Obtaining Informed Consent from human subjects is a necessary and important part of research that reflects the principle of respect for persons. Informed consent assures that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate.
The Informed Consent process should be tailored to each individual project; what is appropriate and approved for one project may not be appropriate or approved for another. When developing Informed Consent procedures and forms Investigators should keep in mind the prospective participant population, the risk involved in the research, the sensitivity of the research, and the research procedures.
The IRB has developed the guidance documents below to help Investigators develop appropriate Informed Consent procedures and forms.
- General Information about Informed Consent
- Information regarding Waiving Informed Consent or Required Elements of Informed Consent
- Methods for Obtaining Documentation of Informed Consent
- Information regarding Waiving Documentation of Informed Consent
- Information regarding Informed Consent with Minors or individuals who are Mentally Impaired
- Policy for Translated Informed Consent Forms (for Non-English Consent Forms)
- General Consent Form Template
Things to Keep in Mind when Developing Informed Consent Procedures for your Project:
Regarding the Prospective Participant Population:
Will prospective participants be old enough to provide legal consent?
If participants will not be old enough to provide legal consent, Investigators generally needs to obtain consent from a parent/guardian as well as assent from the minor. For more information, please review the IRB's Guidance on Informed Consent for Research with Minors.
In some cases, the IRB may approve requests to Waive Informed Consent of parents for research with minors. In order to Waive the Informed Consent of parents, Investigators would need to show that their research qualifies for a Waiver. The criteria to apply for a waiver are on the Request for a Waiver of Informed Consent or Elements of Informed Consent form.
Will prospective participants be literate?
Will prospective participants be able to speak and read English? Will they be able to speak and read another language?
What reading comprehension level do you expect prospective participants will have?
If you are conducting research with another cultural group, is it culturally appropriate to ask participants to read and sign informed consent forms?
Information that should be included in the IRB application regarding Informed Consent procedures
- When will participants be given the Informed Consent information?
- How will participants receive Informed Consent information?
- Will the Investigator be reviewing the consent information with participants, or will participants review it on their own?
- Who from the research team will administer the Informed Consent process (e.g. the Principal Investigator, a research assistant)?
- Will the consent process be administered separately to each individual or in a group with other participants?
- How much time will prospective participants have to review the information before they are asked to decide if they will participate in the research?
- How will participants indicate they consent to participate?
- If prospective participants will be signing Informed Consent Forms, how will they return the forms to the Investigator?