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more than once without disclosure Positive studies are more likely to be published twice Negative studies may not be published at all Result: substantial bias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