Principles and Practice of Emergency Research Response
暫譯: 緊急研究回應的原則與實踐

解鎖傳染病研究應對的未來在一個新興傳染病不斷威脅人類的世界中，科學和技術的進步承諾在未來病原體引發大流行之前提供防禦。然而，應急研究應對和準備的領域仍然處於起步階段。直到2014年西非埃博拉疫情爆發，快速研究才被廣泛認可為應急應對的重要組成部分。在經歷了多次疫情和一次全球大流行之後，顯然世界必須準備啟動加速研究應對，以防止或減輕傳染病的爆發、流行病和大流行。然而，這一新興領域充滿了關鍵的科學、倫理和政策問題。地方、國家和全球系統如何能夠跨學科和政治邊界合作以保護健康安全？我們如何能在脆弱或失敗的國家進行嚴謹的研究？在短缺的情況下，公平分配疫苗和治療藥物需要什麼？我們如何能在緊急情況下加速疫苗和治療的試驗，而不妥協科學的嚴謹性或倫理標準？我們如何將社區和利益相關者納入研究準備和應對中？編輯們將數十年的經驗帶入與知名研究科學家和健康政策專家的合作中。他們共同編寫了一本彙編，提出了規範標準並提供了準備和快速研究應對的實用指導。這本開放存取的教科書展示了從健康緊急情況中提煉出的原則和實踐，這些見解為研究應對和準備指明了前進的道路。其目標是阻止疫情變成可避免的大流行，並在無法阻止的情況下減輕疾病、死亡和社會動盪。應急研究應對的原則與實踐將歷史理解與對未來可能性的見解相結合。它將成為通過研究、全球健康政策變革和在最需要的地方改善研究能力來遏制傳染病威脅的不可或缺的指南。編輯們希望這本書能成為政府、健康組織、發展機構、研究人員、政策專家、倫理學家和社會科學家的持續參考資料。為了促進專注和增強學習，它融入了摘要、學習目標、討論問題、實際案例和學習路徑等教學工具。強健的全球健康安全需要對新興和再現病原體的有效準備和應對。本書應能指引我們邁向更具韌性的未來。

Dr. Elizabeth S. Higgs, MD, MIA, DTMH, is a global health science advisor, clinical scientist, and pandemic preparedness research response policy expert working in the Division of Clinical Research at the U.S. National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH). Throughout her career, Dr. Higgs has contributed to critical health emergencies, including H1N1, Ebola outbreaks in West Africa and the DRC, the 2018 Nipah outbreak in Kerala, India, mpox, and SARS-CoV-2, demonstrating that regulatory-level clinical trials during health emergencies are possible and contribute to medical countermeasures that accelerate the end of outbreaks.
Known for global health diplomacy while fostering interagency and multilateral collaborations, she actively engages in strategic global health security initiatives and policy groups, making impactful contributions to key policy documents such as the World Bank's Money and Microbes, the G7 Clinical Trials Charter, and the U.S. National Biosecurity Strategy and Global Health Security Strategy.
Her passions include nurturing sustainable clinical research capacity in low- and middle-income countries and promoting cooperative global clinical trial networks. With a foundation in internal medicine and infectious diseases, Dr. Higgs holds a doctorate in medicine, a master's degree in international affairs, an interdisciplinary bachelor's degree in bioethics, and a Diploma in Tropical Medicine and Hygiene. Through her commitment to response research, she is dedicated to safeguarding and enhancing the well-being of people worldwide in the face of health emergencies caused by emerging infectious disease.
Robert A. Sorenson has worked with the NIAID Division of Clinical Research on infectious disease emergency response policy, especially urgent clinical research response to emerging pathogens, since 2016, after having worked on global health policy issues at the U.S. Department of State since 2009.
