10

The Essential Role of Research Sponsors

Research sponsors become heavily invested in the work undertaken by their grantees. Sponsors’ financial investments can be substantial; as demonstrated in Chapter 1, funders external to academic research institutions invest about $27 billion annually in academic life sciences research (NSB, 2016). Three-quarters of this investment into academic life sciences research comes from the federal government. The remainder—nearly $7 billion annually—is provided by industry, state and local governments, foundations, and other nonprofit entities. Yet in general, research sponsors have not protected their investment by prioritizing the inclusion of disaster resilience principles and practices into the research enterprises they fund.

Disasters could result in several outcomes for research sponsors, from issuing additional funds beyond their initial investments to abandoning the research altogether. Reinvestment may be characterized by sponsors granting additional funds to allow for a re-do of work that has already been paid for or for rebuilding facilities in full or in part to make it possible to continue work that was previously approved. This can create intense

pressure on research sponsors’ budgets, both during the fiscal year of the disaster and in follow-on years. At the federal level this may require new appropriations or fiscal authorities from Congress.

As an example, in the extreme case of Hurricane Sandy, the National Institutes of Health’s (NIH’s) reinvestment toward research grantees amounted to nearly $150 million dollars (HHS, 2015). The fiscal burden of this level of monetary reinvestment is compounded by the cost of the human capital required to implement it. The time and staff resources required to handle the administrative paperwork and delayed grant applications may be considerable. The diversion of staff to attend to administrative tasks may compete with the time and resources required to maintain and manage the regular administration of other ongoing projects not affected by the disaster. These staff hours may be spent on providing extensions, redirecting funding, publishing new funding opportunities, or assisting with animal welfare issues (Bundesen, 2016). The actual cost of this additional work is undefined, at least for NIH, which has not assessed the cost of disasters in terms of staff resources.¹ Proactive measures that reduce the time and administrative burden for recovery are likely to help maintain the overall effectiveness of the research enterprise.

Separate from their fiscal investment, research sponsors are equally invested in the scientific output of the research they fund. The kinds of disasters described in this report can significantly and sometimes permanently undercut those yields; however, NIH has not tallied or otherwise tracked such potential impacts.² Results from the work they funded may be delayed or never completed. These outcomes subvert the funder’s ability to demonstrate institutional progress in a given research area or toward a set of scientific goals prescribed by the institution itself or the funder or perhaps even mandated by Congress. The situation discussed in Chapter 2, in which a researcher at New York University Langone Medical Center (NYU Langone) received permission from NIH to rewrite some of the aims of his open grants, speaks to a capacity and flexibility on the part of NIH to shift goals midstream and to preserve important aspects of a research investment (Fishell, 2013). This is probably a net positive approach overall, allowing NIH to keep good researchers in the system, but it may ultimately alter the sponsor’s own success metrics in a given area of scientific need.

With federal outlays topping $15 billion for the biological sciences and $11 billion for medical sciences (NSF, 2016), there is a critical need for research sponsors to measure their risk, develop mitigation measures, and work in partnership with grantees to implement these measures. While the federal government administers preparedness grant programs for certain sec-

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¹ Personal communication, Michelle Bulls, NIH Office of Policy for Extramural Research, December 14, 2016.

² Ibid.

tors, including for public health and for hospitals, no similar grants exist for academic research institutions (ASPR, 2017; CDC, 2017). As an example, the NIH has not to date attempted to risk-assess its awards in a comprehensive way or to retroactively estimate the number or kinds of awards that tend to be at risk of being affected by disaster.³

Many federal departments and agencies, such as the Departments of Defense, Education, Energy, and Homeland Security, fund biomedical and biological research at academic research institutions; thus, protecting the research investment is ultimately a responsibility that reaches across the federal government (Research!America, 2016). It also encompasses a level of responsibility from private-sector research sponsors, such as foundations, industry, and state and local governments. In 2014, nonprofit organizations provided 5.7 percent ($3.6 billion) of academic science and engineering research and development funding (and industry and state and local governments provided about the same) (NSF, 2016). More than 70 percent of this nonprofit funding is directed toward the life sciences at about $2.5 billion annually (of which $1.5 billion is for medical sciences specifically). The level to which this investment is protected against a disaster is not clear. The committee encourages these research sponsors to consider the applicability of the conclusions and recommendations within this chapter to protecting their own research investments.

This chapter focuses on challenges in and recommendations for protecting the nation’s biomedical research investment. The implementation of these recommendations will be enhanced through collaboration among the federal agencies and with other research sponsors. Because of a relative dearth of information from research sponsors about their resilience-related activities, the committee has reached some conclusions based on as much review of documentation as was available to it in the open-source literature and also based on its own broad, collective experience.

RESEARCH SPONSOR RESPONSIBILITIES: FOSTERING RESILIENCE

A number of high-profile disasters, such as those outlined in this report, have befallen academic research institutions and their research enterprise. Sponsors do understand that their grantees are vulnerable in this way, and some research sponsors do engage in activity toward understanding resilience needs among their grantees and in building such resilience. The committee spent substantial time considering what role research sponsors already have in helping academic research institutions prepare for disasters

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³ Personal communication, Liza Bundesen, NIH Office of Extramural Research, November 17, 2016.

that could adversely affect their ability to meet their funding agreements. A sponsor’s acceptance of a responsibility to facilitate preparedness on the part of its grantees makes sense in terms of protecting its own research investments. Some mechanisms are already in place that at least partially achieve this goal. For example, NIH does have conversations with academic research institutions and principal investigators (PIs) regarding disaster preparedness (NIH, 2017c). Such discussions occur on a case-by-case basis, most likely with institutions that have suffered previous disasters.

