Elsevier

The Lancet

Volume 360, Issue 9342, 26 October 2002, Pages 1326-1328
The Lancet

Department of Ethics
Reporting of ethical issues in publications of medical research

https://doi.org/10.1016/S0140-6736(02)11346-8Get rights and content

Summary

Clinical investigators rarely describe the rationale for ethically controversial features of study design or procedures instituted to enhance the protection of patients taking part in research, or how they ensured informed consent. We recommend a policy of extensive reporting of pertinent ethical issues to promote public accountability for clinical research. Guidelines are presented, and possible objections to this recommended policy are addressed.

Section snippets

Publication of unethical research

Adequate guidance is missing, as to how controversial ethical issues should be addressed. Henry Beecher5 initially exposed unethical conduct in clinical research. He drew an analogy with the US Supreme Court decisions that prohibit the use of criminal evidence obtained by unconstitutional means, and argued that reports with unethical research should not be published in medical journals. A policy prohibiting publication of such research would be a powerful deterrent to the mistreatment of

Scientific methods and ethical considerations

An analogy can be drawn between the rationale for the discussion of scientific methods in published articles, and that of pertinent ethical issues. Medical journals require reports of clinical research to include a methods section, which details study design, techniques of data measurement, and relevant statistical considerations. This requirement helps readers to assess the reliability and validity of the research, and fosters replication of the study. Likewise, research reports should

What ethical issues should be addressed in scientific reports?

Whenever the design of a study has morally controversial features, justification should be provided. Four examples show the range of such study designs. First, in placebo-controlled trials that withhold proven effective treatment, investigators should provide a rationale for the use of placebo.11 An adequate justification would indicate the reasons for placebo as a control, the methodological limitations of an active-controlled trial alternative,12, 13 and the safeguards in place to keep risks

Possible objections

If medical journals insist that investigators address ethical issues, there might be objections. Some might argue that the analogy between the discussion of methodology and that of ethical issues is flawed. Research reports are a form of scientific communication, and a description of study methods allows interpretation of findings and assessment of their scientific value. The description of ethical issues has nothing to do with scientific value and validity. This objection ignores the fact that

Conclusion

In this time of intense concern about the ethics of clinical research, for medical journals to require authors to address pertinent ethical issues would be desirable. Instructions to authors should detail the types of issues to be addressed, and peer reviewers ought to be specifically requested to assess manuscripts with these guidelines. A policy of addressing ethical issues in medical publications has several advantages. First, it encourages serious consideration and discussion of

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