The procedures used in seeking and obtaining informed consent should be designed to communicate with the subject population in terms that they can understand. The informed consent process should ensure that all critical information about a study is completely disclosed, and that prospective subjects or their legally authorized representatives adequately understand the research so that they can make informed choices.
The prospective subjects should be in a position to freely decide whether to initially enroll in the research, or later, to withdraw or continue participating in the research. Prospective subjects should be provided with ample opportunity to ask questions and seek clarification from the investigator. The exchange of information between the investigator and prospective subjects can occur via one or more of the following modes of communication, among others: face-to-face contact mail telephone video or fax. The informed consent process should be an active process of sharing information between the investigator and the prospective subject. Investigators can include physicians, scientists, nurses, administrative staff, teachers, and students, among others. For the purposes of the HHS regulations at 45 CFR part 46, “investigators” are individuals who conduct human subjects research projects, including individuals directly involved in seeking the voluntary informed consent of potential subjects. 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 (e.g., through a flyer, brochure, or any advertisement regarding the research study) and continuing until the completion of the research study. HHS regulations at 45 CFR 46.116 and 45 CFR 46.117 describe the informed consent requirements. Informed consent must be legally effective and prospectively obtained. The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision (2) facilitating the understanding of what has been disclosed and (3) promoting the voluntariness of the decision about whether or not to participate in the research. The Belmont Report states that an autonomous agent is “an individual capable of deliberation about personal goals and of acting under the direction of such deliberation.” Respect for persons requires that prospective research subjects “be given the opportunity to choose what shall or shall not happen to them” and thus necessitates adequate standards for informed consent. The principle of respect for persons requires that individuals be treated as autonomous agents and that the rights and welfare of persons with diminished autonomy be appropriately protected. This requirement is founded on the principle of respect for persons, one of the three ethical principles governing human subjects research described in the Belmont Report.
The requirement to obtain the legally effective informed consent of individuals before involving them in research is one of the central protections provided for under the HHS regulations at 45 CFR part 46.
When informed consent is required, it must be sought prospectively, and documented to the extent required under HHS regulations at 45 CFR 46.117. The HHS regulations at 45 CFR part 46 for the protection of human subjects in research require that an investigator obtain the legally effective informed consent of the subject or the subject’s legally authorized representative, unless (1) the research is exempt under 45 CFR 46.101(b) (2) the IRB finds and documents that informed consent can be waived ( 45 CFR 46.116(c) or (d)) or (3) the IRB finds and documents that the research meets the requirements of the HHS Secretarial waiver under 45 CFR 46.101(i) that permits a waiver of the general requirements for obtaining informed consent in a limited class of research in emergency settings. Regulations & Policy Archived Materials.Subpart C Certification Request to OHRP.Single IRB Exception Determinations has sub items, about Single IRB Exception Determinations.Informed Consent Posting has sub items, about Informed Consent Posting.OHRP Guidance on Maintaining Consistency Regarding the Applicability of the 2018 or Pre-2018 Requirements.OHRP Guidance on Elimination of IRB Review of Research Applications and Proposals.Decision Charts has sub items, about Decision Charts.Path to Revising the Common Rule (2011–2018).Preamble to the Revised Common Rule (2018 Requirements).Regulations has sub items, about Regulations.