Before beginning an IRB submission, there are some items to consider to determine whether IRB review is needed, and the best timing for submitting your request.
Determine whether activities need IRB review
To determine whether your activities appear to be human subjects research requiring IRB oversight, or to request an official determination of “Not Human Subjects Research,” use the Cayuse Human Ethics Initial Submission. In the Getting Started section, choose the option “I need to know if my activity is considered “Human Subjects Research” and answer the additional questions.
To help determine whether or not study activities involve human subjects, you can also use the OHRP Human Subject Regulations Decision Charts or the NIH Decision Tool.
Student research
Student work
Generally, the IRB definition of “research involving human subjects” does not include student coursework or undergraduate honors theses, unless they are to be made available to the public, used by other investigators, or there is a possibility that the research may lead to a formal presentation or publication.
If an instructor determines that there is a possibility that a student’s proposed research project involves human subjects and may result in a formal presentation or publication, the student should submit the project for IRB review.
When student work involving human subjects does not constitute research, the faculty member(s) who assign or supervise the work are responsible for educating their student(s) to safeguard the well being of the subjects.
External research involving UC Santa Cruz students as subjects
External researchers who are not collaborating with UC Santa Cruz researchers and who plan to conduct research involving UC Santa Cruz students do not need a UCSC IRB review, but are asked to notify the UC Santa Cruz IRB and provide their respective institution’s IRB approval as a courtesy by emailing orca@ucsc.edu.
Funding status
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 reviewers, 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 ready to move forward? Learn about the IRB submission process.