KANSAS STATE UNIVERSITY INSTITUTIONAL REVIEW ENTITY DUAL USE RESEARCH OF CONCERN STANDARD OPERATING PROCEDURES

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1 KANSAS STATE UNIVERSITY INSTITUTIONAL REVIEW ENTITY DUAL USE RESEARCH OF CONCERN STANDARD OPERATING PROCEDURES I. INTRODUCTION Despite its value and benefits, certain types of research conducted for legitimate purposes can be utilized for both benevolent and harmful purposes. Such research is called dual use research. 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, material, or national security. II. PURPOSE The U.S. Government (USG) has established a policy with the purpose of establishing regular review of USG funded or conducted research with certain high consequence pathogens and toxins for its potential to be DURC in order to: (a) mitigate risks where appropriate; and (b) collect information needed to inform the development of an updated policy, as needed, for the oversight of DURC. The fundamental aim of this oversight is to preserve the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research. To help accomplish the aims of the DURC review policy, entities receiving funding from the USG must create an institutional review process for assessing and reviewing potential DUR research. This SOP details the K State policies and procedures for compliance with the provisions of the United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern, hereafter referred to as, the USG Policy or the Policy ( III. DEFINITIONS A. Dual Use Research of Concern (DURC) 1. DURC is 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. 2. 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 aerobiology, agricultural science, plant science, animal science, bioinformatics, genomics, proteomics, synthetic biology, environmental science,

2 public health, modeling, engineering of living systems, and all applications of the biological sciences. The term is meant to encompass the diverse approaches for understanding life at the level of ecosystems, organisms, organs, tissues, cells, and molecules. 3. Extramural research is that which is funded by a department or agency under a grant, contract, cooperative agreement, or other agreement and not conducted directly by the department or agency. 4. Intramural research is that directly conducted by a department or agency. B. Institutional Contact for Dual Use Research (ICDUR) The ICDUR serves as an institutional point of contact for questions regarding compliance with and implementation of the requirements for the oversight of research that falls within the scope of the USG Policy and/or meets the definition of DURC. Unless otherwise designated, the Associate Vice President for Research Compliance (AVPR RC) will be the ICDUR. The ICDUR serves as the liaison (as necessary) between the institution and the relevant program officers at USG funding agencies, or for non USG funded research, between the institution and NIH (or the USG agency to which NIH refers the institution). The Vice President for Research (VPR) will appoint the Institutional Contact for Dual Use Research ICDUR. C. Authorized Organizational Representative (AOR) The AOR is named by the applicant organization, who is authorized to act for the applicant and to assume the obligations imposed by the Federal laws, regulations, requirements, and conditions that apply to grant applications or grant awards. This is authorized through delegated authority from the President. D. Institutional Biosafety Committee (IBC) The IBC is responsible for ensuring that research conducted at KSU is in compliance with applicable regulations and guidelines, including the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules and the 5 th Edition of the Biosafety in Microbiological and Biomedical Laboratories (BMBL). These form the basis for campus biosafety policies and procedures, and reviewing individual research proposals for biosafety concerns. The K State IBC is appointed by the Vice President for Research (VPR)/ Institutional Official (IO). The IBC as a whole represents collective expertise and research experience in biohazardous materials and biosafety in experiments that may pose potential risks to health or the environment. Current IBC information and committee membership is found at state.edu/comply/ibc/. E. DURC Institutional Review Entity (IRE) Committee The KSU committee specifically designated to review dual use research in accordance with this SOP and the USG Policy as needed. The Vice President for Research (VPR) appoints members of the KSU IRE in writing who will serve at the discretion of the VPR (Appendix). Page 2 of 7

3 IV. THE AGENTS OR TOXINS OF CONCERN The USG has identified fifteen specific agents and toxins that will be evaluated for DURC potential A. Avian influenza virus (highly pathogenic) B. Bacillus anthracis C. Botulinum neurotoxin (For the purposes of this Policy, there are no exempt quantities of botulinum neurotoxin. Research involving any quantity of botulinum neurotoxin should be evaluated for DURC potential) D. Burkholderia mallei E. Burkholderia pseudomallei F. Ebola virus G. Foot and mouth disease virus H. Francisella tularensis I. Marburg virus J. Reconstructed 1918 Influenza virus K. Rinderpest virus L. Toxin producing strains of Clostridium botulinum M. Variola major virus N. Variola minor virus O. Yersinia pestis V. CATEGORIES OF EXPERIMENTS OF DURC A. Enhance the harmful consequences of the agent or toxin B. Disrupt immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification C. Confer 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 D. Increase the stability, transmissibility, or the ability to disseminate the agent or toxin E. Alter the host range or tropism of the agent or toxin F. Enhance the susceptibility of a host population to the agent or toxin G. Generate or reconstitutes an eradicated or extinct agent or toxin listed above VI. RESPONSIBILITIES A. Responsibilities of KSU Principal Investigators 1. Be knowledgeable about and comply with all institutional and USG policies and requirements for oversight of DURC. 2. Notify the Institutional Contact for Dual Use Research (ICDUR) as soon as: i. The PI identifies the research as involving one or more of the, nonattenuated, 15 agents or toxins listed above (Section 6.2.1, USG Policy). Page 3 of 7

