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Informed Consent Guide

Informed Consent Process

The conduct of research involving human participants requires that participants are provided with the opportunity to give informed consent prior to their participation in the research. The process of obtaining this consent can be carried out in a number of ways: Informed Consent, Oral Consent, and Parent Consent/Assent. The IRB has provided templates below to assist you with your consent forms. Please take the time to review these carefully; not all projects require all the information on the generic template. Example: Photo/video must be deleted if you are not planning to use them in your project. Failure to customize your consent form may result in a delay in IRB approval.

Prior to the start of the research, the principal investigator will review with each of the participants the appropriate consent form. Consent forms provide research participants with sufficient information about the research to ensure that they understand the procedures or activities in which they will be involved, and the risks and potential benefits of the research. It must also inform them of their rights with respect to participation, i.e., that research participation is voluntary and that they have the right to withdraw at any time. The more risk that is posed to research participants by a given study, the greater the care and comprehensiveness of the consent process that will be required by the Institutional Review Board (IRB).

 

Informed Consent

Informed Consent is the written consent form used primarily for those over the age of 18. This is the most frequently used form for research. As a reminder, the informed consent form must be provided in the participant's native language. The IRB committee must have a copy of this form in all languages you plan to interview in prior to IRB approval.  Download Informed Consent Form Template in WORD or as PDF.

Oral Consent

Oral Consent is read to adult participants when a participant is either unable to sign a written form, or interviews are being conducted remotely. Oral consent is also commonly used when research is conducted outside of the US. As a reminder, the oral consent form must be provided in the participant's native language. The IRB committee must have a copy of this form in all languages you plan to interview in prior to IRB approval. Download Oral Consent Form Template in WORD or as PDF.

Parent or Guardian/Child Assent Consent Process

Parent or Guardian/Child Assent Consent forms are used when you would like to conduct research with minors. Both forms are given to the parent or guardian who will fill out the adult portion and distribute the assent portion to the minor child. In other instances, these forms will be used if an adult lacks the capacity to give consent. Parent or Guardian/Child Assent Consent forms are most commonly used in a school setting and the school officials assist in the distribution of forms to families. As a reminder, the consent and assent forms must be provided in the participant's native language. The IRB committee must have a copy of this form in all languages you plan to interview in prior to IRB approval. Download Parent or Guardian/Child Assent Consent form Templates in WORD or as PDF.

Survey/Online Consent

Survey/Online Consent in managed on the landing page of your survey. Requirements for survey participation (age, sex, student status, etc.) must be stated on the landing page and participants must opt-in in order to participate. The IRB requires the language of this landing page to be included in IRB proposal. Download sample survey landing page in WORD or as PDF.

Waiver of Consent

Where there are specific situations where the IRB may waive the requirement for obtaining informed consent (written or oral). This may only be done when research falls under the "Exempt for Further Review" category of IRB review AND all of the following four conditions pertain:

  1. where the risks to participants are minimal
  2. where obtaining consent is practicably impossible
  3. where no therapeutic intervention is involved in the research,
  4. where the waiver does not violate the rights or well-being of the participants

You must demonstrate in writing in their application that these four conditions exist for the IRB to grant such a waiver.

Community Consent

In some circumstances (e.g., aboriginal research) it may be important to seek consent from the community as a whole in addition to getting consent from individual participants. It is your responsibility to consider whether this is needed, and if so, to describe how such consent will be sought.

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