Updated Plain Language Informed Consent Form (ICF) Template + Companion Document

By UCSF HRPP on

What's happening?

Updated versions of the following documents are now available on the IRB website:

Why were the documents updated?

  • Plain Language ICF Template + Companion Document: Revised to improve participant readability and navigation, increase accessibility, and add flexibility across study types. Collaborators include PIs, researcher teams, IRB Members, compliance partners, and a community advisory board.
  • 7–12 Assent Form Template: Revised to better align with children’s developmental needs and make it easier to understand and navigate. Collaborators include IRB Chairs and IRB Members from Pediatrics, a community representative, and, importantly, children in the 7–12 age range!

Main changes

DocumentChanges
Plain Language ICF Template + Companion Document
 

The consent form and companion document have been extensively revised, including formatting, instructions, and standard statements. Key updates include:

  • Readability improvements: Added a table of contents, shortened
    headings, simplified dense paragraphs, and highlighted key information.
  • New statements: Added content on accessibility, translations, Brain MRI
    procedures, and survey/interview discomforts.
  • Revised statements: Revised language on sharing research results, taxable income, Certificates of Confidentiality, and treatment and compensation for injury, and more.
7-12 Assent Form Template

Revisions focus on improving understanding and engagement:

  • Addition of supportive graphics
  • Increased use of clear, age-appropriate language

Implementation: July 1, 2026


New full committee and expedited studies submitted on or after Wednesday, July 1, 2026 must use the updated templates and companion document.

Do I need to use the revised templates?

Study statusGuidance
New studies submitted before July 1st:No. You are encouraged to use the new template, but it is not required.
New studies submitted on or after July 1st:

Yes. The updated templates are required.

  • Submissions using older templates will be returned without review and must be resubmitted using the updated forms. At that point, the study will go back to the bottom of the IRB queue. This can
    significantly delay your review and approval time.
  • Note: This deadline applies to NIH Just-in-Time (JIT) submissions as
    well.
Already-approved studies:No. 
Adding a new consent form via modification to an already-approved study:No. Use of the updated template is encouraged but not required.