Chapter 9 highlighted a number of federal programs relevant to building resilience in academia. Although these programs are not necessarily provided by research sponsors and do not necessarily direct-target academic research institutions, they do demonstrate a federal commitment to disaster resilience that academic research institutions can take advantage of. The Department of Homeland Security (DHS) Campus Resilience Program, now under development, will provide educational resources to help campuses improve their resilience; state universities can take advantage of Federal Emergency Management Agency (FEMA) flood, hazard, and pre-disaster mitigation programs; and academic institutions can apply for National Oceanic and Atmospheric Administration coastal resilience grants (DHS, 2016a; FEMA, 2013; NOAA, 2014). The National Science Foundation (NSF) also funds research on resilient infrastructure and disaster-resilient systems (NSF, 2014).

Another noteworthy indication of federal interest in resilience is NIH’s indirect support of resilience through funding the Disaster Research Response (DR2) program (NIH, 2017a). DR2 provides tools for disaster scientists to aid in the collection of medical and health data during and after disasters. The program’s website provides data collection tools such as surveys, questionnaires, and forms for medical and public health research following disasters; readouts from training exercises such as tabletops; and connection to a network of potential collaborators. The sections that follow explore research sponsor activities related to specific kinds of resilience.

Capital Infrastructure Resilience

Recognizing that infrastructure is necessary to support biomedical and biological research, some government agencies explicitly fund the development of capital infrastructure. For instance, the NSF funds capital infrastructure grants on the basis that “it is essential to prepare the next-generation workforce to develop, maintain, and employ the infrastructure to advance science” (NSF, 2014, p. 8). Capital infrastructure does not refer just to buildings; for NSF it includes advanced computational and data resources and cyberinfrastructure, for example. NSF reports that balancing investment in this infrastructure with the rest of the agency’s science

portfolio is a challenging management responsibility and major investment, but that it is important because “large facilities hold the promise of major discoveries and revolutionary advances” (NSF, 2014, p. 8). Among other NSF programs, the Major Research Equipment and Facilities Construction awards support acquisition, construction, and commissioning of major research facilities and equipment (NSF, 2014). The committee was unable to determine the extent to which this or other NSF grants incorporate resilience of the funded research into the guidelines or requirements.

Additionally, capital expenditures are an allowable use (requiring prior approval) of NIH grant funds (NIH, 2016b). The NIH Grants Policy Statement defines such expenditures as those used to

The NIH grant guidelines have various design documentation requirements, including a design review meant to ensure that minimum requirements are met and that the facility will accommodate the activities for which it is planned; the minimum requirements are outlined in the Code of Federal Regulations (CFR).⁴ NIH construction grants also require the receiving institution to comply with applicable flood insurance requirements per the Flood Disaster Protection Act of 1973.

NIH provides design requirements and guidelines as part of its Design Requirements Manual (DRM) (NIH, 2016a). The manual promulgates minimum performance design standards for NIH-owned and -leased new and renovated buildings and recommends its use for all grant-sponsored capital expenditures. Prior to November 2016, the DRM included an exhaustive set of prescriptive requirements designed to improve the usefulness, safety, and energy efficiency of buildings during normal operating conditions, but it followed the national model building codes and standards and only required research facilities to be designed and constructed to the same fire and life safety standards as commercial office buildings (NIH, 2013a). As a result, after a disaster academic research facilities would need to be repaired or replaced before research operations would be fully functional. As discussed in Chapter 8, this has now changed, and the November 2016 edition of the DRM contains specific provisions for improving the resilience of the built environment during disasters by requiring a project-by-project risk assessment that considers the consequence of system failures and develops appropriate, affordable mitigation actions (NIH, 2016a).

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⁴The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the federal government.

The committee believes that resilience must be built both into research processes and into the facilities that house them and that optimal resilience is likely to occur when both are addressed and in coordinated fashion. The NIH has not tracked the amount of research funds awardees have spent on resilience.⁵

The committee is not aware of guidelines around capital infrastructure resilience that are promulgated by private research sponsors. The committee views this question as an opportunity for engagement with these private research sponsors and a chance to convince them to participate in federal efforts and even to help lead these efforts toward resilience prioritization.

Animal Welfare Resilience

The Animal Welfare Act (AWA) provides an authoritative basis for ensuring the welfare of all vertebrate research animals.⁶ The United States Department of Agriculture (USDA) and other agencies work from this law to promulgate rules, policy, and guidance, some of which directly or indirectly support resilience. By regulation, the USDA requires all facilities that engage in research with warm-blooded animals (with the exception of mice, rats, and birds) to become registered. All such entities must adhere to these regulatory requirements, which generally emphasize the humane care of animal charges. The law does not discuss disaster management for animals used in biomedical research. The NIH Office of Laboratory Animal Welfare (OLAW) provides guidance on, interprets, and ensures compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals for all organizations receiving Public Health Service (PHS) funding (NIH, 2015). Institutions that receive animal research funds from the PHS (which includes funding from the NIH) or are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International must adhere to the standards in the Guide for the Care and Use of Laboratory Animals, which include disaster planning (NRC, 2011a). OLAW uses this guide to enforce PHS humane care and use policy. This guide includes requirements for laboratories to develop plans to protect animal welfare and preserve animal life, when possible, during disasters or other conditions that compromise animal care (Mische and Wilkerson, 2016). Their emphasis tends toward institutional response rather than prevention. These recommendations are described in more detail in Chapter 7.

