Open access, open data, open source and other open scholarship practices are growing in popularity and necessity. However, widespread adoption of these practices has not yet been achieved. One reason is that researchers are uncertain about how sharing their work will affect their careers. We review literature demonstrating that open research is associated with increases in citations, media attention, potential collaborators, job opportunities and funding opportunities. These findings are evidence that open research practices bring significant benefits to researchers relative to more traditional closed practices.DOI:http://dx.doi.org/10.7554/eLife.16800.001 Recognition and adoption of open research practices is growing, including new policies that increase public access to the academic literature  under their open access (OA) option were twice as likely to be cited within 4–10 months and nearly three times as likely to be cited 10–16 months after publication than non-OA articles published in the same journal , Nature Communications (11.3), and BioMed Central’s Genome Biology (11.3). The Cofactor Journal Selector Tool allows authors to search for OA journals with an IF . SHERPA/RoMEO allows authors to check policies from over 2,200 publishers, 72% of which allow authors to archive postprints, either in the form of the authors’ accepted manuscript post-peer review, or the publisher’s formatted version, depending on the policy  provides a template addendum, as well as information on author rights . The SchTo make their findings known to the world, scientists have historically forfeited ownership of the products of their intellectual labor by signing over their copyrights or granting exclusive reuse rights to publishers. In contrast, authors publishing in OA journals retain nearly all rights to their manuscripts and materials. OA articles are typically published under Creative Commons (CC) licenses, which function within the legal framework of copyright law . Under tIf terms of a CC license are violated by a user, the licensor can revoke the license and, if the revocation is not honored, take legal action to enforce their copyright. There are several legal precedents upholding CC licenses, including: (1) Adam Curry v. Audax Publishing ; (2) SocAn emerging and interesting development is the adoption of rights-retention open access policies . To dateEigenfactor.org maintains a list of hundreds of no-fee OA journals across fields  and the Network of Scientific Journals in Latin America, the Caribbean, Spain, and Portugal , each host over 1,000 journals that provide free publishing for authors.Researchers often cite high costs, primarily in the form of article processing charges (APCs), as a barrier to publishing in OA journals. While some publishers – subscription as well as OA – do charge steep fees , many ots fields . Researcs fields . NotablePeerJ, for example, a one-time membership fee of $199 USD allows an author to publish one article per year for life, subject to peer review.  Most Pensoft OA journals charge around €100–400 . Thus, publishing in OA journals need not be any more expensive than publishing in traditional journals, and in some cases, may cost less.Many other OA journals charge minimal fees, with the average APC around $665 USD . At PeerThe majority of OA publishers charging higher publication fees  offer fee waivers upon request for authors with financial constraints. Policies vary by publisher, but frequently include automatic full waivers for authors from low-income countries, and partial waivers for those in lower-middle-income countries. Researchers in any country can request a partial or full waiver if they cannot pay. Some publishers, such as BioMed Central, F1000, Hindawi, and PeerJ, have membership programs through which institutions pay part or all of the APC for affiliated authors. Some institutions also have discretionary funds for OA publication fees. Increasingly, funders are providing OA publishing funds, or allowing researchers to write these funds into their grants. PLOS maintains a searchable list of both institutions and funders that support OA publication costs . FinallyFor academics in many fields, securing funding is essential to career development and success of their research program. In the last three years, new fellowships and awards for open research have been created by multiple organizations . While tIncreasingly, funders are not only preferring but mandating open sharing of research. The United States National Institutes of Health (NIH) has been a leader in this respect. In 2008, the NIH implemented a public access policy, requiring that all articles arising from NIH-funded projects be deposited in the National Library of Medicine’s open repository, PubMed Central, within one year of publication . NIH alsSeveral governmental agencies and charitable foundations around the world have implemented even stronger open access mandates. For example, the Wellcome Trust’s policy states that articles from funded projects must be made openly available within six months of publication, and where it provides publishing fee support, specifically requires publication under a Creative Commons Attribution (CC BY) license . The NetResearchers can check article and data sharing policies of funders in their country via SHERPA/JULIET . BioSharIn our researcher-centric approach, the rationale for data sharing based on funder mandates could be understood simply as ‘funders want you to share, so it is in your interest to do so’. That may be a compelling but dissatisfying reason to practice openly. Fortunately, there are other compelling reasons to share.First, submitting data and research materials to an independent repository ensures preservation and accessibility of that content in the future - both for one’s own access and for others. This is a particular benefit for responding to requests for data or materials by others. Preparation of research materials for sharing during the active phase of the project is much easier than reconstructing work from years earlier. Second, researchers who plan to release their data, software, and materials are likely to engage in behaviors that are easy to skip in the short-term but have substantial benefits in the long-term, such as clear documentation of the key products of the research. Besides direct benefits for oneself in facilitating later reuse, such practices increase the reproducibility of published findings and the ease with which other researchers can use, extend, and cite that work . FinallyJournal of Peace Research offering data in any form – either through appendices, URLs, or contact addresses – were cited twice as frequently on average as articles with no data but otherwise equivalent author credentials and article variables. Studies with openly published code are also more likely to be cited than those that do not open their code  initiated a project to replicate a sample of studies to estimate the reproducibility of psychological science . Completscikit-learn Python package for machine learning  . The decSeveral U.S. institutions have passed resolutions explicitly recognizing open practices in promotion and tenure evaluations, including Virginia Commonwealth University  and IndiPsychological Science, and a sample of comparison journals suggests that this simple incentive increases data sharing rates from less than 3% to more than 38% .Deposit preprints of all manuscripts in publicly accessible repositories as soon as possible – ideally prior to, and no later than, the initial journal submission (see section "Postprints").Publish in open access venues whenever possible. As discussed in Prestige and journal impact factor, this need not mean forgoing traditional subscription-based journals, as many traditional journals offer the option to pay an additional charge to make one’s article openly accessible.Publicly share data and materials via a trusted repository. Whenever it is feasible, the data, materials, and analysis code used to generate the findings reported in one’s manuscripts should be shared. Many journals already require authors to share data upon request as a condition of publication; pro-actively sharing data can be significantly more efficient, and offers a variety of other benefits (see section "Resource management and sharing").Preregister studies. Publicly preregistering one’s experimental design and analysis plan in advance of data collection is an effective means of minimizing bias and enhancing credibility (see section "Open questions"). Since the preregistration document(s) can be written in a form similar to a Methods section, the additional effort required for preregistration is often minimal.DOI:http://dx.doi.org/10.7554/eLife.16800.006 In the interests of transparency, eLife includes the editorial decision letter and accompanying author responses. A lightly edited version of the letter sent to the authors after peer review is shown, indicating the most substantive concerns; minor comments are not usually included.eLife for consideration as a Feature Article. Your article has been reviewed