Plain Language Consent Template

October 11, 2023

New! Plain Language Consent Form Template + Companion Document:

Implementation Deadline for New Studies is November 15th, 2023

The IRB has developed a streamlined Plain Language Informed Consent Template and corresponding Companion Document. These materials were created with the intention of providing potential research participants with an understandable, plainly written consent form, and to help improve overall study activation time.

Please see the IRB’s Plain Language Informed Consent Form Project webpage for information about the aims of the project, a detailed summary of changes, and a Q&A section.

What has Changed?

In short, the main changes are as follows. A more thorough and extensive list is available on the Plain Language Informed Consent Form Project webpage.

  1. A single consent template has replaced the following 5 templates: Biomedical and Cancer, Social and Behavioral, One-time survey, Simple blood draw, and Biological specimens (GWAS compliant).
  2. A Companion Document has been created for use in tandem with the consent template. It contains instructions and IRB-approved statements.
  3. IRB-provided statements have been rewritten in plain language.
  4. Many IRB-provided statements are labeled as “locked,” meaning the language must not be altered. A Memo for Sponsors, signed by UCSF HRPP Director Edward Kuczynski, 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. 

Implementation Q&A

What kinds of studies is the new template designed for?

The new template is designed for use in full committee and expedited studies. It replaces the above-listed templates 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 are still on our website, unchanged.

Do I need to use the new template? If so, when?

  • For new studies submitted before November 15th: No. You are encouraged to use the new template, but it is not required.
  • For new studies submitted on or after November 15th: 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.

 

Visit Plain Language Informed Consent Form Project for more Q&As about the new template, Companion Document, and Memo sponsor. Watch the 3-minute video for a quick demonstration on how to use the template and Companion Document. 

If you have questions, please contact the IRB Office by submitting an Ask Andy query.