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Institutional Review Entity (DURC)

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Submission Information and IRE Procedures

Principal investigators should notify the IRE as soon as a research project is anticipated to involve one of the listed agents or toxins.

Notification should include both the identity of the listed agents and/or toxins that will be used and an assessment if the research using the listed agents and/or toxins will produce or is anticipated to produce any of the listed categories of experiments and/or their effects.

Upon receipt of a notification of potential DURC, IRE management will contact the principal investigator to confirm the notification was received and then disseminate the notification to the IRE membership for review.

IRE review will include verification that the proposed research uses one of the listed agents and/or toxins and a review of the PI’s assessment regarding whether the proposed research will or is anticipated to achieve any of the listed categories of experiments and/or their effects.

If the IRE determines that the research in question does not involve one or more of the categories of experiments detailed above, the research will not be subject to additional review or oversight, but shall continue to be assessed by the PI going forward.  If the IRE determines the research falls within the scope of DURC the IRE will notify the US Government funding agency within 30 days of review.  If the IRE further determines that the research meets the definition of DURC the IRE will work with the PI to develop a draft risk mitigation plan and submit to the US Government funding agency within 90 days for review and approval.

Once a risk mitigation plan is approved, the IRE and PI will implement the plan and the IRE will review the plan and research at least annually.

Any change in the status of a DURC project or risk mitigation plan must be communicated to the IRE as soon as possible and the IRE will notify the US Government funding agency within 30 calendar days.

Submissions for IRE review should be mailed, faxed, emailed or otherwise delivered to the Biosafety Office at the following address:

Institutional Review Entity (IRE)
Biosafety Office/HSE
2024 East Monument Street, Room B-200
Baltimore, MD 21287

Fax: 410-955-5929
Email:  biosafety@jhu.edu or ire@jhu.edu