IRB Assent and Consent Forms

Assent Form Template (DOC 28KB)

Developed for younger children (7-13 years of age) who can read. This template will assist you in developing simple written assent forms for younger children enrolled in your research.

Consent Form Template (DOC 60KB)

Developed for a phase III study and written for the parents. This template will assist you in developing consent forms that contain all the required elements of consent and that meet readability standards for 8th grade reading level or lower.

Consent Form and Assent Form Checklists for Researchers (DOC 53KB)

Use this checklist to prepare your consent form and assent form. The checklists outline the federal and institutional requirements for consent and assent forms.

Short Form - Consent For Use with Language Minorities (Limited or Non-English Speaking Families) (DOC 90KB)

Developed for situations where you did not anticipate recruiting families who do not speak English and there is not sufficient time to obtain a certified translation of the approved English consent form.

Learn how to use these forms (PDF 31KB).

The short form consent has been translated into the following languages:

Emergency Use Consent Form Template (DOC 15KB)

Use this template to prepare a consent form for use in emergency situations, i.e., life-threatening situation for which no standard acceptable treatment is available, and there is not sufficient time to obtain IRB review and approval.

The FDA allows one emergency use of an investigational drug, biological product, or medical device without prospective IRB approval.

See the Emergency Use of an Investigational New Drug or Device Information Sheet (PDF 99KB) for details on emergency use approval.