w88 slot Oversight of Dual Use Research of Concern Policy

w88 slot

The University of Nevada, Reno 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 w88 slot system of oversight.

w88 slot Authority

Vice President for w88 slot and Innovation (VPRI); Environmental Health and Safety (EH&S) Department.

w88 slot

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 w88 slot and must be evaluated for dual use research of concern (DURC) potential.

w88 slot and Toxins

  1. Avian w88 slot (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 w88 slot
  11. Rinderpest virus
  12. w88 slot-producing strains of Clostridium botulinum
  13. Variola major virus
  14. Variola minor virus
  15. Yersinia pestis

Categories of w88 slot

  1. Enhances the harmful consequences w88 slot agent or toxin.
  2. Disrupts immunity or the effectiveness of an immunization against the w88 slot or toxin without clinical and/or agricultural justification.
  3. Confers w88 slot 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 w88 slot or toxin.
  5. Alters the host range or tropism w88 slot agent or toxin.
  6. Enhances the susceptibility of a host population w88 slot agent or toxin.
  7. Generates or reconstitutes an eradicated or extinct agent or toxin w88 slot 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 w88 slot level has been mandated. Non-compliance with the federal DURC policy on w88 slot oversight can result in loss of federal life sciences research funding for the institution.

Reference w88 slot

  • United States Government Policy for w88 slot Oversight of Life Sciences Dual Use Research of Concern, released September 24, 2014

Definitions

Dual use w88 slot

w88 slot conducted for legitimate purposes that generates knowledge, information, technologies, and/or products that could be utilized for both benevolent and harmful purposes.

Dual Use w88 slot of Concern (DURC)

Life sciences w88 slot 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.

w88 slot Contact for Dual Use Research (ICDUR)

An individual designated by the institution to serve as an w88 slot 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 w88 slot Biosafety Officer will serve as the ICDUR.

w88 slot 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 w88 slot 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 w88 slot.
  2. Include individuals with sufficient breadth of expertise to assess the dual use potential of the relevant life sciences w88 slot conducted at the University.
  3. Include individuals with knowledge of federal policies and understanding of risk assessment and risk management considerations, including w88 slot 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 w88 slot project being evaluated, except to provide specific information requested by the IRE.
  5. Engage in discussion with the PI of the w88 slot being evaluated when conducting a risk assessment and developing a risk mitigation plan.

w88 slot

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 w88 slot 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 (w88 slot)

An individual who is designated by the w88 slot institution to direct a project or program and who is responsible to the funding agency or the w88 slot institution for the scientific and technical direction of that project or program. There may be more than one PI on a w88 slot grant or project within a single or multiple institutions.

Responsibilities

Vice President for w88 slot and Innovation (VPRI)

  1. Ensuring that the w88 slot Biosafety Committee has sufficient authority to carry out its role as the w88 slot Review Entity as described in this policy.
  2. Appointing individuals to serve on the w88 slot 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 w88 slot.

w88 slot Biosafety Committee

  1. Serving as the University w88 slot Review Entity as described in this policy.
  2. Reviewing life sciences research involving any of the agents listed in the Scope of this w88 slot 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 w88 slot, determine if the research is DURC.
  4. Developing risk mitigation plans for w88 slot (in conjunction with the PI and funding agency).
  5. Reviewing active w88 slot plans at least annually and ensuring that modifications are made as necessary.
  6. In conjunction with the Biosafety Officer, ensuring compliance with this w88 slot, the federal w88 slot, and approved risk mitigation plans.
  7. Investigating cases of reported or suspected non-compliance with either this w88 slot or the federal DURC w88 slot, to include making recommendations to the VPRI regarding corrective actions.

w88 slot Officer

  1. Serving as the University w88 slot Contact for Dual Use Research as described in this policy.
  2. Serving as a member of the w88 slot Biosafety Committee.
  3. Serving as the w88 slot point of contact regarding compliance with this policy and w88 slot oversight of DURC.
  4. Serving as the liaison between the institution and the funding agency regarding oversight of w88 slot, to include w88 slot-related notifications and other communication with the funding agency.
  5. In conjunction with the IBC, ensuring compliance with this w88 slot, the federal w88 slot, and approved risk mitigation plans.
  6. Providing education and training on DURC as required by this w88 slot, and maintaining records of this training as described in this w88 slot.
  7. Ensuring that records of DURC reviews, and approved risk mitigation plans and reviews and modifications are maintained as described in this w88 slot.

w88 slot

  1. Being knowledgeable about and complying with this w88 slot and the federal w88 slot 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 w88 slot, ii) involves agents or toxins listed in this w88 slot and aims to produce, or can reasonably be anticipated to produce, one or more of the effects listed in this w88 slot, or iii) is within the scope of this w88 slot and may meet the definition of DURC.
    1. Initial notification can be made to the Biosafety Officer or Chair w88 slot 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 w88 slot.
  3. Working with the IBC to access dual use risks and benefits of w88 slot and to develop mitigation measures.
  4. Conducting w88 slot 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 w88 slot have received documented education and training on DURC.
  6. Communicating DURC in a responsible manner throughout the w88 slot project in compliance with the approved risk mitigation plan, being mindful of biosafety and biosecurity issues.

Laboratory w88 slot

  1. Being knowledgeable about DURC and complying with this w88 slot.
  2. Conducting w88 slot 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 w88 slot, or if there are previously unidentified DURC concerns associated with such research.

Oversight of Dual Use w88 slot of Concern

Identification of Potential w88 slot

  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 w88 slot 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 w88 slot 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 w88 slot.

w88 slot 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 w88 slot utilizes one or more of the listed agents or toxins.
  2. For w88 slot 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 w88 slot 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 w88 slot 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 w88 slot review findings (see “Notification of Federal Funding Agencies below).
  4. If the IBC determines that the proposed w88 slot meets the definition of DURC the PI may appeal that decision by submitting a written appeal to the Vice President for w88 slot and Innovation (VPRI) that outlines his or her justification as to why the w88 slot is not DURC. The VPRI’s determination of whether or not the w88 slot is DURC will be final.

Notification of Federal w88 slot Agencies

  1. Notification to the federal funding agency must be made within 30 calendar days of the w88 slot 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 w88 slot.
    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 w88 slot, iv) a description of why the w88 slot was determined to produce one or more of the listed experimental effects. If the w88 slot 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 w88 slot, and if the research is determined to be DURC must provide copies of each institution’s risk mitigation plan.

w88 slot Determined to be DURC

If the IBC determines that the proposed w88 slot 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 w88 slot identify and consider the anticipated benefits along with the identified risks.
  2. Within 90 calendar days of the determination that the w88 slot is DURC, the draft risk mitigation plan must be submitted to the funding agency for final review and approval.
    1. The funding agency w88 slot 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 w88 slot Risk Mitigation Plan

  1. Once the risk mitigation plan has been approved by the funding agency, the w88 slot must be conducted in accordance with the approved plan.
  2. The IBC w88 slot review all active risk mitigation plans at least annually.
    1. If the w88 slot 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 w88 slot 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 w88 slot

  1. The IBC and the biosafety officer will take steps to ensure that active DURC is conducted in compliance with this w88 slot, the federal w88 slot, and the associated approved risk mitigation plans through periodic reviews.
  2. Instances of alleged or suspected non-compliance w88 slot reported to the IBC Chair and the VPRI as soon as possible.
  3. The w88 slot 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, w88 slot 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 w88 slot 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 w88 slot 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 w88 slot grant or contract, plus three years after its completion. Records of such training will be maintained by EH&S.