Standards and Procedures

OPRS SOP 701: General Requirements Of Informed Consent

  1. Office for the Protection of Research Subjects (OPRS)
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  3. OPRS SOP 701: General Requirements Of Informed Consent

Approved Date

Revised Date

Full Details

POLICY

Except as described in SOP 703 and SOP 506, no Investigator may involve a human being as a research participant unless he or she has obtained legally valid informed consent from the participant or the participant's legally authorized representative. 

The University of Illinois Urbana-Champaign IRB (UIUC IRB) reviews the application and any consent documents to ensure that the required elements of informed consent and when appropriate, the additional elements of informed consent are included in the informed consent process. Additional information or language to be included in informed consent may be required based upon the study. The UIUC IRB provides investigators with informed consent checklists which outline required elements, and sample language or information that must be provided during the consent process.

The University of Illinois Urbana-Champaign IRB adheres to the following regulations, as applicable:

  • Department of Health and Human Services (DHHS): 45 CFR 46.116
    • The University of Illinois Urbana-Champaign IRB does not utilize the option for broad consent (45 CFR 46.116(d)).
  • Food and Drug Administration (FDA): 21 CFR 50.25
    • The informed consent requirements related to the content, organization and presentation of information included in the consent form and process as well as the basic and additional elements of informed consent in the Final Rule are not inconsistent with the FDA’s current policies and guidance. The UIUC IRB may approve a consent process for an FDA-regulated study that is consistent with the Final Rule.
  • Department of Defense (DoD): 32 CFR 219.116

These policies apply to adult consent and/or parental permission.

PROCEDURES

  1. General Requirements of Informed Consent

Whether written or oral, consent is obtained in accordance with the following:

  • Before involving a human subject in research, the investigator must obtain legally effective informed consent from the participant or the participant’s legally authorized representative.
  • Consent is sought under circumstances which provide the prospective participant or the legally authorized representative sufficient opportunity to ask questions and consider whether or not to participate. Further, the possibility of coercion or undue influence must be minimized.
  • The information that is given to the participant or the legally authorized representative shall be in language understandable to the participant or legally authorized representative.
  • Any information that a reasonable person would want to have in order to make an informed decision about participation should be provided to the participant or legally authorized representative.
  • 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 an individual may or may not want to participate in the research.
  • The information must be presented in sufficient detail and organized and presented in a way that does not merely provide lists with isolated facts, but rather facilitates the understanding of why one may or may not want to participate.
  • No informed consent, may include any exculpatory language through which the participant is made to waive or appear to waive legal rights or releases or appears to release the Investigator, the Sponsor, or the University of Illinois Urbana-Champaign from liability for negligence.
  • The IRB determines whether the information provided to the potential participant includes the basic required elements of informed consent and when appropriate, the additional elements of informed consent as provided in the applicable regulations. Documentation is made using the Reviewer Checklist.
  • For studies that are no more than minimal risk, the additional elements of informed consent provided in the regulations cited above will not be required. The IRB determines if any of the additional elements of informed consent should be included using the Reviewer Checklist. 
  • For studies that are greater than minimal risk, the additional elements of informed consent provided in the regulations cited above are generally required. The IRB determines if any of the additional elements of informed consent may be omitted. Such a determination will be based upon situations in which the elements are not applicable as defined in the Reviewer Checklist. 
  • Any elements of informed consent required specifically for DoD studies will be required as outlined in the respective regulations.
  1. Additional Requirements for Informed Consent

The IRB determines that the University of Illinois Urbana-Champaign IRB requirements are included in the informed consent process. Documentation is made using the Reviewer Checklist.

  • The University of Illinois Urbana-Champaign IRB requires the use of standard language (e.g., research-related injury, etc.), as applicable. Any change to the standard language must be approved by the IRB at the time of review.
  • The IRB follows applicable Federal, State, or local laws, which require additional information to be disclosed in order for informed consent to be legally valid. If applicable, this information must be provided.
  • In addition to information specifically required by applicable regulations, the IRB may require that information, be given to the participants when in the IRB’s judgment the information would meaningfully add to the protection of the rights and welfare of participants.