Literature DB >> 21817885

Uncertainty and equipoise: at interplay between epistemology, decision making and ethics.

Benjamin Djulbegovic1.   

Abstract

In recent years, various authors have proposed that the concept of equipoise be abandoned because it conflates the practice of clinical care with clinical research. At the same time, the equipoise opponents acknowledge the necessity of clinical research if there are unresolved uncertainties about the effects of proposed healthcare interventions. As equipoise represents just 1 measure of uncertainty, proposals to abandon equipoise while maintaining a requirement for addressing uncertainties are contradictory and ultimately not valid. As acknowledgment and articulation of uncertainties represent key scientific and moral requirements for human experimentation, the concept of equipoise remains the most useful framework to link the theory of human experimentation with the theory of rational choice. In this article, I show how uncertainty (equipoise) is at the intersection between epistemology, decision making and ethics of clinical research. In particular, I show how our formulation of responses to uncertainties of hoped-for benefits and unknown harms of testing is a function of the way humans cognitively process information. This approach is based on the view that considerations of ethics and rationality cannot be separated. I analyze the response to uncertainties as it relates to the dual-processing theory, which postulates that rational approach to (clinical research) decision making depends both on analytical, deliberative processes embodied in scientific method (system II), and good human intuition (system I). Ultimately, our choices can only become wiser if we understand a close and intertwined relationship between irreducible uncertainty, inevitable errors and unavoidable injustice.

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Year:  2011        PMID: 21817885      PMCID: PMC3183244          DOI: 10.1097/MAJ.0b013e318227e0b8

Source DB:  PubMed          Journal:  Am J Med Sci        ISSN: 0002-9629            Impact factor:   2.378


  51 in total

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Review 2.  Ethical issues in the design and conduct of randomised controlled trials.

Authors:  S J Edwards; R J Lilford; D A Braunholtz; J C Jackson; J Hewison; J Thornton
Journal:  Health Technol Assess       Date:  1998-12       Impact factor: 4.014

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6.  A new era of unapproved drugs: the case of Abigail Alliance v Von Eschenbach.

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Journal:  Med Decis Making       Date:  2008 Nov-Dec       Impact factor: 2.583

8.  Trials: the next 50 years. Large scale randomised evidence of moderate benefits.

Authors:  R Peto; C Baigent
Journal:  BMJ       Date:  1998-10-31

Review 9.  Community equipoise and the architecture of clinical research.

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  9 in total

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Journal:  BMC Infect Dis       Date:  2016-08-17       Impact factor: 3.090

Review 5.  Ethics of HIV cure research: an unfinished agenda.

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6.  Treatment success in cancer: industry compared to publicly sponsored randomized controlled trials.

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Journal:  PLoS One       Date:  2013-03-21       Impact factor: 3.240

7.  New treatments compared to established treatments in randomized trials.

Authors:  Benjamin Djulbegovic; Ambuj Kumar; Paul P Glasziou; Rafael Perera; Tea Reljic; Louise Dent; James Raftery; Marit Johansen; Gian Luca Di Tanna; Branko Miladinovic; Heloisa P Soares; Gunn E Vist; Iain Chalmers
Journal:  Cochrane Database Syst Rev       Date:  2012-10-17

8.  At what level of collective equipoise does a randomized clinical trial become ethical for the members of institutional review board/ethical committees?

Authors:  Rahul Mhaskar; Barry B Bercu; Benjamin Djulbegovic
Journal:  Acta Inform Med       Date:  2013

9.  When are clinical trials beneficial for study patients and future patients? A factorial vignette-based survey of institutional review board members.

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  9 in total

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