Hello, AEA365 community! Liz DiLuzio here, Lead Curator of the blog. This week is Individuals Week, which means we take a break from our themed weeks and spotlight the Hot Tips, Cool Tricks, Rad Resources and Lessons Learned from any evaluator interested in sharing. Would you like to contribute to future individuals weeks? Email me at AEA365@eval.org with an idea or a draft and we will make it happen.
Hi everyone, this is Phil Stoeklen writing from Viable Insights – a Tucson-based evaluation and organizational development firm. I’m writing to talk a bit about the topic of IRBs and how they fit into our world of evaluation.
Research ethics bodies can take on many forms and names – Institutional Review Board (IRB), Independent Ethics Committee (IEC), ethical review board (ERB), Research Ethics Board (REB), to name a few. The names adopted depend on a host of factors, such as where the board exists and for what purpose/audience. For the purposes of this blog, however, we will refer to them all as IRBs, as that is likely the term most familiar to folks.
These entities have existed for 5 decades in the United States, having been born out of the 1974 National Research Act. Essentially, the public (and by extension, the legislature), grew sick and tired of hearing about all of the unsavory, unethical, dangerous, and downright cruel research that was being conducted on human subjects in the U.S. and abroad – often at taxpayer expense. Put simply, the National Research Act:
- Created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. This group spent several years identifying and documenting fundamental ethical principles to guide human subjects research. This culminated in the creation of the Belmont Report – a sort of research ethics holy book. In it, the fundamental principles of respect for persons, beneficence, and justice were codified.
- Required all research institutions receiving federal funding to implement Institutional Review Boards (IRBs). Their charge was simple: oversee all human subjects research to ensure that the newly minted ethical standards and federal regulations were being complied with.
So why are we talking about this in a forum for evaluators? We are, after all, doing evaluation not research. Well, part of it is to generate a dialogue around when evaluators actually do need to work with an IRB, and the other part is to [hopefully] cause folks to see IRBs in less of a compliance light, and more of a best practice light.
It is true that evaluation activities oftentimes do not rise to the level of needing an IRB. In 2018, the federal government modified what is known as the “Common Rule”, streamlining the IRB process. The change was pretty expansive, but the most relevant changes are that it added exemption categories for non-risky research activities, and added new informed consent requirements for the research deemed more risky. So where does that leave evaluations at? If an evaluation is being conducted for the sole purpose of quality improvement, the participant’s identity is disconnected from data, and publication could not reasonably be expected to affect the participant adversely, then the project is probably going to be either exempt or not even qualified as research under the federal definition. But what if your evaluation is being funded by federal dollars – does that change the calculus? We think so. Even if the funder doesn’t require it, getting the sign-off from a board will protect you and your participants. Further, if you have aspirations of someday publishing your findings, then you should know that a great many of the journals out there will require an IRB approval as a condition of publication.
These are but a few reasons to reconsider our relationship with IRBs. AEA365 has graciously provided some more stage time for this discussion, so in the coming months we will dive further into the reasons why IRBs are critical tools for evaluation practice. In the meantime, if you are looking for some “light reading”, we’ve included links to several IRB-related resources, including other blogs that we have written on various human-subjects topics. Looking forward to continuing the discussion with you soon.
Rad Resources:
- The Belmont Report
- 45 CFR 46 (HHS Regulations on Human-Subjects Research)
- VIRB Blogs:
- Ethical Research Principles
- Consent in Research
- Incentives in Research
- Vulnerable Populations in Research
- Risk in Research
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