RSRB, WIRB and UCAR
Research involving either human subjects of laboratory
animals is regulated by Government agencies and by UR
policy. UR extends regulatory requirements in this regard
to ANY research activity, regardless of the source of
funding for the activity.
HUMAN SUBJECTS IN RESEARCH
University of Rochester, by action of the President and
Board of Trustees, has established a system of institutional
review boards to review research. These boards, each
the title of Research Subjects Review Board (RSRB), are
supported by a staff office (RSRBO). In addition to the
four RSRBs that the University operates on-site, The
also uses one contract board (Western Institutional Review
Board [WIRB]) to review certain industry supported research.
The RSRBO is located within the Office for Human Subject
Protection, which is part of the Office of the Provost.
The boards review all human
subject research that is conducted or supported by the
UR to determine that the rights and welfare of the volunteers
are adequately protected.
to federal regulations, 'human subject' means a
living individual about whom an investigator (whether
professional or student) conducting research obtains
(1) data through intervention or interaction with
the individual, or (2) identifiable private information.
is Human Subject Research?
University of Rochester Research Subjects Review Board
(RSRB) has instituted an online system for reviewing
research projects. The goal of the online system is to
help streamline the process of submitting and tracking
research applications. You can submit applications online
The RSRBO is located on the first floor of the Medical
Center (1-6124) and the telephone number is (585) 275-2398.
The University's review boards are guided by the ethical
principles described in the 'Belmont
Report' and by the regulations of the U.S.
Food and Drug Administration (21
CFR 50 and 56) and the U.S. Department of Health
and Human Services (45
CFR 46). The University of Rochester maintains
of Compliance with the Office for Human Research
Consistent with the University's policy to apply ethical
standards to all studies, regardless of funding source,
persons involved with human subjects research are required
to take a training program and pass an examination before
acting a an investigator, co-investigator, sub-investigator
or study coordinator. Also, any other person obtaining
research consent from human subjects must successfully
complete the training.
There are two training programs, which are based upon
the risk level of the studies conducted.
Subjects Protection Program (HSPP) is for greater
than minimal risk studies. This is a self-study program
consisting of a manual and an examination. The manual
was developed by UR faculty and staff and reviewed by
an external (national) advisory committee. The advisory
committee included government regulators, renowned clinical
researchers (biomedical and behavioral) and bioethicists.
UR has one Institutional Animal Care and Use Committee
(University Committee on Animal Resources [UCAR]) charged
with reviewing all research protocols involving laboratory
animals. No research involving the use of vertebrate
animals can proceed without the approval of this Committee.
should meet with the Chair of UCAR or a representative
as soon as they decide to use animals in research.
faculty, staff, and students must attend the Animal
Resource Orientation. This orientation is offered
twice a month, and you may not work with animals until
you are certified by attending this session and passing