Informed Consent Process
The informed consent process begins with the presentation of the study to the participant and continues until the participant’s study participation is completed. Obtaining the signature of the participant on an informed consent document is only one part of the process.
The informed consent process emphasizes that the participant is competent to understand the purpose and requirement of the research, is volunteering to participate in the research study, and has the ability to withdraw from the study at any time without any adverse effect. The process starts with the exchange of information, usually in an interview setting. The setting and the tone of the interview must be non‐coercive. A thorough explanation of the study along with all risks, benefits, and alternatives to participation is essential. The individual must be given an opportunity to ask questions and have those questions satisfactorily answered. The participant must be fully informed in order for consent to be truly voluntary. The informed consent document and other materials are used as a guide to this interview which is documented by the signing of the informed consent document along with a note in the research record.
The information that is given to the participant or the representative should be in language understandable to the participant or the representative.
The IRB has the authority to observe or appoint a designee to observe the informed consent process and conduct of the IRB-approved research process.
IRB Consent Forms
A consent form is used to provide information to prospective subjects to enable persons to voluntarily decide whether or not to participate as research subjects. A consent form usually contains the basic elements of informed consent as identified in and required by the Federal regulations for the protection of human subjects (45 CFR 46).
Consent Form Completion Instructions (PDF)
Consent Form Template (PDF)
Assent Form – 13 to 17 years old (PDF)
Assent Form – 12 years old and under (PDF)
What is the difference between a Full Waiver of Consent, Alteration of Consent, and a Waiver of Consent Documentation?
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Waiver of Consent Documentation –45 CFR 46.117(c)
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| What is it? |
Waiving the consent process entirely. Individuals will not be approached for consent or it is not possible to approach them for consent (e.g. secondary data analysis). |
Altering some or all of the elements of informed consent (e.g. through deception). |
Waiving the requirement for a signed consent document (physical or typed), in favor of verbal consent or clicking a button to indicate consent. This is also used for opt-out parental consent, where parents must sign a form for a child not to participate.
In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or legally authorized representatives with a written statement regarding the research. |
| How do I request it? |
In Part 2 Section 7, describe how the project meets each of the following criteria:
- (1) The research involves no more than minimal risk to the subjects;
- (2) The research could not practicably be carried out without the requested waiver or alteration;
- (3) If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
- (4) The waiver or alteration will not adversely affect the rights and welfare of the subjects; and
- (5) Whenever appropriate, the subjects or legally authorized representatives will be provided with additional pertinent information after participation.
Notice that the regulatory criteria for requesting an alteration of consent and a waiver of consent are the same but that they reflect different processes.
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In Part 2 Section 7, describe how the project meets at least one of the following criteria:
- (1) That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context;
- (2) That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or
- (3) If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
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Please note: In the past, the IRB required investigators to address each of the criteria listed at 45 CFR 46.116(f)(3) (no more than minimal risk, impracticality, maintains the rights and welfare, and additional information), when requesting a waiver of consent documentation. Moving forward, the IRB will approve a waiver of consent documentation if investigators address each of the criteria listed at 45 CFR 46.116(f)(3), or at least one of the criteria listed at 45 CFR 46.117(c).
Waiver of Parental Consent (College Students)
If your study involves college students and you wish to include those who may be under 18 years old without requiring them to obtain parental consent, you will need to request a waiver of parental consent. To do this, include the following information in Initial Application Part 2, Section 7 (Consent Process).
