Skip to main content

Table 2 Statements specific to outcomes, ORB or publication bias

From: Reporting of clinical trials: a review of research funders' guidelines

Organisation/Charity

Statements specific to outcomes, ORB or publication bias

Chief Scientist Office of the Scottish Executive Health Department

There should be free access to information both on research being conducted and on the findings of the research – positive or negative-once these have been subjected to appropriate scientific review. When established, findings (including negative findings) are published in ways that allow critical review and dissemination to those who could benefit from them.

Department of Health (England)

When established, findings (including negative findings) are published in ways that allow critical review and dissemination to those who could benefit from them.

World Health Organisation

Procedures for communicating deviation from the original statistical plan (any deviation from the original statistical plan should be described and justified in the protocol and/or in the final report).

The study protocol may include; in the case of a negative outcome, an assurance that the results will be made available, as appropriate, through publication or by reporting to the drug registration authority.

Both authors and publishers have ethical obligations. In publication of the results of research, the investigators are obliged to preserve the accuracy of the results. Negative as well as positive results should be published or otherwise publicly available. Sources of funding, institutional affiliations and any possible conflicts of interest should be declared in the publication. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.

Medical Research Council (UK)

The analysis should follow a carefully written analysis plan. All outcome measures stated in the protocol should be fully analysed.

It is equally unethical not to report results, or to exaggerate the importance of results for medical practice or policy.

Trials should be submitted to a peer reviewed journal irrespective of the results of the trial.

The council's mission to improve quality of life also carries with it the imperative to report results that are directly relevant; there can be no freedom not to do so. This is also required as one of the conditions of gaining ethical approval for studies using human participants. It is increasingly recognised that that many results of clinical studies are not published but are nevertheless significant in building up an overall picture of the efficacy of a particular diagnostic, therapeutic or preventive approach.

The National Health and Medical Research Council (Australia)

Procedures for reporting any deviation(s) from the original statistical plan (any deviation(s) from the original statistical plan should be described and justified in the protocol and/or in the final report, as appropriate).

Disseminating and communicating results, whether favourable or unfavourable, in ways that permit scrutiny and contribute to public knowledge and understanding.

The National Institute for Allergies and Infectious Diseases (USA)

Outcome measures should be prioritized. Generally, there should be just one primary variable, with evidence that it will provide a clinically relevant, valid and reliable measure of the primary objective.

Health and Social Care Research and Development Office (Northern Ireland)

When established, findings (including negative findings) are published in ways that allow critical review and dissemination to those who could benefit from them. Other researchers have access to the data on which the findings are based.

Ataxia UK

Ataxia UK recognises that journals normally publish only positive findings, and that negative findings may nevertheless be of value. Ataxia UK therefore reserves the right to publish summaries of negative as well as positive findings on its website or elsewhere.

Chronic Granulomatous Disorder Research Trust

The Institution will ensure that publication of findings in peer reviewed journals is sought as soon as possible during, and after conclusion, of the Project even where results prove negative.

Cystic Fibrosis Trust

Grantholders are expected to seek publication of findings in peer reviewed journals as soon as possible during, and after conclusion, of the project even where results prove negative.

Multiple Sclerosis Society of Great Britain and Northern Ireland

The Multiple Sclerosis Society requires its researchers to disseminate the results of the research that it funds in the usual manner, for example by publication in peer reviewed journals and presentation at meetings, as soon as possible during, and after conclusion, of the project even where results prove negative or inconclusive.

Researchers should be honest in respect of their own actions in research and in their responses to the actions of other researchers. This applies to the whole range of research work, including experimental design, generating and analysing data, applying for funding, publishing results, and acknowledging the direct and indirect contribution of colleagues, collaborators and others.

Research into ageing

Unless otherwise stated in the Offer Letter, Grantholders are required by the Charity to seek publication of findings in peer reviewed journals (as appropriate) as soon as possible during, and after conclusion, of the Project even where results prove negative.