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⁵ Personal communication, Michelle Bulls, NIH Office of Policy for Extramural Research, December 14, 2016.

⁶ Animal Welfare Act of 1966, P.L. 89-544.

Research-Related Assets Resilience

Some research sponsors, mainly federal research sponsors, require applicants to meet certain requirements related to their research-related assets, specifically, data and samples. While not technically called “resilience” planning, there are policies and programs already in place that do provide for redundancies and protection of research-related assets.

Data repositories are valuable resources that can help ensure that data are shared broadly, consistently, safely, and efficiently for use across the academic biomedical research community. A central data repository can serve to facilitate the standardization of data reporting and can allow additional research to build upon previously collected data.

In 2013, the White House Office of Science and Technology Policy (OSTP) issued Memorandum for Increasing Access to the Results of Federally Funded Scientific Research, which directed all federal agencies with total annual research and development expenditures exceeding $100 million to begin plans to make the published results of federally funded work freely available to the public within 1 year of publication (OSTP, 2013). This policy was aimed at both publications and digitally formatted data. It required researchers to better account for and manage their data, such as through the development of data management plans. In these data management plans, researchers must describe how they will provide for the long-term preservation of, and access to, scientific data in digital formats derived from federally funded research or else explain why long-term preservation and access cannot be justified. Data reservation, retention, and storage policies ensure that data can be reused, meet legal and institutional requirements for retention, and even protect against allegations of scientific misconduct. Policies like these can contribute to disaster resilience. It is important to note that the OSTP memorandum covers only digital recorded factual material necessary to validate research findings and does not include laboratory notebooks, preliminary analyses, drafts of scientific papers, plans for future research, peer review reports, communications with colleagues, or physical objects, such as laboratory specimens (OSTP, 2013, p. 5).

Some federal agencies already had policies in place that partially met the requirements. For example, NIH implemented a public access policy in 2008 that ensured that the public had access to the published results of NIH-funded research (NIH, 2008). In addition to this general public access plan, NIH promulgates discipline-specific policies, such as for clinical trials, genetics, genomics, and consortia-based research (NIH, 2016c). The NIH genomic data sharing policy states that it expected that researchers will submit genomic research data to an NIH-designated data repository (NIH, 2014). NSF states in its data sharing policy that

Each NSF grant contains terms and conditions describing the means of implementing this policy. While the policy does not explicitly state its underlying intent, it appears to be written to ensure the dissemination and sharing of research with other researchers for openness, fairness, and scientific advancement purposes. Furthermore, the resilience of information technology is also a critical disaster mitigation function, as it relates closely to the question of data sharing and storage. For example, NSF’s campus cyberinfrastructure program invests in coordinated campus-level cyberinfrastructure for distributed research projects (NSF, 2017a). NIH supports several dozen data sharing repositories to help facilitate the implementation of these policies (NIH, 2017a).⁷ NSF also supports several data repositories (NSF, 2017a).⁸

The high cost of maintaining and transporting live animal colonies, for instance, can create a significant burden on principal investigators and funding agencies which may necessitate alternative or creative solutions to ensuring their protection (Agca, 2017). These may include the cryobanking of germplasm, developing safe long-term storage options, and facilitating the distribution of biomaterials for future reanimation. Therefore, repositories of physical samples have applications across many biomedical and biological research endeavors. The cost of cryopreservation would normally be considered as a part of an institution’s finance and administration costs (NIH, 2017c). However, NIH has stated that these costs could potentially be allowable as a direct cost, depending upon the particular needs of the project.

Both NIH and NSF fund physical sample repositories (NIH, 2017a; NSF, 2017b). For example, almost two decades ago, in response to the increasing number of genetically modified mouse strains, NIH’s National Center for Research Resources established the Mutant Mouse Resource Research Centers at four regional distribution facilities: Jackson Laboratory; the University of California, Davis; the University of Missouri; and the University of North Carolina, Chapel Hill (MMRRC, 2017). These repositories must also have policies in place to mitigate the impacts of disasters. For example, the University of Missouri implemented multilevel protection plans in order to ensure the integrity, identity, and availability

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⁷ List of NIH data and sample repositories: https://www.nlm.nih.gov/NIHbmic/nih_data_sharing_repositories.html.

⁸ List of NSF data and sample repositories: https://www.nsf.gov/geo/oce/oce-data-samplerepository-list.jsp.

of biospecimens and records for two of its NIH-funded rodent centers (Agca, 2017). Similarly, the National Institute of General Medical Sciences (part of NIH) houses the Human Genetic Cell Repository at the Coriell Institute, an independent research center in Camden, New Jersey (Mintzer et al., 2013). It contains thousands of human cell lines and DNA samples from healthy and diseased individuals. The total Coriell Biobank holds hundreds of thousands of cell lines and DNA samples. This biobank serves as a potential repository for researchers—and one that has incorporated disaster preparedness and emergency operations procedures into its ISO 9001 quality management⁹ program and into emergency operations planning and business continuity planning documents based on Department of Homeland Security guidelines (Mintzer et al., 2013).

