Enhancing Informed Consent in Clinical Trials and Exploring Resistances to Disclosing Adverse Clinical Trial Results

Banja, John D.; Dunlop, Boadie W.

doi:10.1080/15265160902948330

The American Journal of Bioethics

2009

DOI: 10.1080/15265160902948330

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Enhancing Informed Consent in Clinical Trials and Exploring Resistances to Disclosing Adverse Clinical Trial Results

John D. Banja

Boadie W. Dunlop

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Cited by 4 publications

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“…This said, if a genuine case can be made that the disclosure of adverse results from early stage trials will not endanger commercial interests, or if pharmaceutical companies themselves were willing to disclose these results, we would be perfectly happy to endorse their public disclosure. Banja and Dunlop (2009) suggest that Institutional Review Boards (IRBs) could play the role of our envisaged oversight body. Our main concern with this suggestion is that many current IRBs are insufficiently independent to play this role.…”

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Disclosing Clinical Trial Results: Publicity, Significance and Independence

Liao¹,

Sheehan²,

Clarke³

2009

The American Journal of Bioethics

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We shall start by making three clarifications of our position. 1 First, the US Food and Drug Administration Amendments Act of 2007 requires the public disclosure of results from completed clinical studies of approved drugs. 2 Our proposal complements this Act and extends it. Like the FDA, we believe that results from completed clinical studies of approved drugs should be made public. Our proposal focuses particularly on early stage trials such as animal studies, Phase I and early Phase II trials. Here a plausible case can be made that keeping results of these early stage clinical trials from a company's market competitors can make the difference between a company's flourishing and failing in an open market (Liao et al. 2009).Second, we argue that there is a duty to disclose adverse trial results, because there is a human right not to be placed at risk of harm without informed consent. Our view is that information about 'significant risks' must be disclosed for the purposes of informed consent (Liao et al. 2009). Appeals to a threshold of significance can be understood in at least two ways. On an objective interpretation, all risks of harm that exceed a certain degree of likelihood must be disclosed. On a subjective interpretation, all risks of harm that are material to the decision making of particular prospective participants regarding participation in clinical trials must be disclosed. We take no stand on the issue of how to interpret We would like to thank the commentators for their points, and for the opportunity to clarify our proposal.

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confidence: 99%

Disclosing Clinical Trial Results: Publicity, Significance and Independence

Liao¹,

Sheehan²,

Clarke³

2009

The American Journal of Bioethics

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Patients' attitudes about the use of placebo treatments: telephone survey

Hull

Colloca

Avins

et al. 2013

BMJ

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Deception as treatment: the case of depression

Blease

2010

Journal of Medical Ethics

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Is it ever right to prescribe placebos to patients in clinical practice? The General Medical Council is ambivalent about the issue; the American Medical Association asserts that placebos can be administered only if the patient is (somehow) 'informed'. The potential problem with placebos is that they may involve deception: indeed, if this is the case, an ethical tension arises over the patient's autonomy and the physician's requirement to be open and honest, and the notion that medical care should be the primary concern. This paper examines the case of depression as an entry point for understanding the complexities of the prescription of placebos. Recent important meta-analyses of antidepressants claim that they are not significantly more effective in a clinical setting than placebos. Given that antidepressants have numerous adverse side effects and are hugely expensive, this provocative research has serious potential ethical and practical implications for patients and medical providers. Should placebos be prescribed in place of antidepressants? The case of depression highlights another important issue which medical ethical codes have hitherto overlooked: well-being is not synonymous with being realistic about oneself, one's circumstances and the future. While severely depressed individuals are unduly pessimistic about themselves and the world around them, treatment of depressed individuals can be deemed successful when patients have successfully attained those positive illusions that are indicative of psychological health. This is exactly what successful psychological treatments of depression seem to achieve. It is therefore possible that there may be a limited unavoidable role for deception in medicine.

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Enhancing Informed Consent in Clinical Trials and Exploring Resistances to Disclosing Adverse Clinical Trial Results

Cited by 4 publications

References 8 publications

Disclosing Clinical Trial Results: Publicity, Significance and Independence

Disclosing Clinical Trial Results: Publicity, Significance and Independence

Patients' attitudes about the use of placebo treatments: telephone survey

Deception as treatment: the case of depression

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