by three peer reviewers and the eLife Features Editor (Peter Rodgers), and this decision letter has been compiled to help you prepare a revised submission.Thank you for submitting your article "The benefits of open research: How sharing can help researchers succeed" to All three reviewers have agreed to reveal their identity: Robert Kiley; Chris Gorgolewski; Vincent Lariviere.General assessment:This paper is a much-needed overview of benefits and practical advice about open research. Instead of preaching and using moral arguments, the authors focus on benefits to the researcher of doing research openly, and provide evidence that researchers who practice open research  enjoy significant benefits  compared with researchers who don't practice open research.Essential revisions:1) (Section 2.1) Although the authors do provide evidence that OA leads to more citations, I think they need to recognise that there is significant disagreement within the community about this. The paper does cite one study from Davis  but he has published quite a few papers on this topic: please consider citing another one of these studies.2)  It is mi3) (Section 2.3) I found this a little self-contradictory. At the start the authors argue (rightly) that IF are a flawed measure, but then go on to quote the IF of OA journals. I know they go to so say "we reiterate that IF are flawed[…]" but if they really believe this, then arguing that some OA journals have high IF doesn't make sense. Please consider deleting the passage "In the 2012 Journal Citation Report...choose between IF and OA)."https://scholarlykitchen.sspnet.org/2013/03/27/how-rigorous-is-the-post-publication-review-process-at-f1000-research/).4)  This is debatable and should be toned down a bit. Results obtained with F1000 tend to show the opposite (5) (Section 2.5.1) I think this section should mention the recent ASAPbio meeting – and subsequent researcher survey – which seem to suggest that researchers in the life sciences have woken up to the potential of preprints not going to adversely impact them (and ultimately come to believe that it will benefit them) then changing behaviour is always going to be difficult. As such I was surprised that section 3.2 seemed to suggest that Funder mandates are sufficient to bring about this change. Although I agree that some mandates are important, on their own they are not sufficient.6) (Section 3.2) Right at the start of the article  the authors get to the nub of the problem – namely that open practices could present a risk to career advancement. This in my opinion is the big issue. Until researchers are persuaded that making their outputs open is The article would be improved if it recognised that mandates are not enough and then set out a list of things funders could do to help move the needle in this space Further to this: the NIH requires grant applications to include a data-management plans: however, when the NIH is considering grant applications, it does not take into account if applicants have a history of sharing data, and it does not penalize applicants if data from previous grants have not been shared. Until data sharing becomes an important part of review procedure, change will remain slow.7) (Section 2.7) To be transparent, please mention the higher APCs of PLOS journals, as well as of for-profit publishers like Elsevier, Wiley, Springer, etc. When taking about high APCs the authors may also wish to cite the data the Wellcome Trust (and others) have published on this topic (e.g. blog.wellcome.ac.uk/2016/03/23/wellcome-trust-and-coaf-open-access-spend-2014-15/).8) (Section 4.2) Being devil’s advocate here: the authors report that research projects that share data produce twice as many publications as those that do not share data. Isn't the more likely explanation of this relation that successful projects that have published a lot can afford to share data because the risk and consequences of scooping are much lower/smaller?9)  Please a10)  Please e Essential revisions:1) (Section 2.1) Although the authors do provide evidence that OA leads to more citations, I think they need to recognise that there is significant disagreement within the community about this. The paper does cite one study from Davis  but he has published quite a few papers on this topic: please consider citing another one of these studies.To present this information in a more balanced way, we deleted the word ‘overwhelming’ from Section 2.1, first paragraph, and made other minor changes to wording of this section.We added another paper from Davis :P.M. Davis, B.V. Lewenstein, D.H. Simon, J.G. Booth, and M.J.L. Connolly. Open access publishing, article downloads, and citations: randomised controlled trial. BMJ, 337:a568, 2008.We also added citations to 3 other studies which failed to find an OA citation advantage:T.F. Frandsen. The effects of open access on un-published documents: A case study of economics working papers. Journal of Informetrics, 3(2):124–133, 2009.P. Gaule and N. Maystre. Getting cited: does open access help? Research Policy, 40(10): 1332–1338, 2011.V.C. Lansingh and M.J. Carter. Does open access in ophthalmology affect how articles are subsequently cited in research? Ophthalmology, 116(8):1425–1431, 2009.We expanded 2)  It is miWe revised 3) (Section 2.3) I found this a little self-contradictory. At the start the authors argue (rightly) that IF are a flawed measure, but then go on to quote the IF of OA journals. I know they go to so say "we reiterate that IF are flawed[…]." but if they really believe this, then arguing that some OA journals have high IF doesn't make sense. Please consider deleting the passage "In the 2012 Journal Citation Report…choose between IF and OA)."We appreciate the reviewer’s concern, but believe strongly that we have to discuss IF since it is often cited by researchers as a barrier to publishing openly. In numerous author surveys, researchers repeatedly rank impact factor and associated journal reputation as among the most important factors they consider when deciding where to publish. To support this, we added citations to the following author surveys:https://dx.doi.org/10.6084/m9.figshare.1425362.v7Nature Publishing Group (2015): Author Insights 2015 survey. figshare. https://doi.org/10.7717/peerj.365Solomon DJ. (2014) A survey of authors publishing in four megajournals. PeerJ 2:e365 Given our researcher-centric approach, it is important to recognize concerns about IF as a practical, albeit regrettable, reality. We believe that ignoring this reality, and specifically removing the recommended passage with data on the IFs of OA journals, would weaken the paper. This information provides researchers with options that satisfy both their worry about publishing in high IF journals and their wish to do so openly. To clarify our goals with this section, we made several small changes in wording and sentence order, and added a closing statement, which reads:“We hope that in the next few years, use of IF as a metric will diminish or cease entirely, but in the meantime, researchers have options to publish openly while still meeting any IF-related evaluation and career-advancement criteria.https://scholarlykitchen.sspnet.org/2013/03/27/how-rigorous-is-the-post-publication-review-process-at-f1000-research/).4)  This is debatable and should be toned down a bit. Results obtained with F1000 tend to show the opposite :23–27, 1999.S. van Rooyen, T. Delamothe, and S.J.W. Evans. Effect on peer review of telling reviewers that their signed reviews might be posted on the web: randomised controlled trial. BMJ, 341:c5729, 2010.5) (Section 2.5.1) I think this section should mention the recent ASAPbio meeting – and subsequent researcher survey – which seem to suggest that researchers in the life sciences have woken up to the potential of preprints We added mention of the ASAPbio meeting (end of Section 2.5.1) and cited the following references on the meeting and survey:J.M. Berg, N. Bhalla, P.E. Bourne, M. Chalfie, D.G. Drubin, J.S. Fraser, C.W. Greider, M. Hen- dricks, C. Jones, R. Kiley, S. King, M.W. Kirschner, H.M. Krumholz, R. Lehman, M. Leptin, B. Pulverer, B. Rosenzweig, J.E. Spiro, M. Stebbins, C. Strasser, S. Swaminathan, P. Turner, R.D. Vale, K. VijayRaghavan, and C. Wolberger. Preprints for the life sciences. Science, 352(6288): 899–901, 2016.http://asapbio.org/survey. Data available via figshare https://dx.doi.org/10.6084/m9.figshare.2247616.v1.ASAPbio. Opinions on preprints in biology. Accessed May, 2016 at 6) (Section 3.2) Right at the start of the article  the authors get to the nub of the problem – namely that open practices could present a risk to career advancement. This in my opinion is the big issue. Until researchers are persuaded that making their outputs open is not going to adversely impact them (and ultimately come to believe that it will benefit them) then changing behaviour is always going to be difficult. As such I was surprised that section 3.2 seemed to suggest that Funder mandates are sufficient to bring about this change. Although I agree that some mandates are important, on their own they are not sufficient.While we agree that mandates are unlikely to bring about the culture change we would like to see, there is evidence that mandates are effective in increasing rates of article and data sharing . More importantly, our goal with this section is not to argue that mandates are sufficient, but rather that “[researchers] already engaging in [open] practices will likely have a competitive advantage”.The article would be improved if it recognised that mandates are not enough and then set out a list of things funders could do to help move the needle in this space We recognize in the subsequent section (section 4) that “[funder mandates] may be a compelling but dissatisfying reason to practice openly”. However, our primary target audience for this article is researchers, so we have focused on outlining the steps they can take and showing them “there are other compelling reasons to share”.Further to this: the NIH requires grant applications to include a data-management plans: however, when the NIH is considering grant applications, it does not take into account if applicants have a history of sharing data, and it does not penalize applicants if data from previous grants have not been shared. Until data sharing becomes an important part of review procedure, change will remain slow.We added mention of policy revisions implemented by NIH and Wellcome Trust, detailing how funds can be suspended or withheld if researchers do not comply with mandates . We cited the following relevant references, one of which  discusses how both funders have already followed through on enforcement:http://grants.nih.gov/grants/guide/notice-files/NOT-OD-12-160.html. Last updated Feb., 2013.National Institutes of Health (NIH). Upcoming Changes to Public Access Policy Reporting Requirements and Related NIH Efforts to Enhance Compliance, 2012. Retrieved June, 2016 from -1http://www.nature.com/news/funders-punish-open-access-dodgers.15007.Van Noorden, R. Funders punish open-access dodgers. Nature News, 2014. Retrieved June, 2016 from https://wellcome.ac.uk/press-release/wellcome-trust-strengthens-its-open-access-policy.Wellcome Trust. Wellcome Trust strengthens its open access policy, 2012. Retrieved June, 2016 from 7) (Section 2.7) To be transparent, please mention the higher APCs of PLOS journals, as well as of for-profit publishers like Elsevier, Wiley, Springer, etc. When taking about high APCs the authors may also wish to cite the data the Wellcome Trust (and others) have published on this topic (e.g. blog.wellcome.ac.uk/2016/03/23/wellcome-trust-and-coaf-open-access-spend-2014-15/).We added mention of the higher APCs charged by some OA publishers, like PLOS and Frontiers . We also felt the no-cost/low-cost examples here were numerous, so we have stricken two of them.We added the suggested reference from Wellcome Trust, as well as one from Stuart Lawson documenting high APCs:https://dx.doi.org/10.6084/m9.figshare.1507481.v4.S. Lawson. APC data for 27 UK higher education institutions in 2015. figshare, 2016. Retrieved June, 2016 from https://blog.wellcome.ac.uk/2016/03/23/wellcome-trust-and-coaf-open-access-spend-2014-15/. Data available via figshare doi:10.6084/m9.figshare.3118936.v1.Wellcome Trust. Wellcome Trust and COAF Open Access Spend, 2014-15,. Retrieved June, 2016 from We also added a citation to a new study of over 10, 300 OA journals, showing 71% do not charge an APC , and that the average APC for OA journals is around $665 :http://waltcrawford.name/goaj.html.W. Crawford. Gold Open Access Journals 2011-2015. Cites & Insights Books, 2016. Accessed June, 2016 via 8) (Section 4.2) Being devil’s advocate here: the authors report that research projects that share data produce twice as many publications as those that do not share data. Isn't the more likely explanation of this relation that successful projects that have published a lot can afford to share data because the risk and consequences of scooping are much lower/smaller?The authors of Pienta et al. admit that “It is unclear whether larger numbers of primary publications lead to data sharing or if sharing data leads to more primary publications”. However, the authors did control for factors such as Principal Investigator age, gender, career status, and funding history, as well as features of the grant such as duration as an indirect measure of grant size. None of these factors sufficiently explained the primary or secondary publication advantage conferred by data sharing.9)  Please aWe added the columns “Can leave feedback?” and “Third party persistent ID?”. The latter is broader and includes externally managed persistent identifiers such as DOIs, Handles, and ARKs. We added a footnote to the table saying that all the listed preprint servers and repositories are indexed by Google Scholar. After community feedback, we also added several relevant repositories.10)  Please eBased on the information provided by ROARMAP, we added the following explanation and examples to the figure caption:“Data are broken down by policymaker type: funder (e.g. Wellcome Trust), joint funder and research organization (e.g. British Heart Foundation), multiple research organizations i.e. associations and consortia (e.g. Max Planck Society), research organization i.e. university or research institution (e.g. CERN), and subunit of research organization (e.g. Columbia University Libraries).”


Recommendations set ethical and editorial standards for article publication in most leading medical journals. Here, I examine the strengths and weaknesses of the Recommendations in the prevention of commercial bias in industry-financed journal literature, on three levels – scholarly discourse, article content, and article attribution.The International Committee of Medical Journal Editors (ICMJE) Recommendations are for enforcing clinical trial registration and controlling duplicate publication. With respect to article content, the ICMJE promotes stringent author accountability and adherence to established reporting standards. However, the ICMJE accepts the use of commercial editorial teams to produce manuscripts, which is a potential source of bias, and accepts private company ownership and analysis of clinical trial data. New ICMJE guidance on data sharing will address but not eliminate problems of commercial data access. With respect to attribution, the Recommendations oppose guest authorship and encourage clear documentation of author contributions. However, they exclude writers from coauthorship; provide no specific advice on the attribution of commercial literature, for instance with respect to company authorship, author sequence or prominent commercial labeling; and endorse the use of fine print and euphemism. The ICMJE requires detailed author interest disclosures, but overlooks the interests of non-authors and companies, and does not recommend that interests most salient to the publication are highlighted. Together, these weaknesses facilitate “advocacy”-based marketing, in which literature planned, financed and produced by companies is fronted by academics, enabling commercial messages to be presented to customers by their respected clinical peers rather than companies themselves.With respect to overall discourse, the most important measures in the ICMJE Recommendations set important research and reporting standards, without which commercial bias would likely be a significantly greater problem than it is today. However, they also support practices of commercial data control, content development and attribution that run counter to science’s values of openness, objectivity and truthfulness. These weaknesses could be addressed with appropriate modifications to the Recommendations. The ICMJE should also disclose its own commercial interests and funding – not least because publishing organizations that finance it and pay the salaries of some member editors derive substantial revenues from industry.The ICMJE  Good industry science should be welcomed into scholarly literature, but commercial bias may occur on several levels Table . At the terature –3. At ththey use –13. Suchattribution of commercial articles, the identities, roles and interests of contributors and stakeholders may be communicated to readers in a misleading way. In particular, the role of companies may be downplayed and that of academic recruits exaggerated, for instance by placing academics at the head of the author byline and crediting companies only in minor author placements and fine print [Finally, with respect to the ne print , 13–15. ne print , 15–18.Recommendations – previously known as the Uniform Requirements for Manuscripts (URM) [Recommendations include measures that help check commercial bias on all three levels I have described. Yet the Recommendations are also embraced by industry, including trade associations of the publishing, writing, marketing and pharmaceutical sectors [Recommendations rather than the authorship formula alone, evaluating every section in respect of my direct working knowledge of industry practices. I identify numerous protections against commercial distortion, but also widespread weaknesses that facilitate marketing practices. I argue that these weaknesses derive not only from ignorance about marketing, but from longstanding conceptual shortcomings within editorial thought and publication ethics.The International Committee of Medical Journal Editors (ICMJE) is preeminent in setting editorial standards for medical journals. Its ts (URM)  – have gts (URM) , 20, 21  sectors –25 and t sectors , 26 promRecommendations are summarized in Table ICMJE measures to address bias at the level of discourse, content and attribution are summarized in Table Recommendations are largely concerned with individual submissions to journals rather than the research and planning that precedes them. Nonetheless, several measures have been introduced, including limited measures on prior and repeat publication, practices which might be used by marketing to increase visibility of a commercial product, and most importantly, trial registration. Since 2005, the ICMJE has insisted that trials are registered at or before patient enrollment begins, at a major public registry; this measure was specifically designed to address the problem of selective reporting of trials [The ICMJE’s options to prevent discourse-level bias are limited, since the f trials . The Unif trials . It is iIt is largely for peer reviewers to identify content bias, although the ability of peer review to cope with the volume and technicality of industry material has been questioned . The ICMRecommendations advises authors to “avoid entering in to agreements” with companies that might limit their access to the basic data, but this merely advises against restrictive agreements, whereas it should insist on contracts requiring senior academic authors to have full, immediate and enduring use within their institutions of the anonymized patient-level database, with unrestricted rights of analysis, comparison and dissemination.A longstanding area of weakness for the ICMJE concerns company clinical trials data. The ICMJE does not require independent data analysis, or the academic authors to have possession of, or to have looked at, the full data themselves. All that is required is that they should be granted “access” to the data if they request it. In practice, many academic authors only see a results summary prepared by the company. Section IIB of the Recommendations is the impending introduction of guidance on data sharing [Concerns about the meaning of “access to data” and similar proposals to these have been discussed by a number of scholars –33. Acco sharing . Pharmac sharing , 33. A gThere is therefore a plausible case for preventing companies from accessing other companies’ patient-level data, although protocols, summary results and clinical study reports should be publicly available for all trials. Independent academic groups should, however, have full, retrospective access to clinical record forms and patient-level data, including unpublished trials, for any drug with at least one approved indication in any market , 33. FurIt is unlikely the initial ICMJE guidance on data sharing will approach these standards. The draft ICMJE proposals released in January 2016 suggested requiring data sharing only in relation to results reported in the published article, rather than full study databases, and made no mention of protocols, clinical study reports or clinical record forms . FurtherAn important area of weakness for the ICMJE concerns manuscript development, which may be a source of content bias. Firstly, academics performing key roles in industry projects including drafting are more likely to have financial ties to industry than their academic coauthors . A seconThere is a clear distinction between minor editing and ghostwriting; the first involves inconsiderable changes, the second composing… Writing a competent medical report requires thinking logically, analyzing data rigorously and interpreting them critically, organizing relevant material coherently, and presenting results in a lucid form. Writing, if done thoughtfully, may disclose an ill-defined thesis, experimental flaw, or faulty data analysis. How many ghostwriters apply such scrutiny? How can the reader judge the scientific merit of a ghostwritten article? It may be eloquent and persuasive without being true or valid….. Instead of bringing ghostwriters out of the closet, let's flush them out of the profession.… Let's exorcize the ghosts, not acknowledge them.The ICMJE offers no guidance on employee coauthors, but does address a third potential conduit for commercial influence on manuscript development, the use of trade writers. Many academics in other fields would consider the use of trade writers to draft learned text an affront to scholarship, but medical journals and the ICMJE have embraced the practice, on the basis that writing is supposedly a technical, not an intellectual task. Perhaps the most signal exchange occurred in 1995 in JAMA, which though 20 years old merits quotation . DeBakey… a writer, who solely contributes to the writing of a manuscript – visibly or not – does not automatically qualify for authorship…. such assistance should be disclosed, not prohibited. By acknowledging substantial writing and editing assistance, we are not judging whether such aid biases a report… We know of many scientists who require such assistance. … So why shouldn't the actual drafter of the manuscript be publicly credited for such a contribution in the acknowledgment, especially if the writer is employed or paid by a company with a commercial interest in the report? … crediting literary assistance is thoroughly compatible with our efforts to preserve the integrity of scientific publication.But JAMA editors Flanagin and Rennie took the contrasting view that trade writing is mere “literary assistance” for inarticulate doctors, and therefore acceptable:medical subject matter of the articles they draft (though most trade writers have science PhDs), theirs is an intellectual contribution to content nonetheless, and their expertise often exceeds that of the academic authors in two respects - the intellectual task of manuscript composition, and more importantly, their awareness of the commercial nuances of the text. Furthermore, their work is reviewed by company personnel who include true subject-matter experts. In privileging the expertise of academic authors and treating other contributions as auxiliary, medicine’s editorial community has played into the hands of marketing, blinkering itself to the ease with which highly intelligent parties, who for marketing reasons wish to be perceived as mere “assistants”, can subtly frame and spin the content of literature in the service of commerce.Today’s ICMJE policy follows the JAMA view; yet the DeBakeys’ view of writing as composition was correct, and its rejection has facilitated commercialization of academic medical literature. What is most lacking in the JAMA-ICMJE viewpoint is an understanding that while company editorial teams may not have a true expert’s knowledge of the Recommendations concern the attribution of journal articles. The word “attribution” is not currently used in the Recommendations, and it is important for the editorial and ethics communities to consider carefully what attribution involves and how it can be subjected to systematic commercial spin.Arguably the greatest inadequacies of the current documentation, but of communication with the reader. Accordingly, the parties that played the most important role in developing the article and conducting the research it describes should be represented most prominently.Attribution is not coextensive with authorship. Correctly understood, the attribution of a journal article encompasses everything it communicates in order to inform readers about its provenance and development, the identity of its stakeholders and contributors, and their roles and interests. Attribution involves authorship; author sequence; contributor listings; statements in the abstract; and sometimes information provided in the title, footnotes or labeling. Interest declarations also have a bearing upon attribution since they point to the motivations at play in the work. It is also very important to note that attribution is not merely a matter of Recommendations support or tolerate these unethical practices.Unfortunately, the attribution of industry literature is frequently subjected to commercial bias in the service of “advocacy”-based marketing. As discussed above, academic authors are commonly highlighted, while the role of the company is downplayed through minor author placements, vague disclosures and small print , 15. TheSubstantial contributions to the conception or design of the work; or the acquisition, analysis, or interpretation of data for the work; ANDDrafting the work or revising it critically for important intellectual content; ANDFinal approval of the version to be published; ANDAgreement 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.Authorship is the most important component of attribution within scholarly literature, and has a privileged standing within