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 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more than once without disclosure • Positive studies are more likely to be published twice • Negative studies may not be published at all • Result: substantial bias

9. 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

10. 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

11. 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

12. 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

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 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