From Start to Finish: What Goes Into a Study -- Day 1

The majority of the people who I tweet with or who I know are well-versed in thinking up, proposing and completing a study. This won't really be too interesting to them. This might go unnoticed, but I figure it's a good way to document what goes into a study -- from beginning to end.

I am writing this as both an informal log of activity that happens during this study and also as a more inside (fun?) look at what it takes me to get through a study (and hopefully, it's also what generally everyone goes through).

A bit about me and the study: my background is in cognitive neuroscience and my interest at the moment involves human interactions involving social cognition. More specifically, I'm wondering if there exists correlations between brains during acts of cooperation. There are definitely studies based upon capturing acts of human interaction during social interactions but I am interested in specifically acts of cooperation between humans, how it's determined and if there exists a neurological event that is signature to cooperation.

Check out Day 2 – 7 here!

Day 0: Proposing the study and awaiting advisor approval

About a month ago, I asked my advisor Kerry Jordan about what goes into proposing a study to her and what I'd need to do to get the wheels rolling. Her response was very enthusiastic and suggested I write up a short proposal of what I wanted to do. I ended up writing about a page worth of my general methods I'd use in my study and a handful of references to discuss what I should expect if executed correctly (e.g. expected statistics, regions of interest and significance, differences in results per stimuli). She thought it was a good study to try out our new electroencephalography equipment, as well as an easy enough first project for me (and the other grad students who are interested in learning EEG). So she gave me the thumbs up and the next step was working on the IRB proposal.

Day 1: Writing up the IRB protocol

When your project involves studying human response, you will generally have to request approval from your institution review board (IRB). Dr. Jordan said I'd be able to attach an amendment to an existing IRB protocol that had been approved. Another graduate student, Salif Mahamane, was also proposing a study which was similar enough to fit under this existing protocol. Thus, Salif, Dr. Jordan and I had a few days of adding and editing of the current IRB protocol before we submitted it again for review.

Before being able to submit an IRB protocol for review, you usually have to complete an IRB certification course. Think of it like driving school. Teaches you the basics and all the rules, focusing on what to do and (more importantly, in my opinion) what not to do. And usually, every time you switch institutions you will have to go through a new IRB training. A large amount of institutions use The CITI Program, which is what Utah State and UCSF both used to approve me to run participants on studies. I've heard of institutions that offer one-day courses on all of the rules and regulations observed by the institution (this sounds a lot like driving school).

Every IRB is different. My alma mater, Saint Mary's College of California, met twice a month and my old lab never had problems with our old EEG projects being approved. At UCSF, I'm not exactly sure how many times they met but I can imagine they met much more frequently than twice a month. Here at Utah State University, it sounds like the IRB meets frequently but study proposals and subsequent acceptance/denials can last up to a month before you get word back.

Some of my colleagues have lots of experience with interacting with IRBs, and they all sort of echo the idea of writing specific enough so the IRB knows what you're study is doing to a participant but vague enough to be able to manipulate a study without having to propose a completely new IRB protocol. In my study, I used language like participants will be presented with a scenario that requires a response and values will be assigned to responses and used in various analyses and my favorite for example... I learned from a friend that "for example..." and a description of your task doesn't pigeon hole you into a specific study design, because it's just an example based off the frame you've suggested.

In truth, detailing the potential risks of your study is what the IRB is combing for. All IRBs want to keep within their particular institution's ethics and standards. Since we are using neuroimaging equipment, we have a fairly extensive portion dedicated to explaining what EEG is, how it works and what a participant can expect from wearing an EEG headset.

Also, since Kerry Jordan's lab has an interest in cognitive development, our IRBs usually include both adults and children in the protocol, which immediately puts us at a "full review" status -- which means the most thorough review possible (and, of course, the longest turnaround). Again, this echoes the idea that an IRB is scanning for risks and ethics -- with children, it becomes even more sensitive.

And so, here we wait. I'll consider this Day 1 of this study, as it has officially turned from a cool idea into a potentially institutionally approved study protocol. Between now and the next blog post, I'll be spending my time reading related literature and designing the experimental presentation in PsychoPy.

Until next time, friends!

Check out Day 2 – 7 here!

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