medicine. The ICMJE authorship formula is highly restrictive, and currently has four conditions:This formula is designed to ensure that all authors were truly involved in the work, and are willing and able to account for it. Its stringency reflects the need for a consistent mechanism to regulate authorship on projects with numerous participants, but it also reflects the shock suffered by academic medical publishing in the 1980s and 1990s, when fraudulent literature was exposed and personal research integrity became an overriding ethical concern , 38. Accde facto corporate ghost authorship.With respect to commerce, the effects of the ICMJE authorship formula are mixed. Creditably, it militates against lax scientific standards, compels authors to review research and text rigorously, and opposes “guest authorship” – that is, inclusion of authors whose contributions are too modest to merit author status. These benefits apply in commercial and noncommercial work alike. There are, however, four aspects of the ICMJE approach that prove commodious to marketing. Firstly, there is no facility for corporate authorship. This reflects the longstanding preoccupation of medicine’s editors with personal accountability, illustrated by Rennie’s sentiment that “attached to every article there be actual beings, prominently identified, who are prepared to be accountable for all aspects of the reports” . Yet in Secondly, there is no adequate ICMJE guidance on author sequence. In particular, there is no injunction against the “academic frontloading” of author bylines for the purposes of credibility , 15. So Recommendations thereby sanction the industrial production of content using ghostwriting – “where a professional medical writer prepares a manuscript on behalf of a named author, but the writer is not listed as an author” [Neurology, and require writers to be credited as authors [Thirdly, the ICMJE takes the remarkable stance that no medical journal article need ever be written by any of its named authors. Clause 2 of the authorship formula states that revision alone is required; and further text below the formula bars what is ambiguously termed “writing assistance” from byline credit. Consequently, a significant intellectual and commercial contribution to the published work is credited only in fine print. The  author” . The ICM authors .Recommendations do not specifically require key contributors to be authors. The ICMJE formula was conceived as a means of limiting authorship, and does not address the possibility that parties who should be authors might prefer not to be – notably, commercial parties seeking to direct reader attention to academic authors for purposes of endorsement. Text introduced in 2013 states that individuals substantially involved in the work and therefore meeting Condition 1 “should have the opportunity” to work on the manuscript and meet Conditions 2–4, therefore becoming authors. Yet there is no specific demand they should do so, and companies have been known to reduce the number of their deserving employees who become coauthors in order to reduce company visibility [Fourthly, the sibility . A more The ICMJE does not formally recommend contributor listings, but “strongly encourages” them. Contributor listings benefit noncommercial and commercial publications alike, permitting a more granular account of credit and responsibility, and providing a record should concerns about misconduct arise . In induJAMA, which uses structured endnotes organized by contribution type to record the roles of both authors and non-authors. Currently, the CRediT (Contributor Roles Taxonomy) program, a Consortia Advancing Standards in Research Administration Information (CASRAI) initiative, [Currently, contributor listings vary considerably among journals. The clearest and most informative format is exemplified by tiative, , 45 is ade facto retention of authorship, in contrast Smith’s call for authorship’s genuine replacement by a “film credits” approach [But while contributor listings are important, they also illustrate the failure of medicine to distinguish adequately between documentation and communication. The former requires only fine-print; the latter is thwarted by it. Rennie and colleagues’ 1997 proposals suggested contributorship should replace authorship; but they also argued for retention of the byline, for “those who contributed most substantially to the work” . This amapproach , 48. Furapproach , 50. TheRecommendations with respect to authorship and contributorship would in large measure be negated if there was also guidance on prominent labeling of industry publications, requiring readers to be notified at the outset of an industry article’s true provenance, ownership and commercial functions. This could be achieved through a variety of means, for instance naming the company responsible for the work as a lead author, or in the title, or in a label at the head of the text. Such notification would need to be conspicuous, clearly worded, and apparent when the article abstract was viewed online. Clear commercial labelling would also combat the use of academics for endorsement and the production of scholarly articles as marketing vehicles.The weaknesses of the Recommendations contain no provisions for prominent commercial labeling, except in certain non-standard publication settings (Table Recommendations, that oblique language is used when referring to industry. The words “company”, “business”, “corporation”, “pharmaceutical” and “marketing” are entirely absent, and the terms “sponsor” and provider of “support” are preferred. This helps sustain a false depiction of industry research, in which the article and the study it reports appear to belong fundamentally to the authors, while the company that is in fact responsible for both and which owns the data appears to have a secondary and subservient status.Unfortunately, the gs Table . Most usRecommendations have been defended [The ICMJE publishes a detailed conflict-of-interest form which has helped standardize author interest disclosures. The importance of author interest disclosures has recently been debated within the editorial community and the standards set by the defended , 52. Notdefended –55.Interest disclosures present a challenge for print journals because of space considerations; some journals refer readers to online author disclosures. Such problems will increase if articles are required to list more extensive interests including those of stakeholders and non-author contributors. Three steps appear necessary to address these difficulties: firstly, to ensure that critical interests, such as company finance and authors’ relationships with the company, are brought conspicuously to readers’ attention at the outset; secondly, to accompany articles online with standardized grids documenting the interests of companies, authors, contributors and the journal; and thirdly, to establish public registries of comprehensive author interests, as advocated by Rasmussen and colleagues . Such reRecommendations, the quality of medical literature, including commercial medical literature, would be significantly poorer than it is today. Equally, however, the marketing of blockbuster drugs involves industry-financed literature that is commercially biased but ICMJE-compliant. The ICMJE accepts arrangements in which companies instigate trials, analyze and own the data, and plan and produce manuscripts, but attribute these projects primarily to recruited academics. These academics are not guest authors insofar as they contribute actively to projects, and yet they are contingent: were they not available, other academics could and would be recruited, and publications with similar content and identical commercial functions would be generated. The ICMJE Recommendations facilitate these practices, and showcase in their own text a euphemistic language of “sponsors”, “funding” and “support” which falsely implies the corporate masters of this research are mere facilitators.It is clear that without the Recommendations are of long standing, and likely reflect a diversity of underlying causes. Most obviously, it might be considered inevitable that medical publishing’s financial dependency on the pharmaceutical industry should lead to timid editorial standards and incomplete measures. But against such considerations must be set the principled record of some ICMJE editors in resisting commercial influence, and the organization’s substantial achievements, for instance on trial registration.These weaknesses in the ICMJE In fact, a welter of factors probably contribute to the weaknesses in ICMJE policy. These likely include editors’ historical preoccupation with the problem of author accountability, which while important has reduced consideration of other issues; inadequate understanding of commercial practices; the assiduous public relations maneuverings of the publications-marketing trade; the cultural haughtiness of medicine, whose emphasis on professional qualification, status and authority leads naturally to the denigration of writers and elevation of key opinion