Consent and Assent Form Templates

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Consent Form Templates

Sample Assent Forms

COVID-19 Screening and Testing Forms

Other Forms

Exempt Consent Templates and Guidance

 

Consent Form Templates

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 Hospitals Logo

January 2021 (Common Rule Compliant)

January 2021 (Common Rule Compliant)

Social or Behavioral

 

Social or Behavioral - Benioff Children's Hospital Logo

November 2020 (Common Rule Compliant)

November 2020 (Common Rule Compliant

One-time Survey

 

One-time Survey - Benioff Children's Hospital Logo

June 2019 (Common Rule Compliant)

June 2020 (Common Rule Compliant)

Simple Blood Draw

April 2019 (Common Rule Compliant)

Biological Specimens – GWAS Compliant

 

Biological Specimens - GWAS Compliant - Benioff Children's Hospital Logo

November 2020 (Common Rule Compliant)

November 2020 (Common Rule Compliant)

Consent to Be Contacted for Future Research

December 2015
Telephone Script (Main Study Procedures) -- Use this if you are conducting consent for study procedures over the telephone (verbal consent) August 2019
Telephone Script (Eligibility Screening only) -- Use this if the verbal consent is only for an over-the-phone eligibility screening. August 2019

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

 

Consent Form Addendum  - Benioff's Children's Hospitals Logo

July 2020

 

July 2020

Enrollment Exception Consent Form Addendum -- Use if you are submitting a Protocol Enrollment Exception Request Form and there is a specific risk information for the individual subject. January 2018
Expanded Access Consent Form Template October 2020

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 2016

VA Consent Form 10-1086 Template — See the SFVAMC page for info on this form.

 

Sample Assent Forms

Age of Children Last Updated
Assent #1 - For children 7-12 (simple) December 2004
Assent #2 - For more complex study, more mature children December 2004
Assent #3 - For adolescents 13-17 September 2020
Guidance on Obtaining Assent and Parental Permission  

 

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

January 2021

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

Dec 2020

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

Dec 2020

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 Subjects Bill of Rights (English) 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