As part of CalArts’s Mission to expand forms of knowledge and experience in the world, the CalArts Institutional Review Board (IRB) is dedicated to the advancement of student, faculty, and staff research as well as the protection of individuals who participate in such research.
All human subjects research conducted by CalArts students, faculty, or staff, whether conducted inside or outside of the Institute, must be reviewed and approved by the IRB before the study can take place.
What is Human Subjects Research?
Federal regulations define human subjects research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” about “a living individual about whom an investigator conducting research obtains data through intervention or interaction with individuals or identifiable private information” (45 CFR 46.102)
To determine whether your study would qualify as human subjects research, answer the following questions:
- Does the study produce knowledge that will be shared for the benefit of the public (through presentation, publication, performance, or other forms of scholarship)?
- Will the data that informs that knowledge be collected in an organized way (whether in the way the data is collected or in the way the data is analyzed)?
- Is that data collected through intervention or interaction with individuals, or does it involve identifiable information not already readily available to the public?
If you answered yes to all three questions, then your study qualifies as human subjects research and must be approved by the IRB before the study can commence. If you still aren’t sure whether your study qualifies as human subjects research, contact the IRB at IRBemail@example.com.
Submitting a Research Protocol to the IRB
Use the following hyperlinked documents to craft your protocol proposal for submission.
Once complete, submit your proposal and supporting materials to IRBfirstname.lastname@example.org. Depending on the level of review and necessary revisions, the approval process could take anywhere from a week to a month or more.
Once Your Protocol is Approved
Once approved, you may begin conducting your research study with the understanding that you must conduct the study following the procedures described in the approved protocol. If it is necessary to change the study’s procedures, the IRB must be contacted and informed of the necessary amendment to the IRB protocol with an updated protocol document and description of the changes and why they are necessary.
Unanticipated Risks and Adverse Effects
Participants, investigators, or other observers should inform the IRB immediately if any of the following occur:
- Unanticipated risks or adverse effects
- Identifiable data is lost or stolen
- Investigators are deviating from the approved study protocol
The CalArts IRB is required to notify the Office of Human Research Protections in the event of unanticipated risks or injury. Additionally, investigators found to be out of compliance with the approved study protocol may have their study suspended.
If you have any questions or concerns, contact the IRB at IRBemail@example.com or Wenjuan Sang at firstname.lastname@example.org.