Do National and International Ethics Documents Accord With the Consent Substitute Model for Emergency Research?

In this paper I am going to argue a familiar but still controversial thesis about the relation between international ethics and international law, which I would sum up in the following list of propositions:First, international law is a source as well as an object of ethical judgements. The idea of legality or the rule of law is an ethical one, and international law has ethical significance because it gives institutional expression to the rule of law in international relations.Secondly, international law—or, more precisely, the idea of the rule of law in international relations—reflects a rule-oriented rather than outcome-oriented ethic of international affairs. By insisting on the priority of rules over outcomes, this ethic rejects consequentialism in all its forms.

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Implementation of Community Consultation for Waiver of Informed Consent in Emergency Research: One Institutional Review Board's Experience

Journal of Investigative Medicine ◽

10.1136/jim-52-02-20 ◽

2004 ◽

Vol 52 (2) ◽

pp. 113-116 ◽

Cited By ~ 10

Author(s):

Emily S. Dix ◽

Domenic Esposito ◽

Frances Spinosa ◽

Nancy Olson ◽

Stanley Chapman

Keyword(s):

Informed Consent ◽

Community Consultation ◽

Emergency Research ◽

Institutional Review

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Predicting severe pneumonia in the emergency department: a global study of the Pediatric Emergency Research Networks (PERN)—study protocol

BMJ Open ◽

10.1136/bmjopen-2020-041093 ◽

2020 ◽

Vol 10 (12) ◽

pp. e041093

Author(s):

Todd Adam Florin ◽

Daniel Joseph Tancredi ◽

Lilliam Ambroggio ◽

Franz E Babl ◽

Stuart R Dalziel ◽

...

Keyword(s):

Emergency Department ◽

Prediction Model ◽

Severe Disease ◽

Pediatric Emergency ◽

Global Network ◽

Clinical Prediction ◽

Emergency Research ◽

Research Networks ◽

Clinical Prediction Model ◽

Severity Scores

IntroductionPneumonia is a frequent and costly cause of emergency department (ED) visits and hospitalisations in children. There are no evidence-based, validated tools to assist physicians in management and disposition decisions for children presenting to the ED with community-acquired pneumonia (CAP). The objective of this study is to develop a clinical prediction model to accurately stratify children with CAP who are at risk for low, moderate and severe disease across a global network of EDs.Methods and analysisThis study is a prospective cohort study enrolling up to 4700 children with CAP at EDs at ~80 member sites of the Pediatric Emergency Research Networks (PERN; https://pern-global.com/). We will include children aged 3 months to <14 years with a clinical diagnosis of CAP. We will exclude children with hospital admissions within 7 days prior to the study visit, hospital-acquired pneumonias or chronic complex conditions. Clinical, laboratory and imaging data from the ED visit and hospitalisations within 7 days will be collected. A follow-up telephone or text survey will be completed 7–14 days after the visit. The primary outcome is a three-tier composite of disease severity. Ordinal logistic regression, assuming a partial proportional odds specification, and recursive partitioning will be used to develop the risk stratification models.Ethics and disseminationThis study will result in a clinical prediction model to accurately identify risk of severe disease on presentation to the ED. Ethics approval was obtained for all sites included in the study. Cincinnati Children’s Hospital Institutional Review Board (IRB) serves as the central IRB for most US sites. Informed consent will be obtained from all participants. Results will be disseminated through international conferences and peer-reviewed publications. This study overcomes limitations of prior pneumonia severity scores by allowing for broad generalisability of findings, which can be actively implemented after model development and validation.

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More Than Cheating: Deception, IRB Shopping, and the Normative Legitimacy of IRBs

The Journal of Law Medicine & Ethics ◽

10.1111/j.1748-720x.2012.00726.x ◽

2012 ◽

Vol 40 (4) ◽

pp. 990-996 ◽

Cited By ~ 2

Author(s):

Ryan Spellecy ◽

Thomas May

Keyword(s):

Informed Consent ◽

Multicenter Trial ◽

Federal Regulations ◽

Approval Process ◽

Emergency Research ◽

Moral Issues ◽

The Past ◽

Significant Attention

Deception, cheating, and loopholes within the IRB approval process have received significant attention in the past several years. Surveys of clinical researchers indicate common deception ranging from omitting information to outright lying, and controversy surrounding the FDA's decision not to ban “IRB shopping” (the practice of submitting protocols to multiple IRBs until one is found that will approve the protocol) has raised legitimate concerns about the integrity of the IRB process. One author has described a multicenter trial as being withdrawn from consideration at one institution when rejection was imminent, in order to avoid informing other IRBs reviewing the protocol of the study's rejection (a requirement under the federal regulations for emergency research with an exception from informed consent). This practice and IRB shopping seem at odds with the spirit, if not the “letter,” of the regulations. While at first blush these practices seem to cast aspersions on the integrity of clinical researchers, the moral issues raised go deeper than the ethics of cheating.

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Waiver of consent for emergency research

Annals of Emergency Medicine ◽

10.1016/j.annemergmed.2004.01.041 ◽

2004 ◽

Vol 44 (3) ◽

pp. 278-279 ◽

Cited By ~ 2

Author(s):

Andrew D. McRae ◽

Charles Weijer

Keyword(s):

Emergency Research ◽

Waiver Of Consent

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