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CONDUCTING IACUC BUSINESS

IN THE EVENT OF A PANDEMIC OR OTHER SIGNIFICANT EXTENDED EMERGENCY

IACUC MISSION RWU’s Institutional Animal Care and Use Committee (IACUC) will continue during disaster situations, natural or human, to oversee and monitor all research projects and laboratory classes utilizing vertebrates with the same integrity and dedication as regulated by OLAW and USDA.

BACKGROUND Institutions must adhere to provisions of the PHS Policy, the Guide, and the commitments detailed in their Animal Welfare Assurance with OLAW. This includes advance planning for conditions that could arise as a result of a disaster situation (e.g. human pandemic such as influenza, hurricanes and other natural disasters) that could jeopardize the health and wellbeing of animals because of a lack of personnel to care for the animals and/or to conduct IACUC official business.

The US Centers for Disease Control and Prevention (CDC) has suggested institutions should plan for absenteeism of ~40% if a contagion such as the H1:N1 influenza virus should reach pandemic status. Regardless of external events, the Office of Laboratory Animal Welfare at NIH (OLAW) expects each institution’s IACUC to continue to conduct business according to requirements found in the PHS Policy, the Animal Welfare Act and Regulations, and the Guide (OLAW 2009).

OLAW DEFINITIONS:

  • Disaster Situation: Any large scale event, including a pandemic, wherein restriction of campus activities is declared and personnel are not on campus for animal care or oversight.
  • Pandemic: An epidemic of infectious disease that is spreading through human populations across a large region; for instance, a continent, or even worldwide. Health professionals may require cessation of routine business practices in such a situation.
  • Social distancing: Focused measures to reduce contact among people to prevent the spread of disease. OLAW Mandated Policies.
  • Animal facilities must be maintained at a level to ensure animal welfare. Plans should consider appropriate staffing levels, cross-training to cover critical operations, and adequate inventories of essential supplies (e.g., feed, personal protective equipment, wet lab supplies).

The IACUC:

  • The IACUC must continue to be properly constituted.
  • A quorum is required to conduct official business at a convened meeting.
  • The IACUC must ensure that protocol approvals are not allowed to expire or if they do expire, that no further animal activities (e.g., data collection) are conducted.
  • Appointment and training of IACUC members (including nonscientific members and alternates) should be considered as a part of the plan. See NOT-OD-01-017.

RWU Plan for Conducting IACUC Business

The RWU IACUC will adopt the PHS policy provisions for social distancing measures to prevent the spread of disease, including:

  • The number of IACUC meetings will be reduced to as few as one every six months, the minimum allowed by the Guide, to conduct program review and facility inspection.
  • The IACUC will institute alternatives to face-to-face meetings such as teleconference or video conferencing (NOT-OD-06-052).
  • The IACUC will implement their use of designated member review (DMR). During an emergency period, the IACUC chair and attending veterinarian will conduct business on behalf of the committee and will decide if full committee review is required using alternative meeting methods such as teleconference or video conferencing (SKYPE).
  • In the event of the incapacitation of the IACUC chair and attending veterinarian, the IACUC alternate vice chair and alternate veterinarian will act on their behalf for DMR. Alternates for the remaining members will also be activated to maintain quorum.
  • The IACUC will follow the IACUC Emergency Animal Care Plan along with the University Emergency Response Plan.

OLAW Reporting Responsibilities

PHS Policy (IV.F.3) describes three rather specific circumstances that require a prompt report to OLAW: “The IACUC, through the Institutional Official, shall promptly provide OLAW with a full explanation of the circumstances and actions taken with respect to: a. any serious or continuing noncompliance with this Policy; b. any serious deviation from the provisions of the Guide; or c. any suspension of an activity by the IACUC1.”

It should be apparent to most that there will likely be significant deficiencies and serious deviations from the Guide after a natural disaster. OLAW has published guidance on what constitutes “significant” and “serious” in the two slightly different contexts of semiannual reporting and prompt reporting5. “The term ‘significant deficiency,’ used in the PHS Policy and the USDA Animal Welfare Regulations, refers to any facility or program deficiency that is or may be a threat to the health or safety of animals. Program or facility deficiencies, including accidents and natural disasters, which cause injury, death, or severe distress to animals, are, by definition, ‘significant’. Although it is not possible to provide an exhaustive listing of examples, some illustrations of significant facility deficiencies include failures in heating, ventilating, and air conditioning systems and their associated electrical systems; inoperative watering systems; and general power failures of sufficient duration to affect critical areas such as isolators, barriers, surgical suites, and intensive care units…. When deficiencies involve serious or continuing noncompliance with the PHS Policy, serious deviations from the [Guide], or the IACUC suspension of any activity, the circumstances and actions taken must be reported promptly to OPRR [now OLAW] as required in section IV.F.3.a–c. of the PHS Policy. Reporting of such deficiencies should not be deferred for inclusion in the institutional annual report5.”

Answers to the question of when to report will vary depending on the circumstances, but OLAW would like to hear from institutions as soon as possible after the acute crisis phase, and before the inevitable inquiries start coming in from other sources. One of those other sources may be the NIH director asking OLAW about how all those NIH-funded animals at (insert name of your institution) are doing. Animal rights activists may take such an opportunity to initiate complaints, as we saw immediately after Tropical Storm Allison. It is extremely important for us to be able to reassure ourselves and other interested parties that we know what is happening and that everything possible is being done to take care of the animals. The most common way for you to report promptly to OLAW is by telephone; however, fax, email, and other forms of communication all qualify as a “prompt report.” Other reasons to call, aside from being a requirement, include the possibility that we can be of assistance; we may have access to resources or contacts that can help your institution deal with the problems.

As institutions begin to emerge from the acute crisis phase, there will undoubtedly be actions that take immediate priority because of the need to mitigate or prevent further losses. Such priorities include relocating animals, saving frozen tissues and samples, and recovering essential computer files and other records. Although this article does not attempt to elaborate on the disaster preparation phase, an institution’s ability to minimize secondary losses will depend substantially on the effectiveness of that preparation. For example, accurate risk assessment and appropriate prevention strategies may keep animals and other critical assets out of harm’s way for certain types of emergencies.

Next is the difficult task of rebuilding. At this stage, OLAW really does need to know more about the institution’s “reasonable and specific plan and schedule1” to get back to a fully compliant state. PHS Policy does allow for certain deficiencies to exist at Assured institutions provided that they have been identified, along with credible correction plans. These plans are often negotiated with OLAW through the prompt and annual reporting processes and become an integral part of the institutional Assurance. Longer-term disaster recovery efforts may be viewed in the same context as correction of other more routine facility or program deficiencies. Though often on a different scale of importance, the semiannual facility inspection and program review process provides a good model for addressing the disaster recovery phase, which should include establishing specific target dates for correction and should monitor progress on an ongoing basis until completion.

Sometimes a recovery plan requires the development of interim plans. While some damaged facilities may not be suitable for their original design function, they may still be satisfactory to support a more limited role. For example, a damaged building HVAC system may not provide adequate ventilation for animal housing at full capacity, yet it may be acceptable for reduced population loads or lower levels of isolation or containment (OLAW 2009).[1]

[1] http://grants.nih.gov/grants/olaw/disaster_planning.htm