IRB Basic Steps
preparing your IRB: gathering your documents
Before beginning a submission, users should have the following items ready:
- Cayuse IRB "authenticated" account - if you do not have a Cayuse IRB account activated, review Step 2 under the IRB Basic Steps above.
- Complete CSUF required CITI IRB training - if you have not completed our CITI training for the Social Behavioral for Research Investigators, review Step 2 under the IRB Basic Steps above. CITI training is required for anyone who will be directly responsible for study management, data collection, consent process, data analysis, transcription, participant recruitment or follow up. This includes the principal investigator, faculty advisor, co-PI(s), student investigators, and all other engaged research personnel.
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Project Description/Methods - All PIs requesting IRB review of their project/research activity must prepare a detailed description of their project/research which provides the committee with the information about the purpose, method of data collection, and measures taken by the PI to protect human subjects.
- Supplemental documents - PDF files are preferred . Upload the following documents into your online application:
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- Informed Consent forms - All templates can be found on the Consent Forms page.
- Letters of Support from collaborating agencies authorizing the research at their institution (including CSUF departments working with PI to disseminate surveys and/or recruitment material to students across campus). Must be on official letterhead. No emails .
- Approvals from administrators when appropriate. Must be on official letter head. No emails .
- Recruitment documents.
- Questionnaires/Surveys - for data collection.
- Scripts for interviews, etc.
- Debriefing documents - if applicable.
NOTE: If the study calls for translated documents, all documents must be uploaded at the time of submission.
Consent VS Assent
When executed properly, the informed consent process provides sufficient information about study procedures so that a potential participant can make a reasonable decision about participation, based on an understanding of the potential risks and anticipated benefits (if any) of the study. Informed Consent is not a waiver of rights.
Individuals who do not have the authority to consent to participate in research must still provide their assent.
NOTE: Approved assent and consent forms will no longer be stamped.
Consent Document
The CSUF IRB will review the consent document(s) for use in obtaining and documenting consent from study participants. Consent forms must adequately describe the study using language appropriate for the target audience. Both the English version and the translated version are required prior to the CSUF IRB issuing an approval notice.
Customize the sample Consent Form below for participants consenting for themselves who are 18 years of age or older.
Informed Consent Template (English)
Informed Consent Template (Spanish)
Assent Process
Assent is an active affirmation of a desire to participate and differs from consent, which is recognized as being granted from an individual with the legal authority to do so. Even very young children or those with limited cognitive ability can assent and can certainly indicate a desire not to participate, which must be honored. Assent should be administered in a manner that is easily understood by the potential participant (either written or verbal) and should be limited to a one-page format. Illustrations might be helpful and larger type makes it easier for some individuals to read.
ASSENT FROM CHILDREN (45 CFR 46.408 )
Assent from a minor must be obtained in a language that is understandable to him/her and which require use of an age-appropriate assent form (either verbal or written) instead of a consent form used to obtain permission from the minor's parent(s) or guardian(s).
Assent is demonstrated by a child's agreement to participate in research. In California, a child is a person who is under the age of 18 years (unless legally emancipated). It is required that the researcher make adequate provisions to solicit assent.
The CSUF IRB will review a description of the process and procedures for obtaining assent from the child. To determine whether the child is to assent depends on the child's age and maturity. If the child is considered capable of providing assent, whether or not assent is documented, is also determined by the IRB. Generally, the children are able to read and write to some extent by age seven. As such, documenting assent by having a child sign an assent form is usually a procedure that is incorporated for children ages 7-17. When documentation is required, the IRB requires that the investigator conduct the assent process through a verbal script, and the IRB will review the script of what will be said during the verbal consent process. It is also recommended that investigators avoid such language as, "Your mom or dad said it is okay for you to participate," since the language can be deemed coercive.
Assent Form Templates:
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| Ages 6 - 11 |
Assent Form (English)
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Assent Form (Spanish)
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| Ages 12 - 14 |
Assent Form (English)
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Assent Form (Spanish)
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| Ages 15 - 17 |
Assent Form (English)
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Assent Form (Spanish)
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Parental Consent Form Templates:
