Where is your office located?
What are your office hours?
When is your next UPIRB Meeting submission deadline?
What is the difference between Expedited and Exempt?
What is the typical turn around time?
When does my submission need to go to the Full Board?
What do I do if my study has expired? Can I continue collecting data?
What if I just found out if I am suppose to have IRB approval before starting research and I already started?
If you don't see a question here that you think should be here or want to ask the University Park IRB, send the question to: upirb@usc.edu and we'll respond to you and post it on the website if it is a general FAQ. Thank you!
Where is your office located?
UPIRB contact info.
What are your office hours?
Monday-Friday (except University Holidays)
8:30 a.m. - 4:30 p.m.
When is your next UPIRB Meeting submission deadline?
Refer to the UPIRB Meeting Schedule for the latest schedule on meeting submission deadlines. The IRB will review studies that are more than minimal risk at the full board meeting. Studies that qualify for exempt or expedited (no risk or minimal risk) are accepted and reviewed by the staff on an ongoing basis.
What is the difference between Expedited and Exempt?
Studies that qualify for a Claim of Exemption that fall within one of the designated categories as determined by the federal regulations (45 CFR 46.101 (b)) may be submitted to the IRB to concur with the investigator's claim. It is the IRB's policy that studies that are approved for exempt are exempt for the life of the study unless there is a change in the research, e.g., procedures, recruitment, consent documents, etc., in which case, the investigator must submit an amendment to the Claim of Exemption for review and approval. Studies that are considered exempt do not mean that the protection of research subjects does not apply nor do the basic ethical principles of The Belmont Report (Respect for Persons, Beneficence, and Justice) apply to the exempt research.
The IRB reserves the right to adjust the determination based upon the research procedures, the potential risks to human subjects, and other determining factors that may affect the research subjects. Studies that qualify for an expedited review follow the same procedure in submitting an application to the IRB for review. Studies that are minimal risk that meet one of the categories for expedited review according to the federal regulations (45 CFR 46.110, 46.118, or 46.119) will be reviewed by the IRB Chair or one of the IRB Reviewers. These studies along with the studies that are reviewed and approved by the Full Board have an approval period of approximately 365 days (note that according to federal regulations, "An IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year, and shall have authority to observe or have a third party observe the consent process and the research." - 45 CFR 46.109 (e)).
What is the typical turn around time?
Generally, the studies are reviewed in the order that they are received. An investigator can expect to receive some notification (either approval, request for additional information, or submission return if incomplete) via e-mail or through the iStar system within 7-10 working days, this is dependant upon the number of studies submitted prior to yours and how complicated they are.
When does my submission need to go to the Full Board?
Studies that are more than minimal risk are reviewed by the Full Board. Studies such as those involving children, prisoners, or other vulnerable subject populations in which the research procedures are beyond the probability and magnitude of harm or discomfort anticipated in the research that are greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
What do I do if my study has expired? Can I continue collecting data?
Stop collecting data and stop enrolling subjects. Submit a Continuing Review Application via iStar. Investigators may only continue the previously approved research procedures according to the approved protocol if by discontinuing the research procedures it puts the subjects in potential harm or discomfort, generally those who are receiving medical or psychological treatments. The new iStar system will send out reminders electronically.
What if I just found out if I am suppose to have IRB approval before starting research and I already started?
Stop all research activities. Submit an IRB application immediately to the IRB. New applications must be submitted via the iStar System. All data collected prior to IRB approval must be destroyed. If you are a student investigator, work with your faculty sponsor to complete the application, include all the required documents needed in order to conduct research with human subjects, and ensure that there is open communication in the IRB application process through to the completion of the research study (dissertation defense, publication, etc.).