2. What is a consent form?

A consent form is a document required by federal law which provides subjects of research with an explanation of the nature of research and the potential risks of participating. It allows a research subject to be properly informed about making a decision to participate in a protocol. The consent form will explain the research, the duration of the participation, the experimental procedures, the potential benefits of participating, the nature of the confidentiality of the records, whether disclosures will occur and to whom, the contacts in the project if a subject has a question or is experiencing a problem, and the right of the individual to withdraw from the project. The nature and extent of the content of a consent form is approved by Institutional Review Boards, which monitor all human research at academic centers. Institutions such as Columbia University agree to perform research on human subjects by abiding by what is called the Common Rule and providing assurance to the federal government that all ongoing research, sponsored federally or privately, will follow the federal guidelines, which include the right to informed consent by research subjects.