Final answer:
An IRB proposal must include a plan for obtaining informed consent, which details how participants are made aware of study risks and procedures and their consent is documented.
Step-by-step explanation:
When submitting a proposal for IRB approval, a detailed plan for obtaining informed consent from research participants is a critical component. Informed consent ensures that participants are fully aware of the study's procedures, risks, and their rights before agreeing to take part. This process is a cornerstone of ethical research conduct and is mandated by federal law, with the IRB responsible for overseeing its implementation. Proposals must include provisions detailing how consent will be communicated and documented prior to the participation of any individual in the study.