leaders; the cultural insecurity of academic medicine, tacitly compliant with corporate science but clinging to the eidolon of its own lost sovereignty; and a conjunction of self-interest among the pharmaceutical and marketing industries, publishing houses, journals, editors and academic authors, whose finances or careers all benefit from the prevailing editorial and marketing culture.Finally there are conceptual shortcomings within editorial thought, among which the most interesting is perhaps the issue of attribution. Medicine’s editors must understand that attribution is multi-faceted and that even if an article meticulously and fully discloses the role of all its contributors and stakeholders – and this is rarely the case in contemporary industry literature – it will remain poorly attributed if the most prominent features of its attribution do not identify to the reader the dominant parties in its provenance and development. The publication ethics community too has been preoccupied with the important issues of documentation and disclosure to such a degree that it has largely failed to address the importance of communication with the reader. The marketing trade continues to profit from an understanding of attribution subtler than that of editors and ethicists alike.Recommendations in respect of industry. In addition to these, the ICMJE should work alongside academic institutions and societies to achieve an outright ban on advocacy marketing – defined as the dominant attribution of commercially-owned, instigated or financed projects to academics and their institutions. It is reasonable for academics to work with industry in the clinical evaluation of commercial drugs, and to participate in reporting the findings to their medical colleagues; but such projects should always be presented as commercial ones with academic involvement, not the other way round.Table Recommendations, nor is there information on how the ICMJE Recommendations, secretariat, meetings and other activities are organized and financed. This is unacceptable – especially since some ICMJE member journals, who pay the salaries of editors who decide the ICMJE rules, belong to commercial publishing houses, profit from reprint or advertising sales to industry, or are stocked with industry manuscripts.Furthermore, the ICMJE should apply the principles of disclosure it requires of authors to itself. No interest disclosures are currently to be found on the ICMJE website or in the Recommendations are limited in their capacity to prevent commercial bias, but provide valuable protection against the worst potential commercial abuses of literature, such as low methodological standards, guest authorship and nondisclosure of industry involvement. The Recommendations have also been used to raise research standards, for instance in trial registration and the emerging guidance on data sharing. Unfortunately, much of the ICMJE guidance with respect to industry remains weak and incomplete, and advocacy-based marketing is directly facilitated. The ICMJE must bear a degree of responsibility for deficiencies in the quality of medical literature, to the extent that these failings are overlooked or even succored by the standards the ICMJE applies. One must however conclude by supporting the ICMJE Recommendations as a work continually in progress, by acknowledging their many beneficial effects on research and publication standards including in commercial literature, by encouraging their continuing evolution, and by asserting the value of these flawed but essential guidelines.The ICMJE Not applicable.Not Applicable.Recommendations, website and editorials are available online at www.icmje.org.The ICMJE


Ajman (UAE): EDC, Center for Diabetes Education in collaboration with World Association of Medical Editors (WAME), European Medical Writers Association (EPWA) and Eastern Mediterranean Association of Medical Editors (EMAME) organized a two day international conference on Medical Writing here from March 5-7, 2015.Mr. Tom Lang from USA a distinguished Medical Writer was the first speaker in the first session on March 5, 2015. Tracing the history, he gave details of the formation of various professional association of medical, science editors. The International Committee of Medical Journal Editors (ICMJE) he said, came into being in 1968 in response to a letter from a Secretary to the Editors of NEJM, AIM and JAMA about creating a standard reference format for medical journals. A meeting was then held at Vancouver in 1978. At that time ICMJE was a small self appointed working group of editors from general medical journals. It used to meet annually and funded its own programme. It decided to make recommendations for the conduct, reporting, editing and publications of scholarly work in medical journals. Members of this group included Annals of Internal Medicine, BMJ, CMJA, Chinese Medical Journal, and Ethopian Journal of Health Sciences, JAMA, NEJM, Lancet, PLos and a few others. It was in 1979 that it released the Uniform Requirements for Manuscripts Submitted to Biomedical Journals. Since then it has issued important position papers that have changed how science is reported.World Association of Medical Editors (WAME) was founded in 1995 with 22 medical journal editors and scientists from thirteen countries from five continents. It is an alternative to ICMJE which is small and exclusive. Today it has nineteen hundred members from over a thousand journals from ninety two countries. WAME membership is open to decision making editors of medical journals worldwide and to scholars in the field of scientific publishing. Its membership is free. WAME facilitates worldwide cooperation, exchange of educational information, improve editorial standards, promotes the professionalism, expand the influence of medical editors, develop mutual support, encourage research to improve the quality of medical science and practice. WAME support this concept of regional groups based on language and geography. It is a virtual organization. It has different committees on Ethics, Editorial Policy and Education.Council of Science Editors (CSE) was founded in 1957 by the National Science Foundation and the American Institute of Biological Sciences as the Council of Biology Editors. Its name was changed to CSE in 2000 and today it has over eight hundred members. It publishes position papers on its website, offers journal editors certification programme and holds annual conferences with course for journal editors and manuscript editors.European Association of Science Editors (EASE) was founded in 1982 in France by a merger of European Life Science Editors Association and the European Association of Earth Science Editors. At present it has over 550 members representing more than fifty countries. It publishes a quarterly journal European Science Editing; it has published Guidelines for authors and Translators of Scientific Articles and holds its conference annually.Other organizations of Authors, Editors and Medical Writers include American Medical Writers Association (AMWA), European Medical Writers Association (EMWA), and International Society for Medical Publication Professionals (ISMAPP) and the industry sponsored The International Publication Planning Association (TIPPA).Speaking about the formation of Eastern Mediterranean Association of Medical Editors (EMAME) Prof. Farhad Handjani President of EMAME said that it uses potential of people in the region. It also provides an opportunity for networking with people outside the region. We can have joint workshops on Medical Writing, Peer Review. At present EMAME represents over four hundred biomedical journals from the Region. Good research, good papers and good journals are all interlinked. There are certain ethical issues like publication ethics, cut and paste etc., because of pressure to publish on academicians. When there is too much pressure, people start working unethically, he remarked.European Medical Writers Association Mr. Tom Lang said at present has 941 members from Europe, UK and Germany. It is a not for profit organization working with professionals, medical writers, editors, publishers. Its Flagship is workshops and so far it has organized over hundred workshops. Writing, Editing conferences are expensive. Webinars, e learning are being used effectively. The Medical Writing journal has good contents. Speaking about publication ethics, Tom Lang emphasized the importance of transparency. We the Medical Writers are often accused of ghost writing but we are ethical and professional people. There should be transparency when the services of professional medical writers are acquired. Medical Writers prepare ghost papers writing for Pharma industry. They are serving the pharmaceutical industry not science. Continuing Mr. Tom Lang said that professional medical writers are necessary, desirable as it saves the time and money. The authors have complete control on data. He called for close collaboration between the medial editor’s and medial writers.Participating in the discussion Prof.Farhad Handjani said that professional