It has taken 7 months for my 1-year observational pilot study – Maternal Mental Health and Early Childhood Development in Kawempe (MMH4ECD) – to get through the triple-layer ethical review gauntlet. Although most of the work of obtaining ethical clearance is done prior to and during the local review, for an American researcher anyway, unanticipated hurdles may also arise during the “home” review. Case in point, after 15 years doing public health research, I found myself deep down a rabbit hole searching the definition of “intervention”.
My study involves a questionnaire, anthropometric measurements, and a series of focus group discussions and key informant interviews. Participants include mothers and their child under two years old. Before now, I understood “interventional” research as when a researcher actively “interferes with nature” to see its effects on participant outcomes, and “observational” research as when a researcher just records exposures and/or outcomes without changing anything[1]. Accordingly, I considered the MMH4ECD study – in which I’m simply measuring participants’ heights and weights and asking questions at a single time point – to be “observational”.
Not so, according to my “home” IRB!
The key to this curious discrepancy between the word “intervention” as it applies to study design and “intervention” as it applies to anthropometry, is understanding how IRB exemption is determined by the USG’s Code of Federal Regulations (CFR)[2] 45 Part 46 on the protection of human subjects [3]. As illustrated in the flowchart below, studies involving anthropometry are considered exempt under type 3, i.e. as “benign behavioral interventions” that are “brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and [not] offensive or embarrassing”. The MMH4ECD study did not ultimately qualify as exempt, due to anthropometric measurements of children, but after recategorizing as “interventional,” was eventually approved.
Beyond any professional obligations, I care about my study participants’ well-being and want to do the right thing, and so this deep dive into practical research ethics has been a worthwhile part of my ACHIEVE trainee experience. I do wonder, though, if there aren’t opportunities for streamlining the multi-layer ethical review process for international studies. For now, its full steam ahead to data collection!
[1] Aggarwal, R., & Ranganathan, P. (2019). Study designs: Part 4 – Interventional studies. Perspectives in Clinical Research, 10(3), 137. https://doi.org/10.4103/picr.PICR_91_19
[2] An online version of the CFR is here: https://www.ecfr.gov/
[3] Also see Common Rule Bulletin #2: Exemptions (https://irbo.nih.gov/confluence/display/ohsrp/Common+Rule+Bulletin+2)