Responding to Reports of Potential Incidents Involving Breaches of Biocontainment or Biosecurity

This SOP has internal roles only.

Purpose

To respond to reports of potential incidents involving the accidental release, occupational exposure, theft, unauthorized access, or loss of pathogens and toxins that require BSL-3 or higher biocontainment, as specified in the CDC/NIH Biosafety in Microbiological and Medical Laboratories (BMBL).

Procedure

• Background
• Initial Response to a Reported Incident
• Post-Incident Follow Up

Background

NIAID funds domestic and foreign research involving highly pathogenic agents that must be conducted in biosafety level ( BSL) 3 or higher biocontainment facilities. Recipients of NIAID funds agree to comply with NIAID's terms and conditions of award and provide assurances to NIAID that they will comply with all applicable local, state, and federal regulations.

The NIAID Term of Award for Highly Pathogenic Agents defines such agents as those that may warrant a biocontainment safety level of BSL-3 or higher, according to the current BMBL.

While NIH has no regulatory role in the use of these agents, the NIH Office of Extramural Research has defined awardee and NIAID responsibilities to include notification of the funding institute of institutional or regulatory body investigations of certain reportable events (see NIH's Select Agent Information).

In addition to the terms and conditions of award, the NIH Office of Policy for Extramural Research Administration and the Office of Biotechnology Activities have developed additional guidance for biosafety and biosecurity concerns for infectious agents, including select agents and recombinant DNA research.

Federal, local, and state regulations address the biosafety and biosecurity of infectious agents and toxins and are implemented by agencies with statutory authority to do so.

It is imperative that staff respond appropriately if NIAID is notified or becomes aware of a potential incident involving the accidental release, occupational exposure, theft, unauthorized access, or loss of pathogens and toxins that require BSL-3 or higher biocontainment.

Note: Because NIAID has no regulatory authority, we must take care to provide a clear and consistent message to the extramural community to report events promptly to the agency with the legal mandate, while avoiding actions on the part of NIAID that could be perceived as quasi-regulatory.

Note: All communications regarding reports of potential incidents involving breaches of biocontainment or biosecurity are to be handled as “Administrative Confidential.” The privacy rights of people who may be at risk must be protected.

Initial Response to a Reported Incident

• Program Officer or Project Officer
  • Scenario 1: PI reports
  • Scenario 2: Third party reports
  • Scenario 3: Public information
  • Scenario 4: Progress report
  • Scenario 5: Regulatory entity reports
• Division Directors or Designee
• DEA Director or Designee
• Principal Deputy Director, NIAID or Designee
• Division Coordinators or Branch Chiefs
• Grants Management Specialists
• Contract Specialists
• Scientific Review Officers

Program Officer or Project Officer

Scenario 1: If PI reports a potential incident to you, collect basic information and remind the PI of his or her responsibilities to report and act within local requirements. Take the following steps :

1. Counsel the PI to do the following:
   • Adhere to the incident response plan of the awardee institution, including internal notification of institutional officials and official notification of local, state, and federal authorities within specified timeframes.
   • Review the NIAID terms and conditions of grant or contract award to ensure full compliance with NIH and NIAID requirements.
   • Ensure that any involved collaborators and subcontractors comply with all institutional and NIH requirements, if applicable.
2. Remind the principal investigator of the following:
   • Under the terms and conditions of award, the institution has agreed to follow NIH guidelines and comply with all relevant state, local, and federal regulations, including reporting requirements.
   • The PI is responsible for working with the proper institutional officials and regulatory authorities to ensure that all collaborators and subcontractors are compliant with the terms and conditions of the grant or contract.
   • The institution should remain in contact with the program officer to keep NIAID informed of significant developments as a response by institutional and regulatory authorities unfolds.
3. Within 24 hours, prepare a brief memo to the official grant or contract file that includes the following information:

Date:
Location:
Institution:
Principal Investigator:
Grant or Contract #(s):
Nature of Incident (agent, type of breach):
Source of Information:

4. As soon as possible, but not later than within 24 hours, notify the division coordinator and director through your immediate supervisor.

