Get University At Buffalo Institutional Review Boards (irbs): Vice ...

This guide provides detailed instructions on how to complete the University At Buffalo Institutional Review Boards (IRBs): Vice ... form online. By following these steps, users can efficiently report any serious events or problems that may arise during their research.

Follow the steps to effectively complete the IRB form online.

1. Press the ‘Get Form’ button to access the document and open it in your preferred editing tool.
2. Fill out the general information section, including details such as principal investigator, full study title, IRB number, dates of occurrence and report, subject identifier, and enrollment date if applicable.
3. Answer the questions labeled "a-f" to assess whether the event/problem is serious and should be reported. Select ‘Yes’ or ‘No’ for each question.
4. If any answers to questions a-f are ‘Yes,’ continue to complete the rest of the form as instructed. If all answers are ‘No,’ do not use this form and consider the appropriate alternative.
5. In the relationship section, check the relevant option (related, unrelated, or unknown) to describe how the event/problem is connected to the study intervention.
6. Provide a detailed description of the event/problem. Include specifics about who was involved, how and where it occurred, and any increase in risk.
7. Indicate any steps taken to resolve the event or prevent future occurrences, or mark as not applicable.
8. Confirm whether the event/problem has been reported elsewhere. Mark ‘Yes’ or ‘No’ and provide details if applicable.
9. State if the event/problem requires a change to the protocol or consent. If yes, note that both this form and an Amendment Form need to be submitted.
10. Decide whether to notify subjects already enrolled in the study about the event occurrence and detail the method of notification if applicable.
11. Affix the signature of the principal investigator (or authorized designee) and ensure accurate information is provided in the report. Note that a hand-signed document must be submitted to the IRB if filed electronically.
12. Finally, submit the filled-out form and any related documentation to the Children & Youth Institutional Review Board through the specified email or mailing address.

Complete your submission online to ensure the timely reporting of serious events.