The book, which is described as “Part memoir, part scrapbook,” will be the ultimate official record of Leppard's legendary career.Īccording to the press release, the tome “is narrated by the band in their own words, illustrated with photography and memorabilia from the Def Leppard archives. Thus, data about how parents felt about the two approaches was not gathered, but in future studies this would be important information for both the IRB and the study team in terms of utilizing “retrospective consent.” The Belmont Report outlines ethical guidelines for conduct of human subjects research and its first core principal is respect for persons, pragmatically operationalized in the informed consent process which underlines the key point that research is voluntary.Coming soon via Genesis Publications is Def Leppard's first official band biography, titled Definitely: The Official Story Of Def Leppard. The original HIPSTER trial was not primarily intended to examine the parental consequences of the differing consent methods. I won’t give you the “spoiler” here, and hope you will read the article to understand how and if the change impacted the population studied and the trial outcome. Thus “retrospective consent,” also described as deferred consent, allowed the researchers to approach parents a bit later, in the first few days of life, and at a calmer moment. However, as our common sense tells us, and as Songstad and colleagues articulate clearly, the parents of potential subjects were stressed, distressed, and potentially in pain, so not in a mental and emotional state to rationally consider, or even want to consider, research, especially with a tight 4-hour timeline for a decision. Although the potential subjects (preterm infants) were ill and treatment was urgent, their surrogates (the parents) were mainly available and present. There are guidelines for both (1)- emergency use of a test article (device or drug) and (2)-planned research in emergency settings with a waiver of consent, and HIPSTER was neither of these. ![]() ![]() The process of “retrospective consent” or of obtaining consent after study procedures have begun, is not specifically described in the US Code of Federal Regulations. In general, informed consent must be obtained before any research begins. The Ethics Committee then decided, with justification also based on Australian national guidelines, that a “deferred” or “retrospective” consent process was allowable. The audit revealed that many parents were interested in study participation, but did not feel that they could decide as quickly as needed and with enough certainty to participate. The Ethics Committee (wisely I believe) asked the study team to conduct prospective consent for 3 months to be followed by an audit and a re-consideration of the question. A unique set of clinical trial circumstances facilitated this consent process comparison: HIPSTER’s study team initially asked their Ethics Committee (the Australian equivalent of US Institutional Review Board ) to approve a consent process that would allow randomization and initial treatment before parental consent could be obtained. Preterm infants had to be enrolled within 4 hours of beginning CPAP, which was the standard treatment in the neonatal unit. ![]() HIPSTER was a randomized, un-blinded multicenter trial that compared high flow nasal cannula to continuous positive airway pressure (CPAP) as primary respiratory support for preterm infants that needed respiratory support but not intubation within 24 hours of birth. In a recent article in Pediatrics, Nils Songstad and colleagues examine the impact of a non-traditional “retrospective” consent process, versus the usual prospective consent process, on rates of recruitment, characteristics of enrolled subjects and study outcomes in the HIPSTER (Nasal High-Flow Therapy for Primary Respiratory Support in Preterm Infants) study ( 10.1542/peds.2017-2092).
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