An adverse event can occur during the course of a research protocol that either causes physical or psychological harm, increases the risk of physical or psychological harm, or results in a loss of privacy and/or confidentiality to a research participant or others (such as family members). An adverse event may also include any serious continuing noncompliance with the regulations or requirements of IRB.
The most important responsibilities of researchers and staff are:
Types of adverse events include:
*This information is taken from the Office for Human Research Protections' Unanticipated Problems Involving Risks & Adverse Events Guidance
In order to report an adverse event, log in to the MyTC portal and click the Faculty, Student, or Employee Resources tab. On the right side, you will find a link to Mentor IRB. Click My Protocols, and select the protocol you would like to modify. Once that page loads, scroll down and click the Adverse Events tab. Click New Adverse Event.
A researcher is required to submit detailed documentation of the adverse event, including the type of adverse event encountered. A corrective action plan, explaining what will be done to prevent reoccurrence, is also required. Adverse events require prompt reporting; adverse events involving subjects at TC must be reported within five days while adverse events occurring at other sites must be reported within 30 days. It is important for researchers to be as thorough in their explanation as possible; full disclosure will give the IRB staff the best chance at assisting them in their research. An IRB staff member, or the full board, must review and acknowledge the deviation before the researcher can interact with human subjects or data collection can resume. Further action on the researcher's end may be requested by the IRB staff; these decisions are made on a case-by-case basis.
Please review our How to Submit a Modification, Continuing Review, Adverse Event, and Deviation document for more detailed instructions and information on this topic.