“When will the IRB run out of policies to update?” you may be asking yourself by now. Well, pretty much never — regulations, best practices, and accreditation standards keep changing, and we need to keep on keeping up.
The latest revised and updated policies are:
2.3, Use of Single/Central IRBs. As we keep learning more about the single/central IRB process (aka the xIRB process; it’s new-ish to us, too!), we realize our policy on this topic occasionally needs updating as well. This most recent language change beefs up the descriptions a little about which institution is responsible for what in xIRB review situations.
7.4, Review by Convened IRB. It was just time to bring this one into the modern era. (ARIA, is that what you mentioned in this policy? What on earth are you doing here?)
7.8, Data and Safety Monitoring. This policy describes, in what we hope is a more user-friendly way, the requirements for data and safety monitoring information to be included in certain submissions. Data and Safety Monitoring Plans (DSMPs) are required for human subject research that is greater than minimal risk. However, investigators have a lot of flexibility in developing DSMPs. This policy describes what the IRB looks for in assessing whether a DSMP is adequate.
9.2, IRB Notification of Decisions, updates the description of how the IRB relays its decisions and determinations to study teams.
15.5, Informed Consent Process. This policy is an important one, as it is a reminder that a signed consent form alone is not sufficient documentation of an appropriate informed consent process. The entire consent process must be documented in a separate note to the study file, often even in cases where consent documentation is waived, i.e., you don’t obtain a signed consent form. Note that this policy also allows for flexibility in this documentation when appropriate and when the IRB approves an alteration in this documentation.
13.1, Confidentiality Protections. The new and varied ways people can access and use strangers’ information lend this topic new urgency. The IRB pays close attention to the plans to maintain data confidentiality to the extent possible. Getting familiar with this policy will give you an idea of what the IRB looks for when assessing confidentiality protections, so you can address those issues while preparing your submission, instead of waiting for a contingency to be sent back.