FHIR Consent for Research (PSS-2551)

The goal of this project is to produce a FHIR implementation guide for supporting informed consent for research. The main outcome is a FHIR Consent profile but it will also include profiles of other resources (e.g., ResearchSubject), extensions, codes, value sets, and examples as necessary.

This will be guided by a systematic study of the Department of Health and Human Services (DHHS), Protection of Human Subjects informed consent regulations (45 C.F.R. § 46.116), the Food and Drug Administration (FDA) Protection of Human Subjects informed consent regulations (21 C.F.R. § 50.25), and from common information identified in a sample of research consents. A conceptual model will be proposed that abstracts the concepts based on the above sources and will then be mapped to FHIR artifacts.

The starting point for this model will be based on the research conducted in Arizona State University College of Health Solutions under the supervision of Dr. Adela Grando. We hope to rely on contributions from other interested parties and then HL7 membership. Mohammad Jafari will lead the FHIR modelling.