Mr. Sorenson was a Foreign and Civil Service Officer at State for 33 years. After 2001, when family circumstances curtailed his overseas career, he primarily served in the Bureau of Oceans, Environment, and Science, including terms as Deputy Director of the Offices of International Health and Biodefense, Environmental Policy, and Ecology and Terrestrial Conservation. His overseas experience, starting in 1986, included political, consular, environmental, and deputy chief of mission positions in Manila, Moscow, Osaka, Skopje, Tashkent, and Tirana, as well as several temporary duty assignments in crisis spots. He retired from State on New Year's Eve, 2017 and has since been a contractor with NIAID.
As managing editor of PPERR, Mr. Sorenson revived and updated his professional editorial experience, which dated to 1981-1986. He wasa National Fellow at the Hoover Institution in 1999-2000 and has an MA in Russian literature from Cornell University and a BA from St. Olaf College
Nicole Lurie, M.D., M.S.P.H., is Executive Director for Preparedness and Response at the Coalition for Epidemic Preparedness Innovations (CEPI) and Director of CEPI-US. She is also a Senior Lecturer at Harvard Medical School and Professor of Medicine at George Washington University School of Medicine.
She served an eight-year term as Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services from 2009 to 2017. In that role she led the HHS response to numerous public health emergencies, ranging from infectious disease to natural and man-made disasters, and is responsible for many innovations in emergency preparedness and response.
Prior to federal service, she was the Paul O'Neill Professorof Policy Analysis at RAND, and a Professor of Medicine and Public Health at the University of Minnesota. Her research has spanned access to and quality of care, health system redesign, health equity, mental health, public health, and preparedness. She is the recipient of numerous awards and is a member of the National Academy of Medicine. She continues to practice medicine in a community clinic in Washington DC.
Peter Smith is Professor of Tropical Epidemiology at the London School of Hygiene &Tropical Medicine (LSHTM).
He graduated in mathematics and statistics from City University, London and in 1965 joined the Medical Research Council's Statistical Research Unit in London. Since then, he has worked on various aspects of epidemiological and statistical research based in Edinburgh, Kampala, Oxford, Boston and Geneva. He joined LSHTM in 1979 to head the MRC International Statistics & Epidemiology Group. Research interestsinclude large-scale intervention studies against tropical diseases, recently focussing on vaccines.
From 1999 to 2004 Dr. Smith chaired the UK Government Spongiform Encephalopathy Advisory Committee. He has chaired the WHO Global Advisory Committee on Vaccine Safety and the WHO Technical Expert Group on the RTS, S/AS01 malaria vaccine. He served as the Deputy Chair of the Nuffield Council on Bioethics and from 2004 to 2014 was a Governor of the Wellcome Trust. He has served on the Scientific Advisory Committees of the Coalition for Epidemic Preparedness Innovations (CEPI) and the European and Developing Countries Clinical Trials Partnership (EDCTP). He chairs the WHO SAGE Working Group on malaria vaccines and serves on the WHO SAGE Working Group on SARS-CoV-2 vaccines.
Laura Ann McNay, MS, is the Deputy Director for Operations and Management in the Division of Clinical Research, NIAID. She started her career at NIAID in 1991 and has served in many roles at NIAID over the past 32 years. During Ms. McNay's tenure with DCR, she has been responsible for the management and oversight of numerous small and large, multinational clinical trials.
In addition to her role as DCR Deputy Director for Operations and Management, she serves as the DCR Project Lead for the Partnership for Research on Vaccines and Infectious Diseases in Liberia (PREVAIL). PREVAIL is a clinical research partnership between the U.S. Department of Health and Human Services (DHHS) and the Liberian Ministry of Health.
Ms. McNay attended the University of Maryland Baltimore County where she received her bachelor's degree in economics in 1987. In 2002, she received her Master of Science in Management and Healthcare Administration.
