HRRB Policies

Standard Operating Procedures (SOPs)

The UCR Policies and Procedures for Human Research Protection (or SOPs) detail the policies and regulations governing research with human participants and the requirements for submitting research proposals for review by the HRRB.

These policies and procedures also detail:

1)    Written procedures which the HRRB must follow for:

a)    conducting its initial and continuing review of research and for reporting its findings and actions to the investigator and the institution;

b)    determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since previous HRRB review; and

c)     ensuring prompt reporting to the HRRB of proposed changes in a research activity, and for ensuring that such changes in approved research, during the period for which HRRB approval has already been given, may not be initiated without HRRB review and approval except when necessary to eliminate apparent immediate hazards to the participant.

2)    Written procedures for ensuring prompt reporting to the HRRB, appropriate Institutional Officials (IOs), and the federal Department or Agency head of any unanticipated problems involving risks to participants or others, or any serious or continuing noncompliance with 45 CFR 46 or the requirements or determinations of the HRRB suspension or termination of HRRB approval.

The policies and procedures present the most current information for reference by potential investigators and their staff. However, this is not a static document.  The policies and procedures are subject to annual review and revision by the Director, the HRRB, and University counsel.  The Director will keep the University research community apprised of new information that may affect the human research protection program, including laws, regulations, policies, procedures, and emerging ethical and scientific issues on this website, through campus electronic mailing lists, and via regular campus-wide seminars.

Click here to view the UCR Policies and Procedures for Protection of Human Participants in Research in PDF format.

UCR Policies

Click here to view UCR policies.

State of California Policies

• Derivation and Use of Human Stem Cells
• Surrogate Consent Law for Persons with Impaired Decisional Capacity
• Research Using Death Records Produced in the State of California

Federal Policies

• Certificates of Confidentiality
• Family Educational Rights and Privacy Act (FERPA)
• Health Insurance Portability and Accountability Act - HIPAA
  • HIPAA Tutorial
• International Compilation of Human Subjects Research Protections (pdf)
• National Bioethics Advisory Commission - Ethical and Policy Issues in Research Involving Human Participants
• NIH Human Subject Protection Guidelines (45 CFR 46)
• NIH Policy on Children in Research
• NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research - October, 2001
• Prisoners as Subjects
• Participants in Behavioral and Social Sciences Research