Dual Use Research of Concern (DURC)

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Overview

Over the past few years Dual Use Research of Concern (DURC) has been the subject of discussion in the life sciences research community both nationally and internationally.

In 2004, the Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology (National Research Council of the National Academies) published a report entitled “Biotechnology Research in An Age Of Terrorism: Confronting The Dual Use Dilemma”.

As described in the Executive Summary, the Charge of the committee was to:

  • Review the current rules, regulations, and institutional arrangements and processes in the United States that provide oversight of research on pathogens and potentially dangerous biotechnology research, within government laboratories, universities and other research institutions, and industry.
  • Assess the adequacy of current U.S. rules, regulations, and institutional arrangements and processes to prevent the destructive application of biotechnology research.
  • Recommend changes in these practices that could improve U.S. capacity to prevent the destructive application of biotechnology research while still enabling legitimate research to be conducted.

The Committee made seven specific recommendations including the creation of a National Science Advisory Board for Biodefense.  Based on this recommendation the National Science Advisory Board for Biosecurity (NSABB) was convened to address the recommendation of the Report and to develop guidelines for such research.

This website is designed to provide the Boston University (BU) and Boston Medical Center (BMC) research community with information on the topic and will be updated as new information becomes available.

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What is DURC?

The National Science Advisory Board for Biosecurity (NSABB) has defined Dual Use Research of Concern (DURC) as: “research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health and safety, agricultural crops and other plants, animals, the environment or materiel”.

An excellent short video discussing DURC is posted on the NIH Office of Biotechnology Activities (OBA) website.  All investigators are strongly recommended to view the video for a better understanding the issues (http://oba.od.nih.gov/biosecurity/biosecurity.html).

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Review and Monitoring of Dual Use Research

Introduction

In 2009, the Associate Vice President for Research Compliance (AVPRC) appointed an ad hoc Advisory Committee on Dual Use Research of Concern (DURC)[1], chaired by Gregory Viglianti, PhD, to review the information available and to provide recommendations on the actions that Boston University (BU) and Boston Medical Center (BMC) should take to address DURC. The ad hoc committee issued its final report on July 2, 2009, in which it recommended a two-phase approach:

  • Phase-I: The first stage involves the initiation of education and training programs for faculty and staff. As part of Phase-I, the findings of the report were presented to various key stakeholders (the deans, key department chairs, the ad hoc Committee on Biosafety, and the Institutional Biosafety Committee [IBC]). Since the issuance of the report, the chair of the ad hoc committee and the Director of Research Safety have attended  departmental meetings at various colleges and schools at Boston University and have presented the findings of the report and engaged the scientists in these departments in a dialogue regarding DURC. In addition, a website dedicated to DURC was created and additional materials were posted online[2]. This education and awareness training will continue.
  • Phase-II: The second stage involves the development of a formal policy and process in compliance with federal regulations after such regulations have been officially proposed.  We anticipate that the formal policy and process will establish an enhanced program of education and training, review, and decision-making involving a Dual Use Research Review Committee (DURRC), and related institutional action. Implementation of Phase-II is to be initiated after finalized guidelines for DURC have been published.

This report provides the processes established at Boston University and Boston Medical Center to evaluate and monitor Dual Use Research (DUR). The guidelines are intended to establish a more formal process for the implementation of Phase-II of the ad hoc committee recommendations. While there are no formal federal regulations, the National Science Advisory Board for Biosecurity (NSABB) has a number of documents[3] on the topic that form the basis of these guidelines.

Oversight and Monitoring

The NSABB has stated: “Researchers are the most critical element in the oversight of dual use life sciences research. They know the work best and are in the best position to anticipate the types of knowledge, products, or technologies that might be generated, the potential for misuse, and the degree of immediacy of that threat.”

