» Informed Consent Process

Per 45 CFR 46.116(g) of the 2018 Requirements, informed consent is not required for an investigator to obtain information or biospecimens for the purpose of screening, recruiting, or determining the eligibility of prospective subjects if either of the following conditions are met:

(i) The investigator will obtain information through oral or written communication with the prospective subject or legally authorized representative, or

(ii) The investigator will obtain identifiable private information or identifiable biospecimens by accessing records or stored identifiable biospecimens.

If either of the 2 conditions above are met, the IRB may approve the study without need for the research team to request a waiver of consent.

Basic Elements of Informed Consent – to be included in all protocols that receive expedited or full review unless the IRB makes an exempt determination.

1. A statement that the study involves research.
2. An explanation of the purpose of the research.
3. A description of the procedures to be followed.
4. The expected duration of the study (length of time for participation).
5. A description of any foreseeable risks or discomforts.
6. A description of the benefits to the subjects or others that may result from the research.
7. A statement to describe the extent, if any, to which confidentiality of records identifying the subject will be maintained.
8. A statement to inform subjects whether any identifiers associated with their data might be removed and made public or used/not used for future research purposes.
9. An explanation that participation is voluntary and that the subject may discontinue at any time.
10. An explanation of whom to contact with questions about the research.
11. An explanation of whom to contact with questions about subjects’ rights.

Elements of informed consent for clinical trials

1. A statement explaining that the study involves research.
2. An explanation of the purposes of the research.
3. The expected length of time for participation.
4. A description of all the procedures that will be completed during enrollment on the clinical trial.
5. Information about all experimental procedures that will be completed during the clinical trial.
6. A description of any predictable risks.
7. Any possible discomforts (e.g., injections, frequency of blood test, etc.) could occur as a result of the research.
8. Any possible benefits that may be expected from the research.
9. Information about any alternative procedures or treatment (if any) that might benefit the research subject.
10. A statement describing:
    1. the confidentiality of information collected during the clinical trial,
    2. how records that identify the subject will be kept,
    3. the possibility that the FDA may inspect the records.
11. For research involving more than minimal risk information, including:
    1. an explanation as to whether any compensation or medical treatments are available if injury occurs,
    2. what they consist of, or
    3. where more information may be found.
    4. questions about the research,
    5. research subjects' rights,
    6. injury related to the clinical trial.
12. Research subject participation is voluntary.
13. Research subjects have the right to refuse treatment and will not lose any benefits for which they are entitled.
14. Research subjects may choose to stop participation in the clinical trial at any time without losing the benefits for which they are entitled.
15. Contact information will be provided for answers to questions about the research.
16. An explanation of whom to contact with questions about subjects’ rights.

In addition, when appropriate, one or more of the following elements of information must also be provided in the informed consent document:

• A statement that the research treatment or procedure may involve unexpected risks (to the subject, unborn baby, if the subject is or may become pregnant).
• Any reasons why the research subject participation may be ended by the clinical trial investigator (e.g., failing to follow the requirements of the trial or changes in lab values that fall outside of the clinical trial limits).
• Added costs to the research subject that may result from participating in the trial.
• The consequence of leaving a trial before it is completed (e.g., if the research and procedures require a slow and organized end of participation).
• A statement that important findings discovered during the clinical trial will be provided to the research subject.
• The approximate number of research subjects that will be enrolled in the study.

A potential research subject must have an opportunity to:

• read the consent document,
• ask questions about anything they do not understand. 

Usually, if one is considering participating in a clinical trial, he or she may take the consent document home to discuss with family, a friend, or an advocate.

An investigator should only get consent from a potential research subject if:

• enough time was given to the research subject to consider whether or not to participate,
• the investigator has not persuaded or influenced the potential research subject.

The information must be in language that is understandable to the research subject.

Informed consent may not include language that:

• the research subject is made to ignore or appear to ignore any of the research subject's legal rights,
• releases or appears to release the investigator, the sponsor, the institution, or its agents from their liability for negligence.

Participating in clinical trials is voluntary.  You have the right not to participate, or to end your participation in the clinical trial at any time. Read the informed consent document carefully.  Ask questions about any information you don’t understand or find confusing.

FDA Final Guidance: FDA's Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors (August 2023)

There are times when the study requires that at least one of the  required elements of consent 46.116(b) or 46.116(c)  be waived or altered. An example is the use of deception where the consent document does not disclose the full purpose of the research or fully describes all of the study procedures. 

For the IRB to approve the PI’s request to waive or alter elements of consent, the following 5 criteria (same as those for waiving the entire consenting process) must be met: 

(i) The research involves no more than minimal risk to the subjects;  

(ii) The research could not possibly be carried out without the requested waiver or alteration;  

(iii) If the research involves using identifiable private information or identifiable biospecimens, the research could not be possibly carried out without using such information or biospecimens in an identifiable format;  

(iv) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and  

(v) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation. 

The same criteria apply for FDA-regulated studies. 

There are some studies (including those that are FDA-regulated) for which the IRB may waive the entire consenting process if the following 5 criteria are met:

(i) The research involves no more than minimal risk to the subjects;

(ii) The research could not possibly be carried out without the requested waiver or alteration;

(iii) If the research involves using identifiable private information or identifiable biospecimens, the research could not be possibly carried out without using such information or biospecimens in an identifiable format;

(iv) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and

(v) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.

For FDA-regulated studies which involve life-threatening situations, military operations, public health emergencies, the study must also meet criteria described in 21 CFR 50.23.

