Consent Elements

Requirements for Informed Consent

{45 CFR 46.116}

  • In general, no investigator may involve a human being as a subject in research covered under 45 CFR 46 or 21 CFR 50 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 the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.
  • The information that is given to the subject or the representative shall be in 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.

Basic Elements of Informed Consent

In seeking informed consent the following information must be provided to each subject:

  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; 

Note: FDA explicitly requires that subjects be informed that FDA may inspect the records of the study because FDA may occasionally examine a subject’s medical records when they pertain to the study. (21CFR50.25(a)(5))

  1. 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;
  2. 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 
  3. 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.

Additional elements of informed consent

When appropriate, one or more of the following elements of information shall also be provided to each subject:

  1. 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;
  2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;
  3. Any additional costs to the subject that may result from participation in the research;
  4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  5. 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
  6. The approximate number of subjects involved in the study.

The informed consent requirements are not intended to preempt any applicable Federal, State, or local laws which require additional information to be disclosed in order for informed consent to be legally effective.

Nothing in the regulations is intended to limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable Federal, State, or local law.

Exception from prospective informed consent in the FDA Regulations

  1. Emergency use of a test article, provided that such emergency use is reported to the IRB within 5 working days. Any subsequent use of the test article at the institution is subject to IRB review. 21 CFR 56.104(c)
  2. Exception from Informed Consent Requirements for Emergency Research. 21 CFR 50.23 & 24. 

Documentation of Informed Consent

{45 CFR 46.117}

Informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

The consent form may be either of the following:

  1. A written consent document that embodies the elements of informed consent required by 45 CFR 46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed; (See Consent Elements above)

OR

  1. A short form written consent document stating that the elements of informed consent required by 45 CFR 46.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form. (See the Section called “Non-English”)

FDA difference regarding documentation
FDA explicitly requires in 21CFR50.27(a), that consent forms be dated as well as signed by the subject or the subject’s legally authorized representative. HHS regulations do not explicitly require consent forms be dated.