IBC Guidelines

Principal Investigators (PIs) are responsible for full compliance with the NIH Guidelines during the conduct of research involving recom­binant or synthetic nucleic acid molecules.

Before research begins, investigators must:

  • Determine whether the research is subject to Section III-A, III-B, III-C, III-D, or III-E of the NIH Guidelines.
  • Propose physical and biological containment levels in accordance with the NIH Guidelines when registering research with the IBC.
  • Propose appropriate microbiological practices and laboratory techniques to be used for the research.
  • Submit a research protocol to the IBC for review and approval.
  • Seek NIH OSP’s determination regarding containment for experiments that require case-by-case review.
  • Petition of NIH OSP, with notice to the IBC, for proposed exemptions from the NIH Guidelines.
  • Obtain IBC approval before initiating research subject to the NIH Guidelines.
  • Seek NIH approval, in addition to IBC approval, to conduct experiments specified in Sections III-A and III-B of the NIH Guidelines.
  • Provide laboratory research staff with protocols describing potential biohazards and necessary precautions.
  • Inform the laboratory staff of the reasons and provisions for any precautionary medical practices advised or requested (e.g., vaccinations or serum collection).

During research, investigators must:

  • Maintain current training appropriate for their research program and ensure that personnel obtain and maintain this training as well.
  • Supervise laboratory staff to ensure that the required safety practices and techniques are employed.
  • Correct work errors and conditions that may result in the release of recombinant or synthetic nucleic acid materials.
  • Warn laboratory staff about the use of materials that may present an increased danger to researchers with unusual health conditions (e.g., pregnancy, respiratory conditions like cystic fibrosis, or chronic obstructive pulmonary disease).
  • Comply with permit and shipping requirements for recombinant or synthetic nucleic acid molecules.
  • Adhere to IBC-approved emergency plans for handling accidental spills and personnel contamination.
  • Determine the need for IBC review before modifying recombinant or synthetic nucleic acid research already approved by the IBC.
  • Using RCS, submit any subsequent changes (e.g., changes in the source of DNA or host-vector system) to the IBC for review and approval or disapproval.
  • Remain in communication with the IBC throughout the duration of the project.
  • Report any significant problems pertaining to the operation and implementation of containment practices and procedures, violations of the NIH Guidelines, or any significant research-related accidents and illnesses to the IBC, NIH OSP, and, as applicable, the Biological Safety Officer, Greenhouse, or Animal Facility Director, and other appropriate authorities.

Other Guidelines that PIs/Researchers need to be aware of

1. Framework for Nucleic Acid Screening

This framework aims to encourage providers of synthetic nucleic acids to adopt comprehensive, scalable, and verifiable screening mechanisms. It applies to life sciences research funded by the federal government that involves obtaining any type of synthetic nucleic acids—including, but not limited to, DNA and RNA (whether single- or double-stranded) and entire organism genomes (such as those of viruses and bacteria) that contain any synthetic Sequences of Concerns (SOCs). Additionally, it covers federally funded life sciences research involving the acquisition of any benchtop equipment capable of synthesizing nucleic acids.

  • Implementation on October 13, 2024: "At a minimum, DNA or RNA, single- or double-stranded, 200 nucleotides (including the corresponding amino acid sequence, if applicable) or longer should be screened for SOCs. As of October 13, 2026, this screening window will be decreased to 50 nucleotides, and Providers should implement screening mechanisms that detect the potential for shorter nucleotides to be assembled into SOCs when multiple synthetic nucleic acids are ordered by the same customer in a bulk order or for multiple orders over time"

2. Implementation Guidance for the use of DURC and PEPP

The United States Government has introduced a new policy for overseeing Dual Use Research of Concern (DURC) and Pathogens with Enhanced Pandemic Potential (PEPP), along with an accompanying Implementation Guide. This policy will come into effect on May 6th, 2025, and supersede the previous 2012 Federal DURC policy, the 2014 Institutional DURC Policy, and the 2017 PC3O Framework.

This unified policy focuses on rare but highly significant research activities that are subject to intense debate and controversy within the scientific community and among the public. The policy aims to raise awareness of biosafety and biosecurity concerns and to ensure that appropriate risk mitigation measures are implemented to prevent any biosafety or biosecurity incidents. This policy extends to all U.S. federal departments and agencies that provide funding or sponsorship for research falling under the specified oversight criteria.