07/18/2013: IRB-01 Stats
07/18/2013 IRB-01 Stats
IRB-01 annually processes over 700 new studies and 10,000 submissions. The PowerPoint below shows how long it took IRB-01 to review new studies for thefirst half of 2013. It also provides data over the the same period for the prior two years, along with some comparison data from other institutions.
IRB-01 routinely assesses turnaround times. Over the years we’ve implemented a variety of mechanisms to improve our efficiency. For example, we run weekly reports that show all of the submissions that are in process. These reports sort the items by how long they’ve been outstanding and help us prevent items from falling through the cracks.
Speed however isn’t the IRB’s primary mission nor the most important measure of our success. Protecting subjects rights and welfare and insuring regulatory compliance take precedence over speed. IRB-01 routinely passes all of its external audits with little to no issues identified. To that end, sometimes serious concerns about a submission lead to ongoing and protracted correspondence with an investigator, thereby increasing the turnaround time.
One area that could greatly help improve our ability to quickly approve submissions is beyond our control: the quality of submissions. Here are some of the most frequent issues that prevent submissions from being approved which could be easily addressed by the research team prior to submission:
- Inconsistent documents: protocol, consent, and/or other IRB paperwork contains information that is inconsistent. (E.g. the protocol indicates 50 subjects will be enrolled but the consent form states 85).
- Missing forms
- Unanswered questions.
- Complex language in the informed consent form (should be readable by an eighth grader)
- Missing template language and cut/paste errors in the informed consent form.