Administrative Responsibilities/Issues:

Human Subjects

The Research Subjects Review Board (RSRB) provides an excellent web site that details the institution's procedures and policies that govern the use of research subjects. The web site can be accessed at http://www.urmc.rochester.edu/rsrb.

The use of human subjects in research requires approval of protocols and consent/assent forms by an Institutional Review Board (IRB), either the UR's Research Subjects Review Board (RSRB) or the Western Institutional Review Board (WIRB). The RSRB reviews all minimal risk studies, studies that are Principal Investigator (PI) initiated, foundation-funded studies, and all federally-funded studies. The WIRB reviews all industry-sponsored, greater-than-minimal-risk studies. After the protocol and informed consent form are reviewed and approved, the IRB issues a letter of approval to the Principal Investigator.

Many departments/centers utilize an internal process to ensure comprehensive scientific review and approval of protocols, budget review and approval, approval by Division/Department Chairs regarding participation of subinvestigators from other divisions/departments, approval of use of a particular study population, and determination of qualifications/adequacy of coordinator staff. There is then a departmental sign-off before a protocol can be submitted to a review board. If this process is used in your department, it is important to communicate information to the RSRB staff regarding authorized departmental signatories who are empowered to certify scientific review, so that review boards do not accept protocols for review without departmental sanction.

Several funding agencies have implemented the "Just-In-Time (JIT)" human subjects reviews for grants, which means that the principal investigator may wait until after a proposal has been submitted but prior to award issuance to submit a protocol, informed consent and other applicable materials to the IRB for review and approval. Review the proposal instructions from the funding agency to determine whether JIT is applicable for that particular sponsor and proposal. If so, after the approval is received from the IRB, the administrator or ORPA then sends the signed approval to the funding agency. If the funding agency does not use JIT, the IRB approval/pending letter and any other sponsor- required, IRB-related materials must be included in the proposal application to the agency. As a reminder, sponsors that do permit JIT at the proposal stage will often award a project but restrict its use until human subject approval has been received, which can delay program activities. If the PI is submitting a progress report, the face page must have a date: it cannot be pending human subjects review.

• Education in Human Subjects Research: RSRB provides NIH-required, general education in the protection of human subjects, concluding with an open-book exam. The test must be completed by anyone who is involved in the consent process, or whose role is specified in the protocol (key personnel). When in doubt, have the person complete the Human Subjects Protection Program (HSPP) test rather than the Ethical Principles in Research Program (EPRP) test, so that all personnel will be qualified for greater than minimal risk studies. Call the RSRB Office at X3-4127 for a copy of the book and test or access the RSRB web site for additional information at http://www.urmc.rochester.edu/rsrb.

  Although the RSRB instructions indicate that the test should be returned to the Office for Human Subjects Protection (OHSP), it is suggested to instruct staff to return the completed test to the departmental administrator or research coordinator. The test should be sent to OHSP with a note to request that that administrator be copied on the approval letter, which states that the test has been passed, and includes the assignment number. Sponsors may ask for a copy of the actual letter as proof that research personnel have taken the course/test and have satisfactorily passed the examination. The HSPP or EPRP Number must be included on the face page of the RSRB application form, for all key personnel, and later in the document, for anyone else involved in the consent process.
  

• Coordinator/PI Training: RSRB offers a workshop geared to Coordinators and PI's to inform them of their responsibilities regarding human subjects. Issues of personal and UR liability are covered in this training.
  
  
• All human subjects studies must be reviewed by an IRB to determine the level of risk as well as liability issues. RSRB may determine that some studies are exempt from review. Nevertheless, all protocols with anything involving human subjects must be submitted, even surveys and prior data or tissue studies.
  
  
• Minimum Risk: A study is considered of minimal risk when the subjects would encounter risks no greater than they would in everyday situations (e.g. interviews) and usually qualifies for expedited review by the IRB. All project personnel must be trained to work with human subjects before approval to begin the study will be given.
  
  
• Investigator-initiated studies, minimum risk sponsored studies, foundation-funded studies, and all federally-funded studies are reviewed by UR's RSRB office. Industry-initiated studies: Industry-initiated protocols are reviewed by the Western Institutional Review Board (WIRB) in Olympia, Washington.
  
  

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. The web site can be accessed at http://www.urmc.rochester.edu/ucar.

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.