Introduction to the USC Human Subjects Protection Program

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Presentation transcript:

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

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

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

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.

http://istar.usc.edu

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: citi@usc.edu or 213.821.2074 USC CITI FAQs: http://oprs.usc.edu/education/citi/

CITI Homepage: www.citiprogram.org

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: https://ooc.usc.edu

HIPAA

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? USC IRB Contact Information Email: irb@usc.edu Phone: (323) 442-0114 Address: 1640 Marengo Street 7th Floor Los Angeles, CA 90033-8389 Website: http://oprs.usc.edu/upirb/