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

RPAC Memo 22-02 PDF

June 22, 2022

This 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, 2021

This 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, 2017

Standard 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, 2020

This 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, 1995

Requirements 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, 2009

Basic HHS Policy for Protection of Human Research Subjects

HTML Link | PDF PDF

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, 1979

The 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.

Multi-Campus Human Subject Research

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.

Contacts

Ruchika Dhussa

Senior Research Policy Manager

Phone: (510) 987-0194

Email

Agnes Balla

Director

Phone: (510) 987-9987

Email