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Ethical issues in publishing research and ethics committees

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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 ... – PowerPoint PPT presentation

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Title: 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

2
Romeo and Juliet
3
Ethics committees and researchers
4
This ending?
5
Or this?
6
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

7
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

8
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  • Negative studies may not be published at all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

9
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

10
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

11
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

12
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

13
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...

14
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

15
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

16
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

17
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

18
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

19
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
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