Please see the UCSF IRB Initial Review Submission Checklist here.

Yes, please see this link for protocol templates and this link for consent/assent form templates.

After the IRB reviews and approves the consent documents and other study materials (such as advertisements or questionnaires), the investigator is responsible for having these documents translated. Typically, all consent forms, data collection forms, and protocols will need to be translated into the local language. Please confirm local IRB requirements with in-country collaborators.

The investigator is responsible for the cost of translating study materials. These costs may be quite high. Include the costs of written translations, as well as medical interpreter services, on grants and contracts. Industry sponsors often are willing to pay these costs.

Although not required by the UCSF IRB, local IRBs may require translation validation. Some means of validating translations:

• A “certified translation” includes a notarized statement by the translator that he/she understands English and the target language and may list the translator’s credentials. A copy of the certification should be attached to the translation.
• A professional translator “back translates” the consent into English to verify equivalent meaning in the target language.

After translation, submit translated documents to the UCSF IRB for their record. All translated consent forms must be approved by the UCSF IRB. Keep records of all your original documents as well as translated documents.

Per Cancer Center Support Grant (CCSG) Guidelines, it is particularly important for Centers involved in clinical research to establish a mechanism for assuring adequate internal oversight of the conduct of all cancer clinical trials in the institution or institutions that formally comprise the Center. The focus of the Protocol Review and Monitoring System (PRMS) is on scientific merit, priorities and progress of the clinical research in the Center. The PRMS should have the authority to open protocols that meet the scientific merit and scientific priorities of the center and to close protocols that do not demonstrate adequate scientific progress. PRMS responsibilities at this institution are carried out on two separate levels to ensure optimal oversight of progress and performance. There is initial review by the applicable Site Committee(s), followed by independent review by the Protocol Review Committee (PRC). The purpose of this policy is to document the full review processes undertaken by the Protocol Review Committee.

The NCI requires that each Cancer Center maintain a Protocol Review and Monitoring System (PRMS) to assess scientific merit and feasibility of all protocols studying subjects diagnosed with, or at risk for, cancer conducted at the Center, and to monitor for accrual and scientific relevance.  NCI looks for centralized oversight across the entire Center; the Protocol Review Committee (PRC) serves as the centralized portion of this requirement (as opposed to the Site Committees).

Studies exempt from PRC review (see PRMS Protocol Review Committee Review Policy for definitions) can also be exempt from Site Committee review at the committee’s discretion, although individual site committees may choose to review such studies.

Likewise, studies allowed expedited review at PRC (see PRMS Protocol Review Committee Review Policy for definitions) may also receive an expedited review at the Site Committee, although the Chair or Co-Chair has the option to require full committee review whenever warranted. Expedited review consists of the Chair or Co-Chair assigning one reviewer to complete the Expedited Reviewer’s Comments form, and the Chair or Co-Chair completes the Chair or Co-Chair Summary of Review form; the review does not need to be presented/discussed at a full committee meeting (unless the Chair or Co-Chair feels that committee discussion is warranted) but is nonetheless prioritized (meaning the study undergoing review is reflected in both the Competing Trials list and the Protocols in Development list). All other protocols must undergo full committee review and prioritization as in New Protocol Review below; there is no Chair-only review format for new protocols.

The NCI requires that each Cancer Center have a Protocol Review and Monitoring System (PRMS) to assess scientific merit and feasibility of all protocols studying subjects diagnosed with, or at risk for, cancer conducted at the Center and to monitor for accrual and scientific relevance; NCI looks for centralized oversight across the Center.

While the centralized oversight is provided by the Protocol Review Committee (PRC), the Helen Diller Family Comprehensive Cancer Center provides for additional disease-specific input via the various Site Committees.  These Site Committees are charged with the contextual review, feasibility assessment and prioritization of each new concept and protocol as it relates to the patient populations and research focus of each Site Committee.  They consider relevant clinical programs, programmatic goals, expertise, and research interests in assessing both concepts and protocols.  A protocol cannot move forward for review by the Protocol Review Committee (PRC) unless it has full approval from at least one Site Committee.

All studies reviewed by a Site Committee will be subject to:

• prioritization in relation to all other studies reviewed by the committee
• identifying competing protocols
• setting and justifying the accrual goals for each protocol
• monthly safety review (weekly for phase I, early phase, or other high-risk clinical trials)
• required review of all protocol amendments
• annual review for accrual
• possible closure for poor accrual

To apply:

1. Identify the patient population relevant to your protocol
2. View the list of committees and select the committee that best matches your patient population (if your protocol attempts to alleviate a symptom of cancer as opposed to the cancer itself, use the Supportive Care site committee )
3. Contact the administrator for that committee.  They will provide information on what is needed for submission as well as potential review dates.

Please contact us at [email protected] if you are planning on conducting global cancer research and we can direct you to the appropriate resources.

UCSF departments (not including “UCSF affiliated institutions”) pay the UCSF IRB fees through the recharge process for UCSF faculty, staff, and trainees’ studies. 

Mexico

If you are affiliated in a government institution, the review of your protocol by your IRB is usually provided for free but will vary by institution. Reach out to the institution for more information.

Tanzania

There are associated costs with MUHAS IRB ethical clearance, NIMR clearance, COSTECH processing and clearance fees, renewal, and amendment. Please contact [email protected] for  updated fee schedules.

*Of note, you may apply for NIMR and COSTECH concurrently.

Individual investigators will be charged after IRB review has occurred, whether or not the study is finally funded.

• Internal UCSF investigators will be charged through a journal recharge.
• External investigators will be charged through an invoice sent directly to the institution.

Important Note: For both UCSF-affiliated institutions and non-affiliated institutions or organizations, Maria Velasco at 415-502-2180, HRPP Business Analyst, bills the institutions directly, not the individual PIs.

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R​ead more details on the different levels of review here.

Yes. It is always better to be on the safe side and submit to the IRB, even if you plan to use the data for research purposes in the future. 

Exempt research involves human subjects, and although it is exempt from the federal policy, you must submit the study to the IRB.  The IRB will review the application and certify that the study qualifies for the exemption. You will receive an exempt certification letter, not a letter of approval.

Please note UCSF does not allow for reliances on our exempt certification.