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.
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.
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 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 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.
