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October 3, 2001

Ethical Issues in the Reporting of Clinical Trials—Reply

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorJody W.ZylkeMD, Contributing EditorIndividualAuthor

JAMA. 2001;286(13):1577-1578. doi:10.1001/jama.286.13.1573

In Reply: We certainly support the uncertainty principle and the ethical conduct of research. Moreover, we will add that topic to future CONSORT group discussions to receive feedback from other CONSORT group members. We disagree with Drs Djulbegovic and Clarke, however, that the CONSORT statement should explicitly address ethics. We wrote, "Some items not considered essential may well be highly desirable and should still be included in an RCT report even though they are not included in CONSORT. Such items include approval of an institutional ethical review board . . . ."1 Thus, its omission does not indicate that it is unimportant. Quite the contrary, the self-evident importance of such oversight leads to widespread institutional and journal review. Moreover, international organizations, such as the World Medical Association, and national organizations, such as the Office for Human Research Protections in the United States, provide thorough guidance. The CONSORT statement cannot add much to those extensive efforts.