not automatically mean a foreign component exists in every case, but most instances of co-authorship involving a foreign collaboration may require review.

These reminders are provided after NIH issued Notice NOT-OD-26-084, Reminder - Definition of Foreign Components, to clarify that NIH has not expanded its longstanding definition of a foreign component, even as NIH oversight of foreign collaborations has increased. NIH defines a foreign component as the performance of any significant scientific element or segment of a project outside the United States, whether by the recipient or by a researcher employed by a foreign organization, and regardless of whether NIH funds are expended. Examples may include human subjects or animal work at a foreign site, extensive foreign travel for data collection or similar activities, use of facilities or instrumentation at a foreign site, collaborations with investigators at a foreign site expected to result in co-authorship, or receipt of financial support or resources from a foreign entity. For questions, contact the Office of Sponsored Programs.

Federal research security requirements prohibit participation in malign foreign talent recruitment programs (MFTRPs). The U.S. Department of Energy recently highlighted these restrictions as part of its research security communications. Faculty should carefully review any foreign appointment, affiliation, consulting arrangement, talent program, sponsored position, laboratory appointment, or similar offer before accepting or continuing participation. These restrictions are part of the federal government’s broader research security framework and are intended to prevent foreign governments or affiliated entities from using talent recruitment arrangements to obtain U.S. research, technology, intellectual property, or federally funded expertise in ways that conflict with U.S. national and economic security interests.

Arrangements that include compensation, access to research results, obligations to recruit others, duplicate commitments, undisclosed appointments, transfer of intellectual property, or requirements to perform work for a foreign institution may raise research security concerns.

Clemson University's Foreign Talent Recruitment Programs Policy requires annual certification by all research personnel as part of the Conflict-of-Interest disclosure process. The policy also prohibits research personnel from participating in Malign Foreign Talent Recruitment Programs. Faculty with questions about a foreign affiliation or talent program should contact the Office of Research Security before signing or participating.

Faculty, staff, and students traveling to or transiting through Hong Kong should be aware of recent changes to Hong Kong’s National Security Law implementation rules. According to a recent security alert from U.S. Consulate General Hong Kong, individuals in or transiting through Hong Kong, including U.S. citizens, may face criminal penalties for refusing to provide passwords or decryption assistance for personal electronic devices such as laptops and cell phones. The alert also noted that Hong Kong authorities may have expanded authority to take and retain devices they allege are connected to national security matters.

Because travelers may be required to provide access to electronic devices, Clemson personnel should avoid carrying unnecessary sensitive information and should consult the Office of Research Security before international travel involving research, University data, or other sensitive information. When possible, travelers should use loaner devices, limit access to Clemson systems and data to what is necessary for the trip, and follow University guidance regarding secure remote access while abroad.

A joint federal publication, Safeguarding Our Data, Intellectual Property, and Technology from Non-traditional Collectors, warns that foreign governments may seek to acquire U.S. technology and intellectual property by using academics, students, researchers, business professionals, or technology professionals as “non-traditional collectors.” The publication explains that these individuals may not have a direct relationship with a foreign intelligence service, but may still acquire intellectual property, proprietary information, sensitive technology, research data, or personally identifiable information to support a foreign government’s economic, military, technology, or national development goals. The publication specifically identifies countries such as China, Iran, and Russia as examples of governments seeking to acquire U.S. technology and intellectual property through these methods.

The publication encourages organizations to watch for indicators such as false or incomplete information on applications, unusual interest in U.S. government-funded research or personnel, unauthorized use of recording devices or removable media, attempts to conceal foreign affiliations or funding, suspicious computer activity, and efforts to access sensitive information outside the scope of assigned duties. Recommended mitigation steps include vetting individuals with access to sensitive work, protecting important data with encryption and strong authentication, limiting access to sensitive research and information systems, providing clear guidance on device and travel security, and reinforcing reporting mechanisms for suspicious activity. For questions, contact the Office of Research Security.

The National Institutes of Health (NIH) has issued Notice NOT-OD-26-046: Updated Elements of an NIH Data Management and Sharing Plan, which updates the required format and elements for Data Management and Sharing (DMS) Plans. Effective for NIH applications with due dates on or after May 25, 2026, applicants must use a new standardized DMS Plan format.

