Adverse Event

Adverse Event

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:

  • Protection of human subjects
  • Following through with data confidentiality and privacy
  • Collection of clean and reproducible data

Types of adverse events include:

  • Internal (on-site): events experienced by subjects at the institution at which the investigator is enrolled
  • External (off-site): events experienced by subjects enrolled by researchers at other institutions engaged in the clinical trial, in the case of multicenter clinical trials
  • Expected: events whose nature and intensity have been previously observed and documented for the study. For example, a wearable device may cause an allergic skin reaction and the participant experiences such a reaction.
  • Unexpected: events that are not consistent with either (1) the known foreseeable risk with the procedures involved in the research that are described in (a) protocol-related documents, such as the IRB-approved research protocol, any application investigator brochure, and the current IRB-approved informed consent, and (b) other relevant sources of information, such as product labeling and package inserts or (2) the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experience the adverse event and the subject's predisposing risk factor profile for the adverse event. 
  • Serious: usually results in death, hospitalization, disability or incapacity, congenital anomaly or birth defect, or is life-threatening
  • Researcher non-compliance with federal and institutional regulations

*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.

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