4 ii. Notification must include the PI s assessment of whether any research involving these agents or toxins produces, aims to produce, or is reasonably anticipated to produce one or more of the effects listed above (Section 6.2.2, USG Policy). 3. Complete and submit the DURC review form to URCO. 4. Work with the IRE to assess the dual use risks and benefits of the DURC. 5. Work with the IRE to develop a risk mitigation plan. 6. Conduct DURC in accordance with the provisions in the risk mitigation plan. 7. Ensure that laboratory personnel (i.e., those under the supervision of laboratory leadership, including graduate students, postdoctoral fellows, research technicians, laboratory staff, and visiting scientists) conducting life sciences research with one or more of the 15 agents listed in Section 6.2.1, USG Policy, have received institutional training on DURC. 8. Provide the IRE with an annual update of the research, to include any changes or unanticipated results to the activity. 9. Communicate DURC in a responsible manner. Communication of research and research findings is an essential activity for all researchers, and occurs throughout the research process, not only at the point of publication. Researchers planning to communicate DURC should do so in compliance with the approved risk mitigation plan B. Responsibilities of the KSU Institutional Review Entity 1. Be sufficiently empowered by the institution to ensure it can execute the requirements of the USG Policy as it relates to function of the IRE. 2. Include persons with sufficient breadth of expertise to assess the dual use potential of the range of relevant life sciences research conducted at a given research facility. 3. Include persons with knowledge of relevant USG policies and understanding of risk assessment and risk management considerations, including biosafety and biosecurity. The review entity may also include, or have available as consultants, at least one person knowledgeable in the institution s commitments, policies, and standard operating procedures. 4. On a case by case basis, recuse any member of an IRE who is involved in the research project in question or has a direct financial interest, except to provide specific information requested by the review entity. 5. Engage in an ongoing dialogue with the PI of the research in question when conducting a risk assessment and developing a risk mitigation plan. 6. Assess whether research that uses one or more of the agents or toxins listed in Section 6.2.1, USG Policy, also produces, aims to produce, or is reasonably anticipated to produce one or more of the effects listed in Section 6.2.2, USG Policy. 7. For research anticipated to produce at least one of the seven effects, determine whether the research meets the definition of DURC in Section 4.C., USG Policy. A Page 4 of 7

5 risk assessment should underpin the determination of DURC (see Section 8.A of the USG Policy for resources for this assessment). 8. Identify the anticipated benefits of the research identified as DURC (see Section 8.A, USG Policy for resources for this assessment). The anticipated benefits should be considered in conjunction with the previously identified risks (see Section 7.C, USG Policy) in order to develop a draft risk mitigation plan to guide the conduct and communication of the DURC. The risk mitigation plan must be approved by the IRE and the USG funding agency and plans should be evaluated by the IRE at least annually and modified as necessary for the duration of the research. KSU is responsible for ensuring that the DURC is conducted in accordance with the approved risk mitigation plan. 9. Provide notification of the results of this IRE review to the relevant funding agency and the PI. In instances when the research is determined to be DURC, provision of the draft risk mitigation plan must be submitted to the USG funding agency. For non USG funded research, notifications of the results of the review process must be submitted to the NIH Program on Biosecurity and Biosafety Policy at DURC@od.nih.gov., which will receive the notification for administrative purposes and will in turn refer the notification to an appropriate agency based upon the nature of the research. 10. In cases of collaborations involving multiple institutions via a subaward, the ICDUR at the primary institution is responsible for notifying the funding agency of research that falls within the scope of Section 6.2, USG Policy, and if that research is determined to be DURC, providing copies of each institution's risk mitigation plan. Furthermore, the primary institution should ensure that DURC oversight is consistently applied by all entities participating in the collaboration. 11. The KSU IRE will review at least annually the risk mitigation plan. If the research in question still constitutes DURC, the IRE should modify the plan as needed. VII. IRE COMPOSITION The DURC IRE will be composed of at least 5 members appointed in writing by the Vice President for Research (VPR) with the qualifications listed below. The VPR will designate the chair of the DURC IRE. The ICDUR will serve as an ad hoc member of the DURC IRE. Depending on the nature of the activity, the DURC IRE may engage additional consultants or subject matter experts on a case by case basis to provide relevant scientific expertise and assist the IRE in its deliberations. Consultants and/or subject matter experts may be K State faculty or staff, other university scientists (non KSU), or non university personnel. IRE members serve at the discretion of the VPR. VIII. IRE MEETINGS The IRE will meet at the call of the ICDUR as required to review potential DURC activities in accordance with instructions and procedures in the USG Policy and this SOP. The Chair directs the meeting with a quorum (simple majority) being necessary for reviewing activities. PI s are invited and encouraged to attend meetings to provide a brief oral overview of the activity, and Page 5 of 7

