Research Policy Analysis and Coordination
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.
- Agnes Balla: Agnes.Balla@ucop.edu or (510) 987-9987
- Dragana Nikolajevic: Dragana.Nikolajevic@ucop.edu or (510) 987-9634
Requirements for Administration of Agreements with Private Sponsors for Drug and Device Testing Using Human Subjects
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.
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.
Protection of Research Subjects
45 CFR 46: The Common RuleEffective July 14, 2009
Basic HHS Policy for Protection of Human Research Subjects
California Health and Safety Code Section 24170-24179.5
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 is a set of research ethics principles for human experimentation.
Ethical Principles for Medical Research Involving Human Subjects
An Institutional Review Board (IRB) is an administrative committee designated to provide ethical and regulatory oversight of research that involves human subjects.