10/05/2011: Policy Change: Non-reportable adverse events
As of October 5th, 2011, IRB01 will no longer accept Non-Reportable Adverse Events for IND safety reports or other adverse event reports from the study sponsor regarding adverse events that have occurred to a subject enrolled on a different protocol but which shares the same test article. The Non-Reportable Adverse Event form has been eliminated, and the policies and procedure manual has been updated.
Rationale: Researchers conducting multi-site, sponsored research frequently receive IND safety reports or other adverse event reports from the sponsor for adverse events that have occurred to a subject enrolled on a different protocol but which shares the same test article. For many years IRB-01 has not required researchers to submit these events because we do not know enough about the other protocol, such as the disease condition being studied or the treatment regimen being used. Since many sponsors require researchers to submit these events, IRB-01 has allowed researchers to submit the events to our office using the Non-reportable Adverse Event form, which we received and filed, but did not otherwise process or review.
Over the past couple of years the number of non-reportable events that IRB-01 has had to process has increased dramatically, to the point that over the last fiscal year these submissions constituted 10% of our overall volume (about 1,000 non-reportable events were submitted). Also file copy requests have increased dramatically because sponsors want confirmation of receipt or copies of the non-reportable events were not made at the time of submission. After benchmarking with other IRBs, IRB-01 has revised its policy to refuse acceptance of any off-protocol events unless the Principal Investigator and Sponsor determine that the event is both of the following:
- Serious and unexpected, and
- Increases the risk to subjects (past, present, or future) enrolled in the protocol approved by IRB-01.
We have revised our Policies and Procedures manual, our Adverse Event Reporting Guide, as well as our Adverse Event Reporting Form (aka the “5 day form”). We are immediately discontinuing the use of the Non-reportable Adverse Event Form and will no longer accept, process, or file these forms. If your sponsor asks you to report an off-protocol event you simply complete our latest Adverse Event Form and comply with the directions on it. Note: depending on how you answer the questions, the form may indicate not to submit the event. Second, if you determine the off protocol event should be reported, you and the sponsor must provide substantive and meaningful responses to Questions 19.a. through 19.g.
This information is contained in a letter that you can provide to your sponsor: /docs/policychangenonreportableAERs102011.pdf
- IRB Policies & Procedure Manual (see page 62): /docs/irb01ppmanual.doc
- Adverse Event Definitions: /docs/AEDef.doc
- Adverse Event Reporting Guide: /docs/AEGuide.pdf
- Adverse Event Reporting Form (aka the “5 day form”): /docs/AESnU.doc
Adverse Event Cumulative Table for Continuing Review: /docs/AETable.doc
- Excel version: /docs/AEsum.xls