Last time, I began walking you through some of the sections of the REB application and giving you tips for completing them. This week, I will go through the more sections of the application. Next time I will wrap things up! Full disclosure: I am a member of the REB (2012-present). These are my personal opinions and following my advice does not guarantee any particular outcome during the review process.
Participants sub-sections (Section 4.2b) explain what people have to “be” in order to participate (e.g., female student, under 30 years old, enrolled in a GNED, mother to at least 1 biological child). Your exclusion criteria (c) are the opposite, but you may not need to specify them unless there is a grey area (e.g., what if someone is currently pregnant but the child isn’t born yet- do they qualify for the study described above?) or if you have a reason to exclude certain categories (e.g., excluding adoptive mothers if you’re looking at something that requires that the person had physically delivered a baby). HOWEVER, you cannot (and should not) exclude people without reason. So, if you’re asking about the stress of having to care for children during a pandemic, it doesn’t matter if the child is adopted, step, or biological, so you should not exclude adoptive mothers from that study. How do you know how many participants are required (d)? Part of that depends on the statistical analyses you plan to conduct (you can estimate the number of people you need with a complicated power analysis). Or, if you’re not sure, aim for 30 participants per cell. That means, if you’re study is looking at gender differences in performance across 2 different teaching approaches, you’re doing a 2x2 study (males vs female and approach 1 vs approach 2), and you would be aiming to have 120 participants I your study (see this article for rules of thumb for other types of analyses, such as correlations). Keep in mind, that you may have to wait a long time to obtain that many volunteers for your study (in my experience, you can typically expect 10-25% of students in any given GNED class to participate, though that does vary somewhat by program). In your application, it is important that you don’t propose to only collect data from 5-10 students (unless you’re doing a study design where that is appropriate) because the risks increase with smaller sample sizes (both for student identification, and for not being able to conclude anything because you don’t have enough statistical power to do so). You will include your rationale in the following section (e). You will explain your plan in (f) for how you will deal with a situation where more participants volunteer than required, will you accept them all or stop after your “magic number” in (d)?
Risks (Sections 5.1 to 5.4). All studies have risk. Let me repeat. All studies have risks. It is impossible to eliminate all risk. Most will be minimal risk studies (where the participant will encounter no more risk than they do in their daily lives), but there are always going to be some risks. If you answer “no” to all of the risks listed in the application, then the REB will probably worry a little bit that you just aren’t able to see (and mitigate) the possible risks. And that’s not good. So really think about worst case scenarios to help you identify possible risks.
Benefits (Section 5.5) typically include that society will benefit in some way from the knowledge gained in the research. But sometimes participants will have direct/individual benefits as well (e.g., testing a new drug for a disorder may provide some relief to the patient; or teaching students a new way to study may improve their grade in the course). Be sure, however, that the benefits are not only going to be for some of the participants in your study. If there are significant benefits to one group and not to the other, that is not ethical. If you think that will be the case, you should ensure that the other group also has access to the benefit (e.g., the group that didn’t get the new drug treatment is able to access that drug after the study ends or in a second phase of the study where you reverse the groups- those previously receiving the drug now get the placebo and vice versa. In terms of study design, this can also be advantageous because you can show that the “improved” group loses that improvement when they are given the placebo and the other group improves when given the drug).
I hope the tips I have included so far have been helpful. Stay tuned to the next edition for the final sections and wrap-up! If you need help completing the REB application, please feel free to send me an email and we can go over any of the sections you’re struggling with. As always, if you have any suggestions for things you’d like to see from me, please reach out to me via email lynne(dot)kennette(at)durhamcollege(dot)ca or on MS Teams, or pop in during my weekly “office hours” on whereby(dot)com(slash)drlynne (every Friday from 12:30-1:30).
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