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Introduction to the USC Human Subjects Protection Program

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1 Introduction to the USC Human Subjects Protection Program
University of Southern California Institutional Review Board

2 IRB 2 IRBs Complete application Health Sciences/Biomedical
University Park/Social Behavioral Complete application Language that can be understood by the reviewer/layperson All information necessary for the reviewer to make a risk determination All instruments used for the study Consent/permission/assent documents Recruitment Materials All necessary additional information (e.g., Grant Application with budget detail, SOPs). Turn around time iStar CITI 2

3 What is iStar? Online system for submission, tracking and review of IRB applications To generate a user account: istar.usc.edu Click on “Login with USC NetID” Participating IRBs: HSIRB, UP/SBIRB, CHLA

4 Registering for an iStar account
To register simply use the Login with USC Net ID function. You must have USC Shibboleth/Duo function. Otherwise you must register for an iStar account and once your USC NetID is activated, you should contact the iStar helpdesk to link your NetID to your account.

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6 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 Both must be renewed every three years USC CITI Helpdesk: or USC CITI FAQs:

7 CITI Homepage: www.citiprogram.org

8 HIPAA If you are accessing Protected Health Information (PHI) for your study, you are required to complete USC’s HIPAA Privacy Education Program Currently, this is a one-time course requirement All certificates are auto-populated into iStar the evening after completion. If your certificate is not auto-populated, contact the USC CITI Helpdesk. Office of Compliance website:

9 HIPAA

10 HSR Resources OPRS/IRB Websites, booklets, videos:
Sample studies, consent templates / information sheets: Federal Human Subjects Regulations

11 Who Can I Contact for Help?
USC IRB Contact Information Phone: (323) Address: 1640 Marengo Street 7th Floor Los Angeles, CA Website:


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