Immediate/Near Term: Regulatory and Policy Changes
Research Misconduct: Procedures and requirements for research misconduct proceedings for institutions receiving funding from HHS: Rule effective: January 2025, Institutions must comply by: January 2026
- U.S. Department of Health and Human Services (HHS) Final Rule - Public Health Service Policies on Research Misconduct
- Office of Research Integrity (ORI) Release - Public Health Service Policies on Research Misconduct
- Ropes & Gray Highlights of Key Changes to ORI’s Research Misconduct Regulations
NIH Controlled-Access Data and Repositories Security:NIH has updated its security standards in the NIH Security Best Practices for Controlled-Access Data Subject to the NIH Genomic Data Sharing (GDS) Policy for users of controlled-access data under the GDS Policy. Effective January 25, 2025
Research Security Training: Covered individuals as defined by NSPM-33: January 2025
- Harvard Research Security Program
- Harvard Research Security Program Training: Coming January 2025
Synthetic Nucleic Acids: Screening required for purchasers and providers of Nucleic Acid Sequences: April 2025 for 200 base pairs or more. October 2026 for 50 base pairs or more.
Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP): This policy increases oversight of research on biological agents and toxins that, when enhanced, have the potential to pose risks to public health, agriculture, food security, economic security, or national security and also achieves consistent review and oversight of life sciences research proposed for federal funding that may be reasonably anticipated to involve the creation, transfer, or use of pathogens with enhanced pandemic potential (PEPPs) May 2025
Watchlist: Future Regulatory and Policy Changes
Research Security Program: National Security Presidential Memorandum 33 (NSPM-33) requires Research Institutions receiving over $50 million to establish and operate a research security program which includes elements of cybersecurity, foreign travel security, insider threat awareness and identification, and export control training. Estimated Implementation Date: January 2026
Dept. of Justice Notice (DOJ) of Proposed Rulemaking – Preventing Access to Americans’ Bulk Sensitive Personal Data and USG-Related Data by Countries of Concern: DOJ proposed a rule to prohibit and restrict certain data transactions with certain countries or persons
- Comment Period Ended November 29, 2024
- Proposed Rule