What to Consider Before Completing an IRB Application

An Overview of Submitting Human Subjects Research (HSR)

Review the PowerPoint presentation on submitting HSR.

Things to consider before submitting an Initial Submission (application):

Determine whether activities are HSR

In some cases, an activity that involves human subjects may not meet the federal guidelines for IRB review of HSR. For example, a project such as a quality improvement survey or oral history project may involve human subjects, but is not considered "research." Alternatively, a project may be considered research, but the existing data being analyzed has no subject identifiers or codes linking to subject identifiers and therefore the research may not be considered to involve human subjects. 

To receive an official determination by ORCA, please use the Cayuse Human Ethics Initial Submission. For more information about determining whether your project meets the criteria for HSR, you can also see Does my study involve human subjects? If you’ve used the tools available to determine your study does not meet the criteria for HSR, and you do not need to receive an official determination by ORCA, you do not need to complete an Initial Submission. However, please ensure you review the criteria thoroughly before making this determination as research activities involving human subjects cannot receive  IRB approval or an exempt determination retroactively.

Funding

Many study investigators choose to wait until they hear that a proposal will likely be funded before submitting a Cayuse Human Ethics Initial Submission. This saves time for both the PI and the IRB/ORCA, 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."

Exempt vs. non-exempt research

Certain categories of HSR are low-risk and may meet the criteria for exemption from IRB review. At UCSC, Cayuse Initial Submissions are initially reviewed by ORCA to determine whether a study meets the criteria for exemption. 

You can see a listing of the exemption categories, and what types of research may meet the criteria, see Exemption Categories. However, an Initial Submission must be entered in Cayuse Human Ethics for an official determination in order to conduct HSR under an exemption.

While investigators conducting exempt HSR are exempt from the regulations, they must adhere to the ethical principles in the Belmont Report: Respect for Persons (e.g., informing subjects they are in a UCSC research study, describe what they are being asked to do, provide contact information, and tell them they can choose to participate or not, or refuse to answer any questions), Beneficence (minimize any harms including breach of confidentiality), and Justice (equitable selection of subjects).

Study team members and completing training

The UCSC IRB oversees research conducted by UCSC faculty, staff, and students and will sometimes review on behalf of non-affiliated collaborators. 

All faculty, staff, and students engaged in research activities involving human subjects must complete human subjects research protections training before submitting your Cayuse Human Ethics Initial Submission. Training is also required of investigators whose research is  federally funded, such as NIH sponsored research. 

For human subjects research training, UCSC utilizes modules within the CITI Program. The training addresses a broad range of human subjects issues, from logistical to ethical, and promotes compliance with federal guidelines. The CITI training modules required will vary based on the human subjects research activities being conducted as part of a given study. Upon completion of the appropriate modules, completion reports are automatically available to ORCA. Completing the training in advance will help ensure timely processing of your submission.

More information on CITI training can be found on the Training Requirements webpage.

External research involving UCSC students as subjects

External researchers who are not collaborating with UCSC researchers and who plan to conduct research involving UCSC students are asked to notify the UCSC IRB and provide their respective institution's IRB approval as a courtesy. Please contact orca@ucsc.edu.

Choose and Submit an Application Form (Initial Submission)

Contact the Office of Research Compliance (ORCA) with any questions.