The Nuremberg Code: Hippocratic ethics and human rights

Shuster, Evelyne

doi:10.1016/s0140-6736(00)80046-x

Cited by 11 publications

(9 citation statements)

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“…[36][37][38][39][40] IRBs examine the possible risks and benefits for the subjects and approve the informed consent process that is designed to educate and empower prospective subjects. This review is necessitated by the experience that research protocols can either provide benefit or actually harm subjects and on the ethical premise that voluntary informed consent must precede assumption of risk.…”

Section: Discussionmentioning

confidence: 99%

The Quality Improvement–Research Divide and the Need for External Oversight

Bellin

Dubler

2001

Am J Public Health

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Historically, quality assurance studies have received scant ethical attention. The advent of information systems capable of supporting research-grade continuous quality improvement projects demands that we clearly define how these projects differ from research and when they require external review. The ethical obligation for the performance of quality assurance projects, with its emphasis on identifiable immediate action for a served population, is a critical distinction. The obligation to perform continuous quality improvement is a deliverable of the social contract entered into implicitly by patients and health care providers and systems. In this article, the authors review the ethical framework that requires these studies, evaluate the differences between quality assurance studies and classic research, and propose criteria for requiring external review.

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Section: Discussionmentioning

confidence: 99%

The Quality Improvement–Research Divide and the Need for External Oversight

Bellin

Dubler

2001

Am J Public Health

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“…For children to obtain the maximum bene®t and minimum disadvantage of medical innovations, research, both therapeutic and non-therapeutic, will have to be performed on them. However, in some countries there is an anti-research culture and the result may be that``there is a substantial risk that the pathophysiology and treatment of various diseases will be better known in rats than in human beings'' [4]. We should be moving towards an era where large numbers of children with classi®able diseases are admitted into research projects.…”

Section: Discussionmentioning

confidence: 99%

Ethical overview of paediatric research and practice in Europe from the Ethical Working Group of the Confederation of European Specialists in Paediatrics (CESP)

Chambers

Kurz²

1999

European Journal of Pediatrics

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“…The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. The Nuremberg Code [36] Non-statisticians who conduct statistical analyses must have more than simply an instrumental understanding of how to execute the statistical methodology; rather, analysts must understand the statistical foundations and assumptions of methods as well as the science being considered [F.6]. Formal education is not always required for expertise, but statistics and bioinformatics are vast fields with various subspecialties so that training in general statistics may not provide sufficient expertise for specialized applications.…”

Section: Clinical and Translational Research Teams Require Multidiscimentioning

confidence: 99%

“…Doug Altman [64] Sample size estimation should be used to minimize the risk to study subjects while maintaining scientific value, and data monitoring plans should be employed to protect participants throughout the course of the study. The need for power calculations is seen in point #2 of the Nuremberg Code: 'The experiment should be such as to yield fruitful results for the good of society' [36]. Underpowered studies are not likely to yield results with practical translational value; they put subjects at unnecessary risk and waste resources.…”

Section: Appropriate Study Design and Sample Size [D2]mentioning

confidence: 99%

Principles for the ethical analysis of clinical and translational research

Gelfond

Heitman

Pollock

et al. 2011

Statistics in Medicine

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Statistical analysis is a cornerstone of the scientific method and evidence-based medicine, and statisticians serve an increasingly important role in clinical and translational research by providing objective evidence concerning the risks and benefits of novel therapeutics. Researchers rely on statistics and informatics as never before to generate and test hypotheses and to discover patterns of disease hidden within overwhelming amounts of data. Too often, clinicians and biomedical scientists are not adequately proficient in statistics to analyze data or interpret results, and statistical expertise may not be properly incorporated within the research process. We argue for the ethical imperative of statistical standards, and we present ten nontechnical principles that form a conceptual framework for the ethical application of statistics in clinical and translational research. These principles are drawn from the literature on the ethics of data analysis and the American Statistical Association Ethical Guidelines for Statistical Practice.

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The Nuremberg Code: Hippocratic ethics and human rights

Cited by 11 publications

References 0 publications

The Quality Improvement–Research Divide and the Need for External Oversight

The Quality Improvement–Research Divide and the Need for External Oversight

Ethical overview of paediatric research and practice in Europe from the Ethical Working Group of the Confederation of European Specialists in Paediatrics (CESP)

Principles for the ethical analysis of clinical and translational research

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