INTRODUCTION

About the Handbook

This Handbook is intended to be an instructive guide for faculty and campus researchers. It has been designed to inform Berkeley campus faculty members (and other campus researchers) about key "research compliance" regulations mandated by the federal government and by the State of California that require oversight by the campus and additional activities on the part of the researcher.

Included in the Handbook are the following areas:

• Research Using Human Subjects
• Research Using Animal Subjects
• Financial Conflict of Interest in Research
• Research Laboratory Safety
• Research Misconduct
• Research and Security Issues in the Post-9/11 Environment

Research Compliance at Berkeley

The conduct of research at the University of California, Berkeley is governed by the rules and policies promulgated by several jurisdictions, the federal and state governments, the UC Office of the President, the Academic Senates of both the University of California system and the Berkeley campus, as well as the administration of UC Berkeley.

The Office of the Vice Chancellor for Research is responsible for the coordination of research oversight activities for the campus. Included in that authority is the assurance to federal and state regulators that the appropriate infrastructure is in place at Berkeley to safeguard the research enterprise.

The Vice Chancellor for Research has direct responsibility for assuring the humane use of animals in research, the safety of human subjects in research, the management of financial conflicts of interest that arise in research-related activities, and the management of misconduct in science. In addition, the Vice Chancellor shares oversight with Environment, Health & Safety for safety in research laboratories on the Berkeley campus.

Faculty Oversight Committees
http://research.chance.berkeley.edu/main.cfm?id=9

As mandated by federal and state regulations, faculty oversight committees have been established for the review of research-related activities. These committees are charged with the review of the appropriateness of the work to be done by means of a research protocol. All oversight committees are composed of a faculty chair and faculty-voting members. Administrative personnel dedicated to the work of the committee staff the committees.

The Research Protocol

The "research protocol" is a formal design for research involving human subjects or research animals that an investigator submits to an Institutional Review Board (IRB) or an Institutional Animal Care and Use Committee (IACUC) for review. A protocol generally has an objective, rationale, design, eligibility requirements, treatment regimen, and a description of research and data analysis methods. Protocols must conform to stringent federal regulations.

Use of University Facilities
APM-020,:Regulation 4, Special Services to Individuals and Organizations: http://www.ucop.edu/acadadv/acadpers/apm/apm-020.pdf

Regulation 4 states that "Research for the benefit of Federal, State, industrial or other projects is to be undertaken only under conditions approved in advance by the President [of the University]. …University laboratories, bureaus and facilities are not to be used for tests, studies or investigations of a purely commercial character…" It is incumbent upon every faculty member engaged in research on the Berkeley campus to be familiar with this regulation.