IRB Policy 260 - Informed Consent

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Last Updated: Apr 13, 2026, 03:09 PM

Effective date: April 11, 2026 (revised version; originally adopted on October 08, 2021)

I. Policy Purpose 

This policy establishes the requirements for informed consent in research involving human participants. It ensures compliance with applicable federal regulations, including the 2018 revised Common Rule, and aligns with the ethical principles of the Belmont Report. It applies to all SIUC faculty, staff, and students conducting human subjects research.

II. Policy Definitions 

Assent is the affirmative agreement of a child or an individual who lacks decisional capacity to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. 

Child in Illinois, the terms child or children refer to all individuals under 18 years of age unless the individual(s) is legally emancipated. Individuals under 18 years of age who are not emancipated meet the federal definition for “child” (e.g., Department of Health and Human Services, Food and Drug Administration, and U.S. Department of Education). 

Informed Consent is a process by which an investigator provides a prospective participant or their legally authorized representative with sufficient information to make a voluntary and informed decision about whether or not to participate in research. Informed consent is a continuing process, not a one-time event. 

Legally Authorized Representative means an individual or body authorized under applicable law to consent on behalf of a prospective participant to their participation in research. 

Waiver or Alteration of Consent refers to an IRB approval to either waive the requirement to obtain informed consent or alter one or more required elements of informed consent, granted when meeting specific regulatory criteria.

Waiver of Documentation means an IRB approval to conduct research without obtaining a signed consent form, granted when meeting specific regulatory criteria. In some cases, the IRB may require an investigator to provide participants with a written statement about the research.

III. Policy Statement 

Investigators must obtain informed consent from each prospective participant or their legally authorized representative before research begins, unless the IRB has granted a waiver of consent in accordance with applicable federal regulations. 

Informed Consent must include the required elements set out under 45 CFR 46.116 and any other elements as deemed necessary by the IRB or designated reviewer. Investigators must submit their consent documents as part of their submission and the IRB, or designated reviewer, shall review all provisions for consent when reviewing prospective research. 

The informed consent process involves three key features: (1) disclosing to potential participants the information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. Unless waived by the reviewing IRB, Informed consent must be legally effective and prospectively obtained. 

Consent must be voluntary and free from coercion or undue influence. Investigators must inform participants of any new information that may affect their willingness to continue participating and consent cannot include exculpatory language through which a participant waives any legal rights or releases the investigator, sponsor, or institution from liability or negligence.

IV. General Procedures

A. Required Elements of Consent 

Investigators must write consent documents in plain language, avoiding jargon, at a level understandable to the participant population, and in the primary language of the participant. All consent documents must include the required elements of informed consent established under 45 CFR 46.116, or any other elements the IRB or designated reviewer deems necessary. The IRB or designated reviewer shall review the prospective consent process and ensure it meets regulatory standards. At a minimum, the proposed consent process and form must include the following:

  • Research statement: a statement that the study involves research, an explanation of the purpose of the research, an explanation of the expected duration of participation, a description of the procedures involved, and identification of any procedures which will be experimental.
  • Voluntary participation statement: a statement that describes clearly that participation in the research is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
  • Reasonably foreseeable risks or discomforts: a statement that describes foreseeable risks or discomforts associated with the research, the likelihood of their occurrence, and the ramifications associated with the risks. When applicable, this must include a statement warning participants of any unforeseeable risks (i.e., that some risks are currently not known or foreseeable) to the participant, embryos, or fetuses.
  • Reasonably expected benefits to subjects or others: a statement that describes benefits to participants or others that may reasonably be expected from the research including no benefit, if this is applicable. Payment for participation in a research project is not considered a benefit.
  • Appropriate alternatives: a statement that describes with enough detail any alternative procedures or course of treatment that may benefit the participant. If no alternatives exist, the consent form must state that there are no alternatives except not to participate.
  • Extent of confidentiality: a statement that describes the extent to which the investigator/study personnel will maintain or not maintain confidentiality of records identifying the participant (e.g., law requires reporting child abuse, etc.) and describes how the research team will protect participant’s private records during and after the conclusion of proposed research studies. Any research that is subject to audit or inspection must identify who will have access to the subject’s record (e.g., FDA, National Institutes of Health (NIH), IRB, Government Accounting Office, sponsors, or contract research organizations).
  • Compensation or treatment for injury: for studies with greater than minimal risk, a statement explaining any compensation and an explanation of any medical treatments available if injury occurs or where the participant may obtain further information. The IRB informed consent template contains standard statements in accordance with IRB policy.
  • Participant payments: a statement which includes all information concerning the amount and schedule of payment for participation, if applicable.
  • Contact information: a statement that describes contact information details, including telephone numbers, and whom to contact for the following situations: questions about the research (e.g., investigator and other team members), questions about participant rights, comments, suggestions, or input (e.g., IRB approval statement), and in the event of a research-related injury (depending on the nature of the research, the PI or a physician on the research team).
  • Future use statement: One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:(i) 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 (ii) 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. 

