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Ethical issues in publishing research and ethics
committees
Richard SmithEditor, BMJ
Verona October 2002www.bmj.com/talks
Romeo and Juliet
Ethics committees and researchers
This ending?
Or this?
What I want to talk about
• The ethical problems that editors see
• A British view of ethics committees• New thinking on ethics committees• The BMJ view of ethics committees
What are the aims of Committee on Publication Ethics (COPE)?
• To advise on cases brought by editors• Publish an annual report • Publish guidance on the ethics of
publishing• Promote research into publication ethics• Offer teaching and training• www.publicationethics.org
An analysis of COPE’s first 103 cases
• Redundant publication-29 cases• Perhaps a fifth of medical studies are
published more than once without disclosure
• Positive studies are more likely to be published twice
• Negative studies may not be published at all
• Result: substantial bias
An analysis of COPE’s first 103 cases
• Authorship problems-18 cases
• About a fifth of authors appear as authors when they have done little or nothing
• Some junior researchers who have done much of the work are excluded from authorship
An analysis of COPE’s first 103 cases
• Falsification--15 cases• No informed consent--11 cases• Unethical Research--11 cases• No reason to do the research• Patients abused• Wholly unscientific research• Trial against placebo instead of an
evidence based standard treatment
An analysis of COPE’s first 103 cases
• No ethics committee approval--10 cases• Fabrication--8 cases• Editorial misconduct--7 cases• Plagiarism --4 cases• Undeclared conflict of interest--3 cases• This is actually near universal: about two thirds of
authors have a conflict of interest but fewer than 5% declare them
An analysis of COPE’s first 103 cases
• Breach of confidentiality-3 cases• Clinical misconduct--2 cases• Attacks on whistleblowers --2
cases• Reviewer misconduct--1 case• Deception--1 case
A British view of ethics committees
• 1960s: “Human guinea pigs”: a book detailing unethical and dangerous research undertaken by prominent researchers
• Britain takes 20 years to establish ethics committees
• They do important work, but...
Problems with ethics committees
• Poorly equipped to assess the technical aspects of research (but an unscientific study is by definition unethical)
• Poorly trained in law, ethics, and the work they have to do
• Overworked
Problems with ethics committees
• Under-resourced• Too many and inconsistent• Poorly guided• Too bureaucratic• Researchers doing trials across
many committees were driven crazy by the work and inconsistency
Problems with ethics committees
• 1997--multicentre research ethics committees introduced, but the local committees kept control over “local pertinent issues”
• Result: “The cure was worse than the disease”: president of the Royal College of Physicians
• Research governance now being introduced plus a new European directive
New thinking
• Failures of ethics review killed two US research participants
• Include expertise in systematic review, ethics, communications skills, methodology
• Paid, trained, guided, well resourced• Perhaps a few suprainsitutional ethics
committees
• Savulescu J. JME 2002; 28: 1-2
New thinking
• Institute of Medicine report this week
• Replace institutional review boards with “human research participant programme”
• Three reviewing bodies: science, conflict of interest, ethics
• http://national-academies.org
BMJ view on ethics committees
• We insist on ethics committee approval of research studies (? quality improvement projects)
• But we don’t assume that a study is ethical because it has been approved by an ethics committee
• We have rejected as unethical studies approved by ethics committees