The IRB/IEC's purpose is to safeguard all participants' rights, safety and well-being, with particular attention to vulnerable participants; submissions may be combined with regulatory ones and may be made by the investigator or sponsor depending on the region. It should review, as applicable, the protocol and amendments, consent and assent materials and the consent process, the IB or product information such as the SmPC, other participant information and its media, recruitment advertising and process, compensation plans, ongoing safety updates and investigators' CVs or other evidence of qualification, plus anything else it needs. It should review within a reasonable time and record, for the identified trial and documents, the dates of approval, required modifications, disapproval or suspension or termination; carry out continuing review at intervals suited to the risk; may ask for more participant information than the guideline lists; must be satisfied that protocols allowing enrolment without prior consent address ethical concerns and regulation; review minors' assent material against age, maturity and psychological state; and review payment amounts and methods to avoid coercion or undue influence (payments should be prompt, proportional to participation and not entirely conditional on completion; reasonable expense reimbursement is not coercive), ensuring payment details appear in consent materials.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.