On March 29, 2012, the Federal government issued a policy[1] for the oversight of life sciences “dual use research of concern” (DURC) requiring funding agencies to review funded research (including a review of currently funded project that fall under the criteria set in the Policy) for DURC and to establish criteria for the management of any research that is identified as DURC.

BU recommends that its researchers screen their research proposals at the time of submittal to funding agencies against eight (8) questions developed by the IBC, as described below, prior to submission. This early screening will ensure that potential issues related to DURC are addressed at the earliest stage of the research process to avoid unnecessary delays in starting funded research.

At BU, the review process is conducted in two stages by the DURRC with the IBC acting as a screening committee, as described below.

a. Screening of Institutional Biosafety Committee (IBC)  Applications

The IBC has developed eight (8) screening questions that are incorporated into the IBC protocol application. The questions were based on the recommendations of the National Research Council report “Biotechnology Research in An Age of Terrorism: Confronting the Dual Use Dilemma.”

The formal review of potential DUR starts with the researchers responding to the eight (8) questions on the IBC application, which is required for research involving all recombinant DNA (rDNA) and infectious materials, and continues with further review by the DURRC if the answer to any of the following screening questions is yes.

The questions ask the investigators to indicate whether the proposed research is designed to:

  • Enhance the harmful consequences of a biological agent or toxin.
  • Disrupt immunity or effectiveness of an immunization without clinical and/or agricultural justification.
  • Confer to a biological agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against agent or toxin.
  • Facilitate their ability to evade detection methodologies.
  • Increase the stability, transmissibility, or the ability to disseminate a biological agent or toxin.
  • Alter the host range or tropism of a biological agent or toxin.
  • Enhance the susceptibility of a host population.
  • Generate a novel pathogenic agent or toxin, or reconstitute an eradicated or extinct biological agent.

b. Dual Use Research Review Committee (DURRC)

If the answer to any of the screening question is yes, the IBC office will forward the research protocol to the DURRC, which will review the proposal in two stages:

  • Stage-I: A DUR Review Sub-Committee will conduct the preliminary assessment of the research and determine whether it falls under DURC or not. If the DUR Review Sub-Committee determines that the research falls under DURC, then the study will be referred to the full DUR Review Committee. If not, the committee will determine any necessary management plan for the ongoing monitoring of the research project.
  • Stage-II: If a study is considered as DURC, then the full DURRC will conduct a review according to established criteria.

c. Membership of Dual Use Research Committee

The full DURRC will consist of the Director of Research Safety, the Chair of the IBC, the Executive Director of Research Compliance, the Associate Director of Maximum Containment Safety, a representative of the Office of the General Counsel, the Chief of the BU Police Department, the Associate Provost for Research-BUMC, a community member, a representative from Corporate Communications, and representatives of the scientific community. The scientific representatives, the chair of the IBC, and safety specialists will form the sub-committee conducting the Stage-I review.

d. Meetings

The full committee will hold regularly scheduled meetings at least once each calendar quarter to review the status of the DUR oversight at BU and BMC, the latest recommendations of NSABB or other advisory or regulatory bodies, and determine whether any modifications to the oversight program are required. The DUR Review Sub-Committee will schedule additional meetings when the preliminary questionnaire indicates that a study might be subject to DUR review, or if the IBC refers a study. The committee will also review and advise the researchers if their pre-screening during the proposal development indicates there might be a DUR issues.

e. Minutes

The committee will maintain minutes of its deliberations and communicate its management recommendations for oversight to the researchers and IBC in writing.

In order to maintain full transparency on its research involving biological agents and toxins, Boston University has established a policy to post all IBC minutes online[1]. The DURRC will develop a strategy to post the minutes of its meetings and decisions online in a manner that does not compromise security.

f. Review Criteria

Each research initiative that is categorized as DUR or DURC is different and poses unique issues related to the implications of the information, materials, or technologies that may result from the research. Therefore, it is not possible to develop a single review process that can be used for all cases. However, the NSABB has developed a toolkit [1] for such reviews that provides guidance for a comprehensive process. The BU DURRC will perform its reviews based on these guidelines.