The following elements must be included as appropriate:

  • Investigator-initiated termination of participation: a statement that describes the instances in which an investigator may terminate a participant’s participation (e.g., subject noncompliance, subject not benefiting from research, etc.
  • Additional costs: a statement that describes any additional costs a participant may encounter such as transportation, time away from work, parking, health costs, etc.
  • Early withdrawal/procedures for termination: a statement that describes a participant’s right to withdraw from the study and any procedures that may be necessary after an early withdrawal for subject’s safety.
  • Significant new findings: a statement that participants will be told of any new findings which may affect willingness to continue in the research.
  • Approximate number of subjects: a statement that explains the approximate number of participants to be enrolled in the study, worldwide, nationwide and locally, as applicable. 

Where participants have limited English proficiency, investigators must provide consent information in a language the participant understands. In such cases, investigators must submit translated consent documents for IRB review and translation verification. Translated documents must accurately reflect the IRB approved English version.

B. Documentation of Consent 

Investigators must document informed consent using the IRB reviewed and approved consent form and are responsible for version control. The ORC shall maintain records of all IRB approved consent documents and revisions. Investigators must provide participants with a copy of their signed consent form.

C. Active Consent Requirements 

Participants must actively consent to research participation. The IRB generally will not approve research designs that rely on passive consent or opt-out consent processes (in which participants are considered enrolled unless they affirmatively decline).

D. Waiver or Alteration of Consent and Consent Documentation 

The IRB has the authority to approve a consent procedure that does not include or which alters some or all of the federally mandated elements of informed consent, provided the approved procedure meets applicable federal regulations. A summary of applicable waiver federal regulations and institutional requirements is as follows:

  1. Non-FDA regulated studies: to waive informed consent requirements, the IRB must find and document that the study meets the requirements in 45 CFR 46.116(e)(f) or (g).
  2. FDA regulated and/or DHHS funded planned emergency research: the IRB approves exceptions for informed consent requirements if the study meets all of the requirements specified in 21 CFR 50.24 and/or 45 CFR 46.101(i), and IRB policy. The PI makes a preliminary decision to seek waiver of informed consent and submits justification, addressing the reason for each criterion for alteration, for the waiver request in the IRB application. The IRB may waive the requirements or alter elements, in its discretion, if it finds and documents:
    • The research involves no more than minimal risk to the participants.
    • The research will not adversely affect the rights and welfare of participants.
    • The investigator could not practicably conduct the research without the waiver or alteration.
    • Whenever appropriate, study personnel provide participants with additional pertinent information after they begin participation in the study. 
  3. Single subject emergency use of an FDA regulated test article: Even for an emergency use, the investigator is required to obtain the informed consent of the patient or the patient’s legally authorized representative unless both the investigator and a physician who is not otherwise participating in the clinical investigation certify in writing all of the following [21 CFR 50.23(a)]:
    • The subject is confronted by a life-threatening situation necessitating the use of a test article.
    • Informed consent cannot be obtained because of an inability to communicate with, or obtain legally effective consent from, the subject.
    • Time is not sufficient to obtain consent from the subject’s legally authorized representative.
    • No alternative method of approved or generally recognized therapy is available that provides an equal or greater likelihood of saving the subject’s life.
    • Note: If, in the investigator’s opinion, immediate use of the test article is required to preserve the subject’s life, and if time is not sufficient to obtain an independent physician’s determination that the four conditions above apply, the clinical investigator should make the determination and, within 5 working days after the use of the test article, have the determination reviewed and evaluated in writing by a physician who is not participating in the clinical investigation. The investigator must notify the IRB within 5 working days after the use of the test article when an emergency waiver is used [21 CFR 50.23(c)]. The FDA must also be notified. This notification must not be construed as an approval for the emergency waiver by the IRB.
  4. Waiver of parental or guardian permission in non-FDA regulated studies: when consent of parents or guardians is not a reasonable requirement because it poses additional risk to the potential subject or the parents’ interest may not adequately reflect the child’s interest (e.g., neglected or abused children), the IRB may waive parental or guardian permission in accord with 45 CFR 46 Subpart D and 46.408(c) and Subpart A 46.116. All such requests require full board review.