Under the revised format, investigators will respond to a series of structured yes/no questions addressing data sharing, sharing timelines, data availability, protections for human participant data, and, where applicable, genomic data sharing requirements. The format also includes a brief explanation section for any limitations on data sharing and a concise table identifying anticipated data types and established or proposed repositories.

For more information about DMS plans, please visit the library resources or additional context from the Office of Sponsored Programs.

On Feb. 18, The National Institutes of Health (NIH) issued a reminder Notice NOT-OD-26-043: Reminder of Requirement for Certification of IRB Approval to remind the extramural research community of the requirement to provide certification of Institutional Review Board (IRB) approval for all nonexempt human subjects research as part of Just-in-Time requirements. Pending, conditional, interim, or expired IRB approvals do not satisfy this requirement.

The notice also reiterates that NIH funds may not be used to conduct nonexempt human subjects research without current IRB approval. While NIH may, at its discretion, issue an award before IRB certification is received, any resulting award will include restrictions on conducting human subjects research activities until the required IRB approval documentation has been provided and accepted.

If you have any questions about this requirement, please contact the IRB Office at irb@clemson.edu.

In a NIH Extramural Nexus article, Helpful Reminders to Ensure Integrity of NIH-Supported Research When Using AI, NIH reminded the research community that investigators remain responsible for the accuracy, integrity, and confidentiality of all research activities when using artificial intelligence (AI) tools

The article highlights some helpful reminders on the appropriate use of AI tools when applying, managing awards, and conducting the research process. NIH emphasizes that AI tools may be appropriate to assist with application preparation for limited aspects or in specific circumstances, but researchers should be aware that using AI carries its own risks. Applications that are either substantially developed by AI or contain sections substantially developed by AI are not considered the original ideas of applicants and will not be considered by NIH. 

To learn more about responsible AI use at Clemson, visit Clemson’s Generative AI Guideline, Academic and Research AI Usage Quick Guide, AI Tool and University Data Use Guide, and AI Resources and Training pages. Researchers should use these resources to understand appropriate AI use, data protection expectations, disclosure responsibilities, and when a tool or use case should be submitted through Clemson’s CheckIT Technology Approval Process for review. 

Have a TCP or other sponsor-regulated info? Contact the Office of Research Security at researchsecurity@clemson.edu.

Faculty who receive a Data Use Agreement (DUA), data access agreement, Non-Disclosure Agreement (NDA), Material Transfer Agreement (MTA), confidentiality agreement, or similar document from an outside organization should not sign it individually or begin accessing the data before institutional review. These agreements may create legal, regulatory, security, privacy, export control, or sponsor-compliance obligations for Clemson, even when the data appear routine or the project is already underway.

These agreements should be routed to the Office of Sponsored Programs before signature or acceptance. OSP will coordinate with the appropriate Clemson offices as needed to determine whether the agreement requires additional review, such as data security planning, privacy review, export control review, controlled data handling requirements, or use of an approved secure computing environment. Faculty should contact OSP before signing, downloading, receiving, storing, sharing, or analyzing data under a DUA.

Clemson’s policy for addressing Research Misconduct allegations has been updated to comply with a recent Final Rule from the Office of Research Integrity. The new policy has four sections: Definitions, Misconduct Policy, Assessment and Inquiry, and Investigations. In revising the federal policy, ORI stated goals of “Clearer assurance, compliance, and research misconduct processes for institutions to follow” as well as “An expanded list and clarifications of commonly used terms.” The new policy is in effect as of January 1, 2026. Click for more information about the federal policy change.

In addition, the National Science Foundation recently revised its definition of Research Misconduct to include the use of AI. The underlined text has been added:

• RESEARCH MISCONDUCT means fabrication, falsification, or plagiarism, whether committed by an individual directly or through the use or assistance of other persons, entities, or tools, including artificial intelligence (AI)-based tools, in proposing or performing research funded by NSF, reviewing research proposals submitted to NSF, or in reporting research results funded by NSF.

This change was effective for all projects awarded on or after December 8, 2025.

Other Support Disclosure Training: In response to NIH's new requirement that institutions must provide training to NIH applicants on Other Support disclosures, the Office of Sponsored Programs has developed this eight-minute Tiger Training course that covers what, when, where and how disclosures should be made. If you receive a Just-in-Time notification from NIH, you are required to watch this video, which will record the date and time of viewing in your InfoEd profile. Go to Tiger Training, search for "NIH Disclosure Requirements," and enroll in the course. 

