NEW PLAIN LANGUAGE TEMPLATE AND COMPANION DOCUMENT (October 2023) -- The following templates have been replaced by a single Plain Language Consent Template:
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.
Use this template for:
Last Updated October 2023
This document will help you fill out the Plain Language Consent Template. It includes guidance and IRB-required language.
Last Updated October 2023
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
Last Updated May 2022
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
See the SFVAHCS page for more information on these forms.
Ensure your consent document follows these general guidelines:
Use the IRB consent form templates
Consent form templates and corresponding documents are available above. These documents are periodically updated by the IRB, so be sure to always use the currently posted templates when developing a new consent form.
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." See the NCCN Informed Consent Language Database for standardized lay language descriptions of risks and events in clinical research.
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.
Give each consent a unique name in iRIS
When uploading consent forms in iRIS, give each consent document a unique name so the IRB can easily identify the forms (e.g. Control Group Consent, Parental Consent, Optional Specimen Collection Consent, Information Sheet, etc.).
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.
Age of Children
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.
Per UCSF policy, pre-visit COVID-19 screening is required.
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:
Form
Last Updated
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.
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 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?
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:
Federal Requirements for Approving Consent Forms Checklist (Note: UCSF consent form templates incorporate all of the federal requirements.)