推荐杏吧原创

Institutional Oversight of Dual Use Research of Concern Policy

Policy

The 推荐杏吧原创 is committed to conducting life sciences research in a responsible manner, recognizing that certain types of beneficial research can be utilized for harmful purposes. To help ensure that such research is conducted responsibly and in compliance with federal regulations, life sciences research that meets the scope of dual use research of concern specified in this policy will be subject to an institutional system of oversight.

Responsible Authority

Vice President for Research and Innovation (VPRI); Environmental Health and Safety (EH&S) Department.

Scope

Any research, regardless of the funding source, involving any of the agents or toxins listed below that is conducted by University personnel, conducted at University owned or leased facilities (regardless of who conducts the research), or sponsored by the University, and which produces, aims to produce, or can be reasonably anticipated to produce one or more of the effects listed below is within the scope of this policy and must be evaluated for dual use research of concern (DURC) potential.

Agents and Toxins

  1. Avian influenza virus (highly pathogenic)
  2. Bacillus anthracis
  3. Botulinum neurotoxin (any quantity)
  4. Burkholderia mallei
  5. Burkholderia pseudomallei
  6. Ebola virus
  7. Foot-and-mouth disease virus
  8. Francisella tularensis
  9. Marburg virus
  10. Reconstructed 1918 influenza virus
  11. Rinderpest virus
  12. Toxin-producing strains of Clostridium botulinum
  13. Variola major virus
  14. Variola minor virus
  15. Yersinia pestis

Categories of Effects

  1. Enhances the harmful consequences of the agent or toxin.
  2. Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification.
  3. 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.
  4. Increases the stability, transmissibility, or the ability to disseminate the agent or toxin.
  5. Alters the host range or tropism of the agent or toxin.
  6. Enhances the susceptibility of a host population to the agent or toxin.
  7. Generates or reconstitutes an eradicated or extinct agent or toxin listed above.

Background

Although life sciences research is essential for scientific advances in medicine, public health, animal and plant agriculture, and many other areas, it is recognized that in some cases the knowledge, information, products, or technologies resulting from such research could be used to threaten or harm society. In recognition of the potential for both benefit and harm, such research is referred to as dual use research. Dual use research of concern (DURC) is a subset of dual use research that can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to threaten or harm society. In order to ensure that potential risks are properly managed and potential benefits are realized, DURC must be identified, evaluated, and to ensure that appropriate risk mitigation measures are applied, oversight at the federal and institutional level has been mandated. Non-compliance with the federal DURC policy on institutional oversight can result in loss of federal life sciences research funding for the institution.

Reference Regulations

  • United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, released September 24, 2014

Definitions

Dual use research

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)

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.

Institutional Contact for Dual Use Research (ICDUR)

An individual designated by the institution to serve as an institutional point of contact for questions regarding compliance with and implementation of the requirements for the oversight of DURC as well as the liaison (as necessary) between the institution and the relevant USG funding agency. For University Institutional Biosafety Officer will serve as the ICDUR.

Institutional Review Entity (IRE)

A committee established by the institution with the authority and responsibility to review life sciences research for DURC potential and provide oversight of research that is determined to be DURC as described in this policy. The University Institutional Biosafety Committee will serve as the IRE. The IRE must be composed of at least five members and:

  1. Be provided sufficient authority by the university to enable it to execute the requirements described in this policy.
  2. Include individuals with sufficient breadth of expertise to assess the dual use potential of the relevant life sciences research conducted at the University.
  3. Include individuals with knowledge of federal policies and understanding of risk assessment and risk management considerations, including biosafety and biosecurity.
  4. On a case by case basis, recuse any member of the IRE who is involved with, or has a direct financial interest in, the research project being evaluated, except to provide specific information requested by the IRE.
  5. Engage in discussion with the PI of the research being evaluated when conducting a risk assessment and developing a risk mitigation plan.

Life Sciences

Pertains to living organisms (e.g., microbes, human beings, animals, and plants) and their products, including all disciplines and methodologies of biology such as agricultural science, plant science, animal science, bioinformatics, genomics, proteomics, synthetic biology, environmental science, public health, modeling, engineering of living systems, and all applications of the biological sciences. The term is meant to encompass the diverse approaches to understanding life at the level of ecosystems, populations, organisms, organs, tissues, cells, and molecules.