NIH also has a model organism-sharing policy for its grantees, which recognizes not only the importance of sharing and disseminating important research resources, but also the need to support reasonable incentive structures to translate these basic research findings (NIH, 2004). If unique research upon which further studies are dependent has restricted availability, it can impede the advancement of research, especially in the event of a disaster. NIH’s organism sharing policy expects that all applications and proposals that will produce new, genetically modified variants of model organisms and related resources will include a sharing plan or else state why such sharing will be restricted or not possible. Additionally, researchers may request funds in their applications to defray reasonable costs associated with the sharing of model organisms and related research resources.

Research sponsors could consider working with public- and private-sector partners with an interest in ensuring the continuity of research-related assets in order to develop resilient repositories, at the regional and national levels, for data, research methodology, and samples. As discussed above, the OSTP Memorandum for Increasing Access to the Results of Federally Funded Scientific Research does not cover laboratory notebooks, preliminary analyses, drafts of scientific papers, plans for future research, peer review reports, communications with colleagues, or physical objects, such as laboratory specimens (OSTP, 2013, p. 5). OSTP could consider a similar policy to increase the access to and management of physical samples. While the primary purpose for setting up such repositories and sharing requirements for data and physical samples may be transparency and the open sharing of publicly funded information, these things have the added benefit of bolstering disaster resilience. However, the connections with resilience are at best implicit—and these repositories should also have policies in place to mitigate the impacts of disasters. Research sponsors

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⁹ ISO (International Organization for Standardization) 9001:2015, Quality management systems.

might wish to consider leveraging their existing policies and requirements to drive awareness of the value of these policies and requirements for research resilience.

Less opportunity is available for ensuring the resilience of critical reagents and specialized research equipment, but these might also be areas that funders take into consideration as they think about policies for broad-based research laboratory resilience. The committee is not aware of any guidelines around research-related asset resilience promulgated by private research sponsors. The committee views this question as an opportunity for these private research sponsors to become more engaged with this issue, participating in federal efforts and even helping lead these efforts toward resilience prioritization.

Chemical, Biological, and Radiological Threat Resilience

For the academic biomedical research community there are strict regulations in guidance documents that dictate the level of security for some materials or operations related to chemical, biological, and radiological threats (NRC, 2011b). These regulations can contribute to resilience.

There are specific regulations for laboratories that involve DHS chemicals of interest (NRC, 2011b). Additionally, federal, state, and local regulatory agencies are increasingly applying standards to chemical laboratories.

The Federal Select Agent Program (FSAP, http://www.selectagents.gov/index.html) oversees the possession, use, and transfer of biological select agents and toxins (BSAT) and requires registered entities to develop and implement written incident response plans based upon site-specific risk assessments. The Centers for Disease Control and Prevention (CDC) and the USDA administer this program. Any sponsored research—whether publicly or privately funded—that involves working with, storing, or transporting agents on the list must adhere to CDC and USDA regulations designed to promote biosafety and biosecurity. As of 2015, 32 percent of all entities registered with FSAP to possess BSAT were from academic research institutions (FSAP, 2016). In order to comply with regulations, registered entities must each develop and implement a written incident response plan based upon a site-specific risk assessment.¹⁰ An incident response inspection checklist is

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¹⁰ 7 CFR Part 331, Agriculture: Possession, Use, and Transfer of Select Agents and Toxins. http://www.ecfr.gov/cgi-bin/text-idx?SID=4e04f9552158709fb780a99ec462a811&mc=true&tpl=/ecfrbrowse/Title07/7cfr331_main_02.tpl (March 18, 2005); 9 CFR Part 121, Animals and Animal Products: Possession, Use, and Transfer of Select Agents and Toxins. https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&SID=b9126e9fba23e3e7933354a1d2630d72&ty=HTML&h=L&n=9y1.0.1.5.58&r=PART (March 18, 2005); 42 CFR Part 73, Public Health: Select Agents and Toxins. http://www.ecfr.gov/cgi-bin/text-idx?SID=4e04f9552158709fb780a99ec462a811&mc=true&node=pt42.1.73&rgn=div5 (March 18, 2005).

available for use by agency inspectors who conduct BSAT program audits; however, the checklist simply mirrors the requirements outlined in the regulations (Swearengen et al., 2010). The FSAP proactively reaches out to assist entities in transferring or securing BSAT when those entities may be affected by adverse weather events that could affect the safety and security of BSAT (FSAP, 2016). In 2015, FSAP found that there were no reported releases of BSAT associated with weather events.

Biosafety in Microbiological and Biomedical Laboratories, a federal guidance document, offers best practices for the safe conduct of work in biomedical and clinical laboratories from a biosafety perspective (Chosewood and Wilson, 2009). In addition, there are several primary federal Occupational Safety and Health Administration (OSHA) standards that apply to laboratories, such as the Occupational Exposure to Hazardous Chemicals in Laboratories standard, and aspects of laboratory activities, such as working with small animals or in chemical fume hoods (OSHA, n.d.).¹¹ There are also 28 OSHA-approved state plans that have standard and enforcement programs.