Mosoka P. Fallah, PhD, MPH, MA is Program Manager of the Saving Lives and LivelihoodsInitiative, Africa Centres for Disease Control and Prevention. The Initiative supports the acquisition and distribution of 65 million COVID-19 vaccine doses and has a mandate to focus on turning vaccine deliveries into vaccinations. Dr. Fallah completed his PhD in Immunology at the University of Kentucky and his MPH in Global Health/Infectious Disease Epidemiology at the Harvard T. H. Chan School of Public Health. For his work building community-level trust in the Ebola response, Dr. Fallah was named one of the Time Magazine Persons of the Year in 2014.
Dr. Fallah was also the co-founder and Director General of the National Public Health Institute of Liberia (NPHIL), which was founded in response to the devastation of the 2014-2016 Ebola outbreak in Liberia. He has also held positions as a health security technical consultant on pandemic diagnostics with the World Bank, visiting lecturer at Harvard Medical School, and senior consulting scientist atMedical Science & Computing, LLC. He continues to serve as President and CEO of Refuge Place International (RPI), a non-governmental organization dedicated to creating a replicable health care model for economically poor and disenfranchised people residing in the urban slums and poor rural communities of Liberia.

伊莉莎白·S·希格斯醫生 (Dr. Elizabeth S. Higgs, MD, MIA, DTMH) 是一位全球健康科學顧問、臨床科學家及疫情準備研究應對政策專家，現任美國國家過敏與傳染病研究所 (NIAID) 臨床研究部門工作。在她的職業生涯中，希格斯醫生對於多起重大健康緊急事件做出了貢獻，包括 H1N1、非洲西部及剛果民主共和國的埃博拉疫情、2018 年印度喀拉拉邦的尼帕病毒疫情、mpox 及 SARS-CoV-2，證明在健康緊急事件期間進行監管級臨床試驗是可行的，並有助於加速疫情結束的醫療對策。
她以全球健康外交聞名，促進跨機構及多邊合作，積極參與戰略全球健康安全倡議及政策小組，對於《世界銀行的金錢與微生物》、《G7 臨床試驗憲章》及《美國國家生物安全戰略與全球健康安全戰略》等關鍵政策文件做出了重要貢獻。
她的熱情包括在低收入及中等收入國家培養可持續的臨床研究能力，並促進全球臨床試驗網絡的合作。希格斯醫生擁有內科及傳染病的背景，持有醫學博士學位、國際事務碩士學位、生物倫理學跨學科學士學位及熱帶醫學與衛生文憑。通過對應對研究的承諾，她致力於在新興傳染病引發的健康緊急事件中保護和提升全球人民的福祉。
羅伯特·A·索倫森 (Robert A. Sorenson) 自 2016 年以來一直與 NIAID 臨床研究部門合作，專注於傳染病緊急應對政策，特別是對新興病原體的緊急臨床研究應對，此前他自 2009 年以來在美國國務院從事全球健康政策問題的工作。
