Final answer:
In the short form consent process, subjects or their authorized representatives must receive copies of the written informed consent, detailing procedure, risks, and confidentiality, and confirming voluntary participation.
Step-by-step explanation:
In the short form consent process, the subject or the subject's legally authorized representative must receive copies of the informed consent documents. This informed consent form includes a detailed description of what participants can expect in terms of the procedure, the potential risks, benefits, and the confidentiality of data collected. It also ensures that participants know they have the right to withdraw from the study at any point without penalty. If the participants are under 18, their parents or legal guardians are required to provide consent on their behalf. It is crucial that the consent is obtained in writing, and researchers must maintain documentation of this consent to ensure compliance with ethical standards and federal regulations.