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I'm am on staff at a tertiary level college. My colleagues and I are developing a wearable, non-invasive monitor, not too dissimilar from a Fitbit. Naturally, we want to know whether the monitor works or not, but we also want to know (as we go through the development stages) whether it is comfortable to wear, whether it impedes normal activities, whether it's easy to put on and take off, and so forth.

During the initial phase of the project, only the "principal researchers" will be involved; no junior staff. Later, however, we will want to test our prototype with other volunteers. For that reason, someone suggested that even at this early, essentially engineering-oriented stage of the project, we submit an application to our institutional ethics review committee (IRB). That is what we did. The committee has now reported back and said that they want of my colleagues to sign a formal consent form showing "informed consent", and want to see a formal questionnaire that each participant will answer when they have worn the device.

I feel stymied by the fact that there is no "superior authority" whom any of my colleagues can ask about the device, its effects, the teams intentions, or anything else. Every member of the team is an active participant who knows as much as anyone else about it. There is no person to whom any other person's consent is being given. Moreover, every person who tries the device is likely to make their own spontaneous observations about absolutely anything to do with the monitor, whether or not it is about something that is of a priori interest to the team, and whether or not a question appears in a questionnaire. As a minor example, someone might say that the wrist band for the device made them itch, or that they didn't like the color, or that they thought it would fit them better if the holes in the band were made closer together, and so ad infinitum.

Does anyone else have experience of this kind of situation? If so, what was the nature of the consent form? Can you direct me to an example of a consent form used with one or more "self-experimenters"? ... and what solution would you offer for the questionnaire conundrum?

I should perhaps add that I have tried searching using terms like "experimenter participant", "participant observer", "consent self-experimentation" but have not succeeded in finding anything useful.

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  • As a minor example, someone might say that the wrist band for the device made them itch I am quite sure that, you being based in the US, if the wrist instead of being itchy will trigger a serious allergic reaction, the team member will have a lot of pressure to sue "the team" to pay for the treatments, either directly or because the insurance will refuse to cover them. You will find out the hard way who is the principal in the team, even if you have a very flat hierarchy.
    – EarlGrey
    Nov 22 at 7:24
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    On the other hand, since it is clearly more than a hobby, you are working as a team but surely you already discussed how you will patent your instruments or how you will share the profit, don't you?
    – EarlGrey
    Nov 22 at 7:25
  • Thumbs up for worrying about ethics. Good form even if it is causing you some trouble.
    – Boba Fit
    Nov 22 at 13:03

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