Research Policy Analysis and Coordination
Research involving human subjects
UC is committed to the ethical principles for the protection of human subjects in research set forth in the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and protections provided in 45 CFR Part 46. UC recognizes and accepts responsibility, which it shares with its investigators and other researchers, for determining that research involving human subjects fulfills these ethical principles and protections.
Policies & guidance
University Policy for Protection of Human Subjects in Research Link
November 6, 2020RPAC Memo 22-02 PDF
June 22, 2022This Memo provides information on federal Certificates of Confidentiality and highlights good data management practices in cases where identifiable research information is commingled with other data.
RPAC Memo 21-01 PDF
February 16, 2021This Guidance Memo implements procedures for obtaining surrogate consent to adult subjects’ participation in research relating to the subject’s cognitive impairment, lack of capacity, or serious or life-threatening disease.
RPAC Memo 17-04 PDF
August 1, 2017Standard language in Research Informed Consent Forms for Research in which biospecimens and/or information derived from biospecimens are obtained from research participants: commercial rights and research interests.
RPAC Memo 20-04 PDF
August 6, 2020This Guidance Memo explains when it is appropriate to use the Common Rule’s exempt category 4(iii) given UC’s Hybrid Entity status.
RAO Memo 95-05 PDF
February 15, 1995Requirements for Administration of Agreements with Private Sponsors for Drug and Device Testing Using Human Subjects
Contract and Grant Manual Chapter 18
Protection of Research Subjects
External laws, regulations & policies
45 CFR 46: The Common Rule
Effective July 14, 2009Basic HHS Policy for Protection of Human Research Subjects
California Protection of Human Subjects in Medical Experimentation Act Link
California Health and Safety Code Section 24170-24179.5
The Belmont Report Link
April 18, 1979The purpose of the Belmont Report is to protect participants and subjects in the clinical trials and research studies involving ethics and health care research.
The Nuremberg Code Link
The Nuremberg Code is a set of research ethics principles for human experimentation.
Declaration of Helsinki PDF
Ethical Principles for Medical Research Involving Human Subjects
Institutional Review Boards
Institutional Review Boards
An Institutional Review Board (IRB) is an administrative committee designated to provide ethical and regulatory oversight of research that involves human subjects.
UC IRB Reliance Registry
The UC IRB Reliance Registry is an electronic tool that facilitates communication among the Reviewing and Relying campuses for multisite studies that involve human subject research among the UC campuses.
Multi-Campus Human Subject Research & Reliance Registry
Reliance MOU for IRB Review of Multi-Campus Human Subject Research
The Memorandum of Understanding for IRB Review of Multi-Campus Human Subject Research establishes a reliance agreement among the Human Research Protection Programs (HRPP) at the ten campuses of the University of California, the UC Division of Agriculture Natural Resources (ANR), and the Lawrence Berkeley National Laboratory.
UC IRB Reliance Registry
The UC IRB Reliance Registry is an electronic tool that facilitates communication among the Reviewing and Relying campuses for multisite studies that involve human subject research among the UC campuses.
Contacts
Agnes Balla
DirectorPhone: (510) 987-9987
Dragana Alexander
Research Policy ManagerPhone: (510) 987-9634