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Good practices

Ethics in sponsored research

Boas práticas_Bill Dickinson_Flickr3Bill Dickinson/Flickr The Committee on Publication Ethics (COPE), a forum that advises editors of scientific journals about ethics and integrity, gave its seal of approval in November 2015 to the GPP3, the newest version of the code of good practices for publication of research work sponsored by medical, pharmaceutical, and biotechnology firms.  The guide was introduced for the first time in 2003, having been developed by a small group of professionals who worked in the drug industry.  It underwent its first update in 2009 as the result of an effort by 200 collaborators from about 200 publishers and researchers, most of them from the United States.  This time, the scope was expanded to include contributions from members in Europe and Asia.

The code introduces new sections that incorporate directives already formally adopted in other documents, such as the one that denounces plagiarism or the standard that specifies the kinds of contribution that would qualify a researcher to sign an article as author.  Another improvement is the recommendation that certain steps be taken in the publication process, such as laying out a plan to ensure that both positive and negative results are announced, that the data are presented at significant medical conferences at the earliest possible opportunity, and that the publication of findings in more than one periodical be avoided.

Newly included is a chapter on the role of medical editors in drafting the articles.  The guide recommends that authors seek help from those professionals in order to improve the quality and clarity of the texts.  However, only rarely would that contribution entitle an editor to become a co-author of the paper.  The collaboration should be acknowledged in the article so as not to be confused with the work of a ghostwriter.

According to Liz Wager, former chair of the COPE who helped draw up all three versions of the code, the latest document takes a more assertive tone than its predecessors.  “Many of the rules that in the past were preceded by the words ‘we recommend’ have been replaced by statements on what companies, researchers and authors ‘should’ or ‘must’ do,” says Wager in her blog.  Both the newer and older version of the guide clearly state, “all the results of a clinical trial must be reported.”  Although today that statement is backed by other good practices codes and U.S. legislation, at the time when the first GPP was published the subject was surrounded by controversy.  Shortly before the publication of the original version of the guide, the U.S. pharmaceutical industry announced its own directives, according to which only “significant results” needed to be published.  The GPP3 acknowledges that clinical testing results are not always appropriate as the subject of an article but recommends that all data from trials be published in public repositories.

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