• Per Institutional policy, all human subject research protocols must also undergo review by the principal investigator’s home department.  This review is facilitated through the RSRB Online Submission System and includes a comprehensive review of the scientific merit of the proposal, risk identification and management assessment of investigator qualifications and resources.  Departments/centers may also utilize this review process to assess for department/center-specific items such as study budget, approval of the participation of sub-investigators from other departments/centers, and whether study coordination staff is adequate.

• Several funding agencies have implemented "Just-In-Time (JIT)" IRB review for grants, which means that IRB review and approval are deferred until the investigator is notified that the proposal is within a fundable range. Review the proposal instructions from the funding agency to determine whether JIT is applicable for a particular proposal. If applicable, IRB submission should occur after the investigator receives written notification that the proposal is within the fundable range.  Once IRB approval has been obtained, ORPA must send copies of the IRB approval letter to the funding agency. As a reminder, sponsors that support JIT will often award a project but restrict activity until human subject approval has been received.  This can delay program activities.

• OHSP requires all study team members to successfully complete human subjects 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.  Sponsors may request a copy of this certification letter as proof that research personnel have successfully completed the course.  Administrators may consider instructing staff to forward copies of certification letters to the department administrators or study coordinator for maintenance.

Additional information regarding OHSP policies, submitting proposals and completing the required human subjects training are available on the OHSP website:  http://www.rochester.edu/ohsp.

Animal Subjects

The University Committee on Animal Resources (UCAR) provides an excellent web site that details the institutions procedures and policies that govern animal research use. Animal Subjects are safeguarded by the UR's University Committee on Animal Resources (UCAR) office, which provides a regulatory role for the use of animals in a sponsored research project. A protocol must be submitted to UCAR for animal use in research. After the initial approval is received, a UCAR letter of approval is issued for the animal subjects study.

• Animal Subjects Training: Training should be coordinated with the UCAR and/or Vivarium office. Classes are ½ day in length and must be attended by all laboratory personnel that will work with animals.
  
  
• Just-In-Time (JIT) Approval: Several agencies have implemented JIT for animal subjects reviews for sponsored research projects. Basically, JIT means that PI's can wait until after a proposal is submitted and prior to award issuance to send a protocol to UCAR. Review the funding agency instructions to determine whether JIT is permitted. If the agency does use JIT, the proposal still requires the Vivarium signature, via the UCAR office, on the ORPA signoff page. For proposals with a 'Pending' status, or after JIT approval is received, the administrator should send a copy of the pending status or approval letter to the funding agency. If a sponsor does not use JIT, the UCAR approval letter and the protocol must be included in the application packet to the funding agency. As a reminder, sponsors that do permit JIT at the proposal stage will not fund a project until approval has been received, which can delay award issuance. Also, 'Pending' status on a protocol is not permitted on a continuation proposal application.
  
  
• Animal protocols are reviewed yearly. UCAR sends an Annual Protocol Review to the PI on the anniversary date. Animal protocols must be re-approved every 3 years. UCAR sends a memo to the PI 3 months before the expiration date.

Administration of Research Subjects

The Department or Center Administrator may be responsible to oversee the research coordinator's and PI's compliance with human and animal subjects use. While the PI is responsible for keeping the records of the study, the administrator typically ensures that all research staff is appropriately trained and follow the guidelines for human and animal subjects. The Administrator should keep a copy of each proposal, including all related approvals, communication from central business offices (ORPA, ORACS, Auditing, etc.) and, for research subjects, a roster of training (HSPP numbers). The administrator, research coordinator, or support staff person generally does the initial work to obtain signatures from RSRB and UCAR, on ORPA signoff page. Administrators can assist the PI and his study coordinators with grants preparation by working with the Department's internal review process to track grants in preparation; to help prepare the budgets; to act as a liaison with ORPA, RSRB, UCAR, and OHSP; and to prepare the forms pages to include with the grant. The more familiar an Administrator is with the grants preparation process, the more help he or she will be to the PI in getting the complete grant application submitted to the correct agency in a timely fashion.