Journal Assignment Week 9

Adverse Event Reporting Form

When a researcher submits an IRB application, s/he makes a commitment to communicate both discrete adverse events and general problems to the IRB within 1 week of their occurrence/realization. Within one week of receiving the Adverse Event Reporting Form, the IRB Chair will send the researcher confirmation that the event has been recorded in the researcher’s file, along with instructions regarding the continuation of the study.

The purpose of this reporting system is to protect participants, not to punish researchers. In some instances, it might be necessary to revisit the consent process with already enrolled subjects. If the problem prompts a change in the research procedures, the consent process and documentation might require alteration for future study subjects.

An adverse event is any negatively perceived experience that was not described in the IRB application and/or consent form (in terms of its nature, severity, and/or frequency). If the event is perceived negatively by even one person (especially if that person is a participant), then the event must be reported to the IRB.

Unanticipated problems that might affect risk-benefit analysis, confidentiality, or subjects’ willingness to continue in a project must also be reported to the IRB. These problems might include pragmatic challenges to implementing the IRB-approved research design or updates in the research literature that change the risk-benefit relationship. The IRB will consider the effect of the problem on the study and on the subjects already enrolled.

1. Please state the facts of the adverse event or general problem, including relevant dates.

2. How many participants are confirmed to have been affected by this event/problem?

3. How many participants could potentially be affected by this event/problem?

4. Please describe the steps that have been taken to address the problem.

5. Please discuss whether the event provides new information about the study's risks that should be conveyed to participants in a revised consent form or letter.