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Site Variability in Regulatory Oversight for an International Study of Pediatric Sepsis.

Publication ,  Journal Article
Michelson, KN; Reubenson, G; Weiss, SL; Fitzgerald, JC; Ackerman, KK; Christie, L; Bush, JL; Nadkarni, VM; Thomas, NJ; Schreiner, MS ...
Published in: Pediatr Crit Care Med
April 2018

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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Published In

Pediatr Crit Care Med

DOI

ISSN

1529-7535

Publication Date

April 2018

Volume

19

Issue

4

Start / End Page

e180 / e188

Location

United States

Related Subject Headings

  • Time Factors
  • Surveys and Questionnaires
  • Sepsis
  • Research Design
  • Prospective Studies
  • Prevalence
  • Pediatrics
  • Humans
  • Ethics Committees, Research
  • Ethical Review
 

Citation

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ICMJE
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Michelson, K. N., Reubenson, G., Weiss, S. L., Fitzgerald, J. C., Ackerman, K. K., Christie, L., … 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. Pediatr Crit Care Med, 19(4), e180–e188. https://doi.org/10.1097/PCC.0000000000001455
Michelson, Kelly N., Gary Reubenson, Scott L. Weiss, Julie C. Fitzgerald, Kate K. Ackerman, LeeAnn Christie, Jenny L. Bush, et al. “Site Variability in Regulatory Oversight for an International Study of Pediatric Sepsis.Pediatr Crit Care Med 19, no. 4 (April 2018): e180–88. https://doi.org/10.1097/PCC.0000000000001455.
Michelson KN, Reubenson G, Weiss SL, Fitzgerald JC, Ackerman KK, Christie L, et al. Site Variability in Regulatory Oversight for an International Study of Pediatric Sepsis. Pediatr Crit Care Med. 2018 Apr;19(4):e180–8.
Michelson, Kelly N., et al. “Site Variability in Regulatory Oversight for an International Study of Pediatric Sepsis.Pediatr Crit Care Med, vol. 19, no. 4, Apr. 2018, pp. e180–88. Pubmed, doi:10.1097/PCC.0000000000001455.
Michelson KN, Reubenson G, Weiss SL, Fitzgerald JC, Ackerman KK, Christie L, Bush JL, Nadkarni VM, Thomas NJ, Schreiner MS, 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. Pediatr Crit Care Med. 2018 Apr;19(4):e180–e188.

Published In

Pediatr Crit Care Med

DOI

ISSN

1529-7535

Publication Date

April 2018

Volume

19

Issue

4

Start / End Page

e180 / e188

Location

United States

Related Subject Headings

  • Time Factors
  • Surveys and Questionnaires
  • Sepsis
  • Research Design
  • Prospective Studies
  • Prevalence
  • Pediatrics
  • Humans
  • Ethics Committees, Research
  • Ethical Review