NIH Grants and Funding
| From: Lab Animal 31(8):27-30, 2002 |
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.
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).
2. Institute of Laboratory Animal Resources, National Research Council. Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC, 1996).
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).
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).
6. Office of Management and Budget. Circular A-110 (Revised 11/19/93, as further amended 9/30/99).
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.
8. National Institutes of Health. Delays in grant application submissions due to Tropical Storm Allison. NOT-OD-01-041 (21 June 2001).
9. National Institutes of Health. Tropical Storm Allison disaster relief: Allowable costs under NIH and FEMA programs. NOT-OD-02-11 (9 November 2001). .