USC Policies

USC Policies homepage
Policy on Scientific Misconduct (PDF)
Conflict of Interest in Research (PDF)
Guide to Research at USC (PDF)

USC HSPP Policies and Procedures

The HSPP Policies and Procedures provide guidance and information for investigators conducting all types of human subjects research. Please refer to these Policies and Procedures in the prepartion and conduct of all human subjects research.
HSPP Policies and Procedures

Federal Policies and Guidance

FDA
Food and Drug Administration (FDA) Homepage
Food and Drug Administration Regulations - Title 21 Searchable Database
Protection of Human Subjects (FDA Informed Consent) - 21 CFR 50
Financial Disclosure by Clinical Investigators - 21 CFR 54
Institutional Review Boards - 21 CFR 56
Investigational New Drug (IND) Application - 21 CFR 312
Information on Submitting an Investigational New Drug Application for a Biological Product
Information for Sponsor-Investigators Submitting Investigational New Drug Applications
Biological Products: General - 21 CFR 600
Investigational Device Exemptions (IDE) - 21 CFR 812
Clinical Trials and Investigational Device Exemption (application information)
Comprehensive list of Food & Drug Administration Guidance Documents
Exception from Informed Consent Requirements for Emergency Research. (Draft)
Information Sheets
Information for Health Professionals

HIPAA (Privacy Rule)
USC HIPAA Information
USC HIPAA Forms and Instructions
HIPAA Privacy Rule (Office for Civil Rights)
HIPAA Privacy Rule – Information for Researchers (NIH Guidance)

Office for Human Research Protections
Office for Human Research Protections (OHRP)
La Oficina para la Protección de los Seres Humanos en la Investigación (OHRP En Español)
Office for Human Research Protection Policy Guidance by topic
OHRP Compliance Activities: Common Findings and Guidance (7/10/2002) (PDF)
Expedited Categories 45 CFR 46.110, Categories #1-9
Exemption Categories 45 CFR 46.101, Categories (b)(1) thru (b)(6)
Federal Policy for the Protection of Human Rights (45 CFR 46), Subparts A, B, C, & D
The Belmont Report: Ethical Principles and Guidelines for the Human Subjects of Research
Informed Consent Requirements in Emergency Research
Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection (PDF)
The Institutional Review Board Guidebook (IRB Guidebook - revised 1993)
Research with Children

U.S. Department of Education
U.S. Department of Education Protection of Human Subjects in Research Website
Family Educational Rights And Privacy Act (FERPA) 34 C.F.R. Part 99
(Research involving minors in school settings)
Protection of Pupil Rights Amendment (PPRA) 34 CFR Part 98
(Research involving surveys with minors in school settings)
Family Policy Compliance Office

Other Federal Agencies and Guidance
Code of Federal Regulations Index at the General Printing Office
Certificates of Confidentiality
Council for International Organizations for Medical Science
Health Insurance Portability and Accountability Act (HIPAA) Regulations
National Bioethics Advisory Commission (NBAC)
National Bioethics Advisory Commission (NBAC) Reports
National Human Genome Research Institute - Ethical, Legal and Social Implications of Human Genetics Research
National Institutes of Health (NIH)
NIH - Human Subjects Research and IRBs
NIH - Recombinant DNA Advisory Committee (RAC) on Recombinant DNA and Gene Transfer
National Science Foundation (NSF) - Social, Behavioral & Economic Sciences
NSF - Frequently Asked Questions and Vignettes (Interpreting the Common Rule for the Protection of Human Subjects for Behavioral and Social Science Research)
OER Human Subject Web Site: FAQs from Applicants (Office of Extramural Research)
Office of Research Integrity (ORI)
Office of Research Integrity Policies, Regulations and Statutes
U.S. Department of Energy - Protecting Human Subjects Homepage
U.S. Department of Health and Human Services Policies and Guidelines

State Laws Regarding Research

California Health and Safety Code:
Section 24170-24179.5 (Human Experimentation)
Section 24170 (Minimum Stautory Protection for the Citizens)
Section 24185-24187 (Human Cloning)
Section 111515-111545 (Experimental Use of Drugs)
Section 121075-121125 [Acquired Immune Defieciency Syndrome (AIDS)Research Confidenitiality Act]
Section 123445 (Abortion)
Section 124980 (Hereditary Disorders Act)
Section 124320-125300 (Embryo Registry)

California Legislative Information (California Laws Regarding Research with Human Subjects - searchable)

Research Advisory Panel of California (California requires proposed research projects involving certain opioid, stimulant, and hallucinogenic drugs classified as Schedule I and Schedule II controlled substances to be pre-reviewed and authorized by the Research Advisory Panel of California in the Attorney General's Office.)

Welfare and Institution Code 15601 (Elder Abuse and Dependent Adult Civil Protection Act)

California Senate Bill 71 (CA Comprehensive Sexual Health and HIV/AIDS Prevention Education Act)
California Education Code 51513 (Parental Consent for Children to Participate in Research)

California Penal Code:
Penal Code 3500 (Biomedical and Behavioral Research)
Penal Code 3521-3523 (Prisoners Rights as Research Subjects)
Penal Code 1165 (Child Abuse and Neglect Reporting Act)
Penal Code 1160 (Reports of Injuries)

California Institute for Regenerative Medicine (CIRM)

California Code of Regulations, Title 17, Section 2500 (Reporting of Positive Results of Communicable Disease Testing)

International Research

International Research Resources

Responsible Conduct of Research

Above Reproach: Ethical Conduct in Research (Sponsored by the USC Office of Compliance)
Research Ethics Program, University of California, San Diego
Responsible Conduct of Research Education Consortium (RCREC)
NIH Introduction to the Responsible Conduct of Research
ORI Introduction to the Responsible Conduct of Research (PDF)
ORI Website(Office of Research Integrity)
PEERRS (Program for Education and Evaluation in Responsible Research and Scholarship). This program was developed by the University of Michigan Office of the Vice President for Research
RCR and Related Policy Issues
Online Ethics Center for Engineering and Science

Federal Agencies

Food and Drug Administration (FDA)
Office for Human Research Protections (OHRP)
U.S. Department of Health and Human Services
National Institutes of Health
Office of Research Integrity (ORI)
Council for International Organizations for Medical Sciences

Other Laws and Regulations

Laws and Regulations Governing Clinical Research
Regulatory Documentation for IND Studies