索倫森先生在國務院擔任外事及文職官員 33 年。2001 年後，由於家庭情況限制了他的海外職業生涯，他主要在海洋、環境與科學局任職，包括擔任國際健康與生物防禦辦公室、環境政策及生態與陸地保護辦公室的副主任。他的海外經驗始於 1986 年，曾在馬尼拉、莫斯科、大阪、斯科普里、塔什干及地拉那擔任政治、領事、環境及副使館長職位，並在多個危機地點擔任臨時任務。他於 2017 年新年前夕從國務院退休，隨後成為 NIAID 的承包商。
作為 PPERR 的主編，索倫森先生重振並更新了他自 1981 年至 1986 年的專業編輯經驗。他於 1999 至 2000 年擔任胡佛機構的國家研究員，並擁有康奈爾大學的俄羅斯文學碩士學位及聖奧拉夫學院的學士學位。
妮可·盧里 (Nicole Lurie, M.D., M.S.P.H.) 是流行病準備與應對聯盟 (CEPI) 的執行董事及 CEPI-US 的主任。她同時也是哈佛醫學院的高級講師及喬治華盛頓大學醫學院的醫學教授。
她曾於 2009 至 2017 年擔任美國衛生與公共服務部的準備與應對助理部長。在此角色中，她領導 HHS 對多起公共健康緊急事件的應對，涵蓋從傳染病到自然及人為災害，並負責許多緊急準備與應對的創新。
在進入聯邦服務之前，她曾擔任 RAND 的保羅·奧尼爾政策分析教授，以及明尼蘇達大學的醫學與公共健康教授。她的研究範疇包括醫療服務的可及性與質量、健康系統重設、健康公平、心理健康、公共健康及準備工作。她獲得了多項獎項，並是國家醫學院的成員。她仍在華盛頓特區的一家社區診所執業。
彼得·史密斯 (Peter Smith) 是倫敦衛生與熱帶醫學院 (LSHTM) 的熱帶流行病學教授。
他在倫敦城市大學獲得數學與統計學學位，並於 1965 年加入倫敦的醫學研究委員會統計研究單位。自那時以來，他在愛丁堡、坎帕拉、牛津、波士頓及日內瓦等地從事流行病學及統計研究的各個方面。他於 1979 年加入 LSHTM，負責 MRC 國際統計與流行病學小組。研究興趣包括針對熱帶疾病的大規模干預研究，最近專注於疫苗。
從 1999 年到 2004 年，史密斯博士擔任英國政府海綿狀腦病顧問委員會的主席。他曾擔任世界衛生組織 (WHO) 疫苗安全全球顧問委員會及 WHO RTS,S/AS01 瘧疾疫苗技術專家小組的主席。他曾擔任納菲爾德生物倫理委員會的副主席，並於 2004 至 2014 年擔任威康信託的董事。他曾在流行病準備創新聯盟 (CEPI) 和歐洲及發展中國家臨床試驗夥伴關係 (EDCTP) 的科學顧問委員會任職。他擔任 WHO SAGE 瘧疾疫苗工作組的主席，並在 WHO SAGE SARS-CoV-2 疫苗工作組中任職。
勞拉·安·麥克內 (Laura Ann McNay, MS) 是 NIAID 臨床研究部門的運營與管理副主任。她於 1991 年在 NIAID 開始她的職業生涯，並在過去的 32 年中擔任過多個職位。在麥克內女士任職 DCR 期間，她負責管理和監督多項小型及大型的多國臨床試驗。
除了擔任 DCR 運營與管理副主任外，她還擔任利比里亞疫苗與傳染病研究夥伴關係 (PREVAIL) 的 DCR 項目負責人。PREVAIL 是美國衛生與公共服務部 (DHHS) 與利比里亞衛生部之間的臨床研究夥伴關係。
麥克內女士於 1987 年在馬里蘭大學巴爾的摩縣校區獲得經濟學學士學位。2002 年，她獲得管理與醫療行政的碩士學位。
莫索卡·P·法拉 (Mosoka P. Fallah, PhD, MPH, MA) 是非洲疾病控制與預防中心的拯救生命與生計倡議的項目經理。該倡議支持 6500 萬劑 COVID-19 疫苗的獲取與分發，並專注於將疫苗交付轉化為接種。法拉博士在肯塔基大學獲得免疫學博士學位，在哈佛 T.H. 陳公共衛生學院獲得全球健康/傳染病流行病學碩士學位。因為在埃博拉應對中建立社區層級的信任，法拉博士於 2014 年被《時代》雜誌評選為年度人物之一。
法拉博士也是利比里亞國家公共衛生研究所 (NPHIL) 的共同創辦人及總幹事，該機構是為了應對 2014-2016 年利比里亞的埃博拉疫情而成立的。他還曾擔任世界銀行的疫情診斷健康安全技術顧問、哈佛醫學院的訪問講師及 Medical Science & Computing, LLC 的高級顧問科學家。他繼續擔任 Refuge Place International (RPI) 的總裁兼首席執行官，該非政府組織致力於為生活在利比里亞城市貧民窟和貧困農村社區的經濟弱勢和被剝奪權利的人們創建可複製的醫療保健模式。