medical writers are working in various countries but they are not active in our region. Professional medical writers attend workshops and put professionalism in their job. They also organize training courses. Prof. Farhad Handjani was of the view that our own people should also start writing as well. To encourage that we at the Shiraz University of Medical Sciences have started a Masters course in Medical Journalism. We need to open up this concept of professional medical writers in this region and the services of professional medial writes should be included in the acknowledgement section in the manuscript.Mr. Tom Lang’s next presentation was on statistical concepts in clinical research. He pointed out that most authors use only basic statistics if they use it at all. As regards underuse of statistical analyses, upto 80% of articles use only descriptive statistics, a vast majority use only very basic statistics while only 20% were using more advanced statistics methods. Yet another problem was that authors who use statistics make lot of mistakes hence there is a high rate of statistical errors in manuscripts. Almost 70% of articles reporting studied have statistical flaws. Statistical problems in the literature, he said, are widespread, potentially serious, largely unknown with the result that much of the scientific literature, he opined, cannot be trusted.Continuing Mr. Tom Lang said that many people were not aware of the first two problems. When the standard deviation is greater than half the mean, the data is not normally distributed. He then referred to the CONSORT statement. Intermediate results, Mr. Tom Lang said falls between a negative result and positive result. It indicates neither a positive nor a negative finding. He emphasized the importance of using figures and tables accurately as readers remember the usual impression of the figure better than the actual data. All statistical tests have assumptions and if these assumptions are violated, one has less confidence in the results. A visual summary of the study can summarize the study design, show the number of patients at each stage, indicate denominators for proportions, percentage and present the main results of the study.Statistical problems in literature are widespread, potentially serious & largely unknown-Tom LangProf. Jaakko Tuomilehto from Finland talked about writing a programme for diabetes screening. Screening, it was stated is carried out for early detection of disease in individuals who do not show any signs of disease. Screening can be of various types i.e. Mass screening for whole population, selective screening of those at high risk besides multiphase screening wherein several diseases are screened at once while screening for surveillance is for repeated observations. The purpose of screening is to reduce morbidity and mortality. It is done with applying relatively simple inexpensive tests to people who are asymptomatic for the purpose of classifying them with respect to their likelihood of having a particular disease. Screening tests can also be used as diagnostic tests. Diagnosis involves confirmation of presence or absence of disease in someone suspected of or at risk for disease. Screening can be for prevalence of disease and susceptible to benefit from treatment or for risk of future disease and susceptible to benefit from preventive intervention. He then talked about the screening process in detail. Key measures of validity of screening tests are sensitivity, specificity, positive predictive value and negative predictive value. The proportion of all those who do not have the disease and who test positive are known as false positive and the proportion of all those who have the disease but test negative are known as false negative. Sensitivity is the ability of a test to identify those who have a disease while specificity is the ability of a test to identify those who do not have the disease.Speaking about the considerations in screening Prof.Jaakko mentioned severity of the disease, its prevalence, understanding the natural history, diagnosis and treatment, cost, efficacy and its safety. The criteria for successful screening programme is the presence of the disease in the population being screened, high morbidity and mortality and it must be an important public health problem. In addition, early detection and intervention must improve the outcome. Natural history of the disease should be understood in such a way that the detectable sub-clinical disease stage is known and identifiable. It must also be ensured that the screening test is relatively sensitive and specific, should be simple and inexpensive, safe besides being acceptable to the subjects as well as the providers. It must also be able to offer something to those who screen positive. Facilities for diagnosis and appropriate treatment must be available. It is unethical to offer screening when no services are available for subsequent treatment.It is unethical to offer screening when no services are available for subsequent treatment-Prof.JaakkoDiscussing the screening strategies Prof. Jaakko said that the high risk approach should be cost effective, intervention should be appropriate for the individuals, subjects should be motivated. However, it fails to deal with the root causes of the disease and there is small chance of reducing disease incidence at the population level. On the other hand population approach has the potential to alter the root causes of the disease, it also offers greater chance of reducing the disease incidence, offers small benefit to the individuals, there is poor subject motivation and there is the problematic risk-benefit ratio. Higher BMI means higher the incidence of diabetes, hence screening test is justified in this condition. There are certain risks of screening i.e. True positive are labeled as diseased and false positive can have side effects of diagnostic tests and treatment besides anxiety and monetary expenses. On the other hand false negative can delay intervention. There is disregard of early signs and symptoms which may lead to delayed diagnosis. Most diseases do not progress at same rate in every one. Screening will pick up slowly developing disease. Volunteers have better health, lower morbidity and they are likely to adhere to mediations prescribed. In order to find out whether a screening programme is effective, it should be evaluated afterwards but it is rarely done. Prof. Jaakko concluded his presentation by stating that assessing disease screening programme is complex. Proof of value of screening for type 2 diabetes is lacking but there is reasonable supportive evidence. Screening programmes for type 2 diabetes should start with simple self complete screening tools.Prof.Tom Lang first referred to the ICMJE criteria for authorship and to be eligible for authorship, every individual must meet all the ICMJE listed criteria which are as under:Speaking in the workshop on publication ethics Contribution to the researchContribution to preparing the manuscriptApproving the final version to be publishedAgreeing to assist in any investigation of the research.In addition he or she must be able to say which co-author is responsible for each part of the research and have confidence in the integrity of the contribution of all the co-authors.For authors it is extremely important to meet all the four conditions. Just getting grants, referring patients, collecting data or supervising the research does not justify authorship. One should never allow guest or gift authorship to seniors, directors, those who provide patients, samples etc. Authors should be listed in order of greatest contribution to the work from most to the least contribution. It is advisable to decide about listing of authors even before starting the research. It is also essential to acknowledge interest, competing interest, personal financial academic interest. He also referred to outright fraud and citation amnesia. Methods for selection of sample may be there. It is a copy right issue, plagiarism but not fraud. Duplicate submission, simultaneous submissions were also discussed. Duplication publication Mr. Tom Lang opined has effect on practice of medicine as it affects the number needed to treat. Duplicate publication in a different language is allowed provided it is properly acknowledged. Salami slicing means cutting something into thinner pieces. Salami slicing is not a good thing. Article reporting different parts of the same research should indicate that they are all from the same study. Patients have a right to privacy. Image manipulation i.e. changing brightness and contrast on only part of the image, using cloning tools to hide details or cropping images to eliminate information is also included in publication misconduct. Journal of cell biology has started screening the images of all accepted papers since 2002.Journal editors and peer reviewers are not supposed to tell anyone that they have reviewed a particular article or use the information in the article for any other purpose besides delaying their decision on a manuscript until a