Consent/Assent Forms

• Consent Forms
• Assent Forms
• Additional Consent Form Information

Consent Forms

It is very important that any individual's enrollment and involvement in research as a "human subject" be completely voluntary and fully informed. Research participants may withdraw from a study at any time. 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.

» Consent and Assent Forms for Paper Applications

» UW Clinical Trials Consent Form

Assent Forms

For subjects who are not able to give consent, either because they are minors or because they are legally incompetent, agreement to participate is still required. These individuals must not be enrolled if they do not want to participate. Agreement to participate by such individuals who cannot "consent" is called "assent." The form that documents this agreement is called an "assent form".

The assent forms should be seen as examples, rather than as templates to be strictly followed.

• Not everyone can give even assent, and of those who can, not everyone can provide documentation of their assent with an assent form. Whenever possible, 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.

Additional Consent Form Information

• Consent Form Language and Readability
• Consent Form Checklist - 12/07/05 (doc) 58 kb
• Risks of Harm from Standard Care
• Waiver of Written Documentation of Consent
• Waiver of Consent in Emergency Medical Research
• Helpful Hints for Consent Form Submission
• Tips on Informed Consent
• Suggested Material and Wording for Use in Genetic Testing Consent Forms
• Consent Form Frequently Asked Questions (FAQs)

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.