Please see the memo from KESETT Leadership regarding the discussion of KESETT at community events prior to CIRB review:
To: KESETT Sites
From: KESETT Leadership
Re: Discussion of KESETT at Community Events Prior to CIRB review
Cc: Advarra IRB
Thank you for your planned participation in KESETT, an NIH funded clinical trial in patients with status epilepticus in the emergency department. Because those suffering from prolonged seizures are unresponsive and unable to communicate, the trial will be conducted using an exception from informed consent for emergency research (EFIC). As we are still waiting for our DSMB to sign off on the protocol, the initial trial application to the Advarra Central IRB will now occur later in June than originally anticipated.
Some sites have inquired about whether they can start talking about the trial at some existing community events that will be occurring starting in June. In particular, many local Epilepsy Foundation chapters have their annual ‘Stroll for Epilepsy” events starting this month. Many have found these great opportunities to interact with interested people from at-risk communities and discuss planned trials.
The KESETT leadership’s view is that investigators are always permitted to engage with any community and share information about the research you conduct, how it affects people, and why it may matter to them. Talking to people about the trials you do is not itself human participants research. Information about KESETT is already publicly available from NIH on the NIH Reporter website, and the ClinicalTrials.gov website. While we would have very much preferred to have IRB-approved written KESETT EFIC materials available for you to distribute at events in June, we feel that sites can still engage verbally and interactively with community members even without these written materials. Indeed participation in these events, even before IRB review and approval, is very much in the spirit of transparency and engagement upon which the EFIC community consultation and public disclosure requirements are based.
You can direct those with whom you interact to the publicly available information mentioned above, but do not create or distribute any EFIC materials until we obtain IRB approval. We will also not have surveys for you to collect prior to IRB approval. We will include in your site IRB application EFIC summary, all community events you report in which you met with people from the community and had meaningful exchange and engagement.
So, do not miss a good time-limited opportunity in June. Go ahead and go out and talk to people, tell them what is planned and, even more importantly, listen to what they have to say. Take notes of comments and questions, and summarize them in a paragraph or two that you can use in a narrative description of the event, who you talked to, and what you learned from it.
The kind of information that we will want you to be able to describe includes:
- Type of event
- How many people from the community you talked to
- What you heard (narrative summary of comments and questions)
- Who attended (which study team members and the type of community-geographic, disease, both)
- Overview of the demographics of those you heard from