Research Security Training: Research Security Training is available in Tiger Training. To enroll, go to the Research Security Tiger Training course. This training explains the risks and threats facing the global research ecosystem and provides the knowledge and tools needed to protect against them. All individuals involved in research are encouraged to complete the course. Federal agencies now require this training under the CHIPS and Science Act of 2022 (CHIPS Act), National Security Presidential Memorandum-33 (NSPM-33), and related regulations. In line with these requirements, covered individuals (senior/key personnel) on federally funded research and development awards must complete the training every year.

Effective October 1, 2026, NIH will post Notices of Funding Opportunities (NOFO) only in grants.gov. They will no longer be posted in the NIH Guide. View more information.

NATIONAL INSTITUTES OF HEALTH (NIH)

Disclosure Training, Effective Oct. 1, 2025

NIH now requires institutions to provide proposers and senior/key personnel with training on disclosing other support (current and pending) in applications or at other times as defined by a sponsor. The Division of Research will announce the availability of training resources when available.

NATIONAL SCIENCE FOUNDATION (NSF)

Research Security Training, Effective Oct. 10, 2025  

NSF requires proposers and senior/key personnel to complete training on research security within 12 months prior to a proposal submission. The Division of Research will announce the availability of training resources when available. Questions about research security can be directed to the Office of Research Security at researchsecurity@clemson.edu.

In addition, the Responsible Conduct of Research (RCR) requirements have been updated to include training “to raise awareness of potential research security threats, and Federal export control, disclosure, and reporting requirements.” Keep in mind that RCR is now required of undergraduate students, graduate students, postdoctoral scholars, faculty and other senior/key personnel who will be supported by NSF.  The Office of Research Compliance can assist with meeting your RCR requirement.

National Institutes of Health (NIH) issued Notice NOT-OD-25-132, limiting the number of applications PIs can submit in a calendar year and announcing it will not accept proposals generated with AI.

To prevent individuals from straining its review processes by submitting large numbers of applications with the use of AI, the agency said it will only accept six new, renewal, resubmission or revision applications from an individual principal investigator/program director or multiple principal investigators for all review council rounds in a calendar year. This is effective for all submissions on or after Sept. 25, 2025, and applies to all activity codes except training grants (T activity codes) and R13 Conference Grant Applications. 

Additionally, NIH said it will not consider applications that are either substantially developed by AI, or contain sections substantially developed by AI, to be original ideas of applicants. If the detection of AI is identified post award, NIH may refer the matter to the Office of Research Integrity to determine whether there is research misconduct while simultaneously taking enforcement actions including but not limited to disallowing costs, withholding future awards, wholly or in part suspending the grant, and possible termination.

Clemson Computing and Information Technology (CCIT) and University Compliance and Ethics have provided useful guidelines on the use of AI here.  

Update on Changes to 2 CFR 200 – November 2024

The Division of Research has been monitoring changes as documented in 2 CFR 200 (historically referred to as the Uniform Guidance or UG) issued in April 2024 with an effective date of Oct. 1, 2024.  

Two changes are dependent on the negotiation of the new Facilities and Administrative (F&A) Rate Agreement now under negotiation with the Department of Health of Human Services (DHHS):  

• “Equipment” value is defined as items valued at $10,000 or greater; and

• The Indirect Cost rate applied to subrecipients will change to apply to the first $50,000 in subrecipient expenditures. 

No action is needed at this time.  We will provide guidance as soon as we have concluded the rate negotiation. 

Additional changes that may be of interest: 

• Commonly used terminology has been changed: “Non-federal entities” is replaced by “recipient and/or subrecipient;” “Facilities and Administrative Costs” is replaced by “Indirect Costs.” 

• Notices of Funding Opportunity (NOFOs) format and language are being revised to reflect an interest in using “plain language.” This may result in required changes to submission requirements. Changes to NOFOs are expected to be implemented as agencies adjust formatting and details and may eventually be retroactively applied to previously issued NOFOs. Faculty should be alert to changes to be sure to meet changing agency requirements. 

• 2 CFR 200 also removes the requirement for agency approval of certain costs (Example: Clerical and Administrative personnel). Further guidance will be provided to the Clemson community regarding how these costs will be reviewed internally, and the process to verify the allowability of these charges.  

• 2 CFR 200 encourages plans to conduct evaluation of funded projects to demonstrate the efficacy of the federal investment in research and related activities. Costs associated with evaluation activities are encouraged in new proposals. 