Principal Investigator (PI)

An individual who is designated by the research institution to direct a project or program and who is responsible to the funding agency or the research institution for the scientific and technical direction of that project or program. There may be more than one PI on a research grant or project within a single or multiple institutions.

Responsibilities

Vice President for Research and Innovation (VPRI)

  1. Ensuring that the Institutional Biosafety Committee has sufficient authority to carry out its role as the Institutional Review Entity as described in this policy.
  2. Appointing individuals to serve on the Institutional Biosafety Committee so that the committee membership meets the requirements specified in this policy.

Deans, Chairs, and Directors

  1. Ensuring that principal investigators who conduct life sciences research are aware of the responsibilities and procedures contained in this policy.

Institutional Biosafety Committee

  1. Serving as the University Institutional Review Entity as described in this policy.
  2. Reviewing life sciences research involving any of the agents listed in the Scope of this policy through review of a Memorandum of Understanding and Agreement (MOUA) or amendment to an approved MOUA, each as submitted by the PI.
  3. Reviewing life sciences research for DURC potential, and for research that utilizes one or more of the agents or toxins and one of more of the effects listed in this policy, determine if the research is DURC.
  4. Developing risk mitigation plans for DURC (in conjunction with the PI and funding agency).
  5. Reviewing active risk mitigation plans at least annually and ensuring that modifications are made as necessary.
  6. In conjunction with the Biosafety Officer, ensuring compliance with this policy, the federal policy, and approved risk mitigation plans.
  7. Investigating cases of reported or suspected non-compliance with either this policy or the federal DURC policy, to include making recommendations to the VPRI regarding corrective actions.

Biosafety Officer

  1. Serving as the University Institutional Contact for Dual Use Research as described in this policy.
  2. Serving as a member of the Institutional Biosafety Committee.
  3. Serving as the institutional point of contact regarding compliance with this policy and institutional oversight of DURC.
  4. Serving as the liaison between the institution and the funding agency regarding oversight of DURC, to include DURC-related notifications and other communication with the funding agency.
  5. In conjunction with the IBC, ensuring compliance with this policy, the federal policy, and approved risk mitigation plans.
  6. Providing education and training on DURC as required by this policy, and maintaining records of this training as described in this policy.
  7. Ensuring that records of DURC reviews, and approved risk mitigation plans and reviews and modifications are maintained as described in this policy.

Principal Investigators

  1. Being knowledgeable about and complying with this policy and the federal policy for oversight of DURC.
  2. Notifying the IBC as soon as the PI’s research: i) involves one or more of the agents or toxins listed in this policy, ii) involves agents or toxins listed in this policy and aims to produce, or can reasonably be anticipated to produce, one or more of the effects listed in this policy, or iii) is within the scope of this policy and may meet the definition of DURC.
    1. Initial notification can be made to the Biosafety Officer or Chair of the IBC verbally or by e-mail but additional notification through submittal of a MOUA or MOUA amendment must also be made as soon as possible.
    2. Notification must include the PI’s assessment of whether any research involving the listed agents or toxins aims to produce, or can reasonably be anticipated to produce, one or more of the effects listed in this policy.
  3. Working with the IBC to access dual use risks and benefits of DURC and to develop mitigation measures.
  4. Conducting DURC in accordance with the provisions of the approved risk mitigation plan.
  5. Ensuring that laboratory personnel conducting life sciences research with one or more of the agents or toxins listed in this policy have received documented education and training on DURC.
  6. Communicating DURC in a responsible manner throughout the research project in compliance with the approved risk mitigation plan, being mindful of biosafety and biosecurity issues.

Laboratory Personnel

  1. Being knowledgeable about DURC and complying with this policy.
  2. Conducting DURC in compliance with the approved risk mitigation plan.
  3. Notifying the PI of new research or changes to existing research that involves one or more of the agents or toxins listed in the policy, or if there are previously unidentified DURC concerns associated with such research.

Oversight of Dual Use Research of Concern

Identification of Potential DURC

  1. All life sciences research involving microbial agents and toxins, including those listed in the Scope of this policy, must be reviewed and approved by the University Institutional Biosafety Committee (IBC) through submittal of a Memorandum of Understanding and Agreement (MOUA) or amendment to an approved MOUA.
    1. Prior to acquiring or using any of the agents or toxins listed in the Scope of this policy the responsible PI must notify the IBC by submitting a MOUA or MOUA amendment. The IBC must approve the MOUA or MOUA amendment before the PI is authorized to acquire or use the agent(s) or toxin(s) in question.
    2. The PI must identify each of the listed agents or toxins which are involved in the research and must assess whether or not the research will produce, or may produce, any of the effects listed in the Scope of this policy.

