Carol Alderson and Nelson L. Garnett, DVM
When dealing with recovery from a disaster, NIH-funded animal research institutions have certain responsibilities to OLAW and OPERA. The authors outline these responsibilities and identify areas in which these offices can aid the affected institution in the recovery effort.
In the past year, National Institutes of Health (NIH) grantees
have confronted both a tropical storm and a terrorist attack. In
Houston, TX, investigators from the University of Texas Health
Science Center at Houston and Baylor College of Medicine suffered
enormous research losses—including more than 35,000 research animals
and thousands of tumor samples from a 20-year breast cancer
project—as a result of flooding caused by Tropical Storm Allison. In
New York City, the National Development and Research Institute, Inc.
(NDRI), a nonprofit research and educational organization that was
located in Tower 2 of the World Trade Center, lost years’ worth of
data stored on computers as a consequence of the September 11
terrorist attacks. Out of these tragic and unforeseen events, NIH
extramural staff members have learned valuable lessons regarding
methods by which research institutions could prepare for disasters
and possibly thus lessen their impact.
When disaster—whether natural or otherwise—strikes an animal
research facility, the highest priority must be saving human and
animal lives. Nevertheless, once the acute stage of the disaster has
ended, institutions receiving support from the NIH, and, therefore
subject to NIH grants policy and the Public Health Service Policy on
Humane Care and Use of Laboratory Animals1 (PHS Policy),
have certain responsibilities to two related components of the NIH,
Office of Extramural Research (NIH/OER). These are the Office of
Laboratory Animal Welfare (OLAW) and the Office of Policy for
Extramural Research Administration (OPERA).
Drawing mainly on experiences related to the aftermath of
Tropical Storm Allison, we will address institutional
responsibilities to OLAW and OPERA, as well as provide insights
regarding the help that these two offices can provide to affected
institutions. The OLAW section addresses the issues of communicating
information important to the oversight of laboratory animal welfare
such as reporting the extent of losses and damage to the program of
animal care and use and the institution’s plan for recovery to its
former fully compliant condition. The OPERA section deals with those
NIH grants policy issues relevant to disaster recovery and serves to
assist institutions with the rapid return to productivity in their
NIH-supported biomedical research programs. We will not attempt to
cover in detail the preparedness aspect of the overall disaster
plan.
OLAW Federal Regulations and Policy
Amazingly, there is nothing in the PHS Policy and only one
paragraph in the Guide for the Care and Use of Laboratory
Animals2 (Guide) that even addresses disasters. The Guide
recommends “a disaster plan, as part of an overall safety plan, that
takes into account both personnel and animals,” and states that the
veterinarian or manager should be on the safety committee and an
“official responder,” but provides no additional guidance.
In May 1997, OLAW, Case Western Reserve University, and the Ohio
Scientific Education and Research Association (OSERA) cosponsored a
meeting in Cleveland entitled, “Development of Institutional
Disaster Plans.” Based on this meeting, many institutions started
thinking about being proactive on the subject of disaster planning
and response. In his account of experiences during Hurricane Hugo at
the Medical University of South Carolina in Charleston, Michael
Swindle, DVM, Professor and Chairman in the Department of
Comparative Medicine at the Medical University of South Carolina,
stated: “Experience with hurricanes, which are the only disaster
for which you have significant warning, has taught us that disasters
do not follow SOPs [standard operating procedures]. During the
emergency the outcome will be determined by the ability of the
leadership on site at the time of the disaster to respond and make
decisions spontaneously. Disaster relief agencies will not be
available during the disaster and its immediate aftermath. SOPs are
more useful for the long-term recovery period. Their greatest
usefulness is that they indicate that you have thought about
disasters and not as a document that can be relied upon to be
followed faithfully during a disaster3.”
More information is available in a chapter on emergency
preparedness in the second edition of the ARENA/OLAW IACUC
Guidebook4. In addition, plans are underway at OLAW to
support the development of additional resources for the laboratory
animal community addressing this topic.
When and Why to Contact OLAW
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.
The Long Road to Recovery
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 comes 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.
Get By with a Little Help from your Friends
Another interim plan might involve seeking assistance from
resources outside the institution. For example, in the aftermath of
Tropical Storm Allison, we witnessed excellent cooperative
arrangements between two neighboring institutions. The University of
Texas M.D. Anderson Cancer Center agreed to share some of its
valuable animal housing, research space, and equipment with the
University of Texas Health Sciences Center at Houston to allow vital
research to continue. OLAW was pleased to facilitate that
arrangement by approving the interinstitutional agreements and
appropriate modifications to the respective Assurances.