When will these additional changes go into effect? 

Agencies are in the process of updating their respective terms and conditions for their awards, so there will be a transition period until all agencies have harmonized their requirements. The Division of Research personnel are tracking these changes and will continue to monitor and communicate the changes as federal agencies issue clarifications.  We will keep the Clemson faculty advised as essential information is received and internal process and policy revisions (as needed) are implemented.  

While 2 CFR 200 went into effect on October 1, 2024, there will be some delays for full implementation as federal agencies will be issuing their own respective guidance on implementation schedules. The Division of Research will provide updates as available.  

NIH updates requirements for research with gene drive modified organisms - April 2024

The NIH has published revisions to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines). These revisions are specific for research involving gene drive modified organisms (GDMOs) in research settings. These revisions include:

• Research with GDMOs requires IBC review and approval PRIOR to initiation.
• The minimum containment level for research involving GDMOs will be BSL-2.
• When a researcher at an institution conducts research involving GDMOs, the institution must ensure that the IBC has adequate expertise on the committee as well as a BSO (biosafety officer).

Clemson’s Office or Research Compliance will be updating the e-form in InfoEd to reflect the category for this research (III-D-8).

Click to view the new Guidelines. 

Contact the IBC Office at ibc@clemson.edu if you have any questions.

Common Forms for Biographical Sketch and Current and Pending (Other) Support Forms Released – March 2024

Consistent with the National Security Presidential Memorandum (NSPM) 33, the National Science and Technology Council (NSTC) Research Security Subcommittee is releasing common disclosure forms for the Biographical Sketch and Current and Pending (Other) Support sections of an application for Federal research and development (R&D) grants or cooperative agreements. 

The objective of the Disclosure Requirements and Standardization section of NSPM-33 Implementation Guidance is to, "Provide clarity regarding disclosure requirements (e.g., who discloses what, relevant limitations and exclusions), disclosure process (e.g., updates, corrections, certification, and provision of supporting documentation), and expected degree of cross-agency uniformity".

• Common Form for Biographical Sketch
• Common Form for Current and Pending (Other) Support Information
• Definitions
• NSPM-33 Implementation Guidance Pre- and Post-Award Disclosures Relating to the Biographical Sketch and Current and Pending (Other) Support 

IMPORTANT UPDATE:  Consulting Must Now be Disclosed on Current and Pending Documents

Please note that effective May 20, 2024, consulting activities must now be reported on current and pending documents if they meet any of the following criteria:

1. will require the senior/key person to perform research as part of the consulting activity
2. does not involve performing research, but is related to the senior/key person’s research portfolio and may have the ability to impact funding, alter time or effort commitments, or otherwise impact scientific integrity
3. the consulting entity has provided a contract that requires the senior/key person to conceal or withhold confidential financial or other ties between the senior/key person and the entity, irrespective of the duration of the engagement

Please consult this updated Pre-award and Post-award Disclosures Chart for more information.

Changes for NSF’s Proposal and Award Policies and Procedures Guide (PAPPG) - February 2024

The National Science Foundation has announced a revised PAPPG will become effective May 20, 2024. Below are highlights of these changes:

1. Foreign Subawardees/Consultants: Updated guidance on justifying the inclusion of a foreign organization or individual as a subawardee or consultant.
2. Malign Foreign Talent Recruitment Programs: Individuals who are a party to these programs are ineligible to serve as a Senior/Key Person on NSF proposals and awards; additional university certification that training programs are in place that include cybersecurity, foreign travel security, research security, and export control training.
3. Biographical Sketch: Page limits have been removed.
4. Synergistic Activities: This section has been removed from the biosketch; one page document is now submitted as part of the Senior/Key personnel documents.
5. Current and Pending Support: Consulting activities must now be disclosed under certain circumstances. Please see additional information above in the entry titled, “Common Forms for Biographical Sketch and Current and Pending (Other) Support Forms Released.” Reminder that these must be prepared in SciENcv and certified by the individual senior/key person.
6. Proposal Formatting: Updated to allow for submission of proposal documents in landscape format.
7. Proposal Concept Tool (ProSPCT) – Updated guidelines for when use of the NSF tool is required for proposal submissions.

NIH Notice on Award Closeout Reporting Requirements - February 2024

The National Institutes of Health issued notice Jan. 23 that it is strengthening enforcement of reporting requirements for award closeouts. Noncompliance will damage institutional reputation and negatively affect future awards that come to Clemson.

