• Social or behavioral research
• Investigational drugs, biologics or devices
• Medical record reviews
• Human biological specimens
• Emergency setting research
• Vulnerable populations
• Human gene transfer/recombinant DNA
• NIH Genomic Data Sharing (GDS) policy and Genome-Wide Association Studies (GWAS)

Please review the IRB guidance while designing your study to ensure compliance.

Effective, June 15, 2015, UCSF PIs are no longer required to obtain scientific/scholarly review or feasibility analysis prior to submitting a research project to the IRB, unless it is required by the PI's division, department or organization. Upon review, the IRB will determine if the study has adequate scientific merit to comply with the following regulatory criteria for approval of research (45CFR46.111):

• Risks to participants are minimized by using procedures consistent with sound research design and which do not unnecessarily expose participants to risk.
• Risks to participants are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result.

The IRB may still request a scientific review if it is unclear whether a study has adequate scientific merit. In such cases, the PI will be referred to the Clinical and Translational Science Institute (CTSI) CRS Protocol Services at UCSF for scientific review.

Important Note: The IRB strongly recommends that scientific or scholarly review be conducted before greater-than-minimal risk investigator-initiated study without external funding is submitted to the IRB. This review will help assure the quality of the IRB submission and reduce turnaround time for review and approval.

Researchers may also wish to contact the CTSI Consultation Services for questions about study design and implementation, data management, biostatistics and scientific protocol development.

If the PI's division, department or organization require scientific review, below are some options for review:

External funding agency: Some external funding agencies conduct scientific review. A list of Funding Agencies that Conduct Acceptable Scientific Merit Review is on the HUB.

If you wish to add another agency, please send an e-mail to [email protected] and provide the name and address of the agency so that it can contact agency to inquire about its review process. If acceptable, the agency will be added to the list.

Internal scientific review committees: Committees include, but are not limited to the Comprehensive Cancer Center Protocol Review Committee (PRC), the Clinical Research Services (CRS) Advisory Committees, the Immune Tolerance Network (ITN) and the VAMC Clinical Research Subcommittee.

If an existing internal scientific review committee is not available, see below for guidance on establishing an internal scientific review committee.

To submit a new study, click on the Add a New IRB Study link in the IRB Study Assistant tab iRIS. This will take you to the IRB Application.

The Application in iRIS is a smart form that builds and branches based on how you answer key questions. Click Save and Continue to the Next Section to progress through the Application. If you change any text boxes or radio buttons, click Save and Continue through the rest of the sections in case the change alters the branching. Most questions have help bubbles that offer guidance on how to respond.

Anyone with an iRIS account can fill out the IRB Application. However, you must be listed as an investigator, key study personnel or study contact in section 3 in order to access the study in iRIS later. Also, the PI must ultimately submit the new study.

After you complete the last section in the IRB Application, you will automatically enter the Initial Review Submission Packet after you save this section.

The Initial Review Submission Packet “packages” the Application and documents together for submission. If there are any special processing instructions, list them in section 1.8.

As you progress through the packet, you will see the IRB Application form you just filled out in section 2.0. You then will be prompted to attach a) consent documents (if applicable) and b) other study documents. Refer to the Initial Review Submission Checklist for a list of items that should be attached.

If the study involves the San Francisco Veterans Affairs Medical Center, you also will be prompted to attach certain signed VA forms. A copy of the submission will be emailed to the VA R&D Committee, but that review will be done outside of the iRIS system.

PI signoff occurs by following these steps:

a) PI verifies that he/she is eligible to serve as PI in the "Principal Investigator Eligibility Statement" section.

b) Click Approve.

c) Click Save Signoff.

d) Once the PI signs off and submits the study, you may expect the following confirmation notice via email (for expedited/exempt studies):

This email is confirmation that your Expedited/Exempt study was successfully submitted on {Date of Submission}:

IRB# xx-xxx

Study Title

Study Alias

Submissions are screened in the order of receipt.* An analyst will be assigned when your submission is next in the queue. If you do not see an analyst assigned when you click on “Track Location” this means we are working on items received before your submission.

Please review the interactive tutorial iRIS 101: Homepage Orientation & Finding your IRB Forms & Documents for instructions how to track your study and identify the IRB analyst.

The IRB does try to accommodate requests in the Special Processing Instructions area of the Initial Review Submission Packet Form, but this is not always possible.

