New Study

 

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?

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?

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

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 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.

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 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.

1. Add a New Study in the IRB Study Assistant tab in iRIS

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.

2. Complete 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.

3. Attach consent forms and other study documents in the Initial Review Submission Packet

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.

4. The PI must electronically sign off on the initial submission

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.

5. Respond to pre-review corrections within 3 weeks and post-review corrections within 45 days

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).

Submission Standards and Study Preparation Tips

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.

“Submission Standards Not Met” determinations

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. 

New study preparation tips

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

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.

 

Last updated: December 18, 2024