In response to the questions posed in this scenario, the Office of Laboratory Animal Welfare (OLAW) and the United States Department of Agriculture, Animal and Plant Health Inspection Service, Animal Care (USDA, APHIS, AC) offer the following clarification and guidance:
This column presents readers with a direct question: “are there any circumstances in which an IACUC Chairperson would be within his or her rights to reject apparently duplicative research before the protocol reached the full committee?” In addition, issues of ethical behavior, conflict of interest and noncompliance are raised by the scenario.
The Public Health Service (PHS) Policy on Humane Care and Use of Laboratory Animals (Policy) and the Animal Welfare Act and Regulations (AWARs) authorize a single direct responsibility to the IACUC Chairperson: to designate at least one member of the committee to conduct designated member review of protocols1,2. The APHIS Animal Care Inspection Guide recognizes the Chairperson as being responsible for all the activities of the IACUC, which include but are not limited to scheduling meetings, setting the meeting agenda, sending a list to members of protocols to be reviewed, moderating meetings, sending required reports to the Institutional Official and ensuring the facility's compliance with the AWARs3; the Chairperson may designate these responsibilities among the committee and IACUC staff. All other functions and responsibilities of the IACUC are for the full committee to consider and take appropriate action and are not for the Chairperson alone to decide.
The PHS Policy and the AWARs require that members not participate in the review or approval of protocols in which there is a conflicting interest1,2. In the scenario, the Chair determined to delay a proposal from IACUC consideration until he could prepare and have approved a similar protocol. This unethical action circumvented the committee's review for the Chairperson's personal advantage and is a conflict of interest that is unbefitting his appointment as Chairperson and IACUC member.
In the case of NIH-funded research, the PHS Policy and NIH Grants Policy Statement require verification of IACUC approval of those components related to the care and use of animals1,4. Federal requirements cannot be met if the protocol is not presented to the IACUC. Therefore, the Chairperson's actions constitute a reportable noncompliance to OLAW. In addition, the PHS Policy states that no PHS support for an activity involving animals will be provided unless the institution assumes responsibility for compliance with the Policy1. As such, compliance is an institutional responsibility. OLAW would expect the institutional leadership to take corrective measures to ensure the integrity and impartiality of the IACUC.
The AWARs are silent on how an institution can determine which research projects it will pursue. Those decisions are typically made at higher levels of the institution.
References
Public Health Service. Policy on Humane Care and Use of Laboratory Animals (US Department of Health and Human Services, Washington, DC, 1986; amended 2002).
Code of Federal Regulations. Title 9, Ch. 1, Part 2, Subpart C. §2.31(d)(2).
United States Department of Agriculture. Consolidated Inspection Guide (United States Department of Agriculture, Riverdale, MD, 2010). http://www.aphis.usda.gov/animal_welfare/2011_Inspection_Guide//9.8.3%20Membership.pdf
US National Institutes of Health. NIH Grants Policy Statement. Part II: Terms and Conditions of NIH Grant Awards. Subpart A. 4.1.1 Animal Welfare Requirements. (US National Institutes of Health, Bethesda, MD, 2012). http://grants.nih.gov/grants/policy/nihgps_2012/nihgps_ch4.htm#animal_welfare_requirements
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Brown, P., Gipson, C. Response to Protocol Review Scenario: A word from OLAW and USDA. Lab Anim 42, 83 (2013). https://doi.org/10.1038/laban.235
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DOI: https://doi.org/10.1038/laban.235
