1. USC Institutional Review Boards
Kristin J. Craun, MPH, CIP
Senior Director USC IRB
RoseAnn Fleming, CIP
Associate Director

2. Why do we have a Human Subjects Protection Program?
HSPP identifies and resolves the potential conflicts that exist when a subject’s participation to benefit mankind place him or her at personal risk or harm
Evaluates regulatory permissibility and scientific value of proposed studies
Determines if a subject’s participation places him/her at personal risk or harm
Establishes an administrative infrastructure to manage, unify, and support these efforts

3. What is Human Subjects Research?
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Human subject*:
Living individual(s) about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
*as defined in 45 part 46 / policy on the protection of human subjects
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4. What is an Institutional Review Board(IRB)?
A committee that:
Reviews and approves Human Subjects Research
Functions as a surrogate human subjects advocate
Is composed of faculty, staff or students of the institution and local community members
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5. USC’s Institutional Review Boards:
USC has:
3 health science IRBs
1 social behavioral IRB

6. IRB Changes
Centralized IRB office reviewing all human subjects research for both University Park and Health Science Campus
New IRB Leadership/Staffing: Undergoing a search for a new IRB Chair for the health Sciences IRB
Industry sponsored studies IRB is accepting sponsor informed consent templates
Increase in number of ceded reviews per NIH single IRB mandate
Streamlining minimal risk/exempt research under our flexibility policy (non-FDA non-Federally funded research)
Improved Communication/Collaboration with USC Clinical Trials Office (CTO)

7. Institutional Review Board (IRB) Submissions
greater than minimal risk; e.g. drug study/domestic violence study
reviewed by a full committee
Full Board
minimal risk; e.g. blood draw / alcoholism
IRB Chair/designee reviews
Expedited
(9 categories)
not greater than minimal risk; e.g. blood pressure / educational tests
IRB Chair /designee/staff reviews
Exempt
(6 categories)
e.g. analyzing discarded tissue
IRB Chair/designee/staff review
Coded Data / Specimens
doesn’t meet federal definition or is coded data
IRB Chair/designee/staff reviews
Not Human Subjects Research
Minimal risk means that 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.

8. What is CITI (Online Human Subjects Education)?
CITI—Collaborative Institutional Training Initiative
Courses Available:
RCR
GCP
COI
CRC
HSR
CITI Helpdesk:
or (213)
CITI FAQs:
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9. What is iStar? iStar (Online IRB application submission system)
Three participating IRBs: (HSIRB, UPIRB, CHLA)
iStar allows single sign on through USC NetID

11. Resources: IRB Wesbite: https://oprs.usc.edu/hsirb/
OPRS/IRB Websites, booklets, videos:
Sample studies, consent templates / information sheets:
Human Subjects Research Booklets:
Obtaining an iStar Account:
RCR Training: