Informed Consent

Required Documents

• If your protocol involves only adults (adults are people 18 years and older), please provide an Adult Informed Consent Form.

• Agreement from minors (under 18 years of age) in human subjects research is called assent, rather than consent; only the adult parent or guardian can legally provide consent. If your protocol involves children or adolescents, please provide a Minor Assent Form and a Parent/Guardian Consent Form. Note: If you are recruiting at a high school, some students are 18 years of age and do not need parental consent, but rather should provide their own consent using an adult consent form.

• If your study involves a medical experiment as defined under California Health and Safety Code, Sections 24170-24179.5, the inclusion of the Bill of Rights is also required (available in English or Spanish). At the discretion of the IRB, inclusion of a Bill of Rights may also be requested for some studies that are not medical experiments; this will be determined during the review process.

• If you are conducting recruitment or data collection activities off-campus, a Permission Letter from the institutional authority at your chosen location may be required before your protocol is approved to begin.

Please note, all of our consent, assent, and permission forms are templates to be used and modified to fit your study. Each form has instructional language included to tell you how to modify the form, and which language needs to stay. Please be sure to delete all instructional language before submitting the form.

Waivers of Consent

In certain limited situations, it is possible for the IRB to grant a waiver of documented informed consent. The IRB may consider a waiver request when:

• the research involves no more than minimal risk to the subjects;
• the research could not practicably be carried out without the waiver or alteration;
• the waiver or alteration will not adversely affect the rights and welfare of the subjects; and
• whenever appropriate, the subjects will be provided with additional pertinent information after participation.

If you feel a waiver may be appropriate, please ensure that your Cayuse protocol has provided ample justification of the above listed criteria. 

Important Informed Consent Process Reminders

• Do not use an unapproved consent form. Approved consent forms bear the stamp of the IRB, including approval and expiration dates.
• Do not use an expired consent form. Confirm the approval and expiration date is within the IRB approval period.
• If changes are made to the informed consent document during the course of the study, it is the investigator's responsibility to ensure that participants sign the latest approved version of the consent document.
• Do not verbally interpret the English version of the consent form into other languages. Investigators must use an IRB-approved, translated consent form. Subjects cannot waive their right to receive a translated informed consent document.
• Make sure to provide the participant their own copy of all consenting documents, including consent or assent form, Bill of Rights, etc.

The responsibility of ensuring that a potential participant understands the research and the risks and benefits involved falls upon the Investigator, not upon the potential participant.