The Nuclear Regulatory Commission regulates research and test reactors, which are reactors primarily used for research, training, and development in fields including physics, chemistry, biology, medicine, and numerous others (Nuclear Regulatory Commission, 2015). Most of these reactors are at U.S.-based colleges and universities. The elements of regulation include licensing, inspection, and security measures. The Nuclear Regulatory Commission also regulates medical and research uses of ionizing radiation. Medical uses, including medical research, are governed under Title 10, Part 35 of the CFR, whose requirements govern licensing, training, and safety.¹² The Nuclear Regulatory Commission also regulates radioactive materials, which may be found in research institutions and hospitals.

GAPS IN RESEARCH SPONSOR RESILIENCE EFFORTS

There has been no national conversation about disaster resilience at academic research institutions or about the kinds of guidelines or requirements for resilience that should be implemented to protect the research investment, nor has funding been allotted toward this. But in light of numerous disasters and our struggle to pay for them, it is urgent that the subject be addressed.

Most attention toward disaster recovery has been in the reaction to a recent disaster. Contingencies related to disasters are largely uncovered by the

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¹¹ 29 CFR § 1910.1450, Occupational Health and Safety standards: Occupational Exposure to Hazardous Chemicals in Laboratories. https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10106 (March 26, 2012).

¹² 10 CFR Part 35, Medical Use of Byproduct Material. https://www.nrc.gov/reading-rm/doc-collections/cfr/part035 (April 24, 2002).

existing laws, regulations, policies, or guidance outlined above. The baseline that these provide should be expanded into improved sponsor resilience engagement in a proactive fashion that would address the following gaps:

• Overall lack of disaster resilience policy or guidance. The NIH has not developed a policy statement concerning the disaster resilience of its funded entities. NIH’s Office of Policy for Extramural Research Administration (OPERA) webpage on grants compliance and oversight (https://grants.nih.gov/policy/compliance.htm) outlines a fairly extensive list of select policy topics, including animal welfare, human subjects research, intellectual property, research integrity, and lobbying guidance. Disaster resilience is not, however, among these topics. The animal welfare section of the guide, while useful, is directed at ensuring compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals, which does not address disaster resilience (NIH, 2015). While the policy guide does address floods, it does so only to the point of requiring compliance with flood insurance requirements for construction grants to entities in flood-prone areas.
• Nonsystematic engagement of extramural grantees on resilience. Different NIH centers discuss or work with extramural grantees on a case-by-case basis on disaster preparedness plans and other elements of resilience. OPERA does not have standard criteria or guidance for its centers on how to engage the grantees on this topic.¹³ Disaster preparedness training is not an element of the NIH training program for first-year grantees and early scientists.
• Lack of inclusion of resilience guidance or requirements within facilities and capital infrastructure grants. These grants generally do not consider resilience in their standards and guidelines.
• Insufficient communication about resilience to grantees and applicants. To the extent that NIH does have resilience requirements, guidelines, or best practices from institutions that have experienced disasters, these are not readily available on NIH’s OPERA website or otherwise communicated to grantees. This may be the case for many other research sponsors as well. The ability of sponsors to generate best practices concerning resilience is hampered by the lack of any individual sponsor taking the lead on convening sponsors to discuss the challenges and develop guidance.
• Lack of contingency plan for animal welfare. In addition to the Guide for the Care and Use of Laboratory Animals, a regula-

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¹³ Personal communication, Michelle Bulls, NIH Office of Policy for Extramural Research, December 14, 2016.

• tion for animal emergency response was proposed in 2012 by the USDA, as described in Chapter 7 (NRC, 2011a; USDA–APHIS, 2012). These regulations would have required a contingency plan for animals from each regulated facility. The proposed rule has been under an indefinite stay since 2013. Thus, at this time, the Guide remains the primary guidance document for animal research disaster planning, and elements of an all-hazards, comprehensive planning approach that is congruent with the national planning frameworks remain missing (NRC, 2011a).

• Lack of addressing of research asset resilience. Sponsor policies and requirements do not generally address the resilience of research-related assets such as data, samples, reagents, and specialized research equipment.

RESEARCH SPONSOR RESPONSIBILITIES: FACILITATING RESPONSE AND RECOVERY

To protect their research investments, it is in the best interest of research sponsors to also take an active role in response and recovery activities. The approach to doing this has so far varied by research sponsor. At NIH, coordination with federal, state, and local agencies to ensure the continuation of NIH-funded research has been a priority (NIH, 2013b). NIH’s level of assistance is tailored to the disaster; in a notable example, approximately 250 NIH staff members were deployed to the field post-Katrina to work with academic partners (NIH, 2005). NIH’s response activities range from permitting the limited expenditure of award funds to continue paying salaries and fringe benefits, providing extensions, waiving certain prior approval requirements, and assisting with animal welfare issues (NIH, 2013b).

Because each disaster is unique, the particulars of NIH response and recovery efforts are determined on a case-by-case basis (NIH, 2013b). In the case of Hurricane Sandy, NIH issued numerous grants designed to assist recovery, including supplemental funding to cover losses, the restoration of new and early research investigator pilot studies, facilities reconstruction grants, and animal colony, instrumentation, and equipment funds, to name a few.

