Saint Martin’s University Institutional Review Board
IRB background
Saint Martin’s University recognizes, and affirms,
the need for academic freedom in the conduct of research, and the value
of well-designed, responsible activities, which involve human subjects.
At the same time, the University recognizes, and accepts, its
responsibility to assure the protection of any human subjects so
involved. The use of human subjects in research or investigational
activities imposes both ethical and legal responsibilities upon the
institution, the project director, and the investigator(s), for assuring
that the rights and welfare of those subjects are adequately protected.
Saint Martin’s University thus requires that the project director, the
investigator(s) and the institution utilize these policies, and their
associated procedures, to monitor activities to insure that such
protection occurs.
These university policies, with their associated
guidelines, forms, and procedures, have been prepared to help project
directors and investigators meet individual and institutional
obligations with respect to human subjects. They have been developed in
accordance with Federal requirements
(45
CFR 46, and
21 CFR 56), policies of Saint Martin’s University, ethical codes of
the various professional organizations, and the ethical principles
embodied in a respect for the rights and well-being of persons who may
be subjects of research. These basic ethical principles include: respect
for persons (acknowledging autonomy and protecting those with diminished
autonomy); beneficence (doing no harm, or maximizing possible benefits
while minimizing possible harms); and justice (sharing equitably the
burdens and benefits in the population).
Current law places the burden of liability for
negligence and harm directly on the researcher and the institution.
These guidelines are formulated to help protect the University, the
researcher, and in the case of students, the faculty advisor, from
liability through imposition of minimum standards for research and
developed procedures for careful review of projects. Failure to follow
these guidelines may cause individuals to incur personal liability for
negligence and harm. Failure to follow these guidelines may also cause
the University to lose federal funding, prevent individuals from
applying for or receiving federal research funds, and prevent the
University from engaging in research which falls under Federal Food and
Drug Administration rules. In addition, failure to follow these
guidelines will be viewed by the University as violation of university
policies and procedures, which will result in appropriate administrative
action.