Examples of Consent and Assent
Forms and Protocols
These sample forms are being developed; more will be posted as they become
available.
The assent forms should be seen as examples, rather than as templates to be
strictly followed. There are certain things to remember about assent.
- Some people are not able to give consent, either because they are
minors or because they are legally incompetent. They must still
agree to participate, and must not be enrolled if they do not
want to participate.
- Their agreement to participate is called "assent," not "consent,"
becaused they cannot give consent. The form that documents this
agreement is called an "assent form".
- Not everyone can give even assent, and of those who can, not everyone
can provide documentation of their assent with an assent form. However,
in the absence of reasons to the contrary, an assent form should be
used to document assent.
- Like consent, assent is supposed to be "informed" -- that is, subjects
should know what they are getting into, and what effects their
participation is likely to have. Information presented in a foreign
language -- whether Russian to an English speaker, technical jargon to
a lay person, or adult language to a child -- is not informative.
- Since assent forms can be used with a very
wide range of people, they should be written to suit the people with
whom they are to be used. In other words, an assent form that is to
be used with subjects who are not quite 18 years old, and unable to
give consent only because of their ages, should be very different from
one used with adult subjects who have been declared incompetent because
of severe cognitive deficits, or with children between the ages of 8 and
10 years.
- It is, ultimately, the investigator's responsibility to devise
appropriate forms. It is the reviewing Committee's responsibility to
decide whether or not the forms are appropriate, but the Committees
cannot be responsible for writing all consent and assent forms.
- Questions about revisions should be addressed to the Administrator of
the
reviewing Committee. Questions about materials that are being developed
but have not yet been submitted for review can be addressed to the
the main Human Subjects Division office (543-0098), where they
will be referred to an appropriate Coordinator.