*If you checked use of CRS services in the Sites section of the Study Application, the submission will be routed to the IRB after completion of CRS review and will be screened in the order of receipt to the IRB.

You may receive a request from the IRB to make changes to your study during the pre-review screening process or after formal IRB review. Review the Responding to Stipulations in iRIS page for help with your response.

To speed new clinical trials to enrollment, you must respond to pre-review corrections for a new full committee review study within 3 weeks. New study submissions will be withdrawn if a response to request for corrections is not received within 21 days. Post-full committee review changes will be due within 45 days. Receiving responses sooner will lead to faster study approvals.

The level of review the study requires determines how the IRB reviews the study (e.g. full committee studies are reviewed at a regular IRB meeting, while expedited and exempt studies are reviewed by 1-3 IRB reviewers outside of a meeting).

IRB sumissions must be complete and review-ready when they are first submitted to the IRB. 

Poorly-prepared submissions negatively impact the review and approval times of well-prepared submissions by diverting significant time and resources to a small fraction of submissions that do not meet our basic standards for review. 

Submissions determined to be Submission Standards Not Met will be retracted by the IRB and returned to the PI in draft form if significant omissions/issues are identified. Reviewed submissions will be processed in order of the date received complete and review-ready.

The most common omissions/issues include:

• Missing scientific protocol (required for all Greater than Minimal Risk studies and studies where UCSF will be reviewing for other sites). Here are resources for building a protocol, including a protocol template: https://hub.ucsf.edu/protocol-development
• Informed consent forms are not on the UCSF IRB Plain Language Template. Note: New studies submitted on or after 11/15/2023 must use the currently posted consent form templates. Please see the UCSF IRB’s Plain Language ICF webpage.
• Informed consent forms have language that removed, added to or altered IRB locked language/Informed consent forms have missing sections, renamed sections or have sections that are out of order
• Informed consent forms were not submitted/Informed consent forms include track changes or comments/Informed consent forms are not Word versions (PDF versions not accepted)
• Major inconsistencies within the IRB Study Application or between the IRB Study Application and study documents
• Incomplete or incorrect responses that result in skipping sections or items in the IRB Study Application
• All relevant risks to participation have not been listed in the IRB Study Application or informed consent form
• Missing important documents (e.g., Investigators Brochure, recruitment materials, non-standard instruments, etc.)

Submissions determined to be Submission Standards Not Met twice will be withdrawn by the IRB. The PI will need to submit a new study application if there is the wish to pursue the research.  Repeated determinations of Submission Standards Not Met will require a Corrective Action Plan discussion with the HRPP Director before any further submissions will be considered. 

Please follow the IRB's preparation tips below. The IRB highly recommends PIs log into iRIS to review submissions in their entirety BEFORE study staff route to them for signoff in iRIS. Once routed for signoff, the submission has to be retracted before any changes can be made.

IRB Study Application

• Provide the requested information in an easy-to-read summary of the study.
• As much as possible, avoid the use of jargon, define acronyms and provide context for uncommon procedures to help the IRB members quickly understand what the research involves and assess risk.
• Use care when sourcing information from the sponsor’s protocol – some protocols are well written and brief while others include too much detail for the IRB review. Most content will need to be edited down.
• Proofread the entire application, checking for clarity, completeness and consistency throughout.
• If you started with a copy of another study, pay careful attention to ensuring that any remnants of the original study have been removed and replaced with details about the new study. Leftover references to procedures and risks from other studies are a common cause for confusion and return by the committee.
• Address any potentially controversial or ethical issues upfront.

Consent Documents

• Write the consent forms in UCSF’s format. Note: New studies submitted on/after 6/1/22 must use the currently posted consent form templates. 
• Use simple 8th-grade-level language. 
• Define all medical and technical terms and acronyms.
• Do not alter the treatment and compensation for injury language (see restrictions on changes).
• Proofread the consent forms carefully. The IRB will no longer ask you to fix typos.

Study Documents

• Use easy-to-interpret document names and categories so reviewers can quickly see what the document is.
• Proofread the attachments and make sure they are consistent with the IRB Application.

Before You Submit

• Review the Initial Review Submission Checklist prior to submitting to make sure the submission includes all the required components.
• Proofread the submission to ensure there aren’t inconsistencies between sections or between the application and attachments.