A consent form is a document that provides potential research subjects with 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. The consent form should be easily identified in bold text as "Consent to Participate in Research" at the top of the first page, and the title of the research should be descriptive and not overly technical. Section headings should be used to identify the basic and any additional elements of informed consent.
Informed consent is the process in which a healthcare provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention. Informed consent is both an ethical and legal obligation of medical practitioners in the US and originates from the patients right to direct what happens to their body.
The informed consent process is the critical communication link between the prospective human subject and an investigator, beginning with the initial approach of an investigator to the potential subject and continuing until the completion of the research study. For most research, informed consent is documented using a written document that provides key information regarding the research. The consent form is intended, in part, to provide information for the potential subject’s current and future reference and to document the interaction between the subject and the investigator. However, even if a signed consent form is required, it alone does not constitute an adequate consent process. The informed consent process is an ongoing exchange of information between the investigator and the subject and could include, for example, use of question and answer sessions, community meetings, and videotape presentations.
Guidelines to document informed consent include that there must be a mark made by the study subject, the study team should have a reasonable way to verify the identity of the individual signing the informed consent form, a copy of the informed consent form must be provided to the study subject, and the study team must retain the study document for their records. While we are accustomed to thinking that documentation of consent is an in-person inked signature, there are many alternatives that satisfy these requirements. These alternatives include a virtual meeting or teleconference where the study team witnesses the signing of the informed consent form by the study subject.
