A Framework for Risk-Benefit Evaluations in Biomedical Research

Rid, Annette; Wendler, David

doi:10.1353/ken.2011.0007

Cited by 109 publications

(111 citation statements)

References 61 publications

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“…The use of placebo controls must therefore be scrutinized like most other research procedures. This implies -consistent with the earlier-mentioned criteria for acceptable placebo use -that the risks of withholding or delaying an established effective intervention must be minimized and justified in relation to the potential clinical benefits to participants and/ or the scientific and social value of the knowledge to be gained from the research Brody, 2003, 2007;Rid and Wendler, 2011).…”

Section: 'Acceptable' Risk From Withholding Treatmentmentioning

confidence: 61%

Placebo-Controlled Trials, Ethics of

Graaf

Rid

2015

International Encyclopedia of the Social &Amp; Behavioral Sciences

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There are often good scientific and ethical reasons for using placebo controls in clinical trials. At the same time placebo use is controversial, especially when an established effective treatment is being withheld from the control group. This article gives an overview of the key ethical positions in the controversy around placebo-controlled trials. While some argue that placebo controls can only be used when withholding or delaying an established effective treatment poses no or negligible risks to participants, others hold that the risks should be low or acceptable in light of the social value of the knowledge to be gained from the research. The article also describes different positions on placebo use in trials in low-and middle-income countries where study participants may not have had access to an established effective treatment outside the trial.

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Section: 'Acceptable' Risk From Withholding Treatmentmentioning

confidence: 61%

Placebo-Controlled Trials, Ethics of

Graaf

Rid

2015

International Encyclopedia of the Social &Amp; Behavioral Sciences

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“…9,12,[14][15][16] Definitions and meanings of risk vary, however, and understanding these in terms of hazard, exposure, consequence and probability is complex. 6 In this study, we identified three major differences in perspectives about risk between HCPs and ISCIs.…”

Section: Discussionmentioning

confidence: 99%

“…3,4 However, risk is a complex concept with different meanings, definitions and layers. 5,6 Academic papers dissect risks according to different definitions, phrasing risks in terms of an unwanted event, the cause of an unwanted event or a probability formula. 7,8 They analyze risks within levels of uncertainty, 9,10 and consider, on a theoretical level, and without reference to a practical definition, which risks would be acceptable to the SCI population on micro, meso and macro levels.…”

Section: Introductionmentioning

confidence: 99%

Dissociations in the meaning of risk between health-care professionals and individuals with spinal cord injury

Eijkholt

Illes

2013

Spinal Cord

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Objective: Risks have been a central concern in stem cell research overall, and in clinical trials of individuals with spinal cord injury (ISCIs) in particular. We sought to elucidate how two important stakeholder groups-health-care professionals (HCPs) and ISCIs-view and value both the physical and non-physical risks of stem cell interventions. Setting: The study was conducted in Canada, and included participants from both Canada and the United States America. Study design: We used semi-structured interviews to gain perspectives on risk from HCPs and ISCIs. Methods: We applied a constant comparative analytic strategy to derive themes from the discourse collected through the interviews. Results: We identified three major themes about risk from 12 HCP and 24 ISCI participants: focus, rationale and approach. The salient components of the themes differed: HCPs focus on the physical causes of risks, and the ISCIs on their downstream consequences as well as on non-physical risks; HCPs are concerned about evidence, and ISCIs about experience; and HCPs approach risk narrowly, whereas the approach of ISCIs is more broad and contextualized. Conclusion: Although major themes were common to the two stakeholder groups, the components of the themes were dissociable and illustrate differences in what HCPs and ISCIs worry about, why they worry and how they approach their worries. We draw upon these findings to make recommendations for improving risk communication and informed consent for stem cell research for spinal cord injury.

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“…This technique is important for many kinds of laboratory research, but in addition it has potential technological applications in such diverse fields as medicine, agriculture, and industry. Indeed, recombinant DNA methods are already being employed to produce medically important hormones, such as insulin and human growth hormone 23 .…”

Section: Scientific Freedom In Research At the Molecular Levelmentioning

confidence: 99%

Scientific Freedom & Limits - Clinical Research Perspective

Fakruddin

Chowdhury

Hossain

et al. 2013

Bangladesh J Bioethics

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Being a scientist, especially a clinical research one, is a noble but tough job. Scientific job is different from other jobs in terms of working hour and pressure; they need more freedom in their job & research that also put lots of responsibility on them. Research is funded by public money and it is the responsibility of scientists to gain maximum output from it. Clinical research is very complex and involves the use of animal, microbial as well as human samples and volunteers which make it more prone to ethical scrutiny. Minority of researchers who commit fraudulent use of public money & unethical clinical practice threaten public support for science. Now a day, there is growing concern of public and politicians on the freedom of scientists and unethical scientific practice in clinical trials. The most efficient measures to prevent scientific misconduct are awareness-notably, self-awarenesseducation and transparency. Most of the developed countries have formulated their own guidelines to ensure proper utilization and ethical clinical research and trials. Bangladesh is still lagging behind in terms of regulation and monitoring of clinical research and trials. This review aims to make related peoples to be aware of the necessity of its own guidelines for clinical research and trials.

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A Framework for Risk-Benefit Evaluations in Biomedical Research

Cited by 109 publications

References 61 publications

Placebo-Controlled Trials, Ethics of

Placebo-Controlled Trials, Ethics of

Dissociations in the meaning of risk between health-care professionals and individuals with spinal cord injury

Scientific Freedom & Limits - Clinical Research Perspective

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