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  • How do you handle unconsented participants?

    #1

    In our system our participants must sign a consent form before they are entered into OpenSpecimen. The consented participants are added to a Collection Protocol called “CONSENTED”. For those participants that do not consent, they are stored in another system (Patient Registry System) until they consent. If they never consent, then they never get entered into OpenSpecimen.

    We wish to have all participants entered into OpenSpecimen.

    One possibility of handling unconsented participants is to enter them into OpenSpecimen under a Collection Protocol called “UNCONSENTED” and when they do consent, they are moved to the “CONSENTED” protocol.

    Does this sound reasonable? How are other people handling situations similar to this?

    Any suggestions would be appreciated.
    Thanks in advance.

    Note: This scenario was simplified for easy understanding.

    #2

    Hi Kenneth,

    While other adopters can answer, here is my take as developer:

    1. Do not use different CPs. There is no easy way to move participant from one CP to another.

    2. Instead, use just one CP.

    3. There are easy ways to query for consented vs non-consented participants with a CP. See sample query: https://openspecimen.atlassian.net/wiki/x/hLE6BQ

    4. Also during distribution, you can restrict that only consented samples can be distributed. For more details: click here

    Let me know if you have any questions. If you attend the community call tomorrow, we can demo this and discuss further.

    ~Sri

    #3

    Hello,

    I’m trying to revive this topic. Our Cancer Tissue Pathology team has an Unconsented collection protocol set-up in OpenSpecimen. We enter patients and their specimens that could be possibly consented to within the allotted time-frame. If these patients haven’t consented, we de-identify the patient info and keep specimens in the Unconsented protocol. Participants that get consented are then registered under the correct CPs and we move their Visits and Specimens with their original labels under the proper consented CPs.

    This process is quite complicated as we make a backup of all CP data involved in the process, disable the target CP labels and barcodes. Afterward, we complete multipe data transfers in sequence: Patient, Visit, Parents & Derivatives, and then Aliquots. Then we restore the CP label to the original formats.

    We would like to know if any organization using OpenSpecimen has a method of managing unconsented patients and specimens? There has to be a better way…