Biosecurity and the Culture of Responsibility

As discussed previously, the major concern with DURC is its potential use for nefarious purposes. Therefore, in addition to basic biosafety concerns that are associated with any research involving use of pathogenic agents, DURC raises issues of biosecurity. In its report titled “Guidance for Enhancing Personnel Reliability and Strengthening the Culture of Responsibility,” the NSABB provides the following:

What is a “culture of responsibility” in the context of biosecurity?

Bearing in mind the fact that scientific knowledge can be used for positive as well as for negative purposes, all scientists—especially those working in the life sciences—must cultivate among themselves a culture of responsibility with regard to the conduct and the results of their research. The goal remains the generation and advancement of knowledge, but in some cases, such knowledge may be applied for harmful purposes. Scientists’ beliefs, attitudes, and values must reflect a heightened awareness of the implications of their research, especially of any potential for the deliberate misuse of the information, products, and technologies generated from that research. They must consciously demonstrate their commitment to preventing their work from being used for nefarious purposes through the day-to-day practice of mindful research.

In cultivating and sustaining a culture of responsibility, scientists who conduct research must recognize that they engage in a continuous, reciprocal process of promoting and bearing mutual responsibility for their work. They must hold themselves and their peers accountable, collegially and with a shared commitment to advancing science and maintaining public trust.

Boston University and Boston Medical Center have a developed and implemented a comprehensive safety program that has established a culture of safety. The basic principle of the culture of safety program relies on each individual accepting his or her roles and responsibilities and actively promoting and engaging in safe practices. In addition, Boston University’s RCR Program provides instruction in responsible conduct of research to students and postdoctoral researchers in the sciences and engineering. The DURC training and awareness program[2], which was implemented during Phase-I, has further enhanced the awareness of DURC issues within the research community at BU and has contributed significantly to enhancing the culture of responsibility.

[1] Dual Use Research (DUR) is defined as: “development of new technologies and generation of information with potential for benevolent and malevolent purposes.”

[3] For a list of documents see Section-7: References or:  http://oba.od.nih.gov/biosecurity/biosecurity_documents.html

[4] A copy of the full policy may be found at: http://oba.od.nih.gov/biosecurity/bio_usg_activities.html

[5] Publicly Posted BU IBC minutes are available at: http://www.bu.edu/orccommittees/ibc/committee/ibc-minutes/

[6] Appendix-4: Points to Consider in Risk Assessment and Management of Research That is Potentially Dual Use of Concern (Page-51).

[7] For a copy of the BU Awareness Training see: http://www.bu.edu/orc/files/2010/11/Dual-Use-Research-of-Concern_Nov2010.pdf

Full Review and Monitoring Program

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Screening of IBC Applications

The IBC has developed eight (8) screening questions that are incorporated in the IBC protocol application. The questions were based on the recommendations included on the of National Research Council report “Biotechnology Research in An Age Of Terrorism: Confronting The Dual Use Dilemma.”

The questions ask the investigators to identify if the proposed research is designed to:

  1. Enhance the harmful consequences of a biological agent or toxin
  2. Disrupt immunity or effectiveness of an immunization without clinical and or agricultural justification
  3. Confer to a biological agent or toxin, resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against agent or toxin
  4. Confer to a biological agent or toxin, resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin, or facilitate their ability to evade detection methodologies
  5. Increase the stability, transmissibility, or the ability to disseminate a biological agent or toxin
  6. Alter the host range or tropism of a biological agent or toxin.
  7. Enhance the susceptibility of a host population.
  8. Generate a novel pathogenic agent or toxin, or reconstitute an eradicated or extinct biological agent.

Currently, the responses to these questions are being reviewed by the IBC and if any research is identified as DURC, they will be referred to the Associate Vice President for Research Compliance for further review and action.

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Additional Resources

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