Human factors testing and ethics approval – protecting you and us

PUBLISHED 14th July 2017

There are occasions where it is necessary to simulate a use scenario with a very high degree of realism. For example, a manufacturer approached us recently asking us to run a study which would have involved participants taking a sample of their own blood with a sterile lance. Not a problem in principle, but for very obvious reasons we proposed to submit the protocol for prior approval by an ethics committee.

The manufacturer did not agree, and wanted us to run the study very quickly, without ethics approval.

We stuck to our guns and insisted that we must have ethics approval, to cover ourselves, and of course the manufacturer (as study sponsor). They disagreed, and so we had to part ways. They chose another supplier who was willing to perform the study without the cover of ethical approval.

I was surprised by their bravery, but I did not feel it right to expose our study staff to involvement in an invasive procedure in an unapproved study.

So, that begs the question ‘is ethics/IRB approval necessary for human factors studies?’

The golden rule is that if your study involves an intervention, if the device being tested is one with significant risk, if you are planning to involve vulnerable populations, then YES, you must get ethics/IRB approval.

And by the way, if you provide any type of feedback from (for example) a diagnostic device, then you have intervened, because you have sent the participant away from your study armed with knowledge that they did not have when they arrived. You do not know how they will modify their behaviour, or treatment when they get home. So you have been complicit in an intervention. And you must obtain ethics/IRB approval for doing so.

We always think hard about whether ethics / IRB approval is required, based on years of experience. We know that it introduces delay, but it protects you as study sponsor, us as the investigators, and of course the participant.