A philosophy professor interested in writing an article about her experiences trying out new teaching techniques was told by her administration that in order to permissibly do so, she would need approval from the university’s institutional review board (IRB).
She was told that merely trying out the techniques, which were developed from her engagement with Philosophy for Children (P4C), did not require IRB approval, but doing so and then writing about it for a publication about teaching philosophy would.
She is curious what others think about this, whether it is standard practice at other universities, and if there is something she can point her administrators to in order to help them realize they needn’t have this requirement.
Advice and accounts of experiences with similar situations welcome.
Assuming the instructor plans to gather and include observational data about student reactions/performance (e.g., cross-course comparisons; pre- or post-intervention results; student evaluation responses) or information about measurable outcomes for students (e.g., evaluation/assessment results), it is not surprising that the university would require a protocol for IRB review. Even if these data were de-identified in the reported results and posed little risk to the students, the data are nonetheless acquired via focused study or observation of human subjects. The study will likely be classified as Exempt and go through a fairly quick and smooth review process.
On the other hand, if the instructor plans only to write their reflections about their own teaching experience, with anecdotes drawn from memory, without having collected data (or referring to data collected), it seems to me outside the purview of the IRB.
According to HHS, much educational research is exempt from full IRB review:
(d) Except as described in paragraph (a) of this section, the following categories of human subjects research are exempt from this policy:
(1) Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
At my university, research like this would require a review to confirm its exempt status, but it’s a simpler process than going to the IRB.
Right, at most institutions, the IRB claims the sole right to determine whether a study is exempt. Researchers are not supposed to decide for themselves.
As someone who’s written reasonably extensively about my own teaching experience as a research program, I’ll echo the people saying this could broadly be something that needs IRB approval, but if it does, it will almost certainly fall in the “exempt” category that would result in an expedited review. I would suggest reaching out informally to the IRB office to see what they suggest. They may even tell you that approval is unnecessary.
It’s important, though, to be really clear about how you want to talk about the experience. Take two papers I wrote, one on whether we should restrict mobile devices in class and another that looked at students’ sense of community in a First Year Seminar. The first paper talked about student experiences, but nothing more concrete than “students seemed fine with the experience and I received no complaints.” The latter included a validated survey instrument filled out by essentially every first year student at my institution. The former was so vague that I doubt very much even an exempt ruling from the IRB would have been necessary (I don’t know for sure because educational research at my institution is covered by a blanket IRB approval). The latter definitely needed approval.
Hi Jake! Would you mind sharing the citation (or a link) for your paper on students’ sense of community? This is similar to some of the work I just started doing on increasing belonging and wellbeing in a first-year class. I’m thinking about going through our IRB next year so I can do a full-on SoTL study. (I’ve done -a SoTL study already with another course, so I’m already familiar with the process.) I’d love to read your work!
Former IRB chair here. One thing that is confusing (and it could that I am confused too!) is that a designation of “exempt” is *determined by an IRB*. So, when people say the project is “exempt”, they don’t mean, “You don’t need to go through your IRB before starting the project.” They mean, “You must go through your IRB, which will (likely) determine that it falls under the HHS “exempt” category.”
The kind of work described in the post would have to go through our IRB. If you’re collecting data simply for the purposes of improving a program (i.e. program evaluation), then you don’t need to seek IRB approval. But if you’re looking to extract some broad, general conclusions, which you want to report in a publication, then it becomes research.
I’ll add: our IRB would probably not count the work as “exempt”, but instead”expedited”, if it involves observing or surveying minors who are taking part in a P4C program.
I’m on my university’s IRB. It’s hard to say much given the level of detail provided in the OP (not much). For example, will data be collected? Who is the audience for the writing the professor plans to do (internal program development purposes or sharing with a wider audience?) The professor should write the IRB directly, explain what she wants to do and how, and they will let her know how to proceed.
I’ll just chime what the others have said, and add (though Moti also says it): just ask the IRB. They field inquiries like that all the time (at least, we did when I served on my university’s board).
