Sample items from UW-Madison's checklist

Eliminates needless submissions

IRBs and investigators sometimes waste time on unnecessary IRB submissions. A simple initial review triage checklist can eliminate this problem, one IRB has discovered.

"We have a high volume of research we see," says Carol Pech, PhD, associate director, health sciences institutional review boards office of the University of Wisconsin–Madison.

So what the IRB doesn't need are needless submissions.

"We don't want someone to go to through the effort of doing an IRB application so we can tell them they didn't need to come to us," Pech says.

The solution is an initial review application triage checklist that can quickly let an investigator know whether the IRB review is required.

For example, the IRB does not require researchers to submit an IRB application for a single case report that will be published or if they are doing research with secondary analysis of available data, Pech explains.

"Also, there may be residents who are doing a quick project, so let them know of research they can do without having to come to the IRB," she adds. "We have groups where we see a number of exemption applications, and we'll target those groups, who are often pharmacy and nursing students."

Here are some sample items from the UW-Madison IRB initial review application triage checklist:

1. Is the project limited to preparing for publication a single case report involving up to three (3) patients?

— If the answer is yes, then: Case reports involving three or fewer patients do not require IRB review, but the HIPAA Privacy Rule may still apply.

— If the answer is no, then an IRB review may be required.

2. Is the proposed research study limited to secondary analysis of data from a publicly available dataset found at the institution's website?

— If yes, then research involving only analysis of data from a listed publicly available dataset is not considered "human subjects research" and does not require IRB approval.

— If no, then an IRB review may be required.

3. Is the proposed research study limited to the inclusion of deceased individuals?

— If yes, then research involving information or samples from deceased individuals only does not constitute human subjects research and therefore does not require IRB oversight.

— If no: If your project involves data or samples from deceased and living individuals, or all living individuals, your study involves human subjects research and IRB review is required.