Does your IRB track human subjects research training (via requiring submission of certificates) for outside PIs and their study staff during continuing review? Is so, at what interval do you require training to take place?
Comments & Events
Robin Krause
Yes we do track the training and we defer to their institution's research training policy. For example, for our institution the CITI Research training courses our good for 5 years. However, at other institutions it varies - it could be 1 year up to five years some even longer. We have only had a few instances that the PI has not taken the training in ten years (their institution only required them to take it once) and we asked that they take the refresher course to ensure that they are up to date on the revised common rule changes and they are reminded of their responsibilities.
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Al Demaria
Massachusetts Department of Public Health IRB requires up-to-date CITI training certification every 3 years.
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Joni Koenig
The Colorado Department of Public Health and Environment IRB requires human subjects training every three (3) years. Our policy is that human subjects training has to be taken within the last 3 years. Proof of training is verified prior to initial approval. If study personnel are not compliant, they must stop all study involvement and are administratively removed from the study. If an investigator is not compliant, a study may be suspended until the training is taken. Neither happens very often because prior to either action, I will have notified the individual (and the principal investigator if study personnel) of the training requirement at least three separate times - at 3 months prior to expiration, at 1 month prior to expiration, and at 1 week prior to expiration.
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Richard Danila
We do not
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Lou Gonsalves
The Connecticut Department of Public Health requires human subjects research training to have been taken in the past 3 years, and a copy of up-to-date certification is required for all study personnel. This is checked at the time of IRB approval, and at each annual continuing review. We use a training log form for the PI to keep track.
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Robin Krause
NYS Department of Health is similar to Colorado's. Training is verified at each review whether it is Initial, Continuing or PAM. We also notate in approval letters if anyone's training is going to expire within the next year along with a paragraph to remind the PIs that it is their responsibility to ensure everyone involved in the study maintains valid training.
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Craig Conover,Medical advisor, Chicago DPH, IRB Chair IL DPH
Thanks for all the replies. For us, verifying training after initial approval seems to take a fair amount of effort.
We are thinking of extending the interval to 5 years, and with submission of progress reports/status updates, having the PI verify that training for all study personnel is up to date. And randomly auditing.
We are thinking of extending the interval to 5 years, and with submission of progress reports/status updates, having the PI verify that training for all study personnel is up to date. And randomly auditing.