UCSF IRB’s Plain Language Informed Consent Form Project October 2023

The new informed consent form template has been streamlined to include only the information that is necessary for all studies. Additional instructions, alternate statements, and locked language are included in a Companion Document for study teams to copy and paste into the template as appropriate.

This single template replaces the following previous templates:

• Biomedical and Cancer
• Social and Behavioral
• One time survey
• Simple blood draw
• Biological specimens (GWAS compliant)

Watch the 3-minute demonstration video about how to use the template and Companion Document. The Companion Document will be updated regularly with additional instructions and statements.

Informed consent forms are meaningful only if people can understand them. Plain language aims to make information easily understandable and accessible to a wide range of readers. It focuses on using clear, concise language, short sentences, and organizing information in a logical manner.

The IRB has revised the informed consent form template language and achieved at or below the 8^th grade readability score (per the Flesch-Kincaid scale) by:

• Using plain language
• Shortening sentences
• Removing redundant or unnecessary information

The font and size are now Calibri 14-point. This is in line with the U.S. State Department’s decision in January 2023 to use Calibri 14-point font to help readers who are visually impaired.

The new template includes IRB-approved language that must not be revised. We refer to this as “locked language.” This language has been vetted for accuracy and readability by the IRB and other stakeholder offices at UCSF. It is denoted in the Companion Document by a lock symbol.

We developed a Memo for Sponsors, signed by HRPP Director Edward Kuczynski, which includes all locked statements and explains that the IRB will not allow any changes to them. Provide this to your Sponsor upfront so they know there is non-negotiable language.

Locked statements will be translated into the non-English languages most amongst UCSF's participant populations. An announcement will be made once the translations are available.

Since UCSF affiliated with Benioff Children’s Hospital Oakland, the IRB has offered two versions of each consent form: one with the Benioff Children’s Hospital logo and one without. The logo has caused delays in getting approval for studies that rely on a non-UCSF IRB. There will now be only one version of each template form without a logo.

The new template is designed for use in full committee and expedited studies. It replaces the above-listed templates (see Summary of Changes #1) and should be used for those types of studies.

The new template does not replace any of the following: Exempt study consent templates, consent addendum templates, telephone consent scripts, HUD consent template, expanded access consent template, or assent form templates. These templates remain unchanged on our website.

• For new studies submitted before November 15^th: No. You are encouraged to use the new template, but it is not required.  
• For new studies submitted on or after November 15^th:  Yes. You must use the new template. If you use an old template, your study will be considered Submission Standards Not Met by the IRB and returned to you without review, in draft form. You will need to resubmit the study using the new informed consent form template. At that point, the study will go back to the bottom of the IRB queue. This can significantly delay your review and approval time. Please note that this deadline applies to NIH Just-in-Time (JIT) submissions as well. 
• For already-approved studies: No. Studies that have already been approved do not need to be modified to follow the new templates.  
• For already-approved studies that are adding a brand-new consent form via Modification Form submission: No. You are encouraged to use the new template whenever you create a brand-new informed consent form, but it is not required.

Yes. JIT studies must follow the implementation guidelines detailed in question #2, above.

No. The template was carefully crafted to ensure that all elements of consent per the regulations are included. The section numbers also allow participants to ask questions more easily (e.g., “I have a question about section 3.1.”). You may only remove a section if the template instructions specify that it can be deleted if not applicable to your study.

No. The locked language must be used without edits or additions.

Per FDA guidance: “… the IRB has the responsibility and authority to determine the adequacy and appropriateness of all of the wording in the consent, see 21 CFR 56.109(a), 111(a)(4) and 111(a)(5). If an IRB insists on wording the sponsor cannot accept, the sponsor may decide not to conduct the study at that site.” You may provide the Memo for Sponsor to support the use of UCSF’s locked language.

Yes. The study team must provide information written at or below an 8^th grade reading level. We recommend using the Flesch-Kincaid score tool in Word to measure reading level.

Your study will be considered Submission Standards Not Met by the IRB and returned to you without review. The submission will be sent back with you in draft form. You will need to resubmit the study using the correct informed consent form template. At that point, the study will go back to the bottom of the IRB queue.

Your study will be considered Submission Standards Not Met by the IRB and returned to you without review. The submission will be sent back with you in draft form. You will need to resubmit the study using the correct informed consent form template. At that point, the study will go back to the bottom of the IRB queue.

The IRB does not plan to release a new template every year. The Companion Document will be updated periodically. Always be sure to use the current Companion Document on the IRB website.

Yes. The plain language informed consent does not replace an informed consent discussion. The discussion is an in-depth conversation about the study, allows the potential participant to ask questions, and allows the researcher to gauge and ensure comprehension.