Publishing research results
Publishing results is a fundamental part of scientific work. Through publication, results are communicated to the rest of the scientific community and the public. This enables others with knowledge in the area to confirm the results or point out possible mistakes/inaccuracies. Moreover, such openness means that a discussion with respect to values can be conducted concerning the methods and consequences of science. Moreover, in the Universal declaration on human rights, the United Nations states that everyone "has the right freely to share in scientific advancement and its benefits", something which the publishing of research contributes to.
The CUDOS norms have often served as a foundation for publication ethics, asserting that there is no ownership of knowledge. This should not be interpreted as a denial of the fact that copyrighting is applicable to scientific publications, but instead as an expression of an ideal signifying that knowledge should be shared with all of mankind. A burning question is whether this openness can be preserved in a climate characterized by increasingly severe economic competition. Should companies that sponsor research be able to hinder or delay publication of results? Should scientists be able to distribute their results freely or should the market economy's rules apply? In its policy briefing nr 21, "Open Access", the European Science Foundation discusses the latter question. The Foundation also has a policy regarding scientific communication and one concerning open access in biomedicine. A recent initiative is the Berlin Declaration on Open Access to Knowledge in the Sciences and Humanities. This declaration has been signed by Sveriges universitets- och högskoleförbund and by the Swedish Research Council (VR). VR has included a demand for Open Access publication from the 2010 calls for proposals and in 2015 issued a proposal for national guidelines (Förslag till Nationella riktlinjer för öppen tillgång till vetenskaplig information).
Now the US Congress (Section 801 of Food and Drug Administration Amendments Act of 2007) and the European Research Council (ERC) have announced guidelines with mandatory open access policies that direct researchers to deposit their manuscripts with PubMed Central or other specified online medical databases that are freely available to the public. The ERC Guideline states that "all peer-reviewed publications from ERC-funded research projects" should be deposited into "an appropriate repository where available . . . and subsequently made Open Access within 6 months of publication." Also in the EU, parts of the FP7 has an Open Access policy. The American Guidelines apply to all clinical trials in the U.S.
Further, The International Association of Scientific, Technical and Medical Publishers has issued statements that supports open access. See also the Washington D.C. Principles For Free Access to Science, the Bethesda Statement on Open Access Publishing, the Panton Principles and the PRISM Principles. Important is also the OECD Principles and Guidelines for Access to Research Data from Public Funding. For questions concerning ownership, copyright and patent, click here.
Pre- and postpublication sharing of data
In some areas of science, notably in "community resource projects", there is a strive for greater sharing of data through prepublication. This was summarized in the so-called Bermuda Principles and in the conclusions of the Toronto International Data Release Workshop.
A similar idea is found in the argument for deposition of data in postpublication databases. An example is the "International Mouse Strain Resource". There are many positive policies on this from journals such as Science and Heredity, and from national authorities such as the American NAS and NIH, and the Brittish MRC. For example, data from NIH-financied associational studies of genes shall be made public through dbGaP. And the NSF promotes Dryad - an international repository of data underlying peer-reviewed articles in the basic and applied biosciences. See also the "Sharing Data Report" from the Wellcome Trust, "Sharing Clinical Trial Data in the Interest of Patients and Research" from The European Forum for Good Clinical Practice and "Principles for Responsible Clinical Trial Data Sharing" from European Federation of Pharmaceutical Industries and Associations, EFPIA.
A new policy in Europe on data from clinical tríals will be in force from January 1 2015: "European Medicines Agency policy on publication of clinical data for medicinal products for human use".
Guides for how to handle the sharing of data while keeping standards of confidentiality have been proposed in the articles 'Preparing raw clinical data for publication: guidance for journal editors, authors, and peer reviewers' and 'Towards agreement on best practice for publishing raw clinical trial data'. There is also a suggested code of conduct for analysis of published raw data from the Trials Journal ("Suggested code").
A researcher should investigate whether funding agencies, one's institution, or target journals have policies on sharing data. When applicable, data sharing should be planned before the study and described to ethical review committees. Even when no explicit demands exist, it is a fundamental principle of the scientific method that we are able to re-examine data and gather the data from many studies, in order to promote scientific advances.
