title: Time required to initiate outbreak and pandemic observational research.
abstract: Observational research focused upon emerging infectious diseases such as Ebola virus, Middle East respiratory syndrome, and Zika virus has been challenging to quickly initiate. We aimed to determine the duration of start-up procedures and barriers encountered for an observational study focused upon such infectious outbreaks.
  
  
  
  At 1 pediatric and 5 adult intensive care units, we measured durations from protocol receipt to a variety of outbreak research milestones, including research ethics board (REB) approval, data sharing agreement (DSA) execution, and patient study screening initiation.
  
  
  
  The median (interquartile range) time from site receipt of the protocol to REB submission was 73 (30-126) days; to REB approval, 158 (42-188) days; to DSA completion, 276 (186-312) days; and to study screening initiation, 293 (269-391) days. The median time from REB submission to REB approval was 43 (13-85) days. The median time for all start-up procedures was 335 (188-335) days.
  
  
  
  There is a lengthy start-up period required for outbreak-focused research. Completing DSAs was the most time-consuming step. A reactive approach to newly emerging threats such as Ebola virus, Middle East respiratory syndrome, and Zika virus will likely not allow sufficient time to initiate research before most outbreaks are advanced.
authors.affiliation: Department of Critical Care Medicine, Sunnybrook Health Sciences Center, Toronto, Ontario, M4N 3M5, Canada.
authors.forename: Asgar H
authors.initials: AH
authors.lastname: Rishu
authors.affiliation: Department of Critical Care Medicine, Sunnybrook Health Sciences Center, Toronto, Ontario, M4N 3M5, Canada.
authors.forename: Nicole
authors.initials: N
authors.lastname: Marinoff
authors.affiliation: Division of Critical Care Medicine, Dalhousie University and the Capital District Health Authority, Halifax, Nova Scotia, B3H 1V7, Canada.
authors.forename: Lisa
authors.initials: L
authors.lastname: Julien
authors.affiliation: Département de Pédiatrics et Soins Intensifs, Hôpital Ste-Justine, l'Université de Montréal, Montréal, Québec, H3T 1C5, Canada.
authors.forename: Mariana
authors.initials: M
authors.lastname: Dumitrascu
authors.affiliation: Section of Critical Care Medicine, St Boniface Hospital, University of Manitoba, Winnipeg, Manitoba, R2H 2A6, Canada.
authors.forename: Nicole
authors.initials: N
authors.lastname: Marten
authors.affiliation: Section of Critical Care Medicine, St Boniface Hospital, University of Manitoba, Winnipeg, Manitoba, R2H 2A6, Canada.
authors.forename: Shauna
authors.initials: S
authors.lastname: Eggertson
authors.affiliation: Department of Critical Care Medicine, Royal Columbian Hospital, University of British Columbia, Vancouver, British Columbia, V3L 3W7, Canada.
authors.forename: Su
authors.initials: S
authors.lastname: Willems
authors.affiliation: Department of Critical Care Medicine, Foothills Hospital, University of Calgary, Alberta, Canada T2N 2T9.
authors.forename: Stacy
authors.initials: S
authors.lastname: Ruddell
authors.affiliation: Department of Critical Care Medicine, Foothills Hospital, University of Calgary, Alberta, Canada T2N 2T9.
authors.forename: Dan
authors.initials: D
authors.lastname: Lane
authors.affiliation: Section of Critical Care Medicine, St Boniface Hospital, University of Manitoba, Winnipeg, Manitoba, R2H 2A6, Canada.
authors.forename: Bruce
authors.initials: B
authors.lastname: Light
authors.affiliation: Department of Critical Care Medicine, Foothills Hospital, University of Calgary, Alberta, Canada T2N 2T9.
authors.forename: Henry T
authors.initials: HT
authors.lastname: Stelfox
authors.affiliation: Département de Pédiatrics et Soins Intensifs, Hôpital Ste-Justine, l'Université de Montréal, Montréal, Québec, H3T 1C5, Canada.
authors.forename: Philippe
authors.initials: P
authors.lastname: Jouvet
authors.affiliation: Division of Critical Care Medicine, Dalhousie University and the Capital District Health Authority, Halifax, Nova Scotia, B3H 1V7, Canada.
authors.forename: Richard
authors.initials: R
authors.lastname: Hall
authors.affiliation: Department of Critical Care Medicine, Royal Columbian Hospital, University of British Columbia, Vancouver, British Columbia, V3L 3W7, Canada.
authors.forename: Steven
authors.initials: S
authors.lastname: Reynolds
authors.affiliation: Division of Infectious Diseases, Department of Medicine and Clinical Epidemiology, Sunnybrook Health Sciences Centre, University of Toronto, Toronto, Ontario, Canada M4N 3M5.
authors.forename: Nick
authors.initials: N
authors.lastname: Daneman
authors.affiliation: Departments of Medicine and Critical Care Medicine, Sunnybrook Health Sciences Center, Institute of Health Policy Management and Evaluation, University of Toronto, Toronto, Ontario, Canada M4N 3M5. Electronic address: rob.fowler@sunnybrook.ca.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Fowler
mesh_terms: D019985:Benchmarking; D021821:Communicable Diseases, Emerging / Q000453:epidemiology* / Q000517:prevention & control; D004812:Epidemiologic Methods; D006801:Humans; D064887:Observational Studies as Topic; D009864:Ontario / Q000453:epidemiology; D058873:Pandemics; D012107:Research Design
keywords: Canada; Critical; Intensive care; Outbreak; Pandemic; Research