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A request for assistance for students, residents, and the like

Many UAMS programs require students, residents, or fellows to complete a research or quality improvement project. For many of these people, this will be the first time they’ve had to interact with an IRB. If you’ve been working in research for a while, you probably already know the ins and outs of submitting a project for review. However, the process can be pretty intimidating for those new to it.

So, if you have any students, residents, or fellows in your area, and they look like they could use some assistance with the IRB process, please, please, please provide them close guidance as they work their way through the submission and review maze. A couple of examples of ways you can help:

  1. Teach them about the human subject research determination form process. Rather than just telling your students, “Oh, it’s just a QI project; it doesn’t need IRB review,” remind them that the *only* way to find out for sure whether something needs review is to submit a human research determination form through CLARA. Also, determining whether something needs review or not is trickier than it looks, so please don’t guess (or have your student guess). The determination form is short, and you get a response in a few days. It’s a small inconvenience, and much better than learning too late that your “quality improvement project” was really research requiring review.
  2. Steer them to the appropriate tools in developing their protocol. We’ve seen a lot of relatively simple studies written up using a┬áneedlessly complex clinical trial protocol template. We’ve also seen a lot of protocols dashed together by people who just haven’t been doing research long enough to know the level of detail a research protocol requires. Newcomers to research probably also aren’t aware of all the relevant regulatory requirements, such as what needs to be included in an informed consent process, and when the consent process can be waived. Helping them put their submissions together, and offering feedback along the way, will help these new researchers get their protocols approved faster. Handing them a template, or an old protocol and/or consent form of yours, and telling them to adapt these to their project and then sending them on their way, will not. In fact, a poorly written submission will likely have to be returned to the PI several times, along with a request that they work with a mentor before resubmitting. This backing-and-forthing tends to be frustrating for everybody involved, and could avoided if new researchers get some assistance up front.