Ethical issues in publishing research and ethics

committees

Richard SmithEditor, BMJ

Verona October 2002www.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

• 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)?

• 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

• 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• Negative studies may not be published at all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 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 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 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 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

• 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

• 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 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 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

• 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 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

• 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