Ethical issues in publishing research and ethics committees

1
Ethical issues in publishing research and ethics
committees

• Richard Smith
• Editor, BMJ
• Verona October 2002
• www.bmj.com/talks

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Romeo and Juliet
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Ethics committees and researchers
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This ending?
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Or this?
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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

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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

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An analysis of COPEs 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• Negative studies may not be published at all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

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An analysis of COPEs 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

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An analysis of COPEs 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

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An analysis of COPEs 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

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An analysis of COPEs first 103 cases

• Breach of confidentiality-3 cases
• Clinical misconduct--2 cases
• Attacks on whistleblowers --2 cases
• Reviewer misconduct--1 case
• Deception--1 case

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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...

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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

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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

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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

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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

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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

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BMJ view on ethics committees

• We insist on ethics committee approval of
  research studies (? quality improvement
  projects)
• But we dont 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