To: Investigators and Study Teams

Updated IRB Consent Form Templates:

Implementation Deadline for New Studies is June 1, 2022

The IRB consent and assent form templates have undergone extensive revisions to bring our campus into compliance with new policies and regulations, to reduce the number of stipulations regarding the most common consent form errors, to better inform research participants, and to provide more detailed instructions to study teams. The updated templates are now available at https://irb.ucsf.edu/consent-and-assent-form-templates.

New studies submitted on/after June 1, 2022, are required to follow the new templates (see details on implementation below).

What has Changed?

A thorough summary of the revisions is attached.

Of note, there are two critical changes to ensure compliance with University and State regulations:

1. If a study involves the research collection of tissue derived from clinical specimens requiring pathology review, the consent form must include a specific risk statement per UCSF’s Research Tissue Acquisition Policy. More details on page 3 of the attached summary document.
2. If a study involves HIV testing for research purposes—even if only for eligibility screening— the consent form must state that all HIV positive test results (not just new cases) will be reported to the county health department and will include personally identifiable information on the participant.  More details on page 6 of the attached summary document.

Implementation: Instructions for Studies with Consent Forms/Assent Forms

1. New studies submitted to the IRB between now and May 31^st:

The IRB strongly recommends that all new studies use the new templates but will not withhold approval if old templates are used.

Exception: The ‘Research Tissue Acquisition Policy’ statement and/or the ‘HIV reporting’ statement (mentioned above) must be in the consent form if applicable to the study. The IRB will return the submission with a stipulation for this before approval can be granted.

2. New studies submitted to the IRB on/after June 1^st:

All new studies submitted on or after June 1, 2022, are required to use the new templates. New studies received on/after June 1^st that do not use the new templates will be considered non-compliant with Submission Standards, will be retracted by the IRB, and returned to the PI in draft form.

3. Already approved studies:

Studies that have already been approved do not need to be modified to follow the new templates.

Exception: If the ‘Research Tissue Acquisition Policy’ statement and/or the ‘HIV reporting’ statement (mentioned above) apply to your study, you must submit a minor modification to the IRB to add the statement/s as appropriate. Submit the modification immediately.

Bookmark Tip

The URL for each revised template has changed. If you had any individual templates bookmarked, please update the bookmarks to the new URLs. Each new template is dated May 3, 2022 in the footer.

The following templates have been revised as part of this effort:

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