DURC Determination

  1. For each MOUA or MOUA amendment that involves one of more of the listed agents or toxins, the IBC will verify that the research utilizes one or more of the listed agents or toxins.
  2. For research that is determined to involve one or more of the listed agents or toxins, the IBC will review the PI’s assessment of whether the research produces, aims to produce, or is reasonably anticipated to produce one of the listed effects.
  3. If the IBC concludes that one or more of the effects may be produced, it will conduct a risk assessment to determine whether the research meets the definition of DURC.
    1. If the IBC determines that the proposed research does not meet the DURC definition, then the research is not subject to additional DURC oversight; however, the IBC must notify the funding agency of the institutional review findings (see “Notification of Federal Funding Agencies below).
  4. If the IBC determines that the proposed research meets the definition of DURC the PI may appeal that decision by submitting a written appeal to the Vice President for Research and Innovation (VPRI) that outlines his or her justification as to why the research is not DURC. The VPRI’s determination of whether or not the research is DURC will be final.

Notification of Federal Funding Agencies

  1. Notification to the federal funding agency must be made within 30 calendar days of the institutional review for DURC potential of any research that involves one or more of the listed agents or toxins and one or more of the listed experimental effects, including whether or not the research meets the definition of DURC.
    1. For non-federally funded research, notification should be made to the NIH Program on Biosecurity and Biosafety Policy.
    2. This notification must include the following: i) grant or contract number, ii) name of the PI, iii) the name of the listed agent(s) or toxin(s) involved in the research, iv) a description of why the research was determined to produce one or more of the listed experimental effects. If the research that was determined by the IBC to meet the DURC definition, the following additional information must be included: i) the name of the investigator responsible for the performance of the DURC (if different from the PI), and ii) a description of the IBC’s basis for the determination.
    3. When elements of DURC are carried out at multiple institutions through a sub-award, the primary institution is responsible for notifying the funding agency of research that is within the scope of this policy, and if the research is determined to be DURC must provide copies of each institution’s risk mitigation plan.

Research Determined to be DURC

If the IBC determines that the proposed research meets the definition of DURC then the following is required.

  1. The IBC, working in conjunction with the PI and the funding agency, will develop a draft risk mitigation plan. The draft risk mitigation plan must identify and consider the anticipated benefits along with the identified risks.
  2. Within 90 calendar days of the determination that the research is DURC, the draft risk mitigation plan must be submitted to the funding agency for final review and approval.
    1. The funding agency must provide an initial response within 30 calendar days and should finalize the plan within 60 calendar days after receiving the draft plan.

Implementation of the DURC Risk Mitigation Plan

  1. Once the risk mitigation plan has been approved by the funding agency, the DURC must be conducted in accordance with the approved plan.
  2. The IBC must review all active risk mitigation plans at least annually.
    1. If the research still constitutes DURC, the plan must be modified as needed.
    2. The funding agency must be notified within 30 calendar days of any of the following: i) any change in the status of a DURC project, including whether the research has been determined to no longer be DURC, and ii) changes to risk mitigation plans (changes must be approved by the funding agency).

Compliance with DURC Policy

  1. The IBC and the biosafety officer will take steps to ensure that active DURC is conducted in compliance with this policy, the federal policy, and the associated approved risk mitigation plans through periodic reviews.
  2. Instances of alleged or suspected non-compliance must be reported to the IBC Chair and the VPRI as soon as possible.
  3. The IBC will investigate alleged or suspected non-compliances and submit a report with its findings and recommendations to the VPRI.
  4. Instances of non-compliance and mitigation measures to be implemented to prevent reoccurrences of similar non-compliance, must be reported to the funding agency within 30 calendar days.

Training

  1. Individuals who conduct life sciences research with one or more of the agents or toxins listed in the Scope of this policy must be provided education and training on DURC.

Records

  1. Records of DURC reviews conducted by the IBC and completed risk mitigation plans must be maintained for the term of the research grant or contract, plus three years after its completion, but no less than eight years. Records of DURC reviews conducted by the IBC will be maintained by the Biosafety Officer.
  2. Records of DURC training must be maintained for the term of the research grant or contract, plus three years after its completion. Records of such training will be maintained by EH&S.