Consent vs. Assent
The informed consent process when executed properly 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.
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. If relevant, the investigator will be asked to translate consent documents into the subject's primary language after the English version of the consent form has received CSUF IRB approval. Both the English version and translated version are required prior to the CSUF IRB issuing an Approval Notice.
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 they 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.
The following additional information relates to minor participants but can be adapated accordingly for use with adult individuals wherein assent is necessary:
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 requires use of an age appropriate assent form (either verbal or written) instead of a consent form used to obtain permission from the minor's parents(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 able to assent depends on the child's age and maturity. If the child is considered to be capable of providing assent, whether or not assent is documented is also determined by the IRB. Generally, children are able to read and write to some extent by age 7. As such, documenting assent by having the child sign an assent form is usually a procedure that is incorporated for children age 7-17. When documentation is not 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 this language can be deemed coercive.