A rant on ethics approval

I’m in the processes of trying to get ethics approval for another study (we’ll call it A). This study is very similar to a study I already have approval for (a study we’ll call B). So similar, that I was able to copy about 90% of our ethics application from the first one. I tweaked it a bit to reference the new study, had my supervisor look it over and then submitted it. While I’ve been doing this, we also had another ethics application that we were submitting. This one is not similar to our current (or past) ones, but some of the ideas behind parts of it have similarities. We’ll call this third ethics form C.

Now, let me say, that in the time I’ve been at this university (now almost five years) the ethics application process has changed three (yes THREE) times! Each time is suppose to be simpler, clearer and easier. I disagree that this has been the case. My first application, when submitted, was approved in less than 24 hours. Since then, I’ve been required to rework my application at least once (usually two or three times) before approval.

In this case, both of the current ethics forms (A and C) are in the process of trying to get approval. And in both of the cases, we’ve received a first round of edits needed. Now here’s where my rant comes in. The changes don’t make sense based on our previous experience with submitting ethics. Something that is okay on one form, or a required change, is no longer okay. Something that gets pointed out in one doesn’t get identified in another. It’s beyond frustrating. Let me share a couple of examples:

  • In from B we detailed that our study would be accessed online. Because it’s online, we would not be able to collected signatures for the participant consent. Instead, we put a copy of the form at the beginning, and required participants check a box before continuing into the study indicating they agreed to the participant consent. During our approval process, we were told this wasn’t good enough. They needed to be told the participant consent form again at the end of the study before submitting. So we changed that. Our new study A follows the exact same setup. However, this time we’re being quizzed on why we have them consenting twice, as this should only happen once.
  • In form C, we included some recruitment material. So far, in our approval process, there has been no comment about this. In form A, we also needed recruitment material so we designed it after the one we submitted with form C. Here we got told that the recruitment material was not okay and to redo it.

I could go on. And don’t even get me started on what it means to approve a study for “general audience.” Because apparently a “general audience” is a very specific one, and asking university students to participate (as part of who you’ll recruit) is not a general audience.

What bothers me the most about this whole process, is that there does not appear to be anyway to learn from previous applications and minimize the number of corrections you need to make. Because there doesn’t appear to be any set requirements that you’re trying to meet. Instead, it seems to be at the whim of whoever is examining your application form and how they’re currently feeling. And because of this, getting approval for a simple study that involves no risk to participants, has nothing to do with health, can be accessed online by anyone who wants to try it, ends up being ridiculously hard. And, it ends up wasting everyone’s time – the people submitting and the people approving.

Is it really that hard to put together a reasonable, clear, easy to follow form for researchers to submit? And does it really need to get that complicated in determining what to approve when there’s no risk to participants? There’s not even any identification being collected – all data is anonymous! Because of this process, I’m going to need to spend another day making corrections to the form, and explaining every change I make. On top of that, there’ll probably still be another round of edits, as I’m not sure I understand what the problems are. Ugh. 😦

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