History: Original Date

Approved: December 16, 2014

Revised: September 29, 2015

Next Review Date: September 2018

Purpose

The purpose of this policy is to outline Boston University’s (“BU”) institutional oversight of Dual Use Research of Concern according to the “United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern” released on September 24th, 2014.

Covered Parties

This policy applies to all individuals engaged in Dual Use Research at or under the auspices of BU.

Affiliated Institutions:

This policy also applies to all individuals engaged in Dual Use Research at or under the auspices of Boston Medical Center (“BMC”).

Definitions

Dual Use Research (“DUR”) is defined as research conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that could be utilized for both benevolent and harmful purposes. Dual Use Research of Concern (“DURC”) is a subset of Dual Use Research defined as life sciences 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.

Regulatory Background

On September 24, 2014, the United States Government released the “United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern” with effective date of September 24th 2015. The policy addresses institutional oversight of DURC, which includes policies, practices, and procedures to ensure DURC is identified and risk mitigation measures are implemented, where applicable. Institutional oversight of DURC is the critical component of a comprehensive oversight system because institutions are most familiar with the life sciences research conducted in their facilities and are in the best position to promote and strengthen the responsible conduct and communication of DURC.

On March 29, 2012, the Federal government issued the “United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern” that requires funding agencies to review research and research proposals to identify those that qualify as DURC, and to ensure that acceptable risk-reducing mitigation plans are in place.

A Companion Guide, entitled “Tools for the Identification, Assessment, Management, and Responsible Communication of Dual Use Research of Concern,” has been developed to assist institutions, investigators, and Institutional Review Entities in the development of policies and practices for the effective oversight of DURC and in the execution of some of the required steps for institutional review and oversight.

References herein to the Federal government Policies and Companion Guide shall be deemed to include all revisions, updates, and successor federal policies and guidance.

Scope of Research Requiring Oversight Under Dual Use Research of Concern

 

 

DURC Review and Risk Mitigation

 

 

 

 

 

 


Risk Mitigation Plan