ConsentState Value Set: Isn’t it the case that “Agreement to participate in study” will need to be able to pass through multiple temporal stages of agreement to participate in a given individual study, e.g., in Study A, the Research Subject’s agreement to participate in Study A might be:

• Unknown (may be equivalent to Consent.Status value of ConsentState = “unknown”)
• Pending: ResearchSubject may have been asked to participate but has not yet either agreed to participate or refused to participate; (may be equivalent to Consent.Status value of ConsentState = “draft”)
• Agreed to Participate (may be equivalent to Consent.Status value of ConsentState = “active”)
• ** Agreement to Participate or Refusal to Participate is Limited in Scope (would require an explanation of scope limitation)
• Revoked Agreement: ResearchSubject previously Agreed to Participate but at some later time decided to Withdraw his or her agreement (may be equivalent to Consent.Status value of ConsentState = “inactive”)
• Altered Agreement: ResearchSubject at some point renegotiated the prior agreement (which would spawn a child, linked consent entity) to reflect the unchanged, inherited terms and the new or altered terms of the agreement. This might occur, as Wendy Ver Hoef explained: “another use case for having more than one consent is when the protocol changes and request reconsent“; (may be equivalent to Consent.Status value of ConsentState = “inactive”)
• Denied: ResearchSubject previously Agreed to Participate but was later Denied the right to participate for some reason(s) (may be equivalent to Consent.Status value of ConsentState = “inactive”)
• ** Agreement by Proxy: for cases where a currently valid Health Proxy provides agreement to participate on behalf of the ResearchSubject (which would likely lead to multiple analogues of the foregoing states of consent)