The Special Pathogens Research Network: Enabling Research Readiness

Kraft, Colleen S.; Kortepeter, Mark G.; Gordon, Bruce Geoffrey; Sauer, Lauren; Shenoy, Erica S.; Eiras, Daniel P.; Larson, Lu Ann; Garland, Jennifer; Mehta, Aneesh K.; Barrett, Kevin; Price, Connie S.; Croyle, Caroline; West, Lauren R; Noren, B.; Kline, Susan; Arguinchona, Christa; Arguinchona, Henry; Grein, Jonathan; Connally, Chad; McLellan, Susan; Risi, George; Uyeki, Timothy M.; Davey, Richard T.; Schweinle, Jo Ellen; Schwedhelm, Michelle; Harvey, Melissa; Hunt, Richard C.; Kratochvil, Christopher J.

doi:10.1089/hs.2018.0106

Cited by 12 publications

(6 citation statements)

References 20 publications

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“…In addition, if future research is to be conducted using pathogenic samples, many natural history collections are equipped with biosafety level 1 and/or 2 laboratory space. Under certain circumstances, in particular research on designated CDC Select Agents, samples need to be deposited in a biorepository or biobank with higher biosafety level capabilities (145).…”

Section: Best Practices For Integrating Natural History Collections In Host-pathogen Studiesmentioning

confidence: 99%

Preserve a Voucher Specimen! The Critical Need for Integrating Natural History Collections in Infectious Disease Studies

Thompson

Phelps

Allard

et al. 2021

mBio

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Despite being nearly 10 months into the COVID-19 (coronavirus disease 2019) pandemic, the definitive animal host for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), the causal agent of COVID-19, remains unknown. Unfortunately, similar problems exist for other betacoronaviruses, and no vouchered specimens exist to corroborate host species identification for most of these pathogens. This most basic information is critical to the full understanding and mitigation of emerging zoonotic diseases. To overcome this hurdle, we recommend that host-pathogen researchers adopt vouchering practices and collaborate with natural history collections to permanently archive microbiological samples and host specimens. Vouchered specimens and associated samples provide both repeatability and extension to host-pathogen studies, and using them mobilizes a large workforce (i.e., biodiversity scientists) to assist in pandemic preparedness. We review several well-known examples that successfully integrate host-pathogen research with natural history collections (e.g., yellow fever, hantaviruses, helminths). However, vouchering remains an underutilized practice in such studies. Using an online survey, we assessed vouchering practices used by microbiologists (e.g., bacteriologists, parasitologists, virologists) in host-pathogen research. A much greater number of respondents permanently archive microbiological samples than archive host specimens, and less than half of respondents voucher host specimens from which microbiological samples were lethally collected. To foster collaborations between microbiologists and natural history collections, we provide recommendations for integrating vouchering techniques and archiving of microbiological samples into host-pathogen studies. This integrative approach exemplifies the premise underlying One Health initiatives, providing critical infrastructure for addressing related issues ranging from public health to global climate change and the biodiversity crisis.

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Section: Best Practices For Integrating Natural History Collections In Host-pathogen Studiesmentioning

confidence: 99%

Preserve a Voucher Specimen! The Critical Need for Integrating Natural History Collections in Infectious Disease Studies

Thompson

Phelps

Allard

et al. 2021

mBio

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“…In 2016, the NETEC's mandate expanded to include developing infrastructure to support clinical research readiness for future emerging infectious disease outbreaks. The SPRN is composed of the 10 Regional Emerging Special Pathogen Treatment Centers (RESPTCs), which are also the institutions responsible for providing clinical care in their HHS region 16 . The use of an sIRB for research conducted by the SPRN was dictated in part by the new regulatory requirements associated with revision of the Common Rule but also by the recognition that sIRB review has the potential to allow an IRB specialized in preparing for and reviewing research in public health emergencies to be a resource for the 10 RESPTCs.…”

Section: Role and Use Of The Rapid‐response Irb During The Covid‐19 P...mentioning

confidence: 99%

“…The SPRN is composed of the 10 Regional Emerging Special Pathogen Treatment Centers (RESPTCs), which are also the institutions responsible for providing clinical care in their HHS region. 16 The use of an sIRB for research conducted by the SPRN was dictated in part by the new regulatory requirements associated with revision of the Common Rule but also by the recognition that sIRB review has the potential to allow an IRB specialized in preparing for and reviewing research in public health emergencies to be a resource for the 10 RESPTCs. Thus, the Rapid-Response IRB as an sIRB was imbedded into the sustained infrastructure of NETEC and the SPRN.…”

Section: Role and Use Of The Rapid-response Irb During The Covid-19 P...mentioning

confidence: 99%

Rapid Review of Therapy Protocols for Public Health Emergencies

Gordon,

Lowe,

Kratochvil

2024

Ethics & Human Research

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How research during a public health emergency is conducted is recognized as essential to the public health response to that emergency. Such research needs to undergo substantive and meaningful ethical review in a timely manner. Rapid ethical review may be accomplished through a number of mechanisms, including use of local rapid‐response institutional review boards (IRBs). We describe use of such a model in the setting of the 2014 Ebola virus disease epidemic and the Rapid‐Response IRB's subsequent transition to a multisite single IRB model during the current Covid‐19 pandemic. The rapid‐response review model is characterized by a small IRB with extensive use of alternate members with specific expertise and by close collaboration with the investigator in an iterative process.

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“…It also has worked through how to facilitate cooperative research through its central IRB mechanism for the Special Pathogens Research Network, comprising 10 academic centers that serve as regional referral isolation care hospitals. 14 The regulatory process reflects a general posture toward discovery in parallel with clinical care shared across its network partners. 15 Operational efficiency such as that provided by the central IRB was impactful in ensuring the window of opportunity was not lost.…”

Section: Strong Structures Must Also Be Facilementioning

confidence: 99%

Advanced Preparation Makes Research in Emergencies and Isolation Care Possible: The Case of Novel Coronavirus Disease (COVID-19)

Brett-Major

Schnaubelt

Creager

et al. 2020

The American Journal of Tropical Medicine and Hygiene

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The optimal time to initiate research on emergencies is before they occur. However, timely initiation of highquality research may launch during an emergency under the right conditions. These include an appropriate context, clarity in scientific aims, preexisting resources, strong operational and research structures that are facile, and good governance. Here, Nebraskan rapid research efforts early during the 2020 coronavirus disease pandemic, while participating in the first use of U.S. federal quarantine in 50 years, are described from these aspects, as the global experience with this severe emerging infection grew apace. The experience has lessons in purpose, structure, function, and performance of research in any emergency, when facing any threat.

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The Special Pathogens Research Network: Enabling Research Readiness

Cited by 12 publications

References 20 publications

Preserve a Voucher Specimen! The Critical Need for Integrating Natural History Collections in Infectious Disease Studies

Preserve a Voucher Specimen! The Critical Need for Integrating Natural History Collections in Infectious Disease Studies

Rapid Review of Therapy Protocols for Public Health Emergencies

Advanced Preparation Makes Research in Emergencies and Isolation Care Possible: The Case of Novel Coronavirus Disease (COVID-19)

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