Participation should be voluntary and rest on a consent process that leaves participants or their legally acceptable representatives well informed. Each participant should give freely given consent, recorded, before taking part; for people who cannot consent, a representative acting in their best interests consents beforehand while the person is informed in a way they can follow, and minors give assent as appropriate under local law and ICH E11(R1). The process and information should let people weigh benefits, risks and burden and decide, using clear and concise material, and should reflect participant characteristics, trial design, expected benefits and risks, the setting (such as emergencies) and any technology used. Where consent cannot be obtained beforehand in an emergency, it should be sought from the participant or representative as soon as possible under applicable law and IRB/IEC-approved procedures.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.