dc.contributor.author | Michelson, KN | |
dc.contributor.author | Reubenson, G | |
dc.contributor.author | Weiss, SL | |
dc.contributor.author | Fitzgerald, JC | |
dc.contributor.author | Ackerman, KK | |
dc.contributor.author | Christie, LA | |
dc.contributor.author | Bush, JL | |
dc.contributor.author | Nadkarni, VM | |
dc.contributor.author | Thomas, NJ | |
dc.contributor.author | Schreiner, MS | |
dc.contributor.author | Fontela, P | |
dc.contributor.author | Tucci, M | |
dc.contributor.author | Dumistrascu, M | |
dc.contributor.author | Long, Debbie | |
dc.contributor.author | et al. | |
dc.date.accessioned | 2020-02-04T01:12:15Z | |
dc.date.available | 2020-02-04T01:12:15Z | |
dc.date.issued | 2018 | |
dc.identifier.issn | 1529-7535 | |
dc.identifier.doi | 10.1097/PCC.0000000000001455 | |
dc.identifier.uri | http://hdl.handle.net/10072/391090 | |
dc.description.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. | |
dc.description.peerreviewed | Yes | |
dc.language | English | |
dc.language.iso | eng | |
dc.publisher | Lippincott Williams & Wilkins | |
dc.publisher.place | United States | |
dc.relation.ispartofpagefrom | e180 | |
dc.relation.ispartofpageto | e188 | |
dc.relation.ispartofissue | 4 | |
dc.relation.ispartofjournal | Pediatric Critical Care Medicine | |
dc.relation.ispartofvolume | 19 | |
dc.subject.fieldofresearch | Nursing | |
dc.subject.fieldofresearchcode | 4205 | |
dc.title | Site variability in regulatory oversight for an international study of pediatric sepsis | |
dc.type | Journal article | |
dc.type.description | C1 - Articles | |
dcterms.bibliographicCitation | Michelson, 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.updated | 2020-02-04T00:53:18Z | |
gro.hasfulltext | No Full Text | |
gro.griffith.author | Long, Debbie A. | |