Tutorial - Ethics of children in clinical trials

Tutorial - Ethics of children in clinical trials

Conclusions

This tutorial introduced you to the principles of research ethics in general and with specific attention to the ethical challenges of involving children in clinical trials.

Ethics or moral philosophy is concerned with issues of what is right and wrong, good and bad in relation to human action. Ethics is also concerned with the critical evaluation of arguments and judgments about the morality of action.

In the context of research ethics the approaches of moral philosophy are used to analyse the rights and interests of the research subject, the duties and responsibilities of the researcher, as well as the wider public interest in conducting ethical research.

The Declaration of Helsinki, as one of the earliest ethical codes of practice, has had an important influence upon ethical standards in research. Some of the issues raised within Helsinki remain topical and important but the changing field of research requires researchers to reflect on how we justify research ethically.

Research or treatment?

One set of key issues is the identification of the similarities and differences between research and treatment. In particular it is necessary to consider the different standards of justification, including risk and benefit that apply to the two contexts. Treatment aims to provide a direct benefit to the individual patient in circumstances where there is a reasonable degree of certainty that the benefit will apply to the patient and where any risks will be carefully weighed against the benefits. By contrast research can rarely guarantee direct benefit to all research subjects, there will always be disadvantages to participating in research, there may be considerable risks, and there will always be some uncertainty about both risks and benefit.

 

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12 Apr 2017