University Park IRB
The University Park Institutional Review Board (UPIRB) at USC is a committee comprised of faculty, staff, students and members of the community. The UPIRB is charged with the responsibility of reviewing and overseeing primarily socio-behavioral research projects submitted by students, faculty, or staff on the University Park Campus. The review process is designed to protect the rights and welfare of human subjects by ensuring equitable subject selection, assuring adequate informed consent, assessing and minimizing risks, and maintaining privacy and confidentiality. The UPIRB reviews all human research protocols in accordance with federal regulation, state law, and university policy.
The University Park IRB usually meets once a month to review research studies that meet the more than minimal risk category. Studies that meet the minimal risk category (expedited review) or are exempt are reviewed by the UPIRB on an ongoing basis. Please refer to the UPIRB Meeting Dates and Deadlines for details.
Frequently Asked Questions:
What is the typical turn around time?
All iStar applications are reviewed in the order received. Review time is dependent upon the number of studies in queue, but is approximately 5-10 working days for expedited or exempt submissions. Full-Board studies are reviewed, per the IRB meeting schedules.
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 as exempt are exempt for the life of the study. However, if there is a change in the research, e.g., procedures, recruitment, consent documents, etc., the investigator must submit an amendment to the Claim of Exemption for review and approval. Even when a study is determined to be exempt, the protection of research subjects and the basic ethical principles of The Belmont Report (Respect for Persons, Beneficence, and Justice) still apply to the 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 use the same iStar application as Full Board studies and are reviewed with the same rigor in ethical standards. Studies that are minimal risk that meet one of the categories for expedited review according to the federal regulations (45 CFR 46.110) will be reviewed by the IRB Chair or by a designated IRB Reviewer rather than being reviewed by the Full Board. 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 Not Human Subjects Research (NHSR)?
Not Human Subjects Research is an activity that does not meet the federal definition of “Human Subjects” or “Research”. A human subject is defined as a “living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or identifiable private information”. Research is defined as a “systematic investigation, including development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”. NHSR activities are not subject to IRB review. For additional information regarding NHSR, refer to these booklets: Is Your Project Human Subjects Research? | Are You Conducting Research Using Human Subjects?.
When does my submission need to go to the Full Board?
Submissions with one or more of the following criteria usually go to the Full Board:
- studies using vulnerable populations;
- studies taking place internationally (particularly those with little or no provisions for protection of human subjects);
- studies where information may be disclosed that could require mandatory legal reporting (e.g., child/elder abuse, drugs, etc.);
- studies involving deception which raise the risk level of the subjects;
- studies where the IRB staff, chair, member, or designee determines to be greater than minimal risk (minimal risk being federally defined as: the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests); and
- clinical procedures involving drugs and devices.
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.
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. Please contact the IRB office immediately for further instruction.