If you decide to close your registry, you will need to close out the registry and study with the IRB. This is a requirement of 45 CFR 46 – the federal code covering human research protections. Any sponsor with IRB approval to conduct research must report any change to the IRB on a yearly or more frequent basis if such change occurs. This is a federal statute that you agreed when applying to a federally accredited IRB to do research.


The closing out process requires four parts: submitting an IRB to close your registry, removing admins from the portal, communicating to your participants on what the closure means for them/their data, and receiving exports of your registry data. To do this:

1. Reach out to your point of contact at Genetic Alliance to set a closure date for your registry.

2. Next, you must close out your IRB-approved research protocol either with the Genetic Alliance Institutional Review Board, or with another IRB of your choice. Please complete the closure form in the next section, and send it to gro.ecnaillaciteneg|snoissimbus_bri#gro.ecnaillaciteneg|snoissimbus_bri with the subject line "Protocol Closure for [Protocol #]". Please do so before the closure date.

3. Once you receive notice from the IRB about the closure, the PEER iframe must be removed from your website (if it has not been already). Our IRB chair will remind you of this as well when she approves the closure.

4. Please let your point of contact at Genetic Alliance know when your registry iframe is removed from your website, and your point of contact at Genetic Alliance will remove all admins in your portal. At this time, we will send you two items: 1) the most recent export of all your registry data and contacts, and an export of all Kendo grids, and 2) sample messaging announcing the registry closure to your participants.


If you choose to close out your IRB through Genetic Alliance's IRB, the cost will be approximately $300/hour. IRB reviews typically take about 1-2 hours.


The closure form can be found at here. If you have questions related to the application or your application status, please send them to gro.ecnaillaciteneg|snoissimbus_bri#gro.ecnaillaciteneg|snoissimbus_bri.