At a glance, my inclination is towards ‘no’, though the admin is right to be wary of the quality control vs. research aspect. But it would, as the others have said, depend on the details.
The autonomy of the IRB is established in 45CFR46. This means that the only entity that can speak for the IRB is the IRB itself. An administrator cannot and may also be mistaken about how your IRB handles educational research.
Your IRB should have a process for applying for an exemption, under the provisions of the regulations cited in a previous posting. Follow that process, without fail.
If exemption is granted, then include in all publications and presentations a statement that the research was deemed exempt by the IRB. If the IRB requires review, prepare and submit a protocol and, if approved, state in all publications and presentations that the research was reviewed and approved by the IRB. Without fail.
The take-home message is that investigators in human subjects research are accountable to the IRB, which can be something new for many faculty in the humanities disciplines.
I’m on the IRB at my college. One possible problem that I see here is that there likely will be vulnerable populations involved because some of the students in the class will likely have learning disabilities, or autism, or whatever. And, once vulnerable populations are involved, the researcher needs to be careful about anonymizing the data such that readers could never be able to identify any specific students by name. That can be hard to do if the class is small: anonymizing data sometimes isn’t enough to ward off easy identification (e.g., imagine the researcher saying that “the two students with autism had trouble with this particular teaching method” — this is anonymized in that no names are given, but it’s not hard to identify the students). But then again, maybe these worries are irrelevant, because maybe there just won’t be any reference at all in the research to learning differences among the students in the class.
I only bring this up because, when the chair of the IRB at my college emails me as he is trying to do expedited reviews, he is often asking me to look for things he is missing in terms of vulnerable populations or sensitive groups that might be affected by the research. This is always his number-one concern. Then we try to find ways to help the researcher still do the project without running into any problems that would allow readers of the research to identify any of the subjects in the study.
Almost every proposal we review gets approved in an expedited way, that is, in a way that doesn’t require a full meeting of the IRB committee. But even so, many projects have to get slightly amended before being given an expedited approval. Usually expedited approvals are quick: almost always they are finished in a couple weeks.
All this is to say: it’s best to go through the IRB committee before doing the project and writing the paper. Yes, it’s irritating. And, yes, you’ll have to do all the boring ethics modules that the IRB requires before doing the submission, which will take a day or two of your life. But that is better than getting in trouble for some kind of ethics violation related to research.
This last point is really important – I’ve been involved in the compliance aspects of unintended research ethics violations. It’s super stressful for the researchers involved and one frequent outcome is that their data cannot be published. You don’t want to risk this for the sake of a day or two of extra work. Also (though I might be biased as a long term member on a research ethics committee) but I think that doing the ethics modules etc.. and actually writing down your research plan and putting it through the committee improves your research. Yes it is tedious, but there are loads of ways to do bad research, and if your university has a half decent IRB process, you will get useful feedback on your research plan as part of the review.
I have served on my institutions IRB on several different occasions and I can say that the administrator in this situation is entirely correct. The philosophy professor’s interest in writing an article that makes public in some way the results of testing out new teaching techniques in the classroom is what triggers IRB review. What level of review is required is to be determined initially by the chair of IRB. Because of potential conflict of interest, it is not appropriate for the faculty member to make this determination. This is true even if there is no personally identifiable information in the article the faculty member writes.
If the faculty member was simply trying out new teaching techniques in the classroom with no plans to make the results public beyond the university, then there would be no need for an IRB review. This activity is covered by FERPA.
I think a lot of the responses in this thread are assuming a lot based on the original post. Yes, I agree, if the work in question would involve collecting or making use of collected data (even “data” collected in the ordinary course of teaching) for the purpose of drawing generalizable conclusions about those new teaching techniques, then the professor needs to contact the IRB and either ask for exempt status or submit a protocol. (They may have to send a mini-protocol even for exemption, depending on the way they’ve set this up at the particular institution.)
