Consent and Assent Form Templates

Consent Form Templates

PLAIN LANGUAGE TEMPLATE AND COMPANION DOCUMENT (October 2023) -- The following templates have been replaced by a single Plain Language Consent Template:

  • Biomedical and cancer research
  • Social, behavioral, and educational research
  • One-time survey research
  • Simple blood draw research
  • Biological specimens (GWAS compliant)

The new Plain Language Consent Template has numbered sections. Refer to the Companion Document for guidance and IRB-approved wording for each numbered section. Copy statements from the Companion Document into the consent template as appropriate for your study. Watch the 3-minute demonstration video about how to use the template and Companion Document. 

See our Plain Language Informed Consent Form Template Project page for information about the new template and Companion Document, a memo to Sponsors regarding locked consent language, FAQs, and more.

New studies submitted on/after November 15th, 2023, are required to use the new template. See the project website for detailed information about which studies must use the new template. 

Note: The templates on this page are appropriate for studies that require expedited or full committee review. There are separate consent templates for exempt research, which includes some research that involves educational tests, surveys, interviews or focus groups.

Research Consent Template & Companion Document 

Plain Language Consent Template

Use this template for: 

  • Biomedical and cancer research
  • Social, behavioral, and educational research
  • One-time survey research
  • Simple blood draw research
  • Collection and/or storage or biological specimens for research (GWAS compliant)

Last Updated October 2023

Companion Document

 

This document will help you fill out the Plain Language Consent Template. It includes guidance and IRB-required language. 

 

 

 

Last Updated October 2023

Additional Consent Templates: Telephone consent, Addendums, Expanded Access, Humanitarian Use device

Telephone Script (Main Study Procedures) -- Use this if you are conducting consent for study procedures over the telephone (verbal consent)

Last Updated May 2022

 

Telephone Script (Eligibility Screening only) -- Use this if you are conducting consent for study procedures over the telephone (verbal consent)

Last Updated August 2019

 

Consent Form Addendum (general) - Use if you need to provide new study info to previously enrolled subjects. 

Last Updated May 2022

 

Expanded Access Consent Form 

Last Updated May 2022

 

General Data Protection Regulation (GDPR) Addendum template

Last Updated September 2022

 

Humanitarian Use Device - You may also use the sponsor’s version of the consent form, as long as you modify it to identify the UCSF investigator's name, department, and local contact number and provide the contact number for the UCSF IRB (415-476-1814).

Last Updated May 2022

 

VA Consent Form 10-1086 Template  

VA Phone Script for DocuSign 

VA Email Script for DocuSign

See the SFVAHCS  page for more information on these forms.

 

 

Consent Form Guidelines

Ensure your consent document follows these general guidelines:

Write at an eighth-grade reading level and use lay language vs. medical terminology

Write the consent form at or below an 8th grade reading level. We recommend using the Flesch-Kincaid score tool in Word to measure reading level.

Replace or define scientific or technical terms in lay language. For example, use "blood draw" instead of "venipuncture." 

 You can always verbally describe the study in more detail or using more scientific language during the consent conversation (if appropriate). 

Avoid legalistic language

Avoid legal-sounding language, such as "You hereby agree," "You certify that," "You, the undersigned, do acknowledge that," or “You understand that.” 

Use gender-inclusive language

Consent language should not assume the reader’s gender or imply there are only two genders. The template language provided by the IRB is non-binary and non-gendered.

Exception: If a study is focused on participants of specific gender identity (e.g., as an inclusion criterion), it may be appropriate to use gender specific language.

Use the correct forms for parental permission and child assent

In research with children, considerations regarding consent — both process and documentation — become more complex than with adult subjects. See IRB guidance on Children and Minors in Research for information about the documentation needed for consenting children and parents, and use the Sample Consent and Assent Forms for examples of how to write age-appropriate forms.

Include version dates and numbers in iRIS

iRIS also requires that each consent document have a version date and version number. Please note that every time you modify the consent document, iRIS will automatically update the version number. For example, if you add a revision to version 1.0, iRIS will then create version 1.1. We strongly suggest that you also update the version date when you modify the consent document.  If you wish, you can include an internal version number or date in the footer. However, remember to update the date or number each time you revise the document.

Leave 1.25" upper margin for an approval stamp and number each page

Approved consent forms will be stamped in iRIS, and study subjects should sign the stamped version. The approval stamp appears in the upper right-hand corner of each page, so do not include any information in this section of the header. In addition, the upper margin should be at least 1.25" to leave room for the stamp. 

After the consent form expires or is superseded, iRIS will automatically void the consent document. If you need a copy for your records, please print out the consent form before it is voided.

Number the pages of every consent document, preferably in a format like "1 of 2," "2 of 2," in the footer of the document.

 

Sample Assent Forms

Age of Children

Last Updated

Assent #1 - For children 7-12 (simple)

May 2022

Assent #2 - For more complex study, more mature children

May 2022

Assent #3 - For adolescents 13-17

May 2022

COVID-19 Screening and Testing Forms

This section includes forms that can be provided to research participants who attend onsite research visits that require COVID-19 screening or testing per UCSF policy.

Currently, pre-visit COVID testing is not required:

As of December 6, 2022, pre-visit COVID-19 testing is no longer required for any clinical or research visits for asymptomatic persons, including those undergoing aerosol-generating procedures (AGPs).

