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Informed consent is one of the founding principles of research ethics. Its intent is that human participants can enter research freely (voluntarily) with full information about what it means for them to take part, and that they give consent before they enter the research.
The act of giving consent means that a person intends to allow, approve, agree, or is willing to comply with something. A consent form is a document that is signed by a person (or on behalf of the person whom they are a guardian) to show that they are in agreement with the contents of the document.
A document with important information about a medical procedure or treatment, a clinical trial, or genetic testing. It also includes information on possible risks and benefits. If a person chooses to take part in the treatment, procedure, trial, or testing, he or she signs the form to give official consent.
I have had the opportunity to ask questions about this research and I have received satisfactory answers. I understand the general purposes, risks and methods of this research. I consent to participate in the research project and the following has been explained to me: the research may not be of direct benefit to me.
The consent form provides potential research subjects sufficient written information to decide whether to participate in a research study or not based on an explanation of the proposed research and the nature of the participation that is requested of them.

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Considerations in preparing the informed consent document: Elements of consent present. Complete explanations. Lay language. Protection of confidentiality. No unproven claims of effectiveness. Device studies include a statement that the study includes an evaluation of the safety of the test article.
To achieve truly informed consent, four criteria have been identified: Information disclosure. Competence. Comprehension. Voluntariness.