WCG IRB would like to make you aware of a change to one of the typical reconsenting phrases that we commonly use.
What changes will you see?
Currently, we often utilize reconsenting phrases that state:
Please have all participants completing study visits, and all future participants sign the Consent Form(s) specified in this approval. This includes those completing remote visits, but not those who are in follow up only.
or
Please have all future participants sign the Consent Form(s) specified in this approval.
We intend to change these as follows:
WCG IRB reviewed new information in the above consent form(s). Please inform all participants for which there is an in-person or remote interaction and new subjects (if enrolling) of the changes. Document the communication in the research records (e.g., Note to File or participants signing the consent form). This is the Board’s minimum expectation – Sites can choose to inform or reconsent additional participants.
or
Please have all future participants sign the Consent Form(s) specified in this approval. This is the Board’s minimum expectation – Sites can choose to inform or reconsent additional participants.
Why is WCG making this change?
WCG has received a number of questions to clarify the requirements. In addition, WCG has seen a number of reconsiderations for changes to the language to reconsent over and above the directed reconsenting phrase.
WCG notes that the regulations do not require that participants sign a revised consent form when changes are made, just that they are informed. Given that, the new phrasing allows for more flexibility in informing participants and documenting that conversation in other ways outside of requiring signing of a consent form.
It is important to note that if you prefer certain participants be reconsented with an updated consent form, please provide that information via the submission form when the consent form changes are submitted. The Board will accommodate the request if possible as well.