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Regulations and Institutional Policy

It is the policy of Tufts University and Tufts Medical Center that all research projects involving biological agents or toxins specified in the US Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (“Policy for Institutional DURC Oversight”) are subject to review and approval by the institution prior to project initiation. Dual Use Research of Concern (DURC) means research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security.

This policy complies with the federal Policy for Institutional DURC Oversight which applies to institutions receiving federal funding to conduct certain types of life science research. The policies are intended to preserve the benefits of life sciences while ensuring safe research practices and mitigating risks.

Definitions

Dual Use Research of Concern means research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. DURC is research that involves one of the agents/toxins below that is also used in one of the stated Experiments of Concern.

Non-attenuated Agents and Toxins of Concern are those so defined by federal policy, which may be updated periodically; including, but not limited to:

  • Avian influenza virus,
  • Bacillus anthracis,
  • Botulinum neurotoxin,
  • Burkholderia mallei,
  • Burkholderia pseudomallei,
  • Ebola Virus,
  • Foot-and-mouth disease virus,
  • Francisella tularensis,
  • Marburg virus,
  • Reconstructed 1918 Influenza virus,
  • Rinderpest virus,
  • Toxin-producing strain of Clostridium botulinum,
  • Variola major virus,
  • Variola minor virus, and
  • Yersinia pestis.

Experiments of Concern are research that produces, aims to produce, or can be reasonably anticipated to produce one or more of the following experimental effects:

  • Enhances the harmful consequences of the agent or toxin;
  • Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification;
  • Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies;
  • Increases the stability, transmissibility, or the ability to disseminate the agent or toxin;
  • Alters the host range or tropism of the agent or toxin;
  • Enhances the susceptibility of a host population to the agent or toxin;
  • Generates or reconstitutes an eradicated or extinct agent or toxin listed under agents and toxins of concern.

Obligation of Researchers to Identify Research that May Constitute DURC

A Principal Investigator (PI) must identify research that involves Nonattenuated Agents and Toxins of Concern that could meet the definition of an Experiment of Concern. Dual Use Research of Concern falls into both of these categories. The PI is directed to address these categories in the IBC registration and the potential for DURC is reviewed by the appropriate Institutional Biosafety Committee (IBC).

Dual Use Research of Concern Review

The IBC shall review the IBC registration and forward to the DURC Committee if: (i) any work involving Non-attenuated Agents and Toxins of Concern that may involve an Experiment of Concern, or (ii) any other research protocol which the IBC believes should be reviewed by the DURC Committee. The IBC may provide input and make any recommendations to the DURC Committee.

Each DURC Committee shall review the proposed research against the standards set forth in the Policy for Institutional DURC Oversight and any other applicable regulations. If the research is determined to meet the definition of DURC, the DURC Committee must develop a risk mitigation plan with the PI (see below).

Post-DURC Review

    1. Within 30 days of the initial DURC review, the institution will provide the outcome of the DURC Committee review to the appropriate USG funding agency (or NIH, for non-USG funded research). This should include all information required by the Policy for Institutional DURC Oversight.
    2. Within 90 days of the DURC committee review, the institution will provide the draft risk mitigation plan for final review and approval to the USG funding agency (or NIH, for non-USG funded research).
    3. The DURC Committee will ensure that education and training on DURC is completed by individuals conducting life science research with a Non-attenuated Agent or Toxin of Concern.
    4. All risk mitigation plans and associated IBC registration must be reviewed at least annually.

The Dual Use Research of Concern Committees

There are two distinct DURC Committees. Each is responsible for DURC that is determined by its representative IBC – Grafton or Boston/Medford. Each DURC committee is subject to this Policy and the federal Policy for Institutional DURC Oversight. The Committees will be comprised of:

  • Boston/Medford IBC Chair
  • Grafton IBC Chair
  • 2 Scientific Representatives
  • Biosafety Manager
  • IACUC/IBC Regulatory Director

 

Ad hoc participants may be utilized, as needed.