If pre-visit COVID-19 testing becomes required again:

Throughout the pandemic the Office of Research has endeavored to align research-related COVID-19 policies with UCSF Health wherever possible. Therefore, if UCSF Health reinstates the requirement for pre-clinical-visit COVID-19 testing, the Office of Research may again require such testing for pre-research-visit testing as well. In that scenario, research participants will need to be informed about these screening and testing procedures.

The following forms may be given to participants undergoing COVID-19 screening (still required) or testing (if the requirement for testing is reinstated by the Office of Research for the sole purpose of adhering to a UCSF requirement:

FormLast Updated

COVID-19 Screening Information Sheet

COVID-19 Screening Information Sheet (Spanish) - Translation Certificate

Jan 2021

Feb 2022

COVID-19 Testing Assent/Consent Form Addendum: Adults, Adolescents (13+), and Parents of Minors

COVID-19 Testing Assent/Consent Form Addendum: Adults, Adolescents (13+), and Parents of Minor (Spanish) - Translation Certificate 

Dec 2020

Feb 2022

COVID-19 Testing Assent Form Addendum: Children Aged 7-12

COVID-19 Testing Assent Form Addendum: Children Aged 7-12 (Spanish) - Translation Certificate

May 2022

Feb 2022

These forms are specifically designed to be used when COVID-19 screening and/or testing are being done for the sole purpose of adhering to the UCSF Guidance for Onsite Clinical Research Activities, i.e., the screening and/or testing information is not being used for research purposes. The forms should be provided to participants in addition to the main study consent form.

The language in these forms can also be adapted and added to consent forms for studies in which COVID-19 screening and testing procedures are being done for study purposes, i.e., the results of the screening and/or testing will be used as study data. To do this, simply copy the applicable language from these forms and paste it into your own consent form.

Please see the table below for instructions on when and how to use these forms.

 COVID-19 Screening Information SheetCOVID-19 Testing Assent/Consent Form Addendum: Adults, Adolescents (13+), and Parents of MinorsCOVID-19 Testing Assent Form Addendum: Children Aged 7-12
When should the form be used?Use when participants will undergo COVID-19 screening for the sole purpose of adhering to a UCSF requirement for participants to be screened prior to attending an onsite research visit. If there is no such policy in place, this form is not necessary.

Use when participants will undergo RT-PCR COVID-19 testing for the sole purpose of adhering to a UCSF requirement for participants to get an RT-PCR test prior to attending an onsite research visit involving procedures that induce coughing, sneezing, or otherwise increase the risk of aerosolization. If there is no such policy in place, this form is not necessary.

Note: The COVID-19 Screening Information Sheet should also be provided in this scenario.

Use when participants will undergo RT-PCR COVID-19 testing for the sole purpose of adhering to a UCSF requirement for participants to get an RT-PCR test prior to attending an onsite research visit involving procedures that induce coughing, sneezing, or otherwise increase the risk of aerosolization. If there is no such policy in place, this form is not necessary.

Note: The COVID-19 Screening Information Sheet should also be provided in this scenario.

When NOT to use this formDo not use this form if COVID-19 screening is a research procedure, i.e., if any data from the screening will be used in the research. In such a case, information about screening should be incorporated into the main study consent form. You can use wording from the information sheet and insert it into your consent form as applicable.Do not use this form if the RT-PCR test for COVID-19 is a research procedure, i.e., if any data from the test will be used in the research. In such a case, information about testing should be incorporated into the main study consent form. You can incorporate wording from the addendum into your consent form as applicable.Do not use this form if the RT-PCR test for COVID-19 is a research procedure, i.e., if any data from the test will be used in the research. In such a case, information about testing should be incorporated into the main study consent form. You can incorporate wording from the addendum into your consent form as applicable.
Who should receive the form?
  • Participants aged 13 years and older
  • Parents of minor participants under the age of 18 years
  • Participants aged 13 years and older
  • Parents of minor participants under the age of 18 years
  • Participants aged 7-12 years
Are signatures needed?

No. This sheet should be provided to the participant, but it should not be signed. Make a note in the study file that the information sheet was given to the participant.

Alternatively, if the study employs a consent form checklist, this step may be added to the consenting checklist to document that the form was given to participants.

Yes. There is a series of signature lines which includes all potential signatures that may apply to your study. Please use only those lines which are appropriate for your study and leave the others blank.Yes. The person conducting the assent discussion should sign the form as documentation that the assent discussion took place.
Does the form need to be submitted to the IRB?

You do not need to submit these forms to the IRB if you agree to use them exactly as written, with no alterations. They are provided as PDFs for this purpose.

It is the PI’s responsibility to ensure that all subjects attending onsite research visits receive the appropriate forms.

Alternatives to using the form as-is

If your study participants will undergo COVID-19 screening and/or testing solely to follow the UC Policy for onsite visits but you do not want to use these forms exactly as written by the IRB, you may:

  1. Incorporate information about COVID-19 screening and testing (as appropriate) into your main study consent form. Changes will need to be reviewed and approved by the IRB prior to use.
  2. Create your own version of the form, which will need to be reviewed and approved by the IRB prior to use.

 

Other Forms

UCSF Subject Authorization for Release of PHI for Research and Additional HIPAA-related Forms and Guidance
Experimental Participants Bill of Rights (English) (with signature) and Other Languages
Federal Requirements for Approving Consent Forms Checklist (Note: UCSF consent form templates incorporate all of the federal requirements.)
Consent Form Checklist for Using a Non-UCSF Consent Form 

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