Rule 3341-7-08 | Protection of vertebrate animals.
(A) Policy statement and purpose
(1) Statement of institutional authority
Bowling Green state university (BGSU) requires that all research, research training, experimentation, biological testing, and related activities, hereinafter referred to as research activities, involving live vertebrate animals conducted at BGSU, or at another institution as a consequence of a subgrant or subcontract or supported activity by BGSU, be reviewed and approved by the institutional animal care and use committee (IACUC) prior to the initiation of the research project. The IACUC is under the authority of the vice president for research and economic development.
(2) Purpose of the IACUC
The purpose of the IACUC is to assure that researchers care for and use animals in ways judged to be scientifically and humanely appropriate. To this end, the IACUC reviews and oversees research with live vertebrate animals to ensure that the research complies with the BGSU PHS assurance, applicable provisions of the Animal Welfare Act, as well as other applicable statutes, laws and regulations pertaining to animal care and use.
(3) Governing principles
The IACUC is guided by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training" and will maintain a program for activities involving animals in accordance with the "Guide for the Care and Use of Laboratory Animals."
(B) Policy
(1) IACUC jursidiction and authority
The IACUC has the authority to review research activities with vertebrate animals when:
(a) The research activities will be conducted by BGSU faculty, staff, or students.
(b) The research activities are under the direction of a BGSU faculty or staff member.
(c) BGSU is the awardee institution (i.e., received an award through a grant, contract, or cooperative agreement), but all activities with live vertebrate animals will be carried out by employees or agents of another institution.
The IACUC has the authority to approve, require modifications, or withhold approval of activities related to the care and use of animals. The IACUC has the authority to suspend an activity involving animals that is not being conducted in accordance with applicable provisions of the Animal Welfare Act, the "Guide," the PHS assurance, or the IACUC approved protocol.
(2) Review by institution
Research covered by this policy may be subject to additional review and approval or disapproval by officials of BGSU. However, those officials may not approve research with animals if it has not been approved by the IACUC.
Inappropriate attempts to influence the IACUC process, individual IACUC members, the office of research compliance staff, or the university animal facility staff will be reported to the vice president for research and economic development. The vice president for research and economic development will investigate and appropriately respond to these concerns, and has the authority to limit or remove an Investigator's privilege to conduct research.
(3) Funded research
If research with animals is being internally or externally funded, the protocol must be reviewed and approved by the IACUC prior to expenditure of any grant funds. The funded grant proposal must substantially correspond to the IACUC approved protocol.
(4) Use of procedures
The IACUC must maintain and follow written procedures consistent with federal regulations.
(5) Inter-institutional collaboration
In instances where BGSU is collaborating with another institution, and both the awardee institution and the performance site have full PHS assurances, duplicate IACUC review is not required. Based on NIH notice NOT-OD-01-017, documentation of review and any significant issues related to the research activity raised during a semiannual program inspection will be maintained by both committees.
(6) Responsible office
The office of research compliance is responsible for the oversight and implementation of this policy.
(7) Implementation of policy
| WHO | TASK |
| IACUC chairperson, research compliance officer | Ensure compliance with BGSU PHS assurance, applicable provisions of the Animal Welfare Act, as well as other applicable statutes, laws and regulations pertaining to animal care and use. Report to the vice president for research and economic development any inappropriate attempts to influence the IACUC process. |
| Vice president for research and economic development | Investigate and act on reports of inappropriate attempts to influence the IACUC process. Evaluate on an on-going basis the animal care and use program for adherence and compliance with federal, state, and local policy and regulation. Evaluate (at least yearly) the IACUC workload in regard to timely and thorough review. |
(8) Related university policies
(a) Policy on misconduct in research
(b) "Bowling Green State University Animal Welfare Assurance: Assurance Number: A3536-01"
(9) Related government policies and guidance
(a) USDA. Animal Welfare Act as amended. 7 USC, 2131-2156.
(b) "Animal and Animal Products." Title 9. C.F.R.
(c) "Public Health Service Policy on Human Care and Use of Laboratory Animals." Washington, DC: US department of health and human services.
(d) Guide for the care and use of laboratory animals, eighth edition. National research council. Washington (DC): national academies press; 2011.
(e) "U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training". Published in the Fed. Reg., May 20, 1985, vol. 50, no. 97, by the office of science and technology policy.
Date: March 23, 2015
Supplemental Information
Amplifies: 3345