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

RAO Memo 95-05 PDF

February 15, 1995

Requirements for Administration of Agreements with Private Sponsors for Drug and Device Testing Using Human Subjects

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 17-05 PDF

Effective January 1, 2003

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.

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

Related resources

Reliance Memorandum of Understanding

The Reliance Memorandum of Understanding allows an Institutional Review Board at any of the UC campuses to rely upon the review and approval, or determination of exemption, of human subject research by an IRB at another of the UC campuses.

Reliance Memorandum of Understanding | MOU Implementation Procedures

AAHRP Link

Association for the Accreditation of Human Research Protection Programs

Contacts

Agnes Balla

Research Policy Analyst

Phone: (510) 987-9987

Email

Dragana Nikolajevic

Research Policy Manager

Phone: (510) 987-9634

Email