Details

Autor(en) / Beteiligte

• Rishu, Asgar H
• Marinoff, Nicole
• Julien, Lisa
• Dumitrascu, Mariana
• Marten, Nicole
• Eggertson, Shauna
• Willems, Su
• Ruddell, Stacy
• Lane, Dane
• Light, Bruce
• Stelfox, Henry T
• Jouvet, Philippe
• Hall, Richard
• Reynolds, Steven
• Daneman, Nick
• Fowler, Robert A

Titel

Time required to initiate outbreak and pandemic observational research

Ist Teil von

• Journal of critical care, 2017-08, Vol.40, p.7-10

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2017

Link zum Volltext

Quelle

MEDLINE

Beschreibungen/Notizen

• Abstract Purpose Observational research focused upon emerging infectious diseases such as Ebola virus, Middle East Respiratory Syndrome (MERS-CoV) 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. Materials and methods At 1 pediatric and 5 adult ICUs, 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. Results The median (IQR) time from site receipt of the protocol to REB submission was 73 (30126) days; to REB approval 158 (42188) days; to DSA completion 276 (186312) days; and to study screening initiation 293 (269391) 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 (188335) days. Conclusions There is a lengthy start-up period required for outbreak-focussed research. Completing data sharing agreements was the most time consuming step. A reactive approach to newly emerging threats such as Ebola virus, MERS-CoV and Zika virus will likely not allow sufficient time to initiate research before most outbreaks are advanced.