Internationally, there are two prominent publication guidelines. In its White Paper on Promoting Integrity in Scientific Journal Publications, the Council of Science Editors (CSE) discusses varies questions of publication ethics. The Vancouver rules for authorship (formal name: Recommendations for the Conduct, Reporting, Editing and Publication of Scholarly Work in Medical Journals, published by the International Committee of Medical Journal Editors, ICMJE) serve as the foremost international standards of publication ethics. ICMJE nowadays states that a trial will be considered for publication only if it has been registered before the enrollment of the first patient.
In 1997, the Committee on Publication Ethics (COPE) was established in the UK, and its Guidelines on good publication practice (now "Code of conduct") have been widely and internationally circulated - over 7000 journals are members using the guidelines. See also EASE guidelines. The publishers have also started to take action. First out were Blackwell (now Wiley), see their Best Practice Guidelines on Publication Ethics: a Publisher's Perspective. Another exemple is Nature's Editorial policies. Elsevier has a Publishing Ethics Resource Kit (PERK). The International Association of Scientific, Technical and Medical Publishers has issued Guidelines for quotation & other academic uses of excerpts.
Publications in medicine
As concerns medicine, it can be added that the Declaration of Helsinki states that results from research not investigated by an ethics committee should not be accepted for publication. All trials involving patients should be published in registries or databases (see further joint position documents from The International Federation of Pharmaceutical Manufacturers & Associations). So the EU asks for all clinical trials to be published in a database, see the Commission guideline on the posting and publication of result-related information on clinical trials.
Reporting guidelines are increasingly common. Some examples: The CONSORT group has issued a Statement on Consolidated Standards of Reporting Trials together with various extensions for different kinds of studies. A similar initiative is the Standards for Reporting of Diagnostic Accuracy (STARD). Epidemiologists are expected to adhere to the STROBE Statement. There are also guidelines for qualitative and internet research, for example. A collection of such guidelines can be found in the right hand panel (bottom).
European Medical Writers Association have developed Guidelines on the role of medical writers in developing peer-reviewed publications and Ghostwriting Guidelines. For editors in the medical field, the World Association of Medical Editors (WAME) has published a number of Policy Statements. There are also Good Publication Practice guidelines for pharmaceutical companies, Good Publication Practices for Sponsored Medical Research and Guidelines for a Code of Ethics for Dental Publications.
A much discussed question regards criteria for authorship. There
has been a consensus view saying that each person listed as an author
shall take public responsibility for the publication's content.
This means that one should be able to explain why and how the observations
were made, and how the conclusions follow from the data. The Vancouver
rules state that authorship credit should be based on
Substantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; AND
Drafting the work or revising it critically for important intellectual content; AND
Final approval of the version to be published; AND
Agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
These criteria have been challenged, however (see CSE's Authorship Task Force). For group authorship, CSE has made a Recommendations for Group-Author Articles in Scientific Journals and Bibliometric Databases. Useful is COPE's How to handle authorship disputes:a guide for new researchers.
Guidelines for publication in Sweden can be found in the (nowadays not actively supported) Swedish Medical Research Council's (MFR) Riktlinjer för god medicinsk forskning. In a guideline from the Swedish Research Council , it is stated, among other things, that researchers have a responsibility to ensure that they are unhindered in reporting results from research supported by the Swedish Research Council, and that the announcement of results may not be delayed by another financier longer than two months, unless a patent application is planned, in which case the time limit is four months.
How to avoid publishing identifying markers when publishing statistical data is covered by the report Statistisk röjandekontroll from Statistiska centralbyrån.
The Office of Research Integrity (USA) has suggested guidelines for how journal editors should handle alleged cheating in its Managing Allegations of Scientific Misconduct. Guidelines on good refereeing practice are included in Science Editors' Handbook (by European Association of Science Editors). See also COPE's Guidelines for retracting articles.
The Society for Neuroscience also has its own Guidelines on Responsible Conduct Regarding Scientific Communication. Also, there are Ethical Guidelines to Publication of Chemical Research and Bioethics Publishing Guidelines.
Occasionally, research subjects/respondents withdraw from a research project and request that their data/information not be published. From a legal perspective, a researcher can in this case assert his/her right by referring to the press law ('Tryckfrihetsförordningen'), however from a research and ethical perspective the issue is not as simple. There is a risk that trust in research will be undermined if the public fears that their right to discontinue an experiment is curtailed in this way. Research subjects participate voluntarily and should not be forced to take part in something they do not accept. Being able to control which information about one's self is made accessible for others is precisely what the right to a private life is about. For documents addressing the research subject's right, see Human Research.
Last updated: 2015-12-30