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

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

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 2 slides

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 Find a different picture- something that shows diversity, or this one is fine. Funny picture after

USC’s Institutional Review Boards: USC has: 3 health science IRBs 1 social behavioral IRB

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)

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.

What is CITI (Online Human Subjects Education)? CITI—Collaborative Institutional Training Initiative Courses Available: RCR GCP COI CRC HSR CITI Helpdesk: citi@usc.edu or (213) 821-2074 CITI FAQs: http://oprs.usc.edu/education/citi/ graphic

What is iStar? iStar (Online IRB application submission system) Three participating IRBs: (HSIRB, UPIRB, CHLA) iStar allows single sign on through USC NetID

http://istar.usc.edu

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