Sponsored Program 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.

Human Subjects in Research

The daily administration of the University’s Human Research Protection Program (HRPP) is overseen by the Office for Human Subject Protection (OHSP).  The OHSP is comprised of three divisions: 

• The Research Subjects Review Board (RSRB) is responsible for reviewing research that is conducted or supported by employees or agents of the University to ensure that the rights and welfare of the human subjects are adequately protected.  OHSP utilizes an external institutional review board for certain studies, however, these still require RSRB administrative review.
• The Research Education & Training Division is responsible for assisting researchers in protecting the rights, welfare and safety of human subjects by providing programs and educational resources in research ethics and human subject safety, with an emphasis on the proper conduct of research.
• The Quality Improvement Division is responsible for the ongoing evaluation of the effectiveness of the HRPP by promoting Institutional and investigator compliance with human subject protection regulations and requirements.

Per the University’s Federal wide Assurance with the Department of Health and Human Service (DHHS), the University will apply the basic federal protections set forth in 45 CFR 46, Subpart A, to all human subject research, conducted or supported by employees or agents of the University of Rochester, regardless of sponsorship.  As such, all research projects involving human subjects must be reviewed and approved by an Institutional Review Board (IRB) prior to initiation. OHSP policies and guidelines for conducting human subject research and submitting proposals are available on the OHSP website.

IRB submissions are facilitated by an online submission and tracking system called CLICK® IRB.  All submissions are filtered through a departmental review process prior to submission to the RSRB.  The purpose of this review is to evaluate the scientific merit of the proposal, complete a risk identification and management assessment and to assess investigator qualifications and resources.  Additional institutional ancillary committee review is also facilitated through CLICK® IRB.  If an Investigator is eligible to use a central or a single IRB for the review of a UR research study, an abbreviated application must be submitted through CLICK® IRB for institutional review.

Consistent with the University's policy to apply ethical standards to all studies, regardless of funding source, individuals involved with human subjects research are required to successfully complete training through an on-line program, called the Collaborative Institutional Training Initiative (CITI Program), prior to conducting any human subject research.  Research personnel, regardless of role, must complete training commensurate with the risk level associated with the type of research conducted (e.g., minimal risk, greater than minimal risk biomedical or greater than minimal risk behavioral).  Once complete, the OHSP Division of Research Education & Training provides study team members a certification letter.  It is the responsibility of research personnel to maintain this documentation.  Recertification is required every 3 years. 

Additional information regarding OHSP policies, submitting proposals and completing the required human subjects training, is available on the OHSP website.

Laboratory Animals

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.

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.