Show simple item record

dc.contributor.authorMichelson, KN
dc.contributor.authorReubenson, G
dc.contributor.authorWeiss, SL
dc.contributor.authorFitzgerald, JC
dc.contributor.authorAckerman, KK
dc.contributor.authorChristie, LA
dc.contributor.authorBush, JL
dc.contributor.authorNadkarni, VM
dc.contributor.authorThomas, NJ
dc.contributor.authorSchreiner, MS
dc.contributor.authorFontela, P
dc.contributor.authorTucci, M
dc.contributor.authorDumistrascu, M
dc.contributor.authorLong, Debbie
dc.contributor.authoret al.
dc.date.accessioned2020-02-04T01:12:15Z
dc.date.available2020-02-04T01:12:15Z
dc.date.issued2018
dc.identifier.issn1529-7535
dc.identifier.doi10.1097/PCC.0000000000001455
dc.identifier.urihttp://hdl.handle.net/10072/391090
dc.description.abstractObjectives: 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.
dc.description.peerreviewedYes
dc.languageEnglish
dc.language.isoeng
dc.publisherLippincott Williams & Wilkins
dc.publisher.placeUnited States
dc.relation.ispartofpagefrome180
dc.relation.ispartofpagetoe188
dc.relation.ispartofissue4
dc.relation.ispartofjournalPediatric Critical Care Medicine
dc.relation.ispartofvolume19
dc.subject.fieldofresearchNursing
dc.subject.fieldofresearchcode4205
dc.titleSite variability in regulatory oversight for an international study of pediatric sepsis
dc.typeJournal article
dc.type.descriptionC1 - Articles
dcterms.bibliographicCitationMichelson, KN et al., Site variability in regulatory oversight for an international study of pediatric sepsis, Pediatric Critical Care Medicine, 2018, 19 (4), pp. e180-e188
dc.date.updated2020-02-04T00:53:18Z
gro.hasfulltextNo Full Text
gro.griffith.authorLong, Debbie A.


Files in this item

FilesSizeFormatView

There are no files associated with this item.

This item appears in the following Collection(s)

  • Journal articles
    Contains articles published by Griffith authors in scholarly journals.

Show simple item record