Ethical Issues
People have debated the ethics of clinical trials for as long as trials have been conducted. The arguments have changed over the years and perhaps become more sophisticated, but many of them involve issues such as the physician’s obligations to the indivi
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Ethical Issues
People have debated the ethics of clinical trials for as long as trials have been conducted. The arguments have changed over the years and perhaps become more sophisticated, but many of them involve issues such as the physician’s obligations to the individual patient versus societal good; clinical equipoise; study design considerations such as randomization and the choice of control group, including use of placebo; informed consent; conduct of trials in underdeveloped areas and world regions; conflicts of interest; participant confidentiality and sharing of data and specimens; lack of publication; and publication bias. A well-designed trial should answer important public health questions without impairing the welfare of participants. There may, at times, be conflicts between a physician’s perception of what is good for his or her patient and the design and conduct of the trial. In such instances, the needs of the participant must predominate. Ethical issues apply in all stages of a clinical trial. In this chapter, we summarize some of the major factors involving ethics in design, conduct, and reporting of clinical trials. As will be noted, several of the issues are unsettled and have no easy solution. We expect, however, that investigators will at least consider these issues in the planning stages of trials, so that high ethical standards can be applied to all trials. Emanuel et al. [1] listed seven criteria that they considered essential to the ethical conduct of clinical research. These criteria are value, scientific validity, fair selection of participants, favorable benefit/risk balance, independent review, informed consent, and respect for enrolled participants (Table 2.1). Independent review is generally conducted by ethics review committees specifically constituted for oversight of research with human subjects. In the United States, such committees are termed institutional review boards (IRBs). Other names used outside the United States are research ethics committees, ethics committees, or ethics review committees. Although the role of ethics review committees is discussed later in this
© Springer International Publishing Switzerland 2015 L.M. Friedman et al., Fundamentals of Clinical Trials, DOI 10.1007/978-3-319-18539-2_2
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2 Ethical Issues
Table 2.1 Requirements for an ethical clinical trial Requirement Value Scientific validity Fair selection of participants Favorable benefit/risk balance Independent review Informed consent
Respect for enrolled participants
Explanation Evaluate an intervention that has the potential to be of social or scientific value Use methods that will produce reliable results Participant selection that avoids placing the vulnerable at undue risk and avoids preferential access of attractive interventions to the privileged Minimize risks and maximize potential benefits, with an estimate that benefits will likely outweigh risks Review of design by individuals not directly affiliated with the research (for example, ethics review committees) Provide informatio
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