In addition to—and, in some cases, providing the foundation for—these kinds of disaster-specific responses are some standing policies. The NIH Grants Policy Statement says that institutions may submit adjustments resulting from natural disasters (e.g., loss of an animal colony) as a component of post-submission grant application material (NIH, 2016b, p. I-51). In addition to the policies identified in the grants policy, the NIH webpage on extramural response to natural disasters and other

emergencies¹⁴ is a resource that provides guidance for NIH’s response and recovery efforts (NIH, 2013b). Specifically, NIH’s disaster response webpage provides resources such as descriptions of disaster preparedness grant programs, announcements of emergency awards, and information about the funding process for such awards (NIH, 2013b). In the event a disaster has befallen a grantee, NIH will consider issues such as

• Whether a federal disaster has been declared;
• The severity of damage inflicted;
• The length of time an institution may be required to close or that is required for recovery;
• The impact on investigators, human research subjects, and animal subjects; and
• The overall impact on the community.

NIH standard policy when an institution is closed due to a natural disaster or other emergency situations is to allow delayed submissions, with the delay not to exceed the time period the applicant organization is closed (NIH, 2013b). NIH also has a policy on relocation support, which is to provide full indirect cost recovery as appropriate for temporary relocations. NIH invests in construction grants that, while not limited to those institutions that have experienced a disaster, nevertheless can benefit them in disaster response and recovery. In the event of a disaster, the efforts will be announced on the disaster response webpage. Overall, the possible response and recovery actions that NIH may take include

• Permitting the limited expenditure of award funds, in accordance with grantee policy, to continue paying salaries and fringe benefits to researchers under unexpected or extraordinary circumstances;
• Assisting with animal welfare issues;
• Waiving certain prior approval requirements;
• Providing extensions of time for financial and other reporting; or
• Publishing opportunities for funded extensions or one-time administrative supplements to current awards targeted at institutions in particularly affected areas.

NSF provides similar response and recovery assistance. It assists in the transfer of awards for faculty and students who temporarily change institutions (NSF, 2005b). NSF considers extensions to submission deadlines on a case-by-case basis. NSF also considers requests for small amounts of supplemental funding to existing awards from institutions serving as hosts

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¹⁴ See https://grants.nih.gov/grants/natural_disasters.htm.

to displaced faculty. After Hurricane Katrina, for instance, NSF announced that it would extend awards that were due to expire within a month and would assist to the extent possible in the transfer of awards to researchers who temporarily moved to other institutions (NSF, 2005a). NSF’s 2017 Proposals and Award Policies and Procedures Guide does not explicitly promulgate resilience requirements (NSF, 2017c).

After Katrina, both NIH and NSF allowed flexible application deadlines for grant proposals (Kaiser, 2005). After Hurricane Sandy, NIH provided supplemental funding under the Disaster Relief Appropriations Act for administrative support and funding for restoring research facilities (NIH, 2013b). Under that act, NIH also provided opportunity for administrative support for researchers seeking to recover Hurricane Sandy–related losses.

GAPS IN SPONSOR RESPONSE AND RECOVERY EFFORTS

In many cases research sponsors have been enthusiastic and progressive in their willingness to help grantees respond to and recover from disasters. They want to ensure the outcomes of their investments and have, in many cases, shown a commitment to ensuring their grantees are able to resume their work. The committee did not learn of major gaps in disaster response and recovery policies among sponsors. However, confusion among researchers and institutions as to their options for handling aspects of response and recovery relevant to their funding and research sponsors has been a common theme. Researchers and institutions have reported facing confusion over the status of their grants in the aftermath of disasters that have significantly affected their ability to continue their funded research. This may reflect a lack of standardization within and among sponsors’ communicativeness of their disaster response policies or a lack of such policies to begin with. While some level of confusion is to be expected after a disaster, some of it could be mitigated through improved pre-disaster planning and communication.

In addition, neither the most current FEMA National Disaster Recovery Framework nor the NFPA 1600 Standard (NFPA, 2014, 2016) nor the ISO 22301 Standard specifically addresses best implementation practices or provides specific guidance in implementing an institution’s disaster recovery plan (FEMA, 2016). The NFPA and ISO are voluntary committees and not compliance-oriented, but there might be benefit to coordination between FEMA and these organizations as well. Importantly, whereas FEMA has guidelines for recovery in laboratories and sponsors such as NIH or NSF sponsor research in those laboratories, the funding agencies do not appear to have any formalized planning or response relationship with FEMA. Federal research sponsors could consider developing a partnership with FEMA to help align response and recovery efforts. This might be facilitated by

including the academic biomedical research community more explicitly in the Healthcare and Public Health Sector–Specific Plan.

NIH documented the lessons learned from its site visit to New York University Langone Medical Center (NYU Langone) after Hurricane Sandy. NIH found that its in-person presence 1 week post-Hurricane Sandy was comforting to NYU Langone personnel (NIH, 2017c). NIH found great utility in providing standard language and guidance to all incident command staff who were providing support, allowing them to clearly and consistently communicate their grant requirements. Based on its Sandy experience, NIH learned that it will be best to include language in future award notices that requests grantees to consider the types of insurance before they request coverage for certain costs from NIH in order to prevent charging costs that will ultimately be paid by insurance or FEMA, a situation that could create financial challenges for grantees. However, NIH did not conduct a formal evaluation of the response efforts as a result of Hurricane Sandy (NIH, 2017c). While documentation of the lessons described above is important and can affect new policy formation, it is not a substitute for rigorous tracking of activities and expenditures during and after disasters. The committee finds that insufficient tracking of response and recovery activities and expenditures hampers the ability of sponsors to assess the impacts of these disasters on their own program success and budgets. An evaluation of prior disaster response and recovery actions would be of substantial value.