E. Waiver of Documentation of Informed Consent  

Federal regulations permit an IRB to waive the documentation (i.e., written signature) requirements for obtaining informed consent under special circumstances.

  • FDA regulated studies: The IRB may, in its discretion, waive documentation for some or all of the participants if the study meets conditions listed in 21 CFR 56.109(c).
  • Non-FDA regulated studies: the IRB may waive the requirements to obtain a signed consent form for some or all of the participants if the study meets the requirements in 45 CFR 117(c).

F. Deception 

Research involving deception or incomplete disclosure of the study's purpose constitutes an alteration of consent and requires IRB approval. An exception exists under 45 CFR 46.104(d)(3) for exempt benign behavioral intervention research, where participants may provide prospective agreement to be deceived without requiring a formal alteration request. For all other research involving deception, investigators must request an alteration of consent, justify the use of deception in their application, demonstrate that the research could not practicably be carried out without it, and describe the debriefing process through which participants will be informed following their participation.

G. Exempt Research 

Federal regulations provide flexibility in the documentation of exempt research. SIUC applies this flexibility so that investigators conducting exempt survey research may use an active consent acknowledgment at the beginning of the survey. For existing data, records, or specimen use approved under 45 CFR 46.104(d)(4)(i) and (4)(ii) consent may not be required when there is no direct interaction with participants. Work approved under 45 CFR 46.104(d)(4)(iii) may still require a HIPAA authorization or HIPAA waiver, if applicable. SIUC does not approve any work under exempt categories of 45 CFR 46.104(d)(7) and (8), both of which require documentation of written broad consent.

H. Electronic Consent 

The IRB may approve the use of electronic means to present consent information and obtain documented consent, provided that the electronic process meets all applicable regulatory requirements and adequately protects participant rights and welfare. Electronic consent processes must provide participants with a means to ask questions and download or print a copy of their signed consent. Investigators proposing electronic consent must describe the proposed process and platform in their IRB application and address how the security and confidentiality of participant information will be protected.

I. Special Populations 

Research involving participants who may have diminished decision-making capacity, including children and individuals with cognitive impairments, requires additional consent procedures in accordance with applicable federal regulations. Investigators must obtain consent from the participant's legally authorized representative and, where appropriate, the assent of the participant. Investigators must describe their proposed consent and assent procedures in their IRB application.

J. Posting Consent Forms 

Certain federally sponsored clinical trials must post a copy of an IRB approved consent form on a public website. The revised Common Rule (at 45 CFR 46.116(h)) requires that for each clinical trial conducted or supported by a federal department or agency, one IRB-approved consent form used to enroll subjects must be posted on a publicly available federal website by the awardee or the federal department or agency component conducting the trial.  

Two federal websites have been identified as places where consent forms can be posted to satisfy 45 CFR 46.116(h): ClinicalTrials.gov and a designated docket folder on Regulations.gov (Docket ID: HHS-OPHS-2018-0021). The awardee or the federal department or agency conducting the clinical trial may select either website to satisfy the posting requirement. Posting to ClinicalTrials.gov requires study registration.

K. Reporting New Information and Continuing Review 

If significant new information emerges during the course of a study that may affect a participant's willingness to continue, investigators must inform participants promptly and, where required, submit a modification to the IRB for review of updated consent documents in accordance with the applicable review policy. 

At the time of continuing review, investigators must confirm that consent documents remain current and accurate. The IRB will determine whether revisions to consent documents are required.

L. Ancillary Regulations 

Some research is subject to additional regulations that require specific notifications or consent process beyond those required by the IRB. For example:

  • Research involving educational records or the use of student coursework/grades is likely subject to the Family Educational Rights and Privacy Act (FERPA). FERPA regulations typically require that students (or parent/guardian) provide written (signed) consent for use of records or coursework for research regardless of the level of IRB review.
  • The Health Insurance Portability and Accountability Act (HIPAA) require signed patient authorization for research use of medical records, unless a Privacy Board or IRB waives that requirement. Authorization content must meet all HIPAA requirements.
  • If the PI conducts research outside the state of Illinois and the research involves children, a LAR, or a guardian, the investigator must follow the requirements of the state/county in which they will conduct the research. The PI must also determine which individuals meet the federal definitions for child/children, LAR, or guardian in the location outside the state of Illinois.