| Original language | English |
|---|---|
| Pages (from-to) | 218 |
| Number of pages | 1 |
| Journal | Lab Animal |
| Volume | 52 |
| Issue number | 10 |
| DOIs |
|
| State | Published - Oct 2023 |
Bibliographical note
Funding Information:In the scenario presented, the GEU IACUC holds that responsibility for fidelity between procedures performed and those approved ultimately lies with the Principal Investigator (PI). In contrast, Dr. Felelős, whose surname translates from Hungarian to “responsible,” does not dispute that noncompliance with the approved protocol occurred, but, rather, appears to question the existence of any regulatory basis for this assertion. In this regard, we will assume that PHS Policy, the Guide for the Care and Use of Laboratory Animals, and the USDA Animal Welfare Act Regulations (AWRs) are relevant to Dr. Felelős’ research at GEU. While neither the PHS Policy nor the Guide note a responsibility of the PI for ensuring compliance of activities with approved protocols, the AWRs define a PI as someone who is “…responsible for a proposal to conduct research and for the design and implementation of research involving animals” (§ 1.1) and state that the IACUC may suspend an activity that is not being conducted in accordance with the description of that activity provided by the PI and approved by the Committee (§ 2.31). Of note, if the work under question was funded by PHS, the IACUC should direct Felelős to the NIH Grants Policy Statement which specifically states an expectation that “…the PI agrees to accept responsibility for the scientific conduct of the project…” (2.3.7.6). Many institutions define a responsibility for PIs to ensure compliance for work conducted under their direct and indirect supervision either in a policy or as a condition of protocol approval by the IACUC.
Funding
In the scenario presented, the GEU IACUC holds that responsibility for fidelity between procedures performed and those approved ultimately lies with the Principal Investigator (PI). In contrast, Dr. Felelős, whose surname translates from Hungarian to “responsible,” does not dispute that noncompliance with the approved protocol occurred, but, rather, appears to question the existence of any regulatory basis for this assertion. In this regard, we will assume that PHS Policy, the Guide for the Care and Use of Laboratory Animals, and the USDA Animal Welfare Act Regulations (AWRs) are relevant to Dr. Felelős’ research at GEU. While neither the PHS Policy nor the Guide note a responsibility of the PI for ensuring compliance of activities with approved protocols, the AWRs define a PI as someone who is “…responsible for a proposal to conduct research and for the design and implementation of research involving animals” (§ 1.1) and state that the IACUC may suspend an activity that is not being conducted in accordance with the description of that activity provided by the PI and approved by the Committee (§ 2.31). Of note, if the work under question was funded by PHS, the IACUC should direct Felelős to the NIH Grants Policy Statement which specifically states an expectation that “…the PI agrees to accept responsibility for the scientific conduct of the project…” (2.3.7.6). Many institutions define a responsibility for PIs to ensure compliance for work conducted under their direct and indirect supervision either in a policy or as a condition of protocol approval by the IACUC.
| Funders | Funder number |
|---|---|
| IACUC | |
| National Institutes of Health (NIH) | 2.3.7.6 |
| Presbyterian Historical Society |
ASJC Scopus subject areas
- Animal Science and Zoology
- General Veterinary