Which is considered an essential element of the informed consent form for a research study?

Question

Quizplus · Accepted Answer

Informed consent is a process of communication between the researcher and the potential subject that enables the subject to make an informed decision about participating in a study. The informed consent form is a written document that summarizes the key elements of this communication process. The essential elements of an informed consent form include a description of the study, the risks and benefits of participating, the right to refuse or withdraw from the study, the confidentiality of data, and whom to contact for questions or concerns.
Option A is not necessarily required as a witnessing signature may not be necessary for all studies, and it may not always be feasible, such as in remote or online studies.
Option B is important, but it is not an essential element of the informed consent form. The listing of members of the IRB (Institutional Review Board) provides information about the group that reviewed and approved the study, but it does not directly inform the subject's decision to participate.
Option D, the listing of the subject's assignment to intervention or control group, is not an essential element of the informed consent form. While this information may be important for the subject to know, it does not pertain to the subject's decision to participate in the study.

Which Is Considered an Essential Element of the Informed Consent