OPERA Know Who Is in Charge
It may be helpful to look at NIH grantee responsibilities before
the declaration of a disaster. These responsibilities begin when an
organization submits a grant application to the NIH. The face page
of the Public Health Service Grant (PHS 398) application includes a
signature block for the authorized organizational official. This is
the official that your organization has authorized to act for the
applicant, and to assume the obligations imposed by the encompassing
federal requirements that apply to grant applications and grant
awards. The official’s signature on the grant application further
certifies that the organization will be accountable for both the
appropriate use of funds and the grant-supported activities
described in the application. In signing a grant application, this
official certifies that your organization will comply with all
applicable assurances and certifications referenced in your
application.
Protect Your Research Assets
If your grant application is successful and the NIH issues your
institution an award, what are your responsibilities associated with
receiving NIH research funds? OMB Circular A-110 (ref. 6) and
Department of Health and Human Services (HHS) regulations at 45 CFR
74 (ref. 7) require recipients of NIH grants and cooperative
agreements to, at a minimum, provide insurance coverage for
equipment acquired with federal funds equivalent to that provided
for equipment owned by the recipient. Also, A-110 and 45 CFR 74
require effective control over and accountability for all funds,
property, and other assets, to provide adequate security for all
such assets and to assure that they are used solely for authorized
purposes. While you may read these requirements as typically
applying to financial management systems and procedures, these same
safeguards apply to the additional systems that support ongoing
research.
What are the best measures for safeguarding your institution’s
research assets? An examination of some basic institutional systems
would be instructive. For example, many institutions locate
emergency power generators in the basement, which is the first area
to suffer damages in a flood. A sensible safeguard would be to have
an emergency generator located somewhere other than the basement of
a building, and to assure that all generators receive regular
fueling. Do you know what is in your research freezer? Prepare an
inventory of the contents of your freezers and valuable research
supplies, maintain the inventory regularly, and store a copy of the
inventory in an alternate location. Another vulnerable area consists
of research data that are stored on one computer without appropriate
backup. There have been unfortunate incidents in which years’ worth
of research data were stored on a single computer without backup,
and then lost in a disaster. Data should be backed up to a secure
network or removable media such as zip disks, CD-ROMs, or an
external hard drive, and stored in a different location. And
remember that both computers and backup systems must always meet the
appropriate level of security that is required for the data
involved.
While, fortunately, NDRI did not lose staff in the attack of
September 11, some investigators lost years’ worth of data that were
stored on their computers. However, one investigator had a method to
protect her data. She backed up her computer and ran a virus scan as
a part of her daily routine. She then transported her backup media
or “shuttle disk” to her home, where she transferred the information
to her home computer. And once a week she backed up her home
computer to a CD that she keeps in a locker at her gymnasium. She
had a plan to protect the contents of her computer and, before last
September, her routine may have appeared excessive. Yet her plan
undoubtedly served her well in this situation.
Take an inventory and determine what components of your research
projects are irreplaceable. Next, determine the means by which you
can protect them. Involve your institutional official. Learn how
your institution’s facilities and information technology (IT)
officials have prepared for a disaster. With this information, you
can prepare a disaster plan for your research.
There’s a Problem—Now What?
The process of assessing research losses can begin only after the
event has passed and your safety can be assured. Once your
organization has begun to estimate losses, it is very important that
you contact the appropriate scientific program officials and grants
management specialists at NIH, usually by an email or a fax message,
to notify them of potential delays, possible research setbacks, or
relocations of research. We suggest also sending a copy of this
notification to your organizational official.
The unforeseen nature of these disasters inevitably leads to a
significant administrative burden to account for and document the
event’s impact. Your organization will be expected to meet the
ongoing responsibilities that are associated with receiving NIH
awards as well as completing the necessary work to document the
losses associated with the event. Institutions that were severely
affected by Tropical Storm Allison retained consultants to advise
and assist them with the myriad of issues.
What Can NIH Do?
The NIH realizes that these events may cause problems for
investigators who are planning to submit competing and noncompeting
grant applications for upcoming receipt dates. The NIH will
typically announce in the NIH “Guide for Grants and Contracts” (NIH
Guide) that late applications from affected institutions will be
accepted by NIH8. The NIH Guide is available directly from the
Office of Extramural Research (OER) website (https://grants.nih.gov/grants/oer.htm).
