The consent discussion and materials should explain, as applicable: the purpose; that the trial is research and its experimental aspects; the product and the chance of random assignment; procedures, including invasive ones; what participants must do; foreseeable risks or inconveniences, including to a partner, embryo, foetus or nursing infant; expected benefits, or that none is intended; alternative treatments and their main benefits and risks; compensation or treatment for trial-related injury; any prorated payment and expected expenses; that participation is voluntary and the participant can stop the product or withdraw at any time without penalty; follow-up for those who stop or withdraw; how data will be handled, including on withdrawal; that consenting allows monitors, auditors, regulators and the IRB/IEC direct access to source records with confidentiality protected; that identifying records stay confidential, identity is protected in publications and the trial may be registered; that relevant new information will be shared promptly; whom to contact about the trial, rights and injury; foreseeable reasons for ending participation; expected duration; approximate number of participants; and that results and actual treatment information will be available on request once the sponsor has them. Participants or representatives should receive copies of the signed form and materials, and of updates during the trial. Minors should receive age-appropriate assent information and give assent as appropriate, with consent sought if they reach legal age during the trial; participants enrolled on a representative's consent should be informed in an understandable way and sign if able.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.