Procedures for Research with Human Subjects (Institutional Review Board)

Procedures for filing an application for human subjects approval with the WCSU Institutional Review Board (IRB) can be found updated at the IRB website.

The WCSU IRB Research Application Guide contains complete instructions for submitting a Research Application.  All necessary documents can be found on the website, including:

• IRB Proposal forms for Exempt, Expedited or Full Review
• The WCSU Informed Consent Guidelines
• Approval Form for Undergraduate Student Research Involving Human Subjects
• Information on available Human Subjects Training through the CITI program List of Frequently Asked Questions
• Protocol Termination Reports

 

Institutional Review Board External Adverse Events

An adverse event is an undesirable and unintended, although not necessarily unexpected, result of therapy or other intervention. Unanticipated Problems that Affect Risks to Subjects (from “Guidelines for Researchers,” 11). If adverse consequences or unanticipated side effects are encountered in the course of a study, or new information becomes available that could change the perception of a favorable risk/benefit ratio, the principal investigator is responsible for informing the Committee PROMPTLY. A copy of every adverse event report, letter, or form submitted to an outside agency (e.g., a federal agency) should also be forwarded to the WCSU IRB in care of the Office of Grant Programs, University Hall, 3^rd Floor, within seven working days after discovery. The WSCU IRB will make the final determination regarding protocol changes required due to adverse event reports.