While the NIH does not have legislative authority to provide
disaster relief for biomedical research organizations, it can
support the ongoing projects that were affected by the event. The
NIH can consider requests for administrative supplements for these
projects. These requests can include extensions in time that involve
personnel costs, as well as replacement of equipment, supplies, and
unique resources damaged or lost as a result of the storm. The
application should state that the requested support does not
represent a duplication of benefits, for example, from
insurance.
The NIH has worked closely with senior staff from the Federal
Emergency Management Agency (FEMA, http://www.fema.gov/) to assist with
the recovery efforts of research institutions affected by Tropical
Storm Allison. FEMA works directly with the states to help plan for
disasters, develop mitigation programs, and meet needs when major
disasters occur. To make sure that institutions affected by Tropical
Storm Allison would obtain maximum compensation for storm-related
losses, the NIH and FEMA determined which costs would be allowable
under their respective programs and then published this information
in the NIH Guide9.
If an institution has a need for physical infrastructure after a
disaster, then the National Center for Research Resources (NCRR),
one of the NIH’s 27 institutes and centers, and the leading federal
sponsor of shared research resources that support scientific
research, can help. The NCRR’s Research Facilities Improvement
Program (RFIP) provides grants to public and nonprofit private
biomedical institutions to expand, remodel, and renovate or alter
existing research facilities or construct new research facilities.
Improvements under this program must support basic and clinical
biomedical or behavioral research as well as research training (see
http://www.ncrr.nih.gov/resinfra/riresfac.htm).
The NCRR also supports the Animal Facilities Improvement Program
(AFIP). The AFIP grants provide for the upgrading of animal
facilities that support biomedical and behavioral research funded by
US PHS agencies. In addition to upgrading the facilities, these
grants assist institutions to comply with the Animal Welfare Act,
administered by the US Department of Agriculture, as well as the
Department of Health and Human Services (HHS) policies related to
the care and use of laboratory animals (see http://www.ncrr.nih.gov/resinfra/riafip.htm).
Please note that eligibility for these programs is not limited to
institutions that have experienced a disaster.
Conclusion
Both authors wish to express their sincere appreciation and
admiration for the many individuals with whom they have interacted
during and after the events mentioned in this article. We recognize
that, without the dedication and sometimes heroic efforts of the
many good people involved, no recovery effort could have been
successful.
Received 5/3/02; accepted 5/15/02.
References 1. Public Health Service.
Public Health Service Policy on Humane Care and Use of Laboratory
Animals (US DHHS, Washington, DC, 1986).
http://grants1.nih.gov/grants/olaw/references/phspol.htm. 2.
Institute of Laboratory Animal Resources, National Research Council.
Guide for the Care and Use of Laboratory Animals (National Academy
Press, Washington, DC, 1996).
http://www.nap.edu/readingroom/ books/labrats/. 3. Swindle,
M.M., Taylor, L.L., Reed, C. & Wagner, J.L. Hurricanes and
animal care programs. Lab Anim. (NY) 22, 25–31 (1993). 4.
ARENA/OLAW. Institutional Animal Care and Use Committee Guidebook
2nd edn (2002).
http://grants1.nih.gov/grants/olaw/ GuideBook.pdf. 5. Potkay,
S., Garnett, N., Miller, J.G., Pond, C.L. & Doyle, D.J.
Frequently asked questions about the Public Health Service Policy on
Humane Care and Use of Laboratory Animals. Contemp. Top. Lab. Anim.
Sci. 36, 47–50 (1997).
http://grants1.nih.gov/grants/olaw/references/faq_labanimals1997.htm#1. 6.
Office of Management and Budget. Circular A-110 (Revised 11/19/93,
as further amended 9/30/99).
http://www.whitehouse.gov/omb/circulars/a110/a110.html. 7. 45
CFR. Part 74. Department of Health and Human Services. Uniform
administrative requirements for awards and subawards to institutions
of higher education, hospitals, other nonprofit organizations, and
commercial organizations; and certain grants and agreements with
states, local governments and Indian tribal governments.
http://www. access.gpo.gov/nara/cfr/waisidx_00/45cfr74_00.html. 8.
National Institutes of Health. Delays in grant application
submissions due to Tropical Storm Allison. NOT-OD-01-041 (21 June
2001).
http://grants2.nih.gov/grants/guide/notice-files/NOT-OD-01-041.html. 9.
National Institutes of Health. Tropical Storm Allison disaster
relief: Allowable costs under NIH and FEMA programs. (9 November
2001).
http://grants2.nih.gov/ grants/guide/notice-files/NOT-OD-02-011.html.
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