Institutional Authority and Responsibilities
The purpose of this Policy is to provide the framework for the institutional review and oversight of certain life sciences research with high-consequence pathogens and toxins to ensure potential DURC conducted at The University of Iowa (“UI” or “Institution”) is identified and, where appropriate, risks are mitigated. The Policy has been developed to comply with the requirements of the “United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern” (“USG Policy”).
The UI’s DURC Policy seeks to preserve the benefits of dual use research while minimizing the risk that the knowledge, information, products, or technologies generated from such research could be used in a manner that results in harm to public health and safety, agricultural crops and other plants, animals, the environment, material, or national security. The UI aims to do so through a coordinated effort involving the following entities and individuals:
The Institution will:
Identify research that falls under the USG Policy.
- Notify the appropriate USG funding agency or the NIH-designated agency of the outcome of the Institutional Review Entity (“IRE”) assessment within 30 calendar days.
- Work with the USG funding agency or NIH-designated agency to complete a draft risk mitigation plan within 90 calendar days of the IRE’s determination that the research is DURC.
- Ensure implementation of the approved risk mitigation plan and provide ongoing oversight of DURC, including providing education and training; maintaining records; and when and as required by the USG Policy, notifying the appropriate USG funding agency or the NIH-designated agency of (i) changes to a DURC project’s status or risk mitigation plan, or (ii) instances of noncompliance with the USG Policy.
- Ensure publications resulting from DURC have undergone sufficient review by the IRE and USG funding agencies.
Office of the Vice President for Research & Economic Development (“OVPR&ED”)
The Assistant Vice President for Research Compliance, who serves as the Institutional Official (“IO”), has responsibility for the UI DURC oversight. The IO will:
- Oversee Institutional compliance with applicable federal regulations, state statutes and regulations, and UI policies and procedures relating to DURC.
- Select and appoint members of the IRE. Committee structure and evaluation criteria will be based upon requirements of the USG Policy.
- Provide adequate resources in support of the IRE and communicate regularly with the IRE Chair on issues related to DURC.
- Provide reports to the VPR&ED as needed, and other campus officials, as required.
- Ensure appropriate coordination and administration of this Policy by the UI’s Environmental Health & Safety (“EHS”) Office.
Institutional Biosafety Committee (“IBC”)
The IBC will periodically review this Policy and recommend actions to improve and strengthen the Policy.
Institutional Review Entity
At a minimum, the IRE membership will consist of at least two Faculty Researchers, one of whom will be from outside the Carver College of Medicine who also serves as Chair; the Carver of College of Medicine’s BSL3 Oversight Committee (CCOMBOC) Chair; the IBC Chair; the Biological Safety Officer/Responsible Official (BSO/RO) within EHS; a representative from the communications staff from the Office of Research and Economic Development, one representative each from the Department of Public Safety, and the General Counsel’s Office in a non-voting ex-officio capacity; and a non-UI affiliated community member.
The charge of the IRE is to:
- Review research that has been identified as potential DURC.
- Conduct a risk assessment for those research projects that meet the scope of the USG Policy.
- When deciding to proceed with a DURC project, recommend strategies for the management of that project and develop a risk mitigation plan.
- Implement the risk mitigation plan in cooperation with the Principal Investigator (“PI”).
- Review annually the status of DURC oversight and all active risk mitigation plans.
- Review and recommend strategies for publication and/or data dissemination-related issues, including but not limited to presentations at conferences, abstracts, databases and repositories.
The BSO/RO will oversee coordination and administration of the IRE and will report any concerns to the IRE. The BSO/RO will also serve as the UI’s DURC point of contact.
The UI PIs will:
- Be knowledgeable about and comply with all Institutional and Federal policies and requirements for oversight of DURC.
- Using a “Notification to IRE of Research that Requires Review” form (see UI’s Program for Institutional DURC Oversight, Appendix A), submit proposed or ongoing research for IRE review as soon as research or proposed research involves one or more of the listed agents or toxins (see Section 6.2.1 of the USG Policy).
- The PI will also provide information to the IRE regarding:
- Research or proposed research with one or more of the listed agents or toxins that also produces, aims to produce, or can be reasonably anticipated to produce one or more of the listed experimental effects (see Section 6.2.2 of the USG Policy); or
- Research or proposed research meeting criteria (b) or (i) above which may meet the definition of DURC, depending on for example whether the listed agent or toxin is in an attenuated form.
- Conduct and communicate DURC in accordance with the risk mitigation plan.
- Ensure all appropriate laboratory personnel conducting DURC receive education and training on DURC.
- Remain in communication with the IRE for the duration of the project.
IRE Committee Process and Actions
The IRE will convene when it is notified by the BSO/RO that a DURC project has been identified and a Notification to IRE of Research that Requires Review Form has been submitted by the PI.
- Research projects may be referred to the IRE by the CCOMBOC, IBC, PI or Biosafety staff. If a referral comes from someone other than a PI, then the PI for the project shall still submit to the IRE a Notification to IRE of Research that Requires Review Form.
- IRE members will disclose any conflicts of interest they have to the IRE Chair, who shall then decide if an IRE member needs to recuse himself or herself from IRE proceedings.
- The IRE will verify if the research utilizes one of the listed agents or toxins and will review the PI’s assessment with criteria from the USG Policy in order to determine if the research meets the scope of the USG Policy.
- If the IRE determines that the research project is not DURC, the PI:
- May continue to seek approval from other Institutional oversight committees (e.g. IBC, IACUC), as necessary; and
- Must annually verify to the IRE the ongoing accuracy of or any changes to the Notification to IRE of Research that Requires Review Form submitted as part of the project.
- If the IRE determines that the research project is DURC, the IRE will work with the PI to complete the assessment form (see UI’s Program for Institutional DURC Oversight, Appendix B).
- Within 30 calendar days of final review by the IRE, the IRE will notify the USG funding agency or NIH-designated agency whether or not the research falls within the scope of USG Policy (see UI’s Program for Institutional DURC Oversight, Appendix C).
- Within 90 calendar days from the time the IRE determined the research to be DURC, the IRE will provide a copy of the draft risk mitigation plan to the USG funding agency or NIH-designated agency.
- If the IRE determines that the research project is not DURC, the PI:
- The IRE will ensure implementation of the finalized risk mitigation plan. The PI must conduct and/or communicate research in accordance with that plan.
- The IRE will hold a scheduled meeting at least once each calendar year to review (i) the status of DURC oversight and all active risk mitigation plans, and (ii) the latest recommendations of regulatory bodies, including the National Science Advisory Board for Biosecurity (“NSABB”).
- Minutes of all IRE meetings, along with DURC reviews, completed risk mitigation plans, and educational and training records, will be maintained by the BSO/RO for a minimum of three years after completion of the DURC project(s), but in no case less than eight years.
- The IRE will review instances of noncompliance with the PI and the resulting report in accordance with the USG Policy.
- When and as required by the USG Policy, the IRE will notify the appropriate USG funding agency or the NIH-designated agency of (i) changes to a DURC project’s status or risk mitigation plan, or (ii) instances of noncompliance with the USG Policy.
- The IRE will provide an annual assurance to the Division of Sponsored Programs that the Institution is in compliance with its reporting obligations.