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Forms & Templates
You must submit a protocol using Cayuse Human Ethics , including a copy of your planned Consent Forms, as well as supporting documentation for your research project.
Informed Consent/Assent Templates and Requirements
Section 46.116 of the Common Rule (Post 2018) describes Consent Form Requirements
- Example of an Informed Consent/Assent Template in [Word]
A Parental Consent Form is used when human subjects are under the age of 18. If subjects are between the ages of 6-18, a Minor Assent Form is also needed.
- Example of Parental Consent in [Word]
NOTE: Before downloading this form, read the Guidelines for Obtaining Minor Assent.
Minor Assent to Participate in Research
A Minor Assent form is used when human subjects are between the ages of 6 and 18. Read the Guidelines for Obtaining Minor Assent which include samples. A Parental Permission to Participate in Research with forms is also required.
Implied Consent for Surveys
An implied consent for Surveys may be used when conducting a non-sensitive survey of non-vulnerable adults or when a survey will be administered online.
This process requires a request for a waiver of federal requirement to document consent in writing, requested through a section of the Cayuse Protocol Submittal.
- Example of Implied Consent for Surveys in [Word]
Verbal Consent Form
This type of Consent might be used when conducting phone interviews. The subject will not sign this form. The investigator will read it aloud to the subject. This process requires waiver of federal requirement to document consent in writing, requested through a section of the Cayuse Protocol Submittal.
- Example of Verbal Consent Form in [Word]
Witness/Translator Consent Form
This type of Consent form is used for subjects who do not speak or read English (the alternative, and preferred method, is to translate an Informed Consent form into the subjects' native language). The Investigator or designated witness/translator will read it aloud to the subject and the witness/translator will verify that the subject understands.
- Example of Witness/Translator Consents Form in [Word]
Focus Group Consent Form
Add this paragraph under “Risks” in the informed consent when conducting research where subjects will be involved in group discussions or focus groups and where they may be discussing sensitive topics.
- Example of Focus Group Consent Form in [Word]
When recruiting subjects through a teacher, department, organization or agency, or if you are conducting research in the classroom, or at a business, organization or agency, you are required to provide the IRB office with a letter of permission to recruit and/or conduct research. Please make sure the letters are signed and on the organization’s letterhead, if possible. Emailed versions are accepted on a case-by case basis. The letter must be attached to the Cayuse Protocol Submittal.
- Example of Permission Letter in [Word].
- Example of a Recruiting Script in [Word]
Use only the elements that apply to your research.
- Example of a Photo Release in [Word]
Use only the elements that apply to your research.
- Example of a Video Release in [Word]
An IRB approval typically expires in 1 year. To request a continuation PRIOR to your protocol expiration date, log onto to Cayuse, choose your original protocol, and request a modification to update your protocol and extend the end date. Submit your Continuation/Renewal Request through Cayuse at least 14-30 days prior to protocol expiration to allow enough time for IRB review and approval.
Modifications of Research Study Protocol
If you need to modify you original protocol, which is required with any substantial changes, and with changes to investigators or methodology, log on to Cayuse and follow the steps to Modify your original protocol. You must submit your Modification Request and receive IRB approval before you collect Human Subject data or perform actions on Human Subjects with the new personnel or methodology.
Completion of Research
When you have completed your research, log on to your Study in Cayuse and follow the steps to initiate the Close out of your Protocol.
Adverse Events & Protocol Deviation/Violation:
Serious and Significant adverse events must be reported to the IRB as soon as possible for the protection of the participant, but within at least 5 working days using the Serious/Significant Adverse Event Report Form, available in [Word].
Deviation Report Form
Deviations from the approved protocol that have already occurred and breaches of scientific integrity and ethics on the part of the researchers should be reported on the Deviation/Violation Report form, available in [Word].