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. In general, informed consent is to be documented by the use of a written consent document, approved by the IRB, and signed (including in an electronic format) by the subject or the subject’s legally authorized representative. A copy of the consent form should be given to the person signing the informed consent document.

To assist investigators and coordinators who are conducting research, information regarding the informed consent process is provided on the HRP website A-Z Guidance. 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 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 prospective subject or the legally authorized representative must be provided with the information that a reasonable person would want to have in order to make an informed decision about whether to participate, and an opportunity to discuss that information.

General Requirements of Informed Consent

Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective participant’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate.

No informed consent may include any exculpatory language through which the participant or the legally authorized representative is made to waive or appear to waive any of the participant’s rights, or releases, or appears to release, the investigator, the sponsor, the institution, or its agents from liability.  

Key Information

The concept of Key Information was introduced in the Revised Common Rule, and while it is only required for federally funded studies, there may be times when the IRB may request a Key Information section be included regardless of funding.  

Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective participant or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension. For additional information about what should be included in the Key Information section, see the guidance on the HRP website entitled “Consent Guidance” 

Basic Elements of Informed Consent

  • 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 that are experimental.
  • 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. Where applicable, informed consent must disclose to subjects when treatments identical to those offered by the research may be obtained outside of the research.
  • A statement describing the extent to which confidentiality of records identifying the subject will be maintained.
  • For 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 and, if so, what they consist of, or where further information may be obtained;
  • 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.
  • One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
    • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens, and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
    • A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

Additional Elements of Informed Consent

  • 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.
  • A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit.
  • A statement regarding whether clinically relevant research results will be disclosed to subjects, and if so, under what condition.
  • For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (ie., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

Broad Consent

UPitt will not approve research utilizing Broad Consent and research reviewed on or after January 21, 2019 will not be reviewed by the UPitt IRB as Exempt under categories 7 and 8

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.