A. UNIVERSITY COMMITMENTS
Brandman University is committed to safeguarding the rights and welfare of all people who participate in research conducted by Brandman faculty. It is also committed to insuring humane care and use of animals in teaching and research. Brandman University supports responsible experimentation which promises to increase knowledge and understanding, and encourages the highest ethical standards among Brandman researchers.
In addition to assuring compliance with Department of Health and Human Services (DHHS) regulations 45 CFR 46, as specified in the Office for Protection from Research Risks (OPRR) 1983 report on Protection of Human Subjects, Brandman accepts responsibility for complying with Food and Drug Administration (FDA) regulations (21 CFR 56) and all other applicable state and local laws as they may relate to research covered by the DHHS policy. Categories of research exempted from this policy are those specifically listed in 45 CFR 46.101 (2) (B) 1 through 5 (see BRANDMAN UNIVERSITY INSTITUTIONAL ASSURANCE Section II.f.).
Brandman University also abides by the provisions of the DHHS Guide to the Care and Use of Laboratory Animals and Principles for Use of Animals; the Animal Welfare Act PL 85-544; and the Standards for Accreditation by the American Association for the Accreditation of Laboratory Animal Care (AAALAC).
B. GENERAL AIM OF THE BUIRB
The central aim of the BUIRB is to protect the rights of human participants in research studies, including their rights to give informed consent and to have their safety protected from undue risk.
C. GENERAL CHARGE TO THE BUIRB
The BUIRB has the responsibility and authority to review and approve all research projects by Brandman faculty and students involving human or animal participants. It will approve only experiments that conform to the professional standards as understood within the relevant discipline.
A. Review all new and ongoing projects involving human participants at convened BUIRB meetings with the majority of the Board's membership constituting a quorum; a BUIRB member whose concerns are primarily in non-scientific areas must be included in the quorum. Voting on projects is limited to duly appointed Board members. Excluded from this process are those submissions which are participant to expedited review.
B. Review projects on an annual basis or more frequently as deemed appropriate.
C. Require written notification by investigators when changes in a research activity are proposed.
D. Require prompt reporting by investigators when unanticipated problems involving risks to participants occur.
E. Suspend or terminate approval of research that has been associated with unexpected serious harm to participants or that is not being conducted in accordance with the BUIRB's decisions.
F. Report to the Vice Chancellor of Academic Affairs of the University any suspension or termination of approved research.
G. Require that the informed consent procedure is in accordance with policy.
H. Notify investigators of the results of BUIRB review.
I. Observe or have a third party observe the consent process and the research, when appropriate.
J. Advise and consult with investigators regarding specific problems associated with protocols involving human participants.
K. Distribute campus guidelines to aid principal investigators in the preparation of their application for approval of research involving human and animal participants.
L. Maintain complete records.
M. Interpret government and University policies pertaining to the protection of human and animal research participants.
N. Develop and publish campus policies and procedures governing review of research involving human or animal participants.
O. Provide consultation through its Chair to any participant or principal investigator.
P. Establish procedures for monitoring implementation of BUIRB action.
Q. Maintain communication with Federal, State, and local agencies and institutions to insure that BUIRB procedures are current and consistent.
R. If the research activity is funded in whole or in part by a DHHS grant, contract, or fellowship, report to the Secretary of DHHS on serious or continuing noncompliance by investigators with the requirements and determinations of the BUIRB; suspension or termination of approved research that is not being conducted in accordance with the BUIRB's requirements; or any unexpected serious harm to participants associated with a research project.
S. Coordinate review of research carried out at non-university sites.
T. Through its Chair, report any changes in BUIRB membership to the Vice Chancellor of Academic Affairs of the University
All review of human participant involvement in research activities covered by this policy shall be carried out by the BUIRB following the procedures set forth in this policy. BUIRB members are appointed by the Chancellor of the University and reviewed by the Faculty Executive Committee.
The BUIRB is sufficiently qualified through the experience, expertise, and diversity of its members, including sensitivity to community attitudes, to command respect for its advice and counsel in safeguarding the rights and welfare of research participants.
The BUIRB is composed of at least five members from the University, representing diverse backgrounds and possessing the professional competence necessary to review the specific research activities assigned to it. The BUIRB shall not consist entirely of men or women or entirely of persons in one profession. BUIRB includes at least one member with no formal affiliation with the University. At any time, consultants may be sought, but these persons may not participate by vote in BUIRB actions.
A. Legal assistance. The University Legal Office is available to the BUIRB and investigators for legal consultation and assistance.
B. Liabilities. The University is legally responsible for the acts and omissions of its investigators while acting in the course and scope of their University duties. In the event of a suit against investigators or members of an BUIRB based on their actions in connection with a research activity involving human participants, the University would be obligated to assume their defense if the research project was approved by an BUIRB in accordance with this policy. If a principal investigator has, or should have, knowledge of the applicable University policy requiring that every research activity placing human participants at risk be reviewed by an BUIRB and fails to obtain such approval prior to involvement of human participants, the investigator would be acting outside the scope of his/her duties and the University would not be obligated to defend or indemnify the investigator if legal actions were initiated by a participant.