In obtaining and documenting consent on paper or electronically, the investigator should follow regulation, GCP and Declaration of Helsinki principles, have IRB/IEC-approved materials and process first, give clear, concise, plain information without unnecessary volume so people understand objectives, alternatives, benefits, risks, burdens, rights and expectations, choose suitable methods (text, images, video, interactive tools) considering the population and offer paper where electronic consent is used, consider remote consent where appropriate and verify the identity of the participant or representative. New information relevant to willingness to continue should be given promptly and documented, assessed for whether re-consent is needed, highlighted in revised materials and approved by the IRB/IEC before use. No one should coerce or unduly influence participation, and materials must not contain language waiving legal rights or releasing parties from negligence liability. Consent should be taken by the investigator or delegated staff, by the representative for those who cannot consent, after ample time and opportunity to ask questions; the form should be signed and dated (physically or electronically) by the participant or representative and the person who conducted the discussion, with an impartial witness present throughout and signing where the participant or representative cannot read. In emergencies without possible prior consent, the representative's consent is sought if present, otherwise enrolment follows the IRB/IEC-approved protocol measures, and consent is sought as soon as possible.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.