Introduction

Dominican University of California has established the Institutional Review Board for Protection of Human Participants (IRBPHP) with the mandate to protect the rights and welfare of human participants recruited to participate in research conducted under the authority of Dominican University of California.

As an institution using human beings as research participants, Dominican is required to provide an assurance to the Federal government that includes a statement of principles governing the institution in the discharge of its responsibility for protecting the rights and welfare of human participants or research conducted at, or sponsored by the institution, whether the research is participant to Federal regulation or not (45 CFR 46.103.b.1).

In 1991, the U.S. Department of Health and Human Services issued a set of revised regulations known as the Common Rule that constitute the core regulatory structure for research that involves human participants. The Institutional Review Board for the Protection of Human Participants of Dominican University of California complies with the Common Rule.

The IRBPHP was developed in accordance with the federal policy, Title 34, Code of Federal Regulations, Part 97, Protection of Human Participants http://www2.ed.gov/policy/fund/reg/humansub/part97.html, and Title 45 Public Welfare, Department of Health and Human Services National Institutes of Health, Office for Protection from Research risks, Part 46, Protection of Human Participants (Revised 1/15/2009) http://www.hhs.gov/ohrp/humansubjects/guidance/. Additionally material from the federal government’s Office of Protection from Research Risks (OPRR) 1993 publication, “Protecting Human Participants: Institutional Review Board Guidebook,” http://www.hhs.gov/ohrp/archive/irb/irb_guidebook.htm was used as well as the American Association of University Professor’s publication, “Protecting Human Beings: Institutional Review Boards and Social Science Research (May, 2000) http://www.cddc.vt.edu/aoir/ethics/public/IRBSS.pdf

California’s legislature enacted several laws that set legal requirements requiring the addition of an Experimental Participants Bill of Rights when students or faculty are conducting medical research (California Health and Safety Code Section 24173(a) http://oag.ca.gov/sites/all/files/agweb/pdfs/research/safety_24173.pdf

These documents are to be cited when appropriate in the text below. Some of the material in Dominican’s original IRBPHP Handbook was modeled with permission after the University of San Francisco Institutional Review Board for the Protection of Human Participants Manual.