What to Consider Before Completing an IRB Application

An Overview of Submitting Human Subjects

Review the attached PowerPoint presentation on Submitting Human Subjects

Is your project being funded?

Many Investigators choose to wait until they hear that a project will likely be funded before submitting an IRB protocol. This saves time for both the PI and the IRB, since many grant applications do not get funded the first time. Most grant applications will allow you to indicate that human subjects review is "pending" or "in process." 

Are you a member of UCSC faculty or staff, or a UCSC student, or will you be working with members of the UCSC community?

The UCSC IRB oversees research conducted by, or pertaining to, the groups listed above. If you do not fall into one of these groups, you may need to pursue IRB review elsewhere. 

Does your project involve human subjects research (as defined by federal guidelines)?

In some cases, a research project that involves human subjects may not meet the federal guidelines for IRB review of human subjects research.  For example, a project such as a quality improvement survey or oral history documentary may involve human subjects, but is not considered "research." Alternatively, a project may be considered research, but the data has been de-identified and therefore the research does not involve human subjects. For more information about determining whether your project meets the criteria for human subjects research, see Am I conducting human subjects research? You may also contact the Office of Research Compliance (ORCA) with questions.

If your project does not meet the criteria for human subjects research, you do not need to complete an application. However, please review the criteria thoroughly before making this determination as the IRB cannot retroactively approve research.

If your project involves human subjects research, could it be exempt from IRB review?

Certain categories of human subjects research are considered such low-risk that they may be exempt from IRB review.  For example, projects involving educational research, interviews, surveys, or public observation may be exempt.  The UCSC IRB will need to review your exemption request to determine whether your study meets the criteria for exemption. Once an exemption request is approved, the approval is valid for the duration of the described research without having to be renewed. 

For more information about what types of research may receive an exemption, see Exemption Categories.

Will you need to complete training prior to submitting your protocol

If you are a UCSC undergraduate or graduate student, you will need to complete the CITI human subjects research training (starting 1/1/2015) before submitting your full protocol or exemption request. Training is also required of faculty researchers for some federally funded research, such as NIH sponsored research. The CITI training only needs to be completed once and your completion report will be automatically submitted to ORCA for processing. The training will help you better understand and address a broad range of human subjects issues, from logistical to ethical, and promotes compliance with federal guidelines. Completing the training in advance will help ensure timely processing of your submission.

For more information on training requirements, see When is IRB training required?

How do you submit an application?

Once you’ve determined whether you need to complete an exemption request or a full protocol, see attachments below to download the correct form. 

If you are a student, before you start filling out the protocol form, work closely with your faculty sponsor or advisor to finalize your research plan. Be prepared to describe

  • your plan to contact and recruit participants;
  • your selection criteria; 
  • your research hypothesis;
  • exactly what you will ask participants to do, including materials and methodologies that will be used (interview or survey questions, focus groups, recruitment scripts, etc.);
  • how you will collect and protect data; and
  • your timeline - when do you want to start (your earliest start date would  be “upon approval”) and when will the research be complete. 

Please send your completed exemption request, full protocol, or any questions to ORCASupplemental materials should be included with the submission, preferably as one PDF document.

What happens once I submit my application? How long does it take to get an approval?

Once ORCA has received your application, you will receive an acknowledgment email including your assigned protocol number. The time it takes to approve an application depends on several factors such as the completeness of your application materials, whether you have addressed all the required elements, the complexity of your project, and the subjects you intend to work with (e.g. inclusion of vulnerable participants). Before making a decision, ORCA may contact you with a request for clarification or modification. In this event, the approval process will resume once you have addressed the requestWe recommend that you allow 4-6 weeks to receive an approval, although the processing time is sometimes much shorter.