News and Insights

Written by Andrea Mirin Both in the course of designing studies and as an IRB, questions arise that lead us to contemplate what may be “best practices” or “best ethical practices” for appropriately recruiting participants. One area of frequent discussion, particularly as an IRB, is related to the “honoraria” [1]  or “incentives” [2]  that are offered. While the amounts offered for a particular participant group are guided by “Fair Market Value,” we should also consider if  when  the compensation for participation is offered, under ethical principles, may be construed as an “unjust inducement.” Unlike clinical trials (at least later stage clinical trials) which may hold out some potential benefit to a participant, human factors studies (a majority of which are simulated studies), will likely have no direct benefit to the participant (Since frequently user groups are those who may or will use a device, their participation and feedback may influence the end-product, which, at

Written by Naomi Cherne When participants in our studies use a product and skip a step or do something that the product’s designer did not intend, we ask them about it. In the discussion that follows they often tell us, very confidently, that they would have known what to do if the manual had emphasized that particular instruction, for example by making it bold, printing it in red, and/or underlining it. This may seem to make sense: the idea is that if some text did not grab your attention, it should be made grabbier. The manual’s designer may hear this feedback and immediately reach for ctrl-B. After all, the point of talking to these participants is to use the information we get from them, right? Yes and no. This feedback is speculative. We have no idea if that participant would actually have known to take that particular action if that particular instruction had been presented in the way they describe. We have no idea if  any  difference in presentation would have infl

Written by Marc Egeth September 25, 2016. Sitting in the Philadelphia airport waiting for a flight through London to Berlin. I checked a manikin. A “m-a-n-i-k-i-n” is a humanoid medical simulation, a “m-a-n-n-e-q-u-i-n” is a dress form. Core was hired to study a medical device in development for marketing in the U.S. and E.U., and the best way to make sure real-life users in the E.U. will understand and be able to use the device is to test it there with study participants carefully selected to be representative of real-life users. The best way to conduct such a test is with the careful attention of an experimenter – in this case, yours truly – who has been developing the study protocols and testing the device in similar ways in the U.S. I don’t speak German, so we have hired a local “moderator” to conduct study sessions and also a live translator. Study sessions will consist of study participants being asked to approach this new medical device and use it, as if for real – but