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Ethical issues in publishing research and ethics committees. Richard Smith Editor, BMJ Verona October 2002 www.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

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ethical issues in publishing research and ethics committees

Ethical issues in publishing research and ethics committees

Richard Smith

Editor, BMJ

Verona October 2002

www.bmj.com/talks

what i want to talk about
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
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
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  • Negative studies may not be published at all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 cases9
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 cases10
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 cases11
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 cases12
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
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
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 committees15
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 committees16
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
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 thinking18
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
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