Office of Research and Project Administration

SPONSORED PROGRAMS COMPLIANCE

3. Protection of Research Subjects

Human & Animal Subject Protection

Research involving either human subjects or 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.

The 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 with 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 University 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.

According 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.

The 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 at https://rsrb01.urmc.rochester.edu/rsrb/. The RSRBO is located in Suite 1-250 of the Saunders Research Building, 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 an Assurance of Compliance with the Office for Human Research Protection (OHRP).

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 as 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.

1. The Ethical Principles in Research Program (EPRP) was designed for studies that are low risk ('exempt studies') or that pose no greater than minimal risk. The program consists of an examination based on the definition of human subject research above, and the ethical principles for research outlined in the Belmont Report.

2. The Human 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.

The 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.

Faculty should meet with the Chair of UCAR or a representative as soon as they decide to use animals in research.

All 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 a quiz.