ACROBAT | 4-MINUTE READ
Informed consent form: What it is and what to include.
Whether you’re running a research study, getting a waiver, or going through an institutional review board, explore the guidelines and processes around informed consent form.
What is an informed consent form?
Informed consent is a part of medical ethics and law that states that a patient should have all the necessary information before making a decision about their medical care. This is because navigating healthcare systems can be a complicated and often opaque process for patients, making informed consent one of the pillars of medical ethics.
An informed consent form serves as a written or digital agreement that gives individuals clear insight into a medical procedure or research study they may take part in. It lays out the goals, steps involved, potential risks, and expected benefits, helping participants make educated decisions before agreeing to proceed. This isn’t just a formality, it’s a meaningful dialogue between the healthcare provider or researcher and the individual, designed to foster understanding and trust.
More than just a document, informed consent is a process that encourages open conversation, giving space for questions and thoughtful reflection. Once the individual feels fully informed, they may sign the document, which also outlines their rights, privacy protections, and who to contact with any concerns. In essence, informed consent is both a record and a relationship — anchoring ethical practice in transparency and respect.
Key elements of an informed consent form.
An informed consent form lays out the essential details in a way that empowers participants to make thoughtful, voluntary decisions. While the format may vary, certain core components are consistently included to ensure transparency and ethical standards.
- Study overview. A brief explanation of the research goals and what the investigators hope to discover or understand.
- Participant involvement. A description of the specific tasks, procedures, or treatments the individual will be asked to undergo.
- Potential risks & benefits. A summary of possible side effects, discomforts, or advantages that may result from participation.
- Privacy & data protection. Information on how personal data will be handled, stored, and who will have access to it.
- Freedom to decline or withdraw. A statement confirming that participation is entirely optional and can be ended at any time without consequences.
- Points of contact. Names, roles, and contact details for both the research team and an independent party available to answer questions or address concerns.
These elements work together to ensure that consent is not just a signature — but a fully informed, voluntary agreement built on trust and clarity.
The process of informed consent.
Informed consent isn’t just a signature, it’s a thoughtful exchange that ensures individuals are truly prepared to make decisions about their medical care or participation in research. The process is designed to be clear, respectful, and empowering, guiding participants through several key steps:
- Clear communication. Healthcare providers or researchers begin by sharing detailed information about the study or treatment in plain, accessible language.
- Facilitating understanding. The explanation avoids technical jargon, helping participants grasp what’s involved without confusion or ambiguity.
- Voluntary choice. Individuals are encouraged to make their own decisions freely, without pressure or influence from others.
- Time to reflect. Participants are given the chance to ask questions and talk things over with trusted people like family members or doctors before deciding.
- Formal agreement. If they choose to proceed, they sign the consent form and receive a copy for their records, marking the completion of the process.
Frequently asked questions.
Keep exploring
https://main--dc--adobecom.hlx.page/dc-shared/fragments/seo-articles/seo-caas-collection