Page Comparison

Things we will not migrate

I think it’s likely I will break something if I try and carry over the existing consent system, including subpopulations, consents, and study consents. I propose to leave these as a v1 model of consent, and create a new v2 version of consent. An app should include a flag indicating whether or not it uses v1 or v2 of the consent system. I don’t propose to go back and migrate existing studies, copying the relevant information from an App to a new Study, as it’s a large and risky undertaking.

Each study has one (and only one) required consent that must be signed to enroll in the study (with the caveat that the required consent may be in multiple languages). The consent can also be flagged if the client should force the user to reconsent (the user enrolled with a prior consent). There can be any number of optional, supplemental consents that can be presented to the user.

The consent includes a model for presenting the consent, and a model for verifying comprehension of the consent. The consent document will be assembled through the use of the content fields of all the document sections, with a signature block at the end of the consent which can be tailored for individual consents.

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The enrollment record which indicates that a participant has been enrolled in a study, will include the GUID of the consent that was used when the participant consented. It may be the same or different as the current required consent guid. If it’s different and the current consent requires re-consent, the app should act like the user has never consented and consent the user again (however, the user is consented and nothing will fail while this is happening, like pending uploads). If it’s not required, no action needs to be taken by the client. (Maybe we show somewhere that there’s a newer version of the consent document, I don’t know).

SQL

The consent signatures table may be able to store signatures for the v2 version of consent, if the consent GUID can be stored in the subpopulation GUID column (the values are in fact globally unique). If a new Hibernate model can be associated to to the same table, it may reduce confusion.

Candidates API

Candidate {
    String anonymousId;
    DateTime firstContactOn;
    DateTime mostRecentContactOn;
    String anonSessionToken;
    // should map 1:1 with a consent, but we can include consentGuid
    String studyId; 
    String userId;
    String stepCompleted; // eligibility, comprehension, consented, demographics
    Enum eligibility; // eligible, ineligible
    List<RejectedAnswer> eligibilityRejections;
    JsonNode clientState;
}

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