Chapter 13 - Informed Consent and Documentation

General Overview of Informed Consent

Informed consent is one of the primary ethical requirements underpinning research involving humans; it reflects the basic principle of respect for persons. It should always be remembered that informed consent is an ongoing process, not a single event, designed to provide potential research subjects with all of the relevant information they need to make a fully informed, autonomous decision as to whether they wish to participate in a research study.

To assist investigators and coordinators who are conducting research, information regarding the informed consent process is provided on the HRPO website. Examples and instructions are available, including guidelines for the informed consent process and sample language for the informed consent document.

IRB Review of Informed Consent Process

During its review of the informed consent process as described in the protocol, the IRB requires that:

  • Adequate opportunity is provided to the subject or the subject’s legally authorized representative to read the consent document and ask questions regarding the study before the informed consent document is signed.
  • The consent process minimizes the possibility of coercion or undue influence. The consent discussion is in language understandable to the subject or the subject’s legally authorized representative.
  • The information communicated to the subject or the subject’s legally authorized representative during the consent process does not include any exculpatory language that waives or appears to waive any legal rights that the subject may have, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for harm caused by their negligence.

In addition, the IRB requires that the consent document include all of the basic elements of consent set forth in 45 CFR 46.116 and, if applicable, 21 CFR 50.25, except those which can be waived, or altered, according to regulation. The IRB may also require that additional elements or information be given to the prospective subjects when, in the IRB’s judgment, the information would meaningfully add to the protection of the rights and welfare of the research subject.

Basic Elements of Informed Consent

45 CFR 46.116 (a) or 21 CFR 50.25(a) include:

  • A statement that the study involves research;
  • A description of any reasonably foreseeable risks or discomforts to the subject;
  • A description of benefits to the subject or others that may be reasonably expected from the research;
  • The disclosure of appropriate alternative procedures or course of treatment, if any, that might be advantageous to the subject;
  • A statement describing the extent to which confidentiality of records identifying the subject will be maintained;
  • For medical research involving more than minimal risk, an explanation as to whether or not any compensation or any medical treatments are available if injury occurs during study participation;
  • The identification of an individual who can be contacted by the subject for answers to questions related to the research, research-related injury, or their rights as a research subject;
  • 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 s/he is otherwise entitled.

Additional Elements of Informed Consent

45 CFR 46.116 (b) or 21 CFR 50.25(b) that should be addressed, as appropriate include:

  • 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;
  • The approximate number of subjects involved in the study.

Consent Form Addendum

When subjects need to be informed of specific changes in the risk or benefit of study participation, an addendum consent, which focuses on the new information, may be more appropriate than a modified consent document.  A consent form addendum may also be used to inform enrolled subjects about significant new findings that may have a bearing on their willingness to continue participation in the study.