THE HEALTHCARE AND PUBLIC HEALTH CRITICAL INFRASTRUCTURE SECTOR

As discussed in Chapter 1, Presidential Policy Directive 21 (PPD-21) advances a national policy to strengthen and maintain secure, functioning, and resilient critical infrastructure (Obama, 2013). There are 16 critical infrastructure sectors considered so vital to the United States that their incapacitation or destruction would have a debilitating effect on national security, economic security, public health or safety, or a combination thereof (DHS, 2013). One of the sectors covers the health care and public health (HPH) capability. The HPH Sector is large and diverse, spanning both the public and private sectors (DHS, 2016b). It includes publicly accessible health care facilities, research centers, suppliers, manufacturers, and other physical assets as well as vast, complex public–private information technology systems. The HPH Sector protects all sectors from hazards such as terrorism, infectious disease outbreaks, and natural disasters. The academic biomedical research community is a component of the research centers referred to in section 3.2 of the sector profile of the HPH Sector-Specific Plan (DHS, 2016b).

The nation’s academic biomedical research community provides essential services that underpin American society, especially with respect to addressing emerging public health issues and CBRNE threats on an emergent and long-term basis. The failure or loss of the academic biomedical research community could have immediate cascading consequences. As an example, the protection, mitigation, and response to a novel infectious disease outbreak depends on the academic biomedical research community supporting the government investigation of the pathogen in order to develop and evaluate experimental therapy and to develop and test the effectiveness of vaccines and other medical countermeasures. The HPH Sector-Specific Plan discusses how the responses to the H1N1 influenza pandemic and the Ebola epidemic in West Africa in 2014 demonstrate the importance of the HPH Sector during a national event or health crisis (DHS, 2016b). The loss of the academic biomedical research community would cripple the nation’s ability to protect, mitigate, and respond to the next serious communicable disease crisis.

In addition, as previously described, select high-consequence pathogens and high-risk radiological sources are kept in the laboratories of the academic biomedical research community which, if the laboratories are not disaster resilient, risks an environmental release and immediate cascading consequences across all critical infrastructure sectors. The physical and economic damage to the academic biomedical research community as a consequence of Hurricanes Katrina, Rita, and Sandy, as well as the lengthy recovery, suggests gaps in the disaster resilience of this critical infrastructure component.

The goals, priorities, and activities included in the HPH Sector-Specific Plan were developed by the Sector Coordinating Council (SCC) and the Government Coordinating Council (GCC), which represent the private and government subsectors, respectively (DHS, 2016b). Currently, the academic biomedical research community is not classified as a subsector and is not actively engaged in the HPH Sector. There are numerous benefits for the academic biomedical research community of becoming engaged in the HPH Sector, and the HPH Sector partnership goals listed in Box 10-1 highlight these benefits.

The HPH Sector-Specific Plan has specifically identified broadening partnerships and identifying new sector members as a priority (DHS, 2016b, p. 50). The academic biomedical research community (from federal research sponsors to academic research institutions) should be considered a subsector of the HPH Sector and be represented on the SCC as well as on the GCC. Participation in the sector is a challenge if leaders are not identified; therefore, academic research institutions could participate on the SCC through appropriate associations. Increased participation of federal research sponsors on the GCC could result in discussions about the fund-

ing of resilience efforts for academic research institutions as well as other ways the government could support resilience efforts for academic research institutions. Working to make the academic biomedical research community more disaster resilient through the development and implementation of risk-based protective programs and resilience strategies for infrastructure would enhance the nation’s disaster resilience and protect the nation’s biomedical research investment.

CONCLUDING OBSERVATIONS

Research sponsors may wish to consider taking a more assertive role in protecting their research investments through resilience initiatives and the development of policies to incentivize resilience. This process should be independent of disaster-related appropriations, and, indeed, the goal is to reduce the likelihood that such appropriations will be needed. While it is probably the case that new authorizing laws—and perhaps even new regulations—are not necessary, a minimum level of policy and guidance will be needed.

The first step might be for research sponsors to foster a culture of safety and security in order to encourage awardees (from the level of the individual to the institution) to adhere to a culture of safety and security regarding research-related assets. Sponsors could be explicit about basic emergency preparedness, design and construction standards, business continuity, and response policies and practices that awardees are encouraged to follow. This might include, for example, the integration of resilience planning for the research enterprise into an academic research institution’s master plan for future campus development or into the development of business continuity plans, as described by Foster and Smith (2015). Each academic research institution should be encouraged to develop its own vision of a resilient research enterprise, one that is consistent with the National Preparedness Goal and the national planning frameworks discussed in Chapters 4–6 and with the design and the construction practices outlined in Chapters 7 and 8.

