pilipili����

CONDUCTING IACUC BUSINESS

IN THE EVENT OF A PANDEMIC OR OTHER SIGNIFICANT EXTENDED EMERGENCY

IACUC MISSION pilipili����’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 .

pilipili���� Plan for Conducting IACUC Business

The pilipili���� 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 ().
• 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 ().

EMERGENCY ANIMAL CARE PROCEDURES IN THE EVENT OF A PANDEMIC OR OTHER SIGNIFICANT EXTENDED EMERGENCY

IACUC MISSION: pilipili����’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. 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).

pilipili���� Plan for Emergency Animal Care

The pilipili���� IACUC will adopt the PHS policy provisions for animal care measures in the event of an emergency or pandemic situation including:

• Implement an IACUC communication call chain
• Close animal facilities to outside tours
• Require cross training of personnel to maintain adequate staffing
• Require PIs to provide the IACUC with an emergency care plan for their protocol listing

1. Location
2. Necessary personnel
3. Required feeding
4. Power requirements
5. Aeration
6. Water quality
7. Priority of euthanasia and preferred method

• Provide PIs access to required IACUC forms for changes in protocols, personnel
• Begin facility inspection and review protocols upon clearance from pilipili���� campus safety
• Provide reports to Provost regarding animal care status and required OLAW/USDA reporting as listed below

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 ().

Institutional Officer

Becky Spritz, PhD (she/her/hers)
Associate Provost for Academic Affairs, Professor of Management
bspritz@rwu.edu
(401) 254-3664
Administration Building 218

IACUC Chairperson

Victoria Heimer-McGinn, PhD
Assistant Professor of Psychology
vheimer-mcginn@rwu.edu
College of Arts & Sciences
CAS 119

Veterinarian

Galit Sharon, DVM, PhD, CertAqV
Fish Medicine Specialist
Associate Professor of Biology & Director, Aquatic Diagnostic Laboratory
gsharon@rwu.edu
(401) 254-3299
MNS 245

Affiliated Scientists 

Cat Conley
Associate Director of Environmental Health and Safety
cconley@rwu.edu
(401)- 254-3781
North Office Building

Andrew Rhyne
Professor of Biology
arhyne@rwu.edu
(401) 254-5750
Marine & Natural Science Bldg
MNS 233

Koty Sharp
Director, Center for Economic and Environmental Development
ksharp@rwu.edu
(401) 254-3170
Marine & Natural Science Bldg
MNS 221

David Taylor
Professor of Biology
dtaylor@rwu.edu
(401) 254-3759
Marine & Natural Science Bldg
MNS 240

Brian Wysor
Professor of Biology
bwysor@rwu.edu
(401) 254-3014
Marine & Natural Sciences Bldg
MNS 230

Affiliated Non-Scientist

Robert McCarthy
Associate Director Research and Sponsored Programs
(401) 254-3552
rmccarthy@rwu.edu
Administration Building, 127

Community Members

Peter Escherich

George Johnson

A. Mission Statement

pilipili���� recognizes the scientific and ethical responsibility for the humane care and use of animals involved in research and education and requires all individuals involved to maintain the highest standards of animal care and consideration. This concern extends to investigators to protect the animals as well as to comply with the specific regulations established and required by the sponsors of their research, University policies and/or Federal regulations.

B. Ethical Issues

The welfare of animals in education and research, carries with it significant obligations. Hence, each staff member, student, faculty member, or research investigator is directly responsible to promote and protect animal care and use within the instructional and research program of the University.

pilipili���� is guided by the ethical principles set forth by the National Institutes of Health (NIH) Policy that requires the appointment of an Institutional Animal Care and Use Committee (IACUC). In accordance with this federal policy, this committee shall oversee protocols relating to the care and use of animals for research and teaching purposes at pilipili����.

C. Federal Regulations

The procurement, care, and use of the animals shall conform to the NIH Guide of the Care and Use of Laboratory Animals in Research (DHEW 78-23), reprinted in 1980 (DHEW 80-23 or succeeding editions) and shall be in accordance with the regulations established under the terms of the Animal Welfare Act, all applicable state and local laws, and the National Academy of Science’s Guide for the Care and Use of Laboratory Animals. The housing, care, feeding, and daily observations of all animals must be supervised by individuals knowledgeable in such matters.

