TY - JOUR
T1 - Site variability in regulatory oversight for an international study of pediatric sepsis
AU - Sepsis Prevalence, Outcomes, and Therapy (SPROUT) Study Investigators and Pediatric Acute Lung Injury and Sepsis Investigators Network
AU - Michelson, Kelly N.
AU - Reubenson, Gary
AU - Weiss, Scott L.
AU - Fitzgerald, Julie C.
AU - Ackerman, Kate K.
AU - Christie, Lee Ann
AU - Bush, Jenny L.
AU - Nadkarni, Vinay M.
AU - Thomas, Neal J.
AU - Schreiner, Mark S.
AU - Fontela, P.
AU - Tucci, M.
AU - Dumistrascu, M.
AU - Skippen, P.
AU - Krahn, G.
AU - Bezares, E.
AU - Puig, G.
AU - Puig-Ramos, A.
AU - Garcia, R.
AU - Villar, M.
AU - Bigham, M.
AU - Polanski, T.
AU - Latifi, S.
AU - Giebne, D.
AU - Anthony, H.
AU - Hume, J.
AU - Galster, A.
AU - Linnerud, L.
AU - Sanders, R.
AU - Hefley, G.
AU - Madden, K.
AU - Thompson, A.
AU - Shein, S.
AU - Gertz, S.
AU - Han, Y.
AU - Williams, T.
AU - Hughes-Schalk, A.
AU - Chandler, H.
AU - Orioles, A.
AU - Zielinski, E.
AU - Doucette, A.
AU - Zebuhr, C.
AU - Wilson, T.
AU - Dimitriades, C.
AU - Ascani, J.
AU - Layburn, S.
AU - Valley, S.
AU - Markowitz, B.
AU - Terry, J.
AU - Donado, J.
N1 - Publisher Copyright:
© 2018 by the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.
PY - 2018/4/1
Y1 - 2018/4/1
N2 - Objectives: Duplicative institutional review board/research ethics committee review for multicenter studies may impose administrative burdens and inefficiencies affecting study implementation and quality. Understanding variability in site-specific institutional review board/research ethics committee assessment and barriers to using a single review committee (an increasingly proposed solution) can inform a more efficient process. We provide needed data about the regulatory oversight process for the Sepsis PRevalence, OUtcomes, and Therapies multicenter point prevalence study. Design: Survey. Setting: Sites invited to participate in Sepsis PRevalence, OUtcomes, and Therapies. Subjects: Investigators at sites that expressed interest and/or participated in Sepsis PRevalence, OUtcomes, and Therapies. Interventions: None. Measurements and Main Results: Using an electronic survey, we collected data about 1) logistics of protocol submission, 2) institutional review board/research ethics committee requested modifications, and 3) use of a single institutional review board (for U.S. sites). We collected surveys from 104 of 167 sites (62%). Of the 97 sites that submitted the protocol for institutional review board/research ethics committee review, 34% conducted full board review, 54% expedited review, and 4% considered the study exempt. Time to institutional review board/research ethics committee approval required a median of 34 (range 3-186) days, which took longer at sites that required protocol modifications (median [interquartile range] 50 d [35-131 d] vs 32 d [14-54 d)]; p = 0.02). Enrollment was delayed at eight sites due to prolonged (> 50 d) time to approval. Of 49 U.S. sites, 43% considered using a single institutional review board, but only 18% utilized this option. Time to final approval for U.S. sites using the single institutional review board was 62 days (interquartile range, 34-70 d) compared with 34 days (interquartile range, 15-54 d) for nonsingle institutional review board sites (p = 0.16). Conclusions: Variability in regulatory oversight was evident for this minimal-risk observational research study, most notably in the category of type of review conducted. Duplicative review prolonged time to protocol approval at some sites. Use of a single institutional review board for U.S. sites was rare and did not improve efficiency of protocol approval. Suggestions for minimizing these challenges are provided.
AB - Objectives: Duplicative institutional review board/research ethics committee review for multicenter studies may impose administrative burdens and inefficiencies affecting study implementation and quality. Understanding variability in site-specific institutional review board/research ethics committee assessment and barriers to using a single review committee (an increasingly proposed solution) can inform a more efficient process. We provide needed data about the regulatory oversight process for the Sepsis PRevalence, OUtcomes, and Therapies multicenter point prevalence study. Design: Survey. Setting: Sites invited to participate in Sepsis PRevalence, OUtcomes, and Therapies. Subjects: Investigators at sites that expressed interest and/or participated in Sepsis PRevalence, OUtcomes, and Therapies. Interventions: None. Measurements and Main Results: Using an electronic survey, we collected data about 1) logistics of protocol submission, 2) institutional review board/research ethics committee requested modifications, and 3) use of a single institutional review board (for U.S. sites). We collected surveys from 104 of 167 sites (62%). Of the 97 sites that submitted the protocol for institutional review board/research ethics committee review, 34% conducted full board review, 54% expedited review, and 4% considered the study exempt. Time to institutional review board/research ethics committee approval required a median of 34 (range 3-186) days, which took longer at sites that required protocol modifications (median [interquartile range] 50 d [35-131 d] vs 32 d [14-54 d)]; p = 0.02). Enrollment was delayed at eight sites due to prolonged (> 50 d) time to approval. Of 49 U.S. sites, 43% considered using a single institutional review board, but only 18% utilized this option. Time to final approval for U.S. sites using the single institutional review board was 62 days (interquartile range, 34-70 d) compared with 34 days (interquartile range, 15-54 d) for nonsingle institutional review board sites (p = 0.16). Conclusions: Variability in regulatory oversight was evident for this minimal-risk observational research study, most notably in the category of type of review conducted. Duplicative review prolonged time to protocol approval at some sites. Use of a single institutional review board for U.S. sites was rare and did not improve efficiency of protocol approval. Suggestions for minimizing these challenges are provided.
KW - institutional review board
KW - pediatrics
KW - research ethics
KW - research ethics committee
KW - sepsis
UR - http://www.scopus.com/inward/record.url?scp=85053849396&partnerID=8YFLogxK
U2 - 10.1097/PCC.0000000000001455
DO - 10.1097/PCC.0000000000001455
M3 - Artículo en revista científica indexada
C2 - 29377867
AN - SCOPUS:85053849396
SN - 1529-7535
VL - 19
SP - e180-e188
JO - Pediatric Critical Care Medicine
JF - Pediatric Critical Care Medicine
IS - 4
ER -