The evaluation of the risks and benefits of phase II cancer clinical trials by institutional review board (IRB) members: a case study

Luijn, H.E.M. van; Aaronson, Neil K.; Keus, Ronald B.; Musschenga, Albert W.

doi:10.1136/jme.2002.001503

Cited by 17 publications

(5 citation statements)

References 13 publications

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“…This concern is reinforced by empirical studies which find significant variation in the assessment of research risks (5)(6)(7). In a survey of 188 IRB chairpersons in the U.S., 23% categorized allergy skin testing as minimal risk in healthy 11-year olds, 43% categorized the same procedure, in the same population, as a minor increase over minimal risk, and 27% categorized it as more than a minor increase over minimal risk (5).…”

Section: The Ethics Of Research Risk and Empirical Datamentioning

confidence: 99%

A proposal and prototype for a Research Risk Repository to improve the protection of research participants

Rid

Wendler

2011

Clinical Trials

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A Research Risk Repository has the potential to significantly improve the consistency and accuracy of the evaluation of research risks. However, currently available data are generally insufficient for this purpose. Future collection and maintenance of data on the risks posed by research interventions will help to ensure that research participants receive appropriate protection and promote important research consistent with adequate subject protection.

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Section: The Ethics Of Research Risk and Empirical Datamentioning

confidence: 99%

A proposal and prototype for a Research Risk Repository to improve the protection of research participants

Rid

Wendler

2011

Clinical Trials

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“…These principles do not seem to have been fulfilled - particularly in the 1990s - due to the absence of sufficient patient information, true and honest information (cf. Q2) and informed decision-making abilities unaffected by stakeholder interests [ 19 , 70 , 78 , 93 ]. "The physician and patient should both undertake self-examination to ensure the treatment is being carried out for the right reasons [ 79 ]".…”

Section: Resultsmentioning

confidence: 99%

Ethical issues in autologous stem cell transplantation (ASCT) in advanced breast cancer: A systematic literature review

et al. 2011

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BackgroundAn effectiveness assessment on ASCT in locally advanced and metastatic breast cancer identified serious ethical issues associated with this intervention. Our objective was to systematically review these aspects by means of a literature analysis.MethodsWe chose the reflexive Socratic approach as the review method using Hofmann's question list, conducted a comprehensive literature search in biomedical, psychological and ethics bibliographic databases and screened the resulting hits in a 2-step selection process. Relevant arguments were assembled from the included articles, and were assessed and assigned to the question list. Hofmann's questions were addressed by synthesizing these arguments.ResultsOf the identified 879 documents 102 included arguments related to one or more questions from Hofmann's question list. The most important ethical issues were the implementation of ASCT in clinical practice on the basis of phase-II trials in the 1990s and the publication of falsified data in the first randomized controlled trials (Bezwoda fraud), which caused significant negative effects on recruiting patients for further clinical trials and the doctor-patient relationship. Recent meta-analyses report a marginal effect in prolonging disease-free survival, accompanied by severe harms, including death. ASCT in breast cancer remains a stigmatized technology. Reported health-related-quality-of-life data are often at high risk of bias in favor of the survivors. Furthermore little attention has been paid to those patients who were dying.ConclusionsThe questions were addressed in different degrees of completeness. All arguments were assignable to the questions. The central ethical dimensions of ASCT could be discussed by reviewing the published literature.

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“…Improving the quality of risk/benefit judgments is a long-standing problem in research ethics 14. Despite the fact that numerous evaluative frameworks have been proposed,15 ethical review boards continue to have difficulty with risk/benefit evaluation 16. This can be explained in part by the relevant likelihoods for harm and benefit remaining implicit in protocols, forcing reviewers to interpret statements in natural language according to their intuitions or subjective experience.…”

Section: Virtues Of Explicit Forecasting In Trial Protocolsmentioning

confidence: 99%

Ethics and epistemology of accurate prediction in clinical research

Hey

2014

J Med Ethics

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All major research ethics policies assert that the ethical review of clinical trial protocols should include a systematic assessment of risks and benefits. But despite this policy, protocols do not typically contain explicit probability statements about the likely risks or benefits involved in the proposed research. In this essay, I articulate a range of ethical and epistemic advantages that explicit forecasting would offer to the health research enterprise. I then consider how some particular confidence levels may come into conflict with the principles of ethical research.

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The evaluation of the risks and benefits of phase II cancer clinical trials by institutional review board (IRB) members: a case study

Cited by 17 publications

References 13 publications

A proposal and prototype for a Research Risk Repository to improve the protection of research participants

A proposal and prototype for a Research Risk Repository to improve the protection of research participants

Ethical issues in autologous stem cell transplantation (ASCT) in advanced breast cancer: A systematic literature review

Ethics and epistemology of accurate prediction in clinical research

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