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.

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).

To view the new Guidelines, please visit: https://osp.od.nih.gov/policies/biosafety-and-biosecurity-policy#tab2/

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

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.

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.

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.

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.

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.

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.

Funding agencies are requiring research teams to develop plans that ensure equity and safety across all research work environments.

Proposals to the National Science Foundation, for example, now must include a plan for providing a safe and inclusive environment for field and off-campus research teams.

The U.S. Department of Energy requires applicants to submit a Promoting Inclusive and Equitable Research (PIER) Plan as an appendix to their proposal narrative.

Guidance on the requirements of these two agencies on the safe worksplaces page. Guidance from other agencies will be posted to the page when available.

A virtual workshop is tentatively scheduled for Sept. 6 at 3:30 p.m. to provide information on Diversity and Inclusion Plans for NSF and DOE proposals. Details on the workshop will be released at a later date. 

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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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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