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I'm a 4th year doctoral candidate who recently finished data collection for my dissertation. However, I have some bad news that wasn't pointed out to me until I trained a prospective research assistant. This research assistant noted that the consent form stated the participant would keep a copy for their records. I never gave them copies throughout the semester at all, nor did I do so for my qualifier project. They did sign the consent form the lab kept though.

This was something that my university requires me to include. That's not mentioning that how I was trained at the start of my Ph.D program didn't even have me debrief participants at the end of my qualifier project, let alone give them a copy of the consent form.

What are my options now? I've considered emailing those who participated by bcc'ing them to ask if they'd like a copy of the consent form or not, just so I can say I remedied it.

I just want to avoid the potential worst case scenario of losing all of the data I worked so hard to obtain this semester.

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    Does your institution require you to do the CITI training? I thought that was considered pretty in depth (if you are US-based). Have you contacted the IRB office to ask for advice? Nov 18, 2023 at 4:56

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Talk to your advisor immediately, in writing by email, and keep a copy of the email, to show that you were proactive about this.

I would not expect this to be a major issue (it's certainly not on par with running an experiment without ethics review board approval), but you should get this cleared up as soon as possible. One possible next step would be to ask the ethics review board for guidance, but again, you should discuss this with your advisor.

Good luck!

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    Likely both OP and their advisor have a duty to report this to the IRB, but it's reasonable to do so together.
    – Bryan Krause
    Nov 18, 2023 at 17:38
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If this is in the United States, you should consult your IRB immediately.

They will probably say it does not matter, but it depends on your experimental design. If you attached something to your subjects and the consent form says how to remove it, you have a big problem. Otherwise, probably not.

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