Elements of Informed Consent
ELEMENTS OF THE INFORMED CONSENT
Subject to certain exceptions, no investigator may involve a human being as a subject in research covered by regulation promulgated by the Food and Drug Administration unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative. An investigator shall seek such consent only under circumstances that provide the prospective subject or their legal representative sufficient opportunity to consider whether or not to participate, and under conditions that minimize the possibility of coercion or undue influence. The information that is given to the subject or their representative shall be in language understandable to the subject or their representative, and should be translated into their native language if they do not speak English. No informed consent, whether oral or written, may include any exculpatory language through which the subject or their 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 or negligence.
[21 CFR 50.20]
The requirements for informed consent set out in the regulations apply to all human subjects entering a clinical investigation that commences on or after July 27, 1981.
[21 CFR 50.21]
ELEMENTS OF INFORMED CONSENT [21 CFR 50.25]
Basic Elements of Informed Consent
In seeking informed consent, the following information shall be provided to each subject:
The statement: “You understand if you wish to contact an impartial third party not associated with this study, you may contact XXXX, at 123 Main Street, Anytown, AT, 00000 (555)555-5555.”
- Statements that the study involves research, an explanation of the purposes of the research, the expected duration of the subject’s participation, and a description of the procedures that are experimental.
- A description of any reasonable foreseeable risks or discomforts to the subject.
- A description of any benefits to the subject or to others, which may reasonably be expected.
- 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 and that notes the possibility that the Food and Drug Administration and the International Cellular Medicine Society IRB may inspect the records.
- For research involving more than minimal risk, an explanation as to whether any compensation is involved, and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, who will pay for the treatment of a study related problem, and 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 medical problem of injury.
- 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.
- The following paragraph:
“Patients must understand that this drug and/or treatment (revise as necessary) may have adverse affects on and may produce abnormal development in the unborn fetus. Female patients: you cannot participate in this study if you are pregnant and you must take a pregnancy test to determine if you are pregnant before starting treatment. It is strongly recommended that you (females) do not attempt to become pregnant or that you (males) do not father a child during the course of this treatment. Please discuss necessary precautions with your physician as well concerns about future child bearing with your physician prior to beginning treatment. Females: Please inform your physician immediately if you suspect you have become pregnant and the treatment will be terminated.”
Additional Elements of Informed Consent
When appropriate, one or more of the following elements shall also 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 with draw from the research and procedures for orderly termination of participation by the subject.
- The approximate number of subjects involved in the study.
The informed consent requirements in these regulations are not intended to preempt any applicable Federal, State, or Local laws which require additional information to be disclosed for an informed consent to be legally effective.
Nothing in these regulations are intended to limit the authority of a physician to provide emergency medical care to the extent that the physician is permitted to do so under applicable Federal, State, or Local law.