Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis

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dc.contributor.author Doig, Christopher J
dc.contributor.author Page, Stacey A
dc.contributor.author McKee, Jessica L
dc.contributor.author Moore, Ernest E
dc.contributor.author Abu-Zidan, Fikri M
dc.contributor.author Carroll, Rosemary
dc.contributor.author Marshall, John C
dc.contributor.author Faris, Peter D
dc.contributor.author Tolonen, Matti
dc.contributor.author Catena, Fausto
dc.contributor.author Cocolini, Federico
dc.contributor.author Sartelli, Massimo
dc.contributor.author Ansaloni, Luca
dc.contributor.author Minor, Sam F
dc.contributor.author Peirera, Bruno M
dc.contributor.author Diaz, Jose J
dc.contributor.author Kirkpatrick, Andrew W
dc.date.accessioned 2019-08-11T03:23:33Z
dc.date.available 2019-08-11T03:23:33Z
dc.date.issued 2019-08-05
dc.identifier.citation World Journal of Emergency Surgery. 2019 Aug 05;14(1):39
dc.identifier.uri http://hdl.handle.net/10138/304475
dc.description.abstract Abstract Background Severe complicated intra-abdominal sepsis (SCIAS) has high mortality, thought due in part to progressive bio-mediator generation, systemic inflammation, and multiple organ failure. Treatment includes early antibiotics and operative source control. At surgery, open abdomen management with negative-peritoneal-pressure therapy (NPPT) has been hypothesized to mitigate MOF and death, although clinical equipoise for this operative approach exists. The Closed or Open after Laparotomy (COOL) study ( https://clinicaltrials.gov/ct2/show/NCT03163095 ) will prospectively randomize eligible patients intra-operatively to formal abdominal closure or OA with NPTT. We review the ethical basis for conducting research in SCIAS. Main body Research in critically ill incapacitated patients is important to advance care. Conducting research among SCIAS is complicated due to the severity of illness including delirium, need for emergent interventions, diagnostic criteria confirmed only at laparotomy, and obtundation from anaesthesia. In other circumstances involving critically ill patients, clinical experts have worked closely with ethicists to apply principles that balance the rights of patients whilst simultaneously permitting inclusion in research. In Canada, the Tri-Council Policy Statement-2 (TCPS-2) describes six criteria that permit study enrollment and randomization in such situations: (a) serious threat to the prospective participant requires immediate intervention; (b) either no standard efficacious care exists or the research offers realistic possibility of direct benefit; (c) risks are not greater than that involved in standard care or are clearly justified by prospect for direct benefits; (d) prospective participant is unconscious or lacks capacity to understand the complexities of the research; (e) third-party authorization cannot be secured in sufficient time; and (f) no relevant prior directives are known to exist that preclude participation. TCPS-2 criteria are in principle not dissimilar to other (inter)national criteria. The COOL study will use waiver of consent to initiate enrollment and randomization, followed by surrogate or proxy consent, and finally delayed informed consent in subjects that survive and regain capacity. Conclusions A delayed consent mechanism is a practical and ethical solution to challenges in research in SCIAS. The ultimate goal of consent is to balance respect for patient participants and to permit participation in new trials with a reasonable opportunity for improved outcome and minimal risk of harm.
dc.publisher BioMed Central
dc.subject Intra-peritoneal sepsis
dc.subject Open-abdomen
dc.subject Randomized controlled trial
dc.subject Multiple organ dysfunction
dc.subject Consent
dc.subject Waiver
dc.title Ethical considerations in conducting surgical research in severe complicated intra-abdominal sepsis
dc.date.updated 2019-08-11T03:23:33Z
dc.language.rfc3066 en
dc.rights.holder The Author(s).
dc.type.uri http://purl.org/eprint/entityType/ScholarlyWork
dc.type.uri http://purl.org/eprint/entityType/Expression
dc.type.uri http://purl.org/eprint/type/JournalArticle

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