No clinical investigator may involve a human being as a subject in research unless the investigator has obtained the legally effective informed consent from the subject. Informed Consent is a written notification to human subjects involved in clinical investigations that provides them with sufficient opportunity to consider whether or not to voluntarily participate in the study. The informed consent document must include all the basic elements of informed consent (outlined later), or it may be a short-form written consent document stating that the elements of informed consent have been presented orally (§50.27). If the short- form method is used, there must be a witness to the oral presentation.
An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate, and minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative shall be in a language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence. The written consent form must be approved by the Institutional Review Board (IRB) and contain the following basic elements:109
1. 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.
2. A description of any reasonably foreseeable risks or discomforts to the subject.
3. A description of any benefits to the subject or to others, which may reasonably be expected from the research.
4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained, and that notes the possibility that the Food and Drug Administration may inspect the records.
6. 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.
7. 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.
8. A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
9. Additional elements of informed consent. When appropriate, one or more of the following elements of information must be provided to each subject:
a. A statement that a 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.
b. Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent.
c. Any additional costs to the subject that may result from participation in the research.
d. The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject.
e. 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.
f. The approximate number of subject’s involved in the study.
The consent form must be signed by the subject or the subject’s legally authorized representative. Each signed consent must be maintained by the clinical investigator and a copy of the informed consent must be provided to the human subject. A combination of oral and written consent may be used. The short-form method of informed consent includes a written summary and a “short form”. A written summary is a document of what is to be said to the subject or representative, and must be approved by the IRB. The summary must include all the basic elements of informed consent (discussed earlier). A short form is a document stating that the elements of informed consent have been presented orally to the subject or the subject’s legally authorized representative. After the oral presentation is provided, the summary must be signed by the witness and the presenter (investigator or investigator’s representative). The short form must be signed by the subject (or the representative) and the witness. A copy of the summary must be provided to the subject (or the representative) in addition to a copy of the short form. The signed documents must be maintained by the clinical investigator.