Storm rages over revisions to Helsinki Declaration

Abstract

A group of UK medical journal editors has issued best practice guidelines to help stem research misconduct, a problem characterised by its chairman as "endemic" in the United Kingdom and the United States. The guidelines, drawn up by the Committee on Publication Ethics (COPE), are intended to promote and safeguard intellectual honesty at all stages in the research and publication cycle, from initial study design onwards. Ethical approval, data analysis, competing interests, authorship, peer review, redundant publication, and editors' duties are among the key areas addressed. The guidance also advises editors on how to investigate suspected cases and what sanctions may be suitably applied when misdemeanours have been detected. The committee was established in July 1997 (BMJ 1997;315:201-2), some two years after Malcolm Pearce, a senior gynaecologist at St George's Hospital in south London, was struck off the medical register by the General Medical Council for fabricating evidence he reported in the British Journal of Obstetrics and Gynaecology. He claimed to have successfully relocated an ectopic pregnancy and described a three year trial of a hormone treatment for recurrent miscarriage. Neither

Use of invasive placebos in research on local anaesthetic interventions

“…Placebos can exist in various forms and can be classified as pharmacological (such as a tablet), physical (for example, a manipulation) or psychological (for example, a conversation) [6]. The ethical debate regarding placebos has continued for several years and concerns about their use remain unresolved [7–10].…”

Pills, Politics, and Placebos

“…The debate has taken on international political importance because it has been acknowledged that such a study would never be tolerated in the western industrialized countries (McNeill, 1998). Dirceu Greco, professor of internal medicine at the Federal University of Minas Gerais, Brazil, suggested that concerns about exploitation of economically deprived countries by industrialized countries would be avoided if the new drug or treatment were tested in the country in which it is to be marketed (Ramsay, 1999;Woodman, 1999).…”

Revising the Declaration of Helsinki: Accord or Discord?

“…This most recent revision in the Declaration (the document was previously revised in 1975, 1983, 1989, and 1996) is aimed at making the document relevant to today's field of medical research. As medicine becomes ever more global in its reach, the controversy regarding local or universal standards of care will continue to challenge both the interests of society and the interests of the individual patients [1][2][3][4][5][6].…”