Consent and Assent Form Templates

Consent Form Templates

NEW TEMPLATES (May 2022) -- The IRB consent and assent form templates have undergone extensive revisions. New studies submitted on/after June 1, 2022, are required to follow the new templates. See the bulletin for details about if/when the following types of consent forms must implement the updates:

  • New studies submitted to the IRB between May 5th and May 31st
  • New studies submitted to the IRB on/after June 1st
  • Already approved studies

These templates 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.

Please note:

Template by Type of Research

Last Updated 

Biomedical and Cancer

Biomedical and Cancer- Benioff Children’s Hospital Logo

May 2022

May 2022

Social or Behavioral

Social or Behavioral - Benioff Children’s Hospital Logo

May 2022

May 2022

One-Time Survey

One-Time Survey - Benioff Children’s Hospital Logo

May 2022

May 2022

Simple Blood Draw

Simple Blood Draw - Benioff Children’s Hospital Logo

May 2022

May 2022

May 2022

May 2022

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

May 2022

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

August 2019

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

Consent Form Addendum - Benioff Children’s Hospital Logo

May 2022

May 2022

Enrollment Exception Consent Form Addedum - Use if you are submitting a Protocol Enrollment Exception Request Form and there is a specific risk information for the individual subject.

January 2018

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).

May 2022

 

See the SFVAHCS  page for more information on these forms.

Sample Assent Forms

Age of Children

Last Updated

COVID-19 Screening and Testing Forms

Per UC policy, research participants must be screened for COVID-19 prior to onsite visits and must be tested if their visit involves aerosolizing procedures. Though the screening & testing aren't being done as part of the research (i.e. not a research procedure where data is being used in analysis), they are being done because the research involves an onsite visit. As such, the participants need to be informed about these procedures. The IRB has created forms to be given to participants who attend onsite visits.

Three new forms are available for use:

Form

Last Updated

COVID-19 Screening Information Sheet

COVID-19 Screening Information Sheet (Spanish)

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)

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)

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 Sheet COVID-19 Testing Assent/Consent Form Addendum: Adults, Adolescents (13+), and Parents of Minors COVID-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 the UCSF Guidance for Onsite Clinical Research Activities, which requires participants to be screened prior to attending an onsite research visit.

Use when participants will undergo RT-PCR COVID-19 testing for the sole purpose of adhering to the UCSF Guidance for Onsite Clinical Research Activities, which requires 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.

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 the UCSF Guidance for Onsite Clinical Research Activities, which requires 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.

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

When NOT to use this form

Do 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 

Last updated: May 5, 2022