Genetic Alliance Institutional Review Board
Direct Submission
In addition, we have provided access to our Study Design Worksheet in the ‘Helpful Resources’ Section below. This self-guided worksheet asks a few questions to assist you in writing your abstract, research and analysis description, and lay summary. You do not have to turn this in; it is only for your use and benefit as you see fit. The worksheet may be especially helpful to those who have less experience writing protocols and IRB Applications.
Helpful Resources
The Study Design Worksheet is a self-guided worksheet to assist you in writing an IRB application. You do not have to turn this in; it is only for your use and benefit as you see fit. The worksheet may be especially helpful to those who have less experience writing protocols and IRB Applications.
SMART IRB offers free resources to walk organizations through the SMART IRB sign-up process. In addition, they provide information on the single-IRB review, setting up a reliance system, implementing an agreement, and how to access funding for applications.
FAQ
How long will it take for me to hear back from the IRB regarding my application status?
Some IRBs meet once every month, making the return time lengthy. Genetic Alliance reviews expedited applications (ones not requiring a full board review) on a rolling basis and usually has a turn-around time of 1-3 days.
How often do I need to update my study information?
AmendmentsAmendments are added as needed. Amendments or modifications represent changes in the protocol within the scope of what the IRB authorized initially. For example, an amendment is usually appropriate if a researcher wishes to add a population to an existing study but does not alter the study procedures or intent. The IRB may have the Chair use an expedited review procedure to review minor changes in an ongoing, previously-approved research study during the period for which approval is authorized. If a proposed change in a research study is not minor (e.g., procedures involving increased risk or discomfort are to be added), you may need a full board meeting before implementing the change.
Re-approval/Progress ReportsRe-approval/Progress Reports are mandatory and are submitted annually by the PI. The focus of the IRB Re-approval/Progress Report is to serve as a reminder to PIs that you, as PI, remain responsible for all other regulatory tasks – e.g., amendments, deviations, adverse event reporting, and terminating a study. This is a time to ask yourself if there have been any changes in the protocol (of most interest is: has something happened that would trigger an IRB review?). It is also a way to provide updated information on your protocol and confirm that the Genetic Alliance IRB approves the continuance of your study.
I am starting a disease registry from scratch. Is there somewhere to go for more help?
Yes, Genetic Alliance offer several services to support you in launching a registry. Our Registry Bootcamp website will give you a hands-on introduction to the process and resources required to launch a registry. Our registry program, the Promise for Engaging Everyone Responsibly (PEER), offers the support and infrastructure that communities need to start collecting data and conducting research.