New Study | Human Research Protection Program (HRPP)

Before Submitting to the IRB
Preparing for Human Subjects Research
What, When and How to Submit via ReGI
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. Students cannot serve as PI. See the PI eligibility section for more info.
New July 1, 2026: Postdoctoral fellows, clinical fellows, and residents are no longer allowed to serve as PI on new studies. They can continue to serve as PI on studies approved prior to this date. See the Study Personnel page for more information.

3. Have you reviewed IRB guidance about your type of research?

There are special considerations for different types of research projects, such as those that involve:

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

4. Does your research also require review by other committees or groups?

In addition to IRB review, your study may require review or consideration by other committees/groups at UCSF or its affiliated institutions. These requirements vary based on the location and type of research you are conducting. The Research Intake Form (described below) can help identify these requirements.
Research Intake Form (New July 2026): Prior to submitting to the UCSF IRB, you are required to complete a Research Intake Form. This form asks a series of questions about your study and provides a checklist of groups that may need to review or approve your specific study, as well as resources that could support you. The IRB does NOT review the Research Intake Form, but you will be asked to confirm completion by your submission reference number in the IRB Study SmartForm. Learn more here.

The list below shows groups that must approve your study BEFORE the IRB will issue approval (if applicable). Your study also may require review by other groups and/or registration on ClinicalTrials.gov.

It is the PI’s responsibility to understand and obtain all required approvals. Some groups review the study before the IRB, while others will review it concurrently or after IRB approval. Do not start Human Research activities until you have obtained all required institutional approvals, including approvals from departments or divisions that require approval prior to commencing research that involves their resources. Contact each group directly with questions.

Committee Approvals Required BEFORE IRB Approval

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.
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 and Monitoring Committee (PRMC) and/or Cancer Center Site Committee review letter in the Local Site Documents section of the IRB Study Smart Form in ReGI.
San Francisco VA Medical Center Research and Development (R&D) Committee	Study undergoes concurrent review. The initial submission is shared with the R&D Committee via ReGI, but the R&D Committee reviews the study outside of the ReGI system. Include the required VA forms in the VA question in the Local Site Documents section of the IRB Study SmartForm.
Other UCSF Regulatory Committees: Radiation Safety Committee Radioactive Drug Research Committee	Concurrent review is allowed, but the IRB will not grant final approval until the other committee has issued an approval. Attach the approval letter in the Local Site Documents section of the IRB Study Smart Form in ReGI.
UCSF Privacy Office	Please see Preparation for Human Subjects Research guidance.

More info on scientific or scholarly review of human research studies

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.

Division, department or organizational requirements

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.

Establishing an internal scientific review committee

An internal scientific review committee may be established within or among the department(s), division(s), organized research unit(s), or other appropriate groups. The following guidelines provide questions to consider when reviewing for scientific or scholarly merit. Please note that not all questions are relevant for every study and there may be additional questions to ask for any given study. The following are suggestions of what to consider.

Sound Scientific Basis and Rationale: Is the protocol scientifically sound and based on well-established scientific principles? Is there convincing clinical and/or preclinical evidence that the trial will have valuable results? Do preclinical studies demonstrate promising results regarding safety and potential efficacy? Is the technology/ understanding sufficiently advanced to warrant detailed clinical investigation?

Appropriateness of the Proposed Study Design: Are the primary and secondary objectives scientifically sound? Is the study designed to meet the objectives? Has an appropriate study configuration been chosen? Does the protocol distinguish between standard and/or routine care and research? Are patient populations and associated criteria for inclusion/exclusion well defined? Are the sample sizes appropriate? Is the statistical design appropriate? Are the endpoints clearly defined?

Competency of Personnel and Adequacy of Proposed Resources: Does the principal investigator have the appropriate expertise and experience to conduct this study? Does the investigative team bring sufficient expertise to the project? Is there sufficient access to resources (e.g., appropriate personnel, equipment, facilities) for the successful and safe conduct of this study?

The Department or Collegiate Scientific Review Form may be used to document the review, but do not submit it to the IRB.

These guidelines do not address administrative matters (i.e., how many people on a committee, who chairs, how to convey information to the researcher) for the Scientific Review Committee.

👥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 Research Gateway IRB (ReGI)

What to Submit: You must submit your study in Research Gateway IRB (ReGI) as described in the How to Submit a New Study user guide. All studies must complete the IRB Study SmartForm, which is an electronic submission form. In addition, study teams must complete a UCSF IRB Application and attach it to the Study SmartForm.

IRB Application – Word Document (New July 2026): Most study information will now be captured in a Word document IRB Application that you will upload on the first page of the SmartForm. Several versions of the IRB Application are available, each suited to a different type of study. Please review the instructions carefully and use the appropriate version for your study. A help guide is also available for each IRB Application.

Migrated Studies - Some approved studies migrated from ReGI will receive a partially pre-populated IRB Application based on information from the study’s most recently approved ReGI application. See more information about migrated studies here.

Other Attachments: 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.

A scientific protocol is required for (1) Minimal risk studies where UCSF is the sIRB and (2) New greater than minimal risk studies:

There are 2 types of studies that require a scientific protocol:

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 ReGI online system to submit your new study and all subsequent submissions to IRB. Review the How to Submit a New Study user guide.

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.

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)

✅Submission Standards and Study Preparation Tips

Submissions determined to be Submission Standards Not Met will be withdrawn 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.
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 Application or between the IRB Study Application, Study SmartForm, and study documents
Incomplete or incorrect responses that result in skipping sections or items in the IRB Application or IRB SmartForm
All relevant risks to participation have not been listed in the IRB 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.

New study preparation tips

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

IRB 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 7/1/2026 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.