1. Forward the memo through your division director to the grants management specialist or contracting officer with a copy to the Division of Extramural Activities (DEA) director.
2. The division coordinator will speak with the program division director and take any needed additional actions in conjunction with the DEA director or designee.

Scenario 2: If an involved third party reports a potential incident to you, take these steps:

1. Remind the person of the following:
   • You can take information volunteered but, due to the Privacy Act, cannot discuss the matter with him or her without authorization by the PI or institutional official.
   • The PI is responsible for ensuring that all participating institutions, including collaborators and subcontractors, comply with local requirements and the terms and conditions of the grant or contract.
2. Recommend to do the following:
   • Adhere to the incident response plan (if available to him or her) in place at the awardee institution, including internal notification of institutional officials and official notification of local, state, and federal authorities within specified timeframes.
   • Notify the PI and institutional officials.
3. If the third party has already provided the following information, incorporate it into a memo to the official electronic grant or contract file. If not, work with the grants or contract management specialist as noted in step 4 below:

   Date:
   Location:
   Institution:
   Principal Investigator, if known:
   Grant or Contract #(s), if known:
   Nature of Incident (agent, type of breach):
   Source of Information:

4. As soon as possible, but not later than within 24 hours, notify the division coordinator and director through your immediate supervisor.
   1. Forward the memo through your division director to the grants management specialist or contracting officer with a copy to the DEA director.
   2. The division coordinator will speak with the program division director and take any needed additional actions in conjunction with the DEA director or designee.

Scenario 3: If you become aware of a report of a potential incident through public information such as press releases or news stories, take the following steps:

1. Within 24 hours, prepare a memo to the official grant or contract file that includes the following information:

   Date:
   Location:
   Institution:
   Principal Investigator, if known:
   Grant or Contract #(s), if known:
   Nature of Incident (agent, type of breach):
   Source of information:
   Copy of media release or URL if on the internet:

2. Through your supervisor, immediately notify the division coordinator and division director in person, by phone, or by email.
   1. Forward the completed memo through the grants management specialist or contracting officer with a copy to the DEA director.
   2. The division coordinator will inform the division director and take any needed additional actions.

Scenario 4: If you identify a potential incident during a routine review of a progress report, take the following steps:

1. Within 24 hours, prepare a memo to the official grant or contract file that includes the following information:

   Date:
   Location:
   Institution:
   Principal Investigator:
   Grant or Contract #(s):
   Nature of Incident (agent, type of breach):
   Source of Information:
   Copy of relevant text in report:

2. As soon as possible, but not later than within 24 hours, notify the division coordinator and director through your immediate supervisor.
   1. Forward the memo through your division director to the grants management specialist or contracting officer with a copy to the DEA director.
   2. The division coordinator will speak with the program division director and take any needed additional actions in conjunction with the DEA director or designee.

Scenario 5: If you are contacted by a regulatory entity reporting an incident, take the following steps:

1. Within 24 hours, prepare a memo to the official grant or contract file that includes the following information:

   Date:
   Location:
   Institution:
   Principal Investigator, if known:
   Grant or Contract #(s), if known:
   Nature of Incident (agent, type of breach):
   Source of Information:
   Any document from the entity regarding the incident

2. As soon as possible, but not later than within 24 hours, notify the division coordinator and director through your immediate supervisor.
   1. Forward the memo through your division director to the grants management specialist or contracting officer with a copy to the DEA director.
   2. The division coordinator will speak with the program division director and take any needed additional actions in conjunction with the DEA director or designee.

Division Directors or Designee

1. When you receive notification from staff or a division coordinator that a potential incident has occurred, determine what additional actions by NIAID may be warranted.
2. Contact the DEA director (or designee) to obtain additional information regarding the incident and to verify NIAID support and terms of award as required.
3. In consultation, the program and DEA director will make a preliminary assessment and report to the principal deputy director, NIAID, to determine the most appropriate course of action. Where applicable, the director, NIH OBA, or CDC liaison will be notified.
4. Await official notification from state or federal regulatory agencies regarding the matter.
5. Assign program staff to work with grants or contracts staff to document a resolution and take any necessary actions after receiving a definitive institutional and regulatory agency response.