The "US Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training" were developed by the US Government’s interagency research animal committee. Both the NIH Policy and the University Policy require that all uses of animals conform to these principles:

1. The transportation, care and use of animals should be in accordance with the Animal Welfare Act (7 U.S.C.2131 et. seq.) and other applicable federal laws, guidelines, and policies.
2. Procedures involving animals should be designed and performed with due consideration of their relevance to human or animal health, the advancement of knowledge, or the good of society.
3. The animals selected for a procedure should be of an appropriate species and quality and the minimum number required to obtain valid results.
4. The use of animals should be planned and conducted so as to avoid unnecessary discomfort, distress, and pain to any animal. Unless the contrary is established, investigators should consider that procedures that cause pain or distress in human beings may cause pain or distress in other animals.
5. Procedures with animals that may cause more than momentary or slight pain or distress should be performed with appropriate sedation, analgesia, or anesthesia. Surgical or other painful procedures should not be performed on unanesthetized animals.
6. Animals that would otherwise suffer severe or chronic pain or distress that cannot be relieved should be painlessly killed at the end of the procedure, or, if appropriate, during the procedure.
7. The living conditions of animals should be appropriate for their species and contribute to their health and comfort. Normally the housing, feeding, and care of all animals used for biomedical purposes must be directed by a veterinarian or other scientist trained and experienced in the proper care, handling, and use of the species being maintained or studied. In any case, veterinary care shall be provided as indicated.
8. Investigators and other personnel shall be appropriately qualified and experienced in conducting procedures on living animals. Adequate arrangements shall be made for inservice training, including the proper and humane care and use of laboratory animals.
9. Where exceptions are required in relation to the provisions of the Principles, the decisions should not rest with the investigators directly concerned, but should be made with due regard by an appropriate review group, such as an institutional animal research committee. Such exceptions should not be made solely for the purposes of teaching or demonstration.
10. Procedures involving field observations on marine mammals require a General Authorization for Scientific Research issued by NOAA for Level B harassment, as per the Marine Mammal Protection Act of 1972.

D. General Policies and Procedures

Using animals for research, teaching, and testing is accompanied by both ethical and legal responsibilities to use them appropriately, both scientifically and humanely. Individual faculty members who use animals in their research or teaching, including those whose research consists of field work involving animals, are, by law, accountable for conforming to the basic regulations and policies governing animal use on campus. Policy decisions at pilipili���� have been made to address research with limited groups of vertebrates (fish, amphibians and marine mammals). Policies may be modified when and if additional groups of animals are used at the institution. These regulations and policies involve:

1. the acquisition, care, and use of animals
2. efforts to minimize animal pain and distress
3. the training of personnel who use animals
4. consideration of alternatives to animal use
5. methods whereby deficiencies in animal care and treatment are reported

Individuals who use animals must know, understand, and comply with applicable laws, regulations, and policies. They are responsible for properly instructing students and employees. The laws governing the use of animals are framed to ensure compliance via both civil and criminal laws. Failure to comply may carry penalties that range from substantial fines to “cease and desist” orders that can suspend all animal research, and all funding for animal research at the offending institution. As a matter of educational policy, faculty who do not themselves use animals must be aware of these regulations and policies, since their students may use animals at a later time. All faculty, staff and students preparing to submit a protocol to the IACUC committee must first complete the online training course at www.citiprogram.org

Any faculty member, staff member, or student who believes that any of the above mentioned principles are being violated may submit a written request to the pilipili���� IACUC for a review of the procedure or situation. The Committee shall review all pertinent facts regarding the alleged violation, and if a violation has occurred, the Committee will recommend corrective action to the responsible individuals, including the appropriate Department Coordinator, Dean of the College, and Chief Academic Officer (Provost).

E. Adjunct Faculty Research

All adjunct faculty research must be co-sponsored by the Dean of the College, where the research will be conducted. Research project proposals must then be submitted to pilipili���� IACUC for review and approval.

F. Research at Other Institutions

If a collaborative research project to be conducted at pilipili���� with live vertebrate animals has been reviewed and approved by another College or University, the research proposal and the signed cover sheet from the said Institution must be submitted to the pilipili���� IACUC for review and approval.

New Protocol Applications

• Research Only Form
• Appendix: Additional Species
• Appendix: Additional Drugs
• Appendix: Additional Personnel
• Research or teaching use
• Observation use only
• Animal products use

Change Protocol Applications

• Change an approved protocol
• Change personnel on an approved protocol

Reporting & Ordering Forms

• Adverse event report form
• Semi-annual review form
• Annual report form
• Project closure form
• Vertebrate ordering form