Office for the Protection of Research Subjects

Research

Education & Certification

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For an application to be approved by the USC IRB, all study personnel must complete Human Subjects (HS) research training. Additional training may be required based on study specific factors. The online course used (unless otherwise stated) is provided by the Collaborative Institutional Training Initiative (CITI) at CITI Program. Please refer to the CITI FAQs for more information.

Refer to the Research Training Finder for course requirements by position.

iStar submissions of any type (new, amendment, continuing review) are prohibited when the requisite certificates are due to expire within 30 days. In addition, the IRB will no longer approve submissions when study personnel are not in compliance with the required certification(s).

All human subjects applications (exempt, expedited and full board) require all study personnel listed in section 2.1 to have current human subjects certificates; all studies that meet NIH’s definition of a clinical trial require all study personnel to have current Good Clinical Practice (GCP) certificates and all studies that accessing protected health information (PHI) require all study personnel to have successfully completed USC’s Research HIPAA certification course.  

Applications submitted without the requisite certificates contribute to delays in the IRB process, including approval. Please refer to Chapter 12.3 of our policies for more information.

Required Training

Conflict of Interest Training

  • COI training is required for all USC researchers who propose or conduct research sponsored by the Department of Health and Human Services (NIH, CDC, HRSA). 
  • COI training certificates are valid for four years and can be renewed by completing a refresher course.
  • This requirement can be satisfied by completing the “HHS Conflict of Interest in Research” course in TrojanLearn. 
  • For instructions on how to complete the training, see HHS Required COI Training.

Environmental Health and Safety

  • EH&S safety training courses ensure that all participants are aware of potential hazards in their work area, knowledgeable of safety measures to protect themselves, and compliant with USC policies as well as state and federal regulations. Find out what courses you need to take, and how to register at EHS Training.
  • Review the Training Catalog for more details on the courses EH&S offer.

Export Controls Course

  • The Office of Culture, Ethics and Compliance (OCEC) provides guidance on export rules and regulations and oversight for activities covered by them, including certain types of research.
  • This requirement can be satisfied by completing the “Export Controls” course in TrojanLearn.

Generic Classroom Courses

  • Mandated at the discretion of the instructor, the “generic classroom” courses are sometimes used as an assignment for research methods courses.
  • There are two generic classroom courses: Generic Classroom in Human Subject and Generic Classroom in Responsible Conduct of Research.

Good Clinical Practice (GCP)

  • GCP is mandatory for Principal Investigators (PI)s and study staff working on FDA regulated studies or NIH funded studies that fit the NIH definition of a clinical trial.
  • GCP training certificates are valid for three years and can be renewed by completing a refresher course.
  • GCP course is offered in three versions (devices, drugs, social-behavioral research). 15 modules must be completed with a passing score of 80%.

Human Subjects Research Training

  • Mandatory for Principal Investigators (PI)s and all personnel listed on an IRB application.
  • The human subjects training certificate is valid for three years and can be renewed by completing a refresher course.
  • This course is offered in a social-behavioral version and a biomedical version. Both versions contain 6 modules with a passing score of 80%.

HIPAA Research Training

  • As Good Clinical Practice (GCP) and/or Human Subjects Research Protection Training (HSR) courses expire, researchers will be prompted to complete the Research HIPAA course
  • The Research HIPAA course is available at CITI and does not replace the USC HIPAA Privacy course offered through the Office of Culture, Ethics, and Compliance. The USC HIPAA Privacy course serves to address site specific guidance and issues related to medical records and practices in the USC Keck clinical settings.

Responsible Conduct of Research Training

Training Resources

CER Recordings and Materials
OPRS and IRB collaborates with the Center for Excellence in Research to provide workshops for USC researchers.

Clinical Research Glossary
A glossary list of research words and their meanings.

CTSI Training and Education
CTSI offers educational opportunities to USC faculty, staff, students, and scholars in a variety of formats to accommodate the various research personnel needs (workshops, seminars, webinars, courses, self-study modules). 

 

Office of Research CER Workshops
More training from the Office of Research.

Research Coordinator Training
Clinical Research Coordinator training.

Single IRB (sIRB) Guide
A how-to guide and essential resources for sIRB.

 

Virtual Office Hours
Office hours to assist investigators preparing a protocol for first-time IRB review.