IRB Assent and Consent Forms

IRB Assent and Consent Forms

• Assent Form Template, revised 10/27/09 (DOC)
  • 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, revised 10/15/09 (DOC)
  • 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, revised 4/29/09 (DOC)
  • 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 Cover Sheet - For Use with Language Minorities (Limited or Non-English Speaking Families), revised 7/10/09 (PDF)
  • To be provided with the Short Form Consent.
  • The short form consent cover sheet has been translated into the following languages:
  • Spanish Version  (PDF)
  • Korean Version  (PDF)
  • Russian Version  (PDF)
  • Somali Version  (PDF)
  • Simplified Chinese  (PDF)
  • Traditional Chinese  (PDF)
  • Vietnamese Version  (PDF)
  • Hindi Version  (PDF)
• Short Form — Consent for Use with Language Minorities (Limited or Non-English Speaking Families), revised 7/10/09  (DOC)
  • 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.
  • The short form consent has been translated into the following languages:
  • Spanish Version (PDF)
  • Korean Version (PDF)
  • Russian Version (PDF)
  • Somali Version (PDF)
  • Simplified Chinese (PDF)
  • Traditional Chinese (PDF)
  • Vietnamese Version (PDF)
  • Hindi Version (PDF)
• Short Form - Assent For Use with Language Minorities (Limited or Non-English Speaking Families), revised 7/10/09  (DOC)
  • Developed for younger children (7-13 years of age) who can read to be used in 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 assent form.
  • The short form assent has been translated into the following languages:
  • Spanish Version (PDF)
  • Korean Version (PDF)
  • Russian Version (PDF)
  • Somali Version (PDF)
  • Simplified Chinese (PDF)
  • Traditional Chinese (PDF)
  • Vietnamese Version (PDF)
  • Hindi Version (PDF)
• Emergency Use Consent Form Template, revised 6/10/09 (DOC)
  • 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) for details on emergency use approval.