What is the duration of the approval period?
- The approval period is three years, pending annual review.
- The PI must submit a brief annual renewal form two months prior to the end of years one and two and a more substantial 3-year renewal form 2 months prior to the end of year three.
What if changes in the approved protocol are proposed?
- All changes in project personnel (addition or deletion) must be reported to the IACUC promptly at all times during the 3-year period using the Personnel Change form.
- All proposed changes to the approved protocol methods (especially changes in species, animal numbers or potentially painful procedures) must be submitted for IACUC review prior to implementation, using the Protocol Amendment form.
What are the key parts of the Animal Care Protocol?
- The use of the species, strains and numbers of animals must be justified scientifically.
- All experiments, endpoints, anesthesia protocols and euthanasia procedures must be described in detail and justified.
- Strategies for the prevention and/or reduction of animal distress, pain and suffering must be described.
How do you define pain and distress?
Pain: perception of noxious stimuli; must rely on subjective human perception of pain.
Distress: unspecified alteration of metabolic, physiological or behavioral parameters. Common indications of distress may include observable behavioral changes, altered reproductive performance, elevation in glucocorticoid levels and elevation of catecholamine levels.
Is information available regarding safety or medical concerns of investigators?
Yes. All researchers are encouraged to request information from the IACUC regarding allergies, potential animal zoonoses (diseases transmissible to humans) and the receipt of prophylactic measures (for example, tetanus and hepatitis immunizations).
Is the IACUC empowered to suspend approved research?
The IACUC is empowered, by federal mandate, to suspend research activities and/or access to the animal research facilities for non-compliance with the approved protocol and/or PHS policies. The IACUC must report major researcher non-compliance to all relevant federal funding agencies.
What about animal welfare concerns?
The IACUC is the designated recipient and responsible party for all complaints regarding animal welfare, from all campus and public sources.
USDA Regulations 9 CFR Part 2, Subpart C, Section 2.31 © (4): (The IACUC) “must review and, if warranted, investigate concerns involving the care and use of animals at the facility resulting from public complaints received and from reports of noncompliance received from laboratory or research facility personnel or employees.”
All issues involving possible instances of misconduct or abuse must be investigated immediately, reviewed by the IACUC and the reported to the VP for Research and, possibly, to the NIH.
Does Rensselaer regularly report animal research activities to federal agencies?
Yes. The IACUC files a report of animal research activities to the Institutional Official (IO) every six months. The IO must file an annual report with the NIH OLAW office and also must file an AWA Assurance statement with the OLAW office every four years.