Introduction to the USC Human Subjects Protection Program

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Introduction to the USC Human Subjects Protection Program

Presentation transcript:

Introduction to the USC Human Subjects Protection Program University Park Institutional Review Board

IRB 2 IRBs Complete application Health Sciences UPC Turn around time Language that can be understood by the reviewer All information necessary for the reviewer to make a risk determination All instruments that will be used for the study Consent/permission/assent documents All necessary additional information (e.g., SOP, CoC). Turn around time iSTAR CITI 2

What is iStar? Online system for submission, tracking and review of IRB applications To request a user account: istar.usc.edu Click on “Obtaining an iStar account” Participating IRBs: HSIRB, UPIRB, CHLA

http://istar.usc.edu Sandbox

What is CITI (Online Human Subjects Education)? CITI—Collaborative Institutional Training Initiative Human Subjects Training Course (+ RCR and GCP) Modules and quizzes on human subjects research ethics, principles, laws and regulations Available 24/7 from any computer Can access course multiple times CITI Helpdesk: citi@usc.edu or 213.821.5272 CITI FAQs: http://oprs.usc.edu/education/citi/

CITI Homepage: www.citiprogram.org

HSR Resources OPRS/IRB Websites, booklets, videos: http://oprs.usc.edu/education/booklets/ Sample studies, consent templates / information sheets: http://oprs.usc.edu/review/forms/ Federal Human Subjects Regulations www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

Who Can I Contact for Help? University Park Campus IRB upirb@usc.edu (213) 821-5272 3720 S. Flower Street Credit Union Building (CUB), #301 Los Angeles, CA 90089 http://oprs.usc.edu/upirb/