On the other hand, as I suggested in my reply to Michael Deem, if the professor only plans to write their personal reflections about their own teaching experience, with anecdotes drawn from memory, without having collected data (or referring to data collected), it seems to me outside the purview of the IRB. Likewise if the scholarship has no aim of contributing to “generalizable knowledge” irrespective of whether “data” was collected (though I think this is less likely to apply in this case). The IRB can demand that I submit for approval an ethnographic study of my suburban hometown in the South, but they cannot do so if I plan to write a memoir about growing up in the same hometown. Also, according to new rules from a few years ago, they cannot demand review for an oral history of the town, even though I would collect a lot of the same data that I would for an ethnography of the same. Such research (oral history) is not even considered “research” by HHS, and does not need to be submitted for review, even for determination of “exempt” status.
So it largely depends on whether the work in question consists of “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge” or not. This definition explicitly excludes “Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.” (This is all in the Common Rule §46.102. See also this.)
I guess any institution can add extra burdens on their faculty if they want, but it is not required by the federal laws that govern these institutions. And faculty should fight such mission creep in their institutions.
Yes–it’s not “human subjects research” and not subject to IRB review if:
1) it does not intervene on individuals or handle their identifiable non-public information or biospecimens (e.g., observational research with public data is not human subjects research)
2) it does not aim to generate generalizable knowledge (e.g., quality improvement initiatives which attempt to understand and improve operations at a specific institution or context, but not necessarily to translate beyond that).
Arguably, a significant amount of experimental pedagogy falls under #2. Note also that whether a professor plans to publish or not is irrelevant to this determination. Aiming to publish does not mean something is human subjects research and therefore needs review (and equally so, not aiming to publish doesn’t mean review is unnecessary!)
Unfortunately, when I put on my epistemologist hat, the distinction in #2 doesn’t make a lot of sense to me. At the very least, generalizability is in reality clearly graded rather than binary, unlike the regulatory determination that’s supposed to be based on it. I get the sense that, because the concepts don’t really bear the weight, the research/quality improvement distinction is not made uniformly and often is governed by implicit practical considerations (most saliently that treating all currently existing QI as research would be a disaster).
Given the lack of clarity and uniformity, it’s always safest to consult admin and the IRB and follow their directions. That being said, we could use a lot more of teachers being thoughtful and rigorous in approaching their teaching, and I should hope that philosophy professors don’t get scared off of experimenting with or talking about their pedagogy by the impression that anything that in ordinary language could be colloquially described as research automatically triggers this cumbersome apparatus. It’s also worth noting that advice from an experienced person can be useful in strategically designing a project in such a way as to either render it not human subjects research at all or, if it is, to be the kind that likely to be determined to be exempt by the IRB.
It is even more restrictive that you suggest I think. Someone writing an oral history might “handle … identifiable non-public information,” but they still do not have to submit their work to IRB review.
The IRB is like the IRS. Even if you don’t owe any money, you first have to file your taxes. Then the IRS gets to tell you, “Congratulations, you don’t owe any taxes.” Similarly, you need to file your proposal with the IRB. At that point the IRB may tell you (as is probably indicated in this case), “Congratulations, your project is exempt.” But researchers don’t get to decide their projects are exempt, any more than earners get to decide they don’t owe any taxes.
Philosopher turned full-time IRB person here. Publishing or an intent to publish is neither necessary nor sufficient to trigger a regulatory requirement for IRB review. The regulations Larry mentions at 45 CFR 46 require IRB review for an activity just in case it counts as research with human subjects, which is defined as a “systematic investigation…designed to develop or contribute to generalizable knowledge” that involves interaction with living human beings (or identifiable data sets or biospecimens). Whether the results of such an activity are published or planned for publication is besides the point and plays no role in the relevant regulatory determinations. People publish the results of many activities that do not meet this definition, and fail to publish the results of many activities that do.
That said, institutions often adopt their own policies in this domain that function to interpret the regulations and, often, impose requirements that go beyond it. So I agree that the best thing to do is go directly to the IRB or human research protections office at the institution and have a conversation with them. The analogy with the IRS is apt!