It is imperative that NIH grant recipients submit timely, accurate reports to detail final grant expenditures, progress and inventions. The NIH will unilaterally closeout awards automatically that have not met the requirement at 120 days unless there is a request to delay closeout. These awards will be marked noncompliant and reported to all sponsors in the System for Award Management (SAM.gov).

Per the NIH announcement: “In addition, failure to correct recurring reporting problems may cause NIH to take one or more actions that may include, but are not limited to, corrective actions, withholding of further awards, suspension or termination per Section 8.5.2 of the NIH Grants Policy Statement.”

NIH notifies principal investigators directly of upcoming closeout reporting requirements at 10, 120 and 150 days before the deadline.  If a request to delay closeout is needed, please contact the post-award representative in your college.

DoD Policy for Risk-Based Security Reviews – October 2023

Researchers seeking funding from the U.S. Department of Defense may need plans to mitigate the risk of unwanted foreign influence.

Per the “Policy for Risk-Based Security Reviews of Fundamental Research,” all fundamental research projects that are selected for award by the DOD must go through a review for potential conflicts of interest and conflicts of commitment that could compromise national security or competitiveness.

Risk indicators include individuals participating in foreign talent recruitment programs or having funding affiliation or association with countries of concern. For its review, DoD will be looking at information included in Current and Pending and Biosketch Disclosures. Clemson’s Office of Sponsored Programs has provided useful materials and webinars on disclosure requirements.

The review begins after a proposal is selected for technical merit. Depending on the outcome of the review, the university may need to develop a mitigation plan for the project under review. Potential mitigation measures may include additional training, termination of relationships deemed problematic, or other measures suggested by the DoD. 

Proposals deemed to pose a security risk that could compromise national security and competitiveness could be rejected.

Questions on the new DOD policy, or requests for assistance creating mitigation plans, can be directed to Rhonda Ryals, director of Export Compliance and Research Security, at rryals@clemson.edu.

NEW RCR TRAINING REQUIREMENTS FROM NSF - JULY 2023

Effective July 31, the National Science Foundation has expanded requirements for Responsible Conduct of Research (RCR) training. The requirement for RCR training now includes “faculty and other senior personnel,” meaning RCR training is no longer limited to students. Additionally, RCR training offerings must include “mentor training and mentorship.”

More information. 

For more information about RCR training, please visit the Office of Research Compliance.

LICENSURE REQUIREMENTS FOR CONTROLLED SUBSTANCES USED FOR RESEARCH - JULY 2023

Individual investigators now must obtain their own licenses to order and store controlled substances for research. The Office of Occupational and Environmental Safety (OES) is coordinating with the S.C. Department of Health and Environmental Control (SC DHEC) and the Drug Enforcement Agency (DEA) to implement this new requirement. Researchers using analgesics, anesthetics, sedatives, etc., should visit the OES Controlled Substances page to determine whether to initiate the registration and licensing process. The Institutional Animal Care and Use Committee (IACUC) will incorporate the licensing requirements into reviews of protocols that list the use of controlled substances and will issue a policy on this by the fall semester.

NEW SUPPORT DISCLOSURE AND BIOSKETCH REQUIREMENT - MAY 2023

Federal agencies are taking numerous steps in accordance with National Security Presidential Memorandum 33 that will require additional information to be disclosed in proposals. Steps by federal agencies include:

• Expanding the types of information that must be disclosed on current and pending/other support and biosketch documents;
• Requiring investigator certification of the accuracy and completeness of this information; and
• Standardizing the reporting forms.

A virtual workshop is tentatively scheduled for Sept. 13 at 3:30 p.m. to provide information on current and pending Disclosure Requirements & SciENcv. Details on the workshop will be released at a later date. 

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DATA MANAGEMENT AND SHARING PLANS - MAY 2023

Federal agencies have begun to implement data management and sharing plans in response to a directive from the Office of Science and Technology Policy that requires public access to federally funded research by December 31, 2025.

NASA and the National Institutes of Health have published plans. These instructions will be incorporated into grant guidelines. Applications that are not compliant risk return without review.

A virtual workshop is tentatively scheduled for Aug. 31 at 1 p.m. to provide information on NIH Data Management and Sharing Plans. Details on the workshop will be released at a later date. 

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