- Before Submitting to the IRB
- Preparing for Human Subjects Research
- What, When and How to Submit via iRIS
- Minimum Submission Standards and Study Preparation Tips
Before Submitting to the IRB
Prior to submitting to the IRB, answer these questions:
1. Does your research require IRB review?
Confirm that the proposed study is human subjects research and needs IRB review. If your study needs IRB review, consider what level of review it may require — that is, full committee review, expedited review or exempt certification.
2. Are you eligible to serve as PI?
The PI must be a UCSF faculty member who meets the eligibility requirements for PI status on grant applications. Postdoctoral fellows, clinical fellows and residents are allowed to serve as PIs if certain conditions are met. Students cannot serve as PI. See the PI eligibility section for more info.
3. Have you reviewed IRB guidance about your type of research?
4. Does your research also require review by other committees or groups?
Depending on the location and type of your research, your study may require review or consideration by these committees/groups at UCSF or its affiliated institutions in addition to IRB review. This is not an exhaustive list. Your study also may require review by other groups and/or registration on ClinicalTrials.gov.
Some of these groups review the study before the IRB, while others will review it concurrently or after IRB approval. Please familiarize yourself with the group's review requirements, and contact the group directly with questions.
| Committee or Group | Timing of Review |
| Conflict of Interest Advisory Committee | Conflicts must be reviewed and approved before funding can be accepted and the research can begin. |
| CTSI Clinical Research Services (CRS) Advisory Committee | Submission is routed to CRS via iRIS for scientific review before IRB review. Submit some forms directly to CRS. |
| Helen Diller Family Comprehensive Cancer Center Committees | Approval is required prior to final IRB approval for cancer-related protocols. Attach the Cancer Center Protocol Review Committee (PRC) review in the Other Study Documents section in iRIS. |
| Inpatient Care Manager(s) – Letter(s) of Support | Submit a letter of support from the relevant Patient Care Manager or similar inpatient unit nurse manager or chief of service with your IRB Application if the study takes place on an inpatient care unit. Exceptions: Research at CRS (Clinical Research Services) sites, NCRU (Neurosciences Clinical Research Unit), SFGH and SF VAMC. Although not required, a letter may need to be provided if requested by the IRB. |
| San Francisco Department of Public Health (SFDPH) | SFDPH instituted a new process in March 2022. Review this link for more information and contact information for SFDPH questions. SFDPH sites and clinics must involve an SFDPH-approved investigator. |
| San Francisco VA Medical Center Research and Development (R&D) Committee | Study undergoes concurrent review. A copy of the initial submission is emailed to the R&D Committee via iRIS, but the R&D Committee reviews the study outside of the iRIS system. Include the required VA forms in the Other Study Documents section in iRIS. |
| Zuckerberg San Francisco General Hospital and Trauma Center (formerly SFGH) | PI submits directly to the Vice Dean's Office after IRB approval. |
Other UCSF Regulatory Committees: | Concurrent review is allowed, but the IRB will not grant final approval until the other committee has issued an approval. Ideally, provide the relevant approval number on the initial IRB Application. Additional info is available in a help bubble in "Other Approvals and Registration" section of the IRB Application in iRIS. |
| UCSF Privacy Office | Please see Preparation for Human Subjects Research guidance |
Preparing for Human Subjects Research
The HIPAA Privacy Rule’s preparatory research provision (45 CFR 164.512 (i)(1)(ii)) permits UCSF Health to use or disclose protected health information (PHI) to researchers for purposes preparatory to research, such as to design a research study, or to assess the feasibility of a research study, provided that UCSF Health obtains the following representations from the researcher:
- The use or disclosure is sought solely to review PHI as necessary to prepare the research;
- No PHI will be removed from UCSF Health during the review (physically or electronically). Removal of PHI from UCSF Health includes printing, downloading, copying, saving, data scraping, faxing, or other means of controlling or retaining the PHI;
- The PHI for which use or access is sought is necessary for the research purposes.
These attestations are currently captured in the Statement of Responsibility form that UCSF Medical Center, UCSF Campus, and Community Affiliate users must sign before accessing, collecting, using, and/or disclosing UCSF P3-Sensitive and P4-Restricted Data (i.e., PHI, PII, and PII-derived data). To check if you have a Statement on file, click here.
UCSF IRB approval is not required for preparatory research activities. However, because research is generally carved out of the covered entity component at UC, researchers may not contact prospective study participants without first obtaining IRB approval of the research and without an IRB-approved waiver of authorization for recruitment. Researchers may identify prospective participants for the purposes of seeking their authorization to participate in research once it is IRB approved.
What, When and How to Submit via iRIS
What to Submit: You must complete an IRB Application in iRIS, as described below. Also submit and attach all applicable study materials listed on the Initial Submission Checklist, such as consent documents, advertisements, etc. Do not submit the checklist to the IRB.
- Minimal risk studies where UCSF is the Single IRB. Follow your sponsor’s guidelines for creating a protocol. Sponsors like NIH may have specific requirements for protocols. You may also visit the UCSF Hub for more resources.
- New studies that present greater than minimal risk to study participants and do not already have a study-specific scientific protocol from the study sponsor or cooperative group (e.g. industry-sponsored protocols, RO1 grants, investigator-initiated cooperative group protocols, and some funding grants that describe the scope of human subjects work). See the original announcement for more info.
When to Submit: There are submission deadlines for studies that require full committee review. We process expedited review and exempt studies on a rolling basis.
How to Submit: You will use the iRIS online application system to submit your new study and all subsequent submissions to IRB. Read the iRIS FAQs and iRIS Accounts and Access page for more info on the program. Technical assistance also is available by clicking on the Help icon in iRIS or at the iRIS Help website.
IRB submissions 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.