For FDA-regulated studies which involve emergency research (e.g., hemorrhagic stroke), the criteria per 21 CFR 50.24 must be met for an IRB to waive the consenting process:

Per 45 CFR 46.117, documentation of informed consent may be either of the following: 

1. The subject or subject’s Legally Authorized Representative (LAR) has signed the informed consent form that meets the requirements of § 46.116. 

1. A short form written informed consent form stating that the elements of informed consent required by § 46.116 have been presented orally to the subject or the subject's legally authorized representative, and that the key information required by § 46. 116(a)(5)(i) was presented first to the subject, before other information, if any, was provided. The IRB shall approve a written summary of what is to be said to the subject or the legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Only the short form itself is to be signed by the subject or the subject's legally authorized 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 subject's legally authorized representative, in addition to a copy of the short form. 

For FDA-regulated research (FDA’s Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors (August 2023), obtaining consent without any documentation at all (e.g., solely via telephone) is not acceptable. At the very least,  “[i]n situations in which the signed document cannot be retrieved . . . and electronic consent is not available, it is acceptable to retain for the study records a photographic image of the signed consent form along with an attestation by the person entering the photograph into the study records that states how the photograph was obtained and that it is a photograph of the informed consent form signed by the subject.” 

California Experimental Subject’s Bill of Rights

The California Protection of Human Subjects in Medical Experimentation Act (Section 24170-24179.5) requires all medical experimentation to be “undertaken with due respect for human life and the right of individuals to determine what is done to their own bodies”. All participants in medical experiments must be provided a written “Experimental Subject's Bill of Rights” in addition to informed consent.

A medical experiment is defined under section 24174 of the California Health and Safety Code as follows:

• The severance or penetration or damaging of tissues of a human subject or the use of a drug or device, as defined in Section 109920 or 109925, electromagnetic radiation, heat or cold, or a biological substance or organism, in or upon a human subject in the practice or research of medicine in a manner not reasonably related to maintaining or improving the health of the subject or otherwise directly benefiting the subject;
• The investigational use of a drug or device as provided in Sections 111590 and 111595;
• Withholding medical treatment from a human subject for any purpose other than maintenance or improvement of the health of the subject.

As defined in Section 109925

1. “Drug” means any of the following:
   1. An article recognized in an official compendium.
   2. An article used or intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings or any other animal.
   3. An article other than food, that is used or intended to affect the structure or any function of the body of human beings or any other animal.
   4. An article used or intended for use as a component of an article designated in paragraphs (1) to (3), inclusive.
2. The term “drug” does not include any device.
3. Any food for which a claim (as described in Sections 403(r)(1)(B) (21 U.S.C. Sec. 343(r)(1)(B)) and 403(r)(3) (21 U.S.C. Sec. 343(r)(3)) or Sections 403(r)(1)(B) (21 U.S.C. Sec. 343(r)(1)(B)) and 403(r)(5)(D) (21 U.S.C. Sec. 343(r)(5)(D)) of the federal act), is made in accordance with the requirements set forth in Section 403(r) (21 U.S.C. Sec. 343(r)) of the federal act, is not a drug under subdivision (b) solely because the label or labeling contains such a claim.
4. Cannabis product, including any cannabis product intended for external use, is not a drug.

As defined in Section 109920, a device means any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, that is any of the following:

1. Recognized in the official National Formulary or the United States Pharmacopoeia, or any supplement to them.
2. Intended for use in the diagnosis of disease or other condition, or in the cure, mitigation, treatment, or prevention of disease in humans or any other animal.
3. Intended to affect the structure or any function of the body of humans or any other animal and that does not achieve any of its principal intended purposes through chemical action within or on the body of humans or other animals and that is not dependent upon being metabolized for the achievement of any of its principal intended purposes.

The Cayuse IRB Application will prompt researchers if certain study procedures meet the requirement for the Experimental Subject’s Bill of Rights form. If any of the following categories apply, please note them in the submission, and ensure the Form is provided to participants.

• Use of a device (e.g., electromyography [EMG], electroencephalography [EEG], inertial sensor, motion capture systems, smartphone apps, electrical stimulation systems, sphygmomanometers and other physiological monitoring devices, and in-vitro testing kits or reagents)
• Use of ingestible substances other than drugs or food
• Invasive medical procedures (e.g., severance, penetration, or damaging of human tissue)
• Withholding medical treatment
• Applying hot or cold to participants
• Electromagnetic radiation
• Other medical experiments as defined under the California Protection of Human Subjects in Medical Experimentation Act

California law requires that the Experimental Subject’s Bill of Rights should remain a separate document from the informed consent form. It must be attached to the front of the informed consent form. In addition, the copy is to be dated and signed by the research participant or the participant’s legally authorized representative. The participant or the participant’s legally authorized representative is given a copy of the Experimental Subject’s Bill of Rights before giving consent to participate in any medical experiment.

The California Experimental Subject’s Bill of Rights must be provided to the participant or the participant’s legally authorized representative in his or her language during the consent process. This also applies when a Short Form is used in the consent process. If you have any questions regarding the use of the form, please contact the IRB Office for additional information.

General Data Protection Regulation (GDPR)

A GDPR Notice and Consent (available in the Forms under the subheader “Consent forms and related documents”) must be used for studies that include collecting data from participants located in a country that belongs to the European Union (EU) or in the European Economic Area (EEA). Additional data security provisions will apply to these studies, and special approval is required.  

Contact the IRB at irb@chapman.edu for more information.