Scope and Usage: If ResearchSubject can be inclusive of devices, animals or tissue samples per “A research subject is the entity of interest in a research study, typically a human being or an animal, but can also be a device, group of humans or animals, or a tissue sample. The ResearchSubject resource describes essential information about the subject, including the gender, birthdate, study, study arm, consent status, and other key items. Human research subjects are usually not traceable to a particular person to protect the subject’s privacy.”, I can understand the need to set the Consent attribute to optional, but if ResearchSubject is human, shouldn’t we have a rule for the Consent resource that makes the consent entity mandatory rather than optional?