What does informed consent mean in the human research context?
A. Ethical Foundation Informed consent is one of the primary ethical considerations in research involving human participants. The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research describes the purpose of consent as the mechanism to ensure that participants understand the research study and voluntarily agree to participate. A copy of the Belmont Report may be found at the following site: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm. The PI and study team members should consider that consent is a process, and not just a form that potential study participants must sign. B. Regulatory requirements for informed consent There are federal requirements that mandate the type of consent that may be obtained, the elements that should be present in a written or oral consent explanation, and who may obtain and give consent for research purposes. Below is an outline of these requirements. Federal Requirements: Informed consent must meet
