I am using nurses as my participants in educational intervention randomised study. They will be trained to use a digital solution as a point of care app on patients using different modalities based on the randomisation. Those who signed up to the study will use the app on patients after training, they will not store any patient details and will use this as often as possible on different patients. As they are participants recruited through information sheet and consent, I won't expect them to be giving information sheet to patients individually and consenting these patients. I expect them to verbally inform patients and seek their oral consent. The study is not looking at the efficiency or psychometric properties of the app but effectiveness of the educational modality.
I would like guidance on this please.
Hello Ibiyemi,
If all patients are treated the same way (via the "digital solution as a point of care app"), and all that differs is the method of how the nursing staff are trained in the use thereof, you likely do not need patient consent. This would likely be the case, for example, if your study was focused on staff satisfaction with their preparation to use the digital solution.
However, if there is any possible concern that the quality of patient care might be at risk due to how staff are trained, or if the focus of the study was that of patient outcomes, then you would absolutely, positively need patient consent, in my opinion.
The final word, however, should fall to whatever health care institution(s) becomes involved with the study. I suspect that their IRB (or equivalent review board) would want to know the details in order to decide whether to approve the study as proposed, or suggest suitable modification(s).
Good luck with your work.
Thank you for your reply. The patients will be treated the same way.
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