What is informed consent?
Informed consent is the federally required process — not just a signature — by which a research team explains a study to you and confirms you understand it before you can enroll. The consent document covers the study purpose, what will happen at each visit, the expected duration, known and possible risks, potential benefits, alternatives to participation, costs and payments, how your data will be protected, who to contact with questions, and the fact that you can withdraw at any time without penalty. Consent is a conversation: the coordinator reads the document with you, answers every question, and you take as much time as you need before signing. You receive a signed copy to keep. Consent must be ongoing: if anything material changes during the study (new safety information, protocol amendments), the team must re-consent you. Signing is not a contract — it confirms understanding, and you can leave the study any time after for any reason.