DEA Director or Designee (ordinarily the director, OIEA, or deputy director, DEA)

1. Coordinate the receipt of information from staff and identification of sources of support insofar as they can be determined from available information.
2. Work with the program division director to assemble information to brief the principal deputy director, NIAID.
3. If a foreign site is involved, notify the director of the Office of Global Research, for possible implications and notification of Department of State.
4. Assess possible award management options and courses of action.

Principal Deputy Director, NIAID, or Designee (ordinarily the Deputy Director for Science and Management or DIR Director)

1. When notification is received from staff that a potential incident has occurred, determine what additional NIAID actions may be warranted in terms of confirmation with senior NIAID officials and relevant NIH and regulatory authorities.
2. Determine appropriate NIH and external regulatory agency contacts to be made and assign staff to follow up with those contacts.
3. Work with the director of the Office of Communications and Government Relations to assess the need for a potential internal and external communication plan and develop a draft communication plan, if applicable.
4. Approve final drafts for all external communications regarding the incident.

Division Coordinators or Branch Chiefs

1. When you receive notification that a potential incident has occurred, work with staff in the program division and DEA to determine what awards are involved and whether additional actions may be necessary.
2. Summarize the background of the awards, agents, and issues, and provide the information and your recommendations to your division director.

Grants Management Specialists

1. If you are contacted by a principal investigator or third party, direct them to the relevant program officer. If you encounter the information in a publicly available source, alert the relevant program officer, the DEA director, and the Grants Management Program's (GMP) point of contact (POC).
2. If you receive notification from a program officer that there has been a potential biosecurity or biocontainment breach at a grantee institution, inform the GMP POC.
3. Work with the GMP POC and program staff to assemble background information regarding the NIAID or other NIH awards that could be affected by the incident. The GMP POC will also notify the program director of GMP.
4. Ensure that follow-up actions are documented and advise program staff of available options.
5. Retain all communications in the electronic grant file.

Contract Specialists

1. If you are contacted by a PI or third party, direct them to the relevant program officer. If you encounter the information in a publicly available source, alert the relevant program officer and the DEA director.
2. If you receive notification from a project officer that there has been a potential biosecurity or biocontainment breach at a contractor institution, inform your supervisor, who will inform the chief contracting officer.
3. Work with your branch chief and program staff, who will notify the chief contracting officer, to assemble background information regarding NIAID or other NIH awards that could be affected by the incident.
4. Ensure that follow-up actions are documented and advise program staff of available options.
5. Retain all communications in the official contract file.

Scientific Review Officers

1. If you encounter the information during the recruitment of peer reviewers, alert the relevant program officer and the DEA director.
2. If you encounter the information during a peer review meeting, alert the program officer. An unofficial report of a potential incident is not equivalent to a biohazard comment or concern, so it is inappropriate to incorporate comments made during the review into the summary statement.

Post-Incident Follow Up

Program Staff

1. At the conclusion of the response to the incident by the institution and after final reports have been made and actions taken by regulatory bodies, work through the grants management or contract specialist to obtain certification from the awardee as to the current status of the facility and staff to continue the research project.
2. After you receive certification from the awardee, work with the grants management or contracts specialist to adjust the terms of award accordingly, if warranted.
3. Work with division staff to monitor the final incident outcomes.
4. Determine whether any lessons emerged that may be shared with the community of awardees who manage such facilities and pursue similar lines of research.

Note: The sensitive nature of such research may limit our ability to collect or publicly disseminate such information due to concerns for the security and privacy of such facilities and investigators.

NIAID-funded facilities networks will be encouraged to share safety information directly with one another through networks that are already established or will be developed.

Contacts

See the relevant section above.

GMP POC -- Contact for NIAID Staff

If you have knowledge to share or want more information on this topic, email deaweb@niaid.nih.gov with the title of this page or its URL and your question or comment. Thanks for helping us clarify and expand our knowledge base.

Links

Select Agent Information, NIH Office of Extramural Research

Biosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition, CDC