What is informed consent?

Informed consent is fundamentally a process that ensures participants have a comprehensive understanding of the research they are engaging in. This involves providing potential subjects with relevant information about the study, including its purpose, procedures, risks, benefits, and their rights as participants. The goal is to empower individuals to make an informed decision about whether or not to participate, acknowledging their autonomy and ability to weigh the potential risks and rewards.

This process is not merely a one-time act; it encompasses ongoing communication, allowing participants the opportunity to ask questions and seek clarity. While formal documentation of consent (like a signed form) is often a part of this process, it is the thorough understanding and voluntary participation that are the core of informed consent. This ensures ethical standards are met in protecting the rights and welfare of research participants, aligning with the principles of respect for persons, beneficence, and justice outlined in research ethics.