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Ethical research publication: who’s responsibility is it?

Liz Wager PhD

Publications Consultant,

Sideview liz@sideview.demon.co.uk

"A discovery does not exist until it is safely reviewed

and in print"

EO Wilson (1929 - )

"Words are, of course, the most powerful drug

used by mankind"

Rudyard Kipling (1865-1936)

Publication matters

Trial participants expect findings to contribute to medical knowledge

Misrepresenting findings (or not publishing them at all) is unethical

But who’s responsible for ensuring good practice?

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Research and publication ethics are a spectrum

Unethical research design

Data fabrication

Inappropriate analysis

Lack of patient consent

Data falsification

Image manipulation

Plagiarism

Redundant publication

Design Analysis Reporting

Authorship abuse

Conduct

Selective / non-

publication

Many players are (or could be) involved:

Researchers (mentors / supervisors) Journals (editors / publishers) Funders Institutions Professional / academic organizations RECs Regulators

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Does the system need to change?

Half of all clinical trials are never published

©SideviewRoss et al PLOS Med 2009;e1000144

Does the system need to change?

About 50% of studies presented at conferences never get published in full (Scherer et al JAMA 1994;272:158-62)

Cohort of RCTs submitted to Swiss REC (to 1998) 52% published by 2006 (von Elm et al Swiss Med Wkly 2008;138:197-203)

22% of trials on CT.gov reported results within 1 year of study end (Prayle et al BMJ 2012)

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Does the system need to change?

German drug assessment body found 74% of data on the antidepressant reboxitine was unpublished

Including the unpublished data changed their recommendation (to “ineffective and potentially harmful”)

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Wieseler et al BMJ 2010;341:c4942Eyding et al BMJ 2010;341:c4737

Does the system need to change?

585 registered trials with >500 participants Completed before Jan 2009 29% (171) unpublished in November 2012 Of the unpublished trials 78% did not have results posted

on CT.gov “The lack of availability of results from these trials … constitutes a failure to

honor the ethical contract that is the basis for exposing study participants to the risks inherent in trial participation. Additional safeguards are needed to ensure timely public dissemination of trial data.”

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Jones et al BMJ 2013;347:f6104published

29 Oct 2013!

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Does the system need to change?

Comparison of protocols cf publications (N=102) Found incomplete reporting of:

• 50% of efficacy• 65% of safety/AE outcomes

Statistically significant outcomes more likely to be reported

62% of trials had at least one primary outcome changed, introduced or omitted

Chan et al JAMA 2004;291:2457-65

Change probably requires a ‘systems’ approach

Incentives Guidelines Training ‘Infrastructure’ / technology

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Many players should be involved:

Researchers (mentors / supervisors) Journals (editors / publishers) Funders Institutions Professional / academic organizations RECs Regulators

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Influence on clinical trials

Funding decision

Publication

Design Analysis Reporting

Conduct

Registration

Ethical approval

Funders RECs

Institutions

Agreement / contract

Regulators

Publishers

Opportunities

Funders could make final payment conditional on report / publication (eg HTA)

Funders could make publication of previous projects a criterion for future funding

Institutions could reward responsible publication (quality and quantity)

Institutions should promote and enforce good authorship practices

Alternative venues for disseminating results (registers, institutional repositories, databanks, websites)*

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alternatives to traditional journals

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More opportunities

Institutions and professional bodies could offer training in RCR / publication ethics

Journals could require use of reporting guidelines (or develop more structured reports)

Funders, RECs, journals could require trial registration

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New trials registered at clinicaltrials.gov May – Oct 2005

Journal policies can be effectiveICJME

deadline

Good news! (Sept 2013)

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Research ethics committees could help prevent other serious problems

Unethical research design

Data fabrication

Inappropriate analysis

Lack of patient consent

Data falsification

Image manipulation

Plagiarism

Redundant publication

Design Analysis Reporting

Authorship abuse

Conduct

Selective / non-

publication

Could RECs extend their remit?

Require researchers to publish all studies (on trial register / repository / journal)

Encourage / check posting on institutional repositories / company websites

Make publication of previous projects a requirement for future approvals

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Are RECs behaving unethically?

“The fate of scientific data is no idle issue. Reliable research syntheses depend on ensuring that as much as possible of the potentially relevant evidence is taken into account in systematic reviews. .. Contrary to a widely held assumption, it is investigators and some research funders—and not necessarily journal editors—who are primarily responsible for under-reporting of research … Prevention of this form of scientific misconduct must therefore involve the bodies to which investigators are answerable, in particular research ethics committees.

The consequences of under-reporting of research are that patients are being expected to accept the harmful side effects of ineffective forms of care; accept advice about the effects of health care which is based on evidence that is less complete than it should be;… and contribute to research … which may not be published if the results come as a disappointment or an embarrassment to the investigators or sponsors.

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Savulescu et al BMJ 1996;313:1390-3

Conclusions

Unethical reporting is a ‘systems problem’ Unethical reporting may harm patients,

harm trial participants, waste resources Responsible research reporting is

EVERYBODY’s responsibilityincluding RECs

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