Site variability in regulatory oversight for an international study of pediatric sepsis

Sepsis Prevalence, Outcomes, and Therapy (SPROUT) Study Investigators and Pediatric Acute Lung Injury and Sepsis Investigators Network

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)e180-e188
JournalPediatric Critical Care Medicine
Volume19
Issue number4
DOIs
Publication statusPublished - 1 Apr 2018

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Research Ethics Committees
Sepsis
Pediatrics
Advisory Committees
Multicenter Studies
Observational Studies

Keywords

  • institutional review board
  • pediatrics
  • research ethics
  • research ethics committee
  • sepsis

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Critical Care and Intensive Care Medicine

Cite this

Sepsis Prevalence, Outcomes, and Therapy (SPROUT) Study Investigators and Pediatric Acute Lung Injury and Sepsis Investigators Network (2018). Site variability in regulatory oversight for an international study of pediatric sepsis. Pediatric Critical Care Medicine, 19(4), e180-e188. https://doi.org/10.1097/PCC.0000000000001455

Site variability in regulatory oversight for an international study of pediatric sepsis. / Sepsis Prevalence, Outcomes, and Therapy (SPROUT) Study Investigators and Pediatric Acute Lung Injury and Sepsis Investigators Network.

In: Pediatric Critical Care Medicine, Vol. 19, No. 4, 01.04.2018, p. e180-e188.

Research output: Contribution to journalArticle

Sepsis Prevalence, Outcomes, and Therapy (SPROUT) Study Investigators and Pediatric Acute Lung Injury and Sepsis Investigators Network 2018, 'Site variability in regulatory oversight for an international study of pediatric sepsis', Pediatric Critical Care Medicine, vol. 19, no. 4, pp. e180-e188. https://doi.org/10.1097/PCC.0000000000001455
Sepsis Prevalence, Outcomes, and Therapy (SPROUT) Study Investigators and Pediatric Acute Lung Injury and Sepsis Investigators Network. Site variability in regulatory oversight for an international study of pediatric sepsis. Pediatric Critical Care Medicine. 2018 Apr 1;19(4):e180-e188. https://doi.org/10.1097/PCC.0000000000001455
Sepsis Prevalence, Outcomes, and Therapy (SPROUT) Study Investigators and Pediatric Acute Lung Injury and Sepsis Investigators Network. / Site variability in regulatory oversight for an international study of pediatric sepsis. In: Pediatric Critical Care Medicine. 2018 ; Vol. 19, No. 4. pp. e180-e188.
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abstract = "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.",
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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 - Tang, Swee Fong

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

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