Protocol Review Process

Protocol Review Process

The DURC shall undertake the following steps in its review of research, which shall involve a two-stage review process 

  1. Determine whether the research utilizes non-attenuated forms of one or more of the listed agents or toxins.
  2. Determine whether the research produces, aims to produce, or is reasonably anticipated to produce one or more of the listed experimental effects.
  3. Determine whether the research is subject to further review in accordance with this policy.
  4. Conduct a risk assessment and determine whether the research meets the definition of DURC. This assessment should involve the PI, as appropriate.
  5. Assess the benefits of the DURC while also considering the risks identified in the previous step.
    • PI develops a draft risk mitigation plan for the identified DURC. This plan should be based on the assessment of the risks and benefits performed in the previous steps. More information on drafting risk mitigation plans can be found in Section D of the Companion Guide (Dual Use Research of Concern:  A Companion Guide).
    • Review, at least annually, all active risk mitigation plans. If the research in question still constitutes DURC, the DURRC should modify the plan as needed. More information on the annual review of active risk mitigation plans can be found in Section E of the Companion Guide (Dual Use Research of Concern:  A Companion Guide).
  6. For research projects that have been determined to be DURC, the DURC component of the project must not be initiated until an approved risk mitigation plan is in place.

United State Government’s Policy

Prior to submitting a manuscript for publication, the Principal Investigator (PI) must submit a Manuscript Clearance Form (PDF File) through the DURC, which specifically monitors for  

  1. General Overview of the Research Information 
  2. Risk Analysis
  3. Benefit Analysis
  4. Considerations for Weighing Risk and Benefits of Communicating DURC Findings
  5. Formulation of Recommendation(s) Regarding Responsible Communication of DURC Findings

There may be some rare situations in which consultation with the relevant Federal agency may be helpful.

Forms:

Principal Investigators Notification to the Institutional Review Committee.

Training:

Contact the Biosafety Officer: Dr. Veena Naik - veena.naik@unt.edu for guidance on Dual Use Research Concern Training.

Frequently Used Resources