We’ve noticed some issues that are almost guaranteed to get you a minor prereview contingency from the IRB office these days. We thought we’d address them on our blog so you can minimize approval delays:
–In new submissions: Failing to request the correct kind of waiver relating to the consent process and documentation. Consent process waivers and consent documentation waivers are two different types of waivers. They each have separate requirements and the IRB must consider different elements for each. To recap, a consent process waiver is appropriate for studies in which no consent process will occur at all, such as a retroactive chart review study. In general, the subjects will never know they or their info were part of a research study. A consent documentation waiver means that some sort of consent process will occur, but you will not collect signed informed consent forms. Subjects will know they are participating in a research study, and may be given written information about the study, but won’t sign consent forms. We see this in survey and focus group research a lot. More information about these two types of waivers and how to request them in CLARA and address them in your protocol can be found in this IRB Blog item and also in IRB Policy 15.3.
–In new submissions and revisions: Incorrect document stacking in CLARA. Remember that when you revise a document, the new clean version should go on top of the old clean version, and the new tracked-changes version should go on top of any previous tracked-changes version. So when you’re done, and you’ve stacked correctly, you’ll have two different stacks in CLARA for the same type of document — one of only clean protocols, and one of only tracked-changes protocols, for example, with the most recent of each on top. Clean and tracked-changes copies should never both be in the same stack. You can get detailed instructions for stacking documents in CLARA. Look for the “help” link in the black bar at the top, and then, under the “Protocols” heading, find the “Managing Documents” link.
Other tips that may speed your submission through the review process are available here.