Incident Reporting Requirements for Research Involving Recombinant or Synthetic Nucleic Acid Molecules

Original Date Approved: 5/17/2016

Next Review Date: May 2019

Purpose

Boston University (BU) is committed to observing federal, state, and local regulations and the National Institute of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules. The purpose of this policy is to set forth the incident reporting requirements for research involving recombinant or synthetic nucleic acid molecules.

Applicability

This policy is applicable to all active IBC protocols involving recombinant or synthetic nucleic acid molecules at or under the auspices of Boston University (BU).

Policy

Any significant problems, violations of the NIH Guidelines, or any significant research-related accidents and illnesses, hereinafter referred to collectively as “incidents,” must be reported to the NIH Office of Science Policy (OSP) and the Boston Public Health Commission (BPHC) within 30 days.

Certain types of accidents must be reported on a more expedited basis:

Spills or accidents in BL-2 laboratories resulting in an overt exposure must be reported immediately to NIH OSP and BPHC.
Spills or accidents occurring in high containment (BL-3 or BL-4) laboratories resulting in an overt or potential exposure must be immediately reported to NIH OSP and BPHC.

Procedures

University personnel involved in an incident will immediately report the incident to the Research Occupational Health Program (ROHP), who will contact:

the Biological Safety Officer (BSO),
the Associate Vice President for Research Compliance,
the Executive Director of Research Compliance,
the Executive Director of Research Assurance and Integrity,
and the Director of Research Safety,

as needed.

The BSO will complete an incident report in the Campus Incident Tracking System (CITS). The form will be completed in a timely manner as determined by the nature of the incident and NIH Guidelines and BPHC reporting timelines. ROHP and the BSO will report the incident to the IBC for review.

Following review by the IBC and the University’s Associate Vice President for Research Compliance, the IBC Office will submit the final incident report to the NIH OSP on behalf of the university and to the BPHC.

Responsible Parties

The BSO is responsible for reporting any incident involving recombinant or synthetic nucleic acid molecules to the IBC. The BSO is also responsible for investigating the incident to identify route cause, training needs, and corrective action measures.

The IBCInstitutional Biosafety Committee The IBC is an instituti... is responsible for reviewing and discussing incidents at each committee meeting and ensuring compliance with all applicable regulations for incident reporting.

The IBC Office is responsible for submitting the final incident report to the NIH OSP and the BPHC.

The ROHPResearch Occupational Health Program ROHP is part of BU R... is responsible for submitting biological research safety reports to the BPHC

Definitions

Recombinant and Synthetic Nucleic Acid Molecules:

molecules that
1. are constructed by joining nucleic acid molecules and
2. that can replicate in a living cell, i.e., recombinant nucleic acids;
nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids; or
molecules that result from the replication of those described in (i) or (ii) above.

Overt Exposure: a definitive contact with a Biosafety Level 2 (BSL-2) or higher recombinant biological agent. Examples of overt exposures include, but are not limited to:

needle sticks
splashes of rDNA agent on personnel

Potential Exposure: a possible personal contact with a Biosafety Level 3 (BSL-3) or higher recombinant biological agent. Examples of potential exposures include, but are not limited to:

BSL- 3 or higher accidents,
equipment failure,
splash to intact skin