2005N-0038 - Adverse Event Reporting to Investigational Review Boards Public Hearing
FDA Comment Number : EC3
Submitter : Dr. Katrina Bramstedt Date & Time: 02/18/2005 04:02:26
Organization : Cleveland Clinic
Health Professional
Category :
Issue Areas/Comments
As a bioethicist currently working at a large academic medical center, and also Directing a program in Research Subject Advocacy (at our GCRC), I have extensive first-hand experience with the matters of AE reporting and review. My experience in the research setting, and my desire to have optimal research subject protections has led me to conclude the following:

1. Much concern is focused on 'Unexpected' AEs, and people tend to forget that even 'Expected' AEs can be cause for concern. Specifically, under the current reporting scheme that most IRBs follow, Expected AEs are batched and reported on a yearly basis by PIs. This one time look makes it impossible to detect trends in a timely fashion. For example, nosebleed is considered an expected AE for bronchoscopy. If you batch these nosebleed reports and submit them at the end of the year as part of continuing review, you have missed the perfect opportunity to detect a trend of increasing frequency of nosebleeds. Further, these nosebleeds might be attribuable to operator technique or even a bronchoscope defect. A year after the fact is too late to be looking at the data for trends. I question the suitability of batch reporting of Expected AEs by PIs to foster research subject protection. I realized the volume of Expected AEs can be large, but we need to remember that research subject safety is our first priority.

2. With regard to the matter of AE reports failing to contain meaningful information for the IRB to review, one partial solution is for PIs to assign a severity score (e.g., 0-5) to ALL AEs, and to also assign an ATTRIBUTION RATING(e.g., possibly related to the protocol, probably related to the protocol) to ALL AEs. This can help put AEs in context for outside reviewers.

Thank you for considering my comments.