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Maintaining :: Undesirable events :: Reporting procedure

Reporting Procedure

Reporting the event

The Reporting Undesirable SBS Research Events form (RUSRE form) goes through a series of questions that will help you to determine if you need to submit the form and the information you need to provide the Board. The form must be submitted within seven days of the event’s occurrence.

Please submit one signed copy of the form through one of the methods below:

  • Email a scanned version of the form to irbsbs@virginia.edu; please include a description of the submission in the email.
  • Faxthe form.
  • Submit a hard copy to our office.

Review Procedure

Once the document is received by our office, it will go through the following steps:

  1. Review by the director, who will determine the accuracy of the report and determine if the event rises to the definitions described in this section. If the event needs further review, it will be put on the next full board meeting agenda.
  2. Review by the full board. The report will be assigned to a primary and secondary reviewer who will review the event and make recommendations to the Board. The Board will discuss the event and make recommendations to amend the protocol or suspend the protocol, if necessary.
  3. Recommendation from the Board. A response letter from the Chair of the IRB-SBS will be sent to the research team with instructions for completing the corrective actions within a specified timeframe.
  4. Reinstating research study. Once the protocol is in a state that satisfies the Board’s concerns regarding the new level of risk (which may require more than one board meeting, depending on the changes required) the protocol is approved and research can continue.
  5. IRB reports to OHRP. As per 45CFR46.103(b)(5), the IRB-SBS will describe the adverse event in a letter sent to OHRP.

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