Policies and Procedures

Human Subjects Protection Program (HSPP) Policies and Procedures (2017)
contain guidance and information for the preparation and conduct of human subjects research. The policies are periodically revised to keep current with changes to institutional policies, Good Clinical Practices (GCP) as well as federal and state regulations. They are a dynamic resource and may change, so check back often for the latest updates.

As part of the Human Subjects Protection Program (HSPP), OPRS is committed to strengthening USC’s policies governing Human Subjects Research (HSR) and ensuring the policies comply with the Federal Regulations for the protection of human subjects (HHS: OHRP / FDA).

Human Subjects Protection Program (HSPP) Policies and Procedures (2017)

Chapter 1 Human Subjects Protection Program
Chapter 2 Ethics
Chapter 3 Federal Regulations and State Laws
Chapter 4 Federalwide Assurances
Chapter 5 Conflicts of Interest
Chapter 6 USC Institutional Review Boards (IRBs)
Chapter 7 Types of IRB Submissions
Chapter 8 Process of IRB Submissions
Chapter 9 IRB Considerations after Initial Approval
Chapter 10 Informed Consent Requirements
Chapter 11 Privacy, Confidentiality and HIPAA
Chapter 12 Subject Compensation and Recruitment
Chapter 13 Investigator’s Role and Responsibilities
Chapter 14 Vulnerable Subject Populations
Chapter 15 Biomedical Research
Chapter 16 Student Research
Chapter 17 Special Research Topics
Chapter 18 FDA-Regulated Research
Chapter 19 Continuous Quality Improvement (CQI)
Chapter 20 Reportable Events, Noncompliance, Suspensions, and Terminations
Chapter 21 Data Safety Monitoring (DSM)
Chapter 22 Complaints Regarding Human Subjects Research
Summary of Policy Changes (2017)

Additional USC Policies and Memos on Human Subjects Research

Flexibility Policy (visit the Flexibility Coalition webpage)
Part 11 Compliance Statement
Scientific Misconduct Policy
Conflict of Interest in Research Policy
Relationships with Industry Policy
Dornsife Imaging Center Policy on Human Subjects Research

USC Committees with Oversight of Research

Research may be subject to additional policies and/or review from one of these USC Research Committees.