6 answer questions. Following questions and/or any comments/clarifications, the PI (and any committee member with a potential conflict of interest) is excused and general committee discussion about the activity ensues. A voice vote, and if necessary, a hand vote determines the issue. A majority vote of a convened quorum is necessary for approval of a proposed activity. Deliberations of the IRE will be duly recorded and appropriate action on possible DURC activities will be taken in accordance with provisions of the USG Policy. Standardized templates will be used to facilitate DURC IRE review and reporting as appropriate. IX. IRE/ICDUR REPORTING A. The ICDUR, in coordination with the University s Authorized Organizational Representative (AOR), as appropriate, will report to the funding agency within 30 calendar days of the institutional review of the research for DURC potential. This initial notification will include: the grant or contract number related to the research (if the research is funded by the USG); the name(s) of PI(s); the name(s) of the agent(s) listed in Section 6.2.1, USG Policy; and a description of why the research is deemed to produce one or more of the experimental effects listed in Section 6.2.2, USG Policy. For research that is determined by the IRE to meet the definition of DURC, the notification should also include: the name of the investigator (if different from the PI) responsible for the performance of the DURC; and a description of the IRE s basis for its determination. B. Within 90 calendar days of the IRE s determination that the research is DURC; the ICDUR, in consultation with the University s Authorized Organizational Representative (AOR), as appropriate, will provide a risk mitigation plan to the USG funding agency for final review and approval. In the case of non USG funded research, the risk mitigation plan will be provided to the USG agency designated by NIH. USG agencies must provide an initial response within 30 calendar days and should finalize the plan within 60 calendar days of receipt of the draft plan. C. The ICDUR, in consultation with the University s AOR, as appropriate, will notify the NIH within 30 calendar days, of: 1) any change in the status of a DURC project at the institution (including whether the research is determined by the IRE to no longer meet the definition of DURC), and 2) details of any changes to risk mitigation plans (such changes need to be approved by the funding agency). Such notification will be made to the USG funding agency or, in the case of non USG funded research, to the USG agency designated by NIH. D. In cases of collaborations involving multiple institutions via a subaward, the primary institution is responsible for notifying the funding agency of research that falls within the scope of Section 6.2 and, if that research is determined to be DURC, providing copies of each institution's risk mitigation plan. Furthermore, the primary institution should ensure that DURC oversight is consistently applied by all entities participating in the collaboration. Page 6 of 7

7 X. DURC APPEAL PROCEDURE After the IRE determines an activity meets the definition of DURC, the PI may request an appeal of the review. The VPR with the assistance of the ICDUR identifies and convenes an ad hoc committee to review the appeal and make a final institutional determination as to whether the activity raises to the level of DURC. The VPR refers the determination back to the ICDUR and the IRE for appropriate action and reporting. XI. REFERENCES A. United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern B. United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern C. Companion Guide to the USG Policies for Institutional Oversight of Life Sciences Dual Use Research of Concern companionguide.pdf D. Frequently Asked Questions (FAQ) about USG Policies for Institutional Oversight of Life Sciences Dual Use Research of Concern faqs.pdf E. Case Studies on the Implementation of USG Policies for Institutional Oversight of Life Sciences Dual Use Research of Concern case studies durc.pdf F. United States Government Policy for Oversight of Life Sciences Dual Use Research of Concern policy durc pdf G. Department of Health and Human Services (DHHS) general information on the USG Dual Use Research Policy H. Additional USG resources Page 7 of 7