The Human Investigation Committee (HIC) revised the policy on “ Identifying, Reporting, and Reviewing Adverse Reactions (AR) and Unexpected Events (UE)”. During the ongoing process improvement activities, the policy was reevaluated using the draft guidance from Office of Human Rights Protection (OHRP) “Reporting and Reviewing Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others”. After careful consideration of the draft guidance, it was determined that the HIC policy should be revised to decrease the number of “not related to study intervention” adverse reactions being submitted to the HIC for review.

The revised policy and flowchart for reporting adverse reactions that occur at WSU or when WSU is the coordinating center has been changed to provide new guidance on when to report an AR to the HIC. Using the new flowchart, once it has been determined that the AR is serious, the relationship to the study intervention is determined. With this change, if the event is not related to study intervention, (e.g., a participant is hospitalized for disease progression, a person in a observation study goes to Urgent Care with chest pain, a participant in a breast cancer study has a gallbladder attack not related to study intervention) it is no longer a reportable adverse reaction. See WSU adverse reaction flowchart http://www.hic.wayne.edu/hicforms/arflowchart1_03_06.pdf

Another change to WSU flowchart is how to determine whether or not the adverse reaction is expected. If the AR is listed in the consent form and is not greater than expected, it is considered an expected event and not reportable. For example, if the participant experiences bruising from a decreased platelet count and decreased platelet count is listed in the consent form, this is an event that is expected and not reportable to the HIC. However, if the same participant developed a subdural hematoma, this event is greater than expected and should be reported to the HIC.

These changes will bring more responsibility to the investigators and sponsors. It will be their responsibility to look for trends in “not related” or “expected” reactions and determine if there is a change in the risk/benefit ratio that must be reported to the HIC. If the protocol is a treatment study that does not have a formal Data Safety Monitoring Board (DSMB), the investigator and/or sponsor must have a data safety plan in place. The plan doesn’t have to be elaborate but should state who will have oversight on reviewing safety data and how the safety is being maintained to protect participants.

In the event the study sponsor requires that certain AR/UE’s be reported to the HIC, that are not reportable per policy, an amendment must be submitted to add these events to the protocol.

If you have further questions about the HIC policies and procedures on AR/UE reporting, you can contact the HIC Education Coordinator, Patti Webber, RN at (313) 577-9534 or email her at pwebber@wayne.edu