Research sponsors could require that grantees have emergency operations plans (EOPs) and business continuity plans at the research enterprise level. For example, academic research institutions and their research enterprises could demonstrate to sponsors that they have adopted and internalized the current, standardized emergency management principles and practices in common use (including National Incident Management System and incident command system principles). However, for an EOP requirement to have meaningful impact, research sponsors will have to establish metrics for determining the operational utility of each EOP and the commitment on the part of the institution and its research enterprise to exercising it and ensuring its success in a disaster. Business continuity planning should be linked to the research enterprise EOP. These plans will identify critical operating functions and causes of business interruption and will describe strategies for the recovery of essential services in priority order. They should include requirements for the maintenance of inventory, including the description of valuable research-related assets, their location, and any assets necessary for the conduct of the research that are not easily replaceable. Sponsors should also incentivize academic research institutions to exceed building code standards for their research enterprise by establishing performance-based design criteria. Academic research institutions should exceed accepted codes to achieve a level of resilience for their research enterprises that is appropriate to their perceived risks and to national design and construction standards.

Having strong data backup procedures in place prior to disasters is likely a determinant of whether research can be successfully continued after a disaster. Researchers should understand the circumstances under which research-related assets, including data, cells, or animals, need to be moved and also how they will be moved (Rising and Lurie, 2013). All written and electronic research data and laboratory records must be regularly updated,

protected with adequate security procedures, and maintained in at least two separate geographic locations. The cost of the data backup may need to be included as an allowable use of the grant; ideally, the funding level of grants would rise to accommodate this expense. National repositories for particular types of cell lines, cryopreservation of unique animals, and even federal or national data repositories could all be useful for protecting against cybersecurity concerns, including cyber terrorism.

NIH could also amend the NIH Grants Policy Statement. NIH OPERA facilitates implementation of NIH or other federal policies and initiatives, ensuring both intramural and extramural compliance with policy and legislative mandates (NIH, 2016b). In this role, it promotes the stewardship of extramural funds. Section 4.1 on Public Policy Requirements and Objectives could be amended to address disaster resilience requirements. Any new resilience policies or guidance so developed should be made easily accessible on the NIH’s website.

The challenges that researchers and their institutions face when responding to and recovering from disasters can be met by having sponsors commit to support. To the extent possible, the most valuable thing a funder can do during the response stage is to clarify its commitment to its grantees. Funders could also require disaster recovery planning. Each institution should have at least a generic recovery plan in place. Such plans should be informed by the plans previously described. Sponsors might also provide best practices and guidance for recovery implementation. Federal sponsors could work with FEMA, NFPA, and ISO to develop best implementation practices and guidance for implementing the NFPA 1600 Standard and ISO 22301 Standard. This might include the promulgation of such advice to academic research institutions concerning how to develop pre-disaster mutual aid or advanced contracting arrangements. Finally, sponsors could require disaster after-action assessments and follow-up. Institutions would be required post-disaster to provide a detailed account of what occurred on their campuses and what plans have been put in place to prevent or mitigate a recurrence of the disaster or its impacts.

that support biomedical research should each identify within their respective agencies a locus of responsibility and authority to lead and coordinate efforts in pursuit of a resilient academic biomedical research community. This initiative would guide and support academic research institutions in their development of disaster resilience programs for their research enterprises.

Possible discussions could include mechanisms for research sponsors to

• Conduct evaluations of prior disaster response and recovery actions taken by research sponsors.
• Communicate with academic research institutions pre-disaster to discuss potential disaster response and recovery actions, set expectations, and highlight current initiatives in place.
• Standardize response and recovery procedures.
• Match or leverage incentives to encourage academic research institutions and researchers to incorporate disaster resilience into their research programs.
• Provide funding sources for capital improvements that will improve the resiliency of research facilities at academic research institutions so that they meet appropriate performance goals.
• Establish resilience standards and require evidence of disaster-resistant design and construction and business continuity planning as conditions of award.
• Increase incentives for offsite storage and duplication of critical samples and data.
• Develop a national approach to preserve unique animal lines, samples, and data through disaster-resilient repositories.
• Explore funding for national centers of excellence for disaster resilience efforts at academic research institutions that would analyze existing data, serve as a repository for after-action reports and post-disaster analyses, and promulgate best practices for the academic biomedical research community.
• Actively participate in the Healthcare and Public Health Sector–specific activities, such as the Government Coordinating Council.

Additionally, the academic biomedical research community (from federal research sponsors to academic research institutions) should be considered a subsector of the HPH Sector and represented on the SCC as well as the GCC. The HPH Sector-Specific Plan has specifically identified broadening partnerships and identifying new sector members as a priority (DHS, 2016b, p. 50). Currently, the academic biomedical research community is not actively engaged in the HPH Sector. Participation in the sec-

tor is a challenge if leaders are not identified; therefore, academic research institutions could participate on the SCC through appropriate associations. An increased participation of federal research sponsors on the GCC could result in discussions about the funding of resilience efforts for academic research institutions as well as other ways that the government can support resilience efforts for academic research institutions. Working to make the academic biomedical research community more disaster resilient through the development and implementation of risk-based protective programs and resilience strategies for infrastructure will enhance the nation’s disaster resilience and protect the nation’s biomedical research investment.

• Active participation of appropriate academic biomedical research community associations and stakeholders on the Sector Coordinating Council.
• Active participation of key federal agencies that support biomedical research on the Government Coordinating Council.

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