Consent v2

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.

class Consent {
    String name;
    String description;
    String language;
    boolean required;
    boolean reconsentRequired;
    String appId;
    String studyId;
    String guid;
    // Name of the approving IRB
    String approvedBy;
    DateTime approvedOn;
    DateTime approvalExpiresOn;
    ComprehensionType type; // summative, formative
    List<DocumentSection> sections;
    // timestamps, deleted, version
}

class DocumentSection {
    int order;
    String title;
    String content; // markdown or HTML
    String summary; // markdown or HTML
    ComprehensionQuestion question; // optional
}

class ComprehensionQuestion {
    String question;
    List<Answer> answers;
}

class Answer {
    String text;
    boolean correct;
    // assuming it was either selected correctly, or in error, the
    // response will be an affirmation or a correction/further explanation
    String response; 
}

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 (Maybe we show somewhere that there’s a newer version of the consent document, I don’t know).