One of the central protections provided for under the HHS regulations at 45 CFR part 46 and FDA regulations at 21 CFR Part 50 is the requirement to obtain the legally effective informed consent of individuals before involving them in research. It is required by the principle of respect for persons that individuals be treated as autonomous agents and that the rights and welfare of persons with diminished autonomy be appropriately protected. 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 informed consent process involves three key features:
(1) disclosing to potential research subjects the information needed to make an informed decision;
(2) facilitating the understanding of what has been disclosed; and
(3) promoting the autonomy of the decision about whether or not to participate in the research. Informed consent must be legally effective and prospectively obtained. HHS regulations at 45 CFR 46.116 and 45 CFR 46.117; FDA regulations at 21 CFR 50.25 and 21 CFR 50.27 describe the informed consent requirements.
Prospective subjects should be provided with ample opportunity to ask questions and seek clarification from the investigator. The prospective subjects should be in a position to freely decide whether to initially enroll in the research, and to later withdraw or continue participating in the research. 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 sufficiently understand the research so that they can make informed choices. The procedures used in seeking and obtaining informed consent should be designed to communicate with the subject population in terms they can understand. Information about a research project must be presented in such a way that enables each person to voluntarily decide whether or not to participate as a research subject.
For most research, informed consent is documented using a written format 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.
The MAH IRB requires the informed consent contain the following information:
• A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
• A description of any reasonably foreseeable risks or discomforts to the subject;
• A description of any benefits to the subject or to others which may reasonably be expected from the research;
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
• A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
• For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available If injury occurs and, if so, what they consist of, or where further information may be obtained;
• An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject, and;
• A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
When appropriate, additional elements of informed consent will be provided to each subject:
• A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
• Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent;
• Any additional costs to the subject that may result from participation in the research;
• The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;
• A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject; and
• The approximate number of subjects involved in the study.
For more detailed information about informed consent please refer to the Informed Consent section of the IRB Administrative Manual