competing work is published. Authors, co-authors and reviewers are supposed to disclose their possible conflict of interest to the journal editor while the possible conflicts of interest among the authors are mentioned in the published manuscript.Predatory journals, Mr. Tom Lang opined are those which offer quick acceptance, have no peer review and they usually inform authors of publication fee after acceptance. They use websites mimicking good reputed journals. He then also referred to Jeffrey Beall who publishes Beal’s list of black list of questionable open access journals. One should look at Directory of Open Access Journals which publishes a white list of legitimate online journals.Plagiarism Mr. Tom Lang said means taking credit for the written or creative work of someone else. Science builds on the work of others so it is the intentional misattribution of the work that is plagiarism not necessarily the use of the work itself. Citation plagiarism or citation amnesia means not giving credit to other authors and letting readers assume that you or someone else deserves the credit. On the other hand outright fraud stands for theft of intellectual property. Self plagiarism means resubmitting large portions of one’s own writing without disclosing its earlier publication to the new editor. Usually it is a copy right issue. During the discussion the contributor ship now being practiced by various journals was also highlighted.Prof. Farhad Handjani discussed research ethics in publications. He pointed out that while practice helps an individual, research benefits many. He mentioned about respect for persons, beneficence and justice. He opined that while doing research one has to think of the society. It was in 1964 that Helsinki declaration was made. It is important that negative results of research are also published. Conflict of interest should be declared. Side effect of some drugs are never published. He then talked about the role of Institutional Review Boards, Ethics Committees and said that ECs should consist of people with different background including lay people and scientists as well. IRBs must look that the risk is minimized, look at favorable risk benefit ratio of studies, equitable subject selection, and informed consent of the research subjects, data should be monitored for safety. Privacy of research subjects should be protected and there should be adequate safeguards for vulnerable individuals. Ethics Committee approval means the Editor cannot question legitimacy of the study. Informed consent of research individuals is very important. It is a process. Informed consent can be oral or written. One should talk to the village chief or community elders before undertaking research in their respective areas. One should also respect the cultural values. Volunteers should have the choice to come out of the study trial. In case the children and adolescents are involved in research, the assent should be given by their parents. Clinical Trials Registration, Prof. Farhad Handjani remarked is a must.IRBs must look at favorable risk benefit ratio of studies, equitable subject selection, & informed consent of the research subjects-Farhad HandjaniJulia Donnelly from UK was the first speaker who discussed how to write a Good Poster and create an impact. Posters, she said, are enlarged, graphical presentation of research data. The abstract represents citable references and it also ensures rapid publication. The advantages of posters are that they can be viewed at leisure time, offers personal contact with the author. They are more comprehensive than an oral presentation. They can also be more memorable than a talk. Their value can be prolonged through handouts and it can also be a fun. However, it also has some disadvantages as the viewer is not comfortably seated. It is easy for the viewer to walk away. If a poster is dull, the viewer may switch off. It is time consuming to produce and at times it is also difficult to decide what to left out. Oral presentation is rated highly as compared to poster presentation. The writer should try to be brief.On Day two of the conference If the poster is brief, structured, good appearance, has better title, lay out is good and conclusions are highlighted, it will have an impact. Most common complaints regarding posters is the use of too small type face or difficult to read, including too much un-necessary data, confusing organization, lack of headings and the information provided is not newsworthy. Some of the key steps in planning poster once the abstract has been accepted are to write the poster text. Have proper layout. Find out what does the abstract say, what results are available, who is your target audience, when the poster is to be presented. Speaking about general principles of poster text, she said that ensure maximum use of white space, remove non-essential information, use abbreviations, and use the active voice, use tables and figures to replace words, have short sentences and use bullets. Write in defined sections and there should be emphasis on results. Write Methodology and Results first. About 10% should be introduction, 15% methods, figures 2%, Results 30%, tables 2%, conclusions 10% and references 5%. Title should be clear, concise with less than ten words. For authorship follow ICMJE guidelines.Introduction in poster should be brief and relevant, limit the information, ask pertinent questions, and use present tense. Poster has to be short and convey the message. In the methods section, include only essential information, describe design. State the results factually without commentary and interpretation, direct the reader to tables and figures and use past tense with short sentences. Poster contents should be brief and relevant. In references list first author and then et al. limit to relevant references, simplify tables, answer question posted in the introduction, give presenter contact with e mail and write poster number. Size of the poster should be as per instructions. Poster must be eye catching, be creative, use colours and unusual format, and locate tables and figures near relevant test, use upper and lower case type. For title use 30-36 point type font, for authors 30 point bold, heading 30 point, body text 20 point and not bold. While reviewing the poster detect errors, inappropriate and poor writing, improve its quality and increase the likelihood of good response. Make sure that the written piece is suitable for a poster, is it suitable for target audience, does it include the right message and does it have appropriate contents. Be clear, concise and avoid un-necessary details.Prof. Paolo Pozzilli from UK discussed pros and cons of peer reviewing. Peer review of a paper, it was stated, can be arranged in your own institution. It is much more critical and dynamic process than many other forms of quality regulation. Peer review is important because it helps determine whether a study’s conclusions follow logically from the procedures used to arrive at it and whether the conclusions makes a significant contribution to our knowledge. Unintentional plagiarism means paraphrasing poorly, changing a few words without changing the sentence structure of the original or changing the sentence structure but not the word, quoting poorly. On the other hand intentional plagiarism means passing off as one’s own pre-written papers from other sources., cut and paste and borrowing others ideas. Ethical medical writers must always acknowledge the original source of the idea, text or illustration. Integrity of clinical trials, it was emphasized, is essential for the development of new drugs, at present it is increasingly under threat from commercial influences resulting in an urgent need for rules and guidelines to safeguard the reliability of trials. Bias in publishing positive results and under reporting of negative results was also highlighted.Ethical medical writers must always acknowledge the original source of the idea, text or illustration - Prof.Paolo PozzilliMr. Shaukat Ali Jawaid in his presentation on Scientometrics talked about Impact Factor, h-Index and other indexes. It was Eugene Garfield who first identified the importance of citations and then crated the Science Citation Index in 1950s. He then demonstrated how Impact Factor is calculated. He also talked about drawbacks of Impact Factor, the other alternatives like h Index, how it is calculated, advantages of h Index and its drawbacks. He also talked about m-Index, g-Index and e-Index and pointed out that each one of them can be manipulated and has its advantages and disadvantages.Mr. Tom Lang from USA discussed what one should know how to get published. He said that one should ask oneself a question as to how will medicine be different if he or she answers research question? If you do not know the answer, it won’t be published. Ask yourself what problems needs to be solved or how something can be done faster, better, cheaper, safer and easier. What is known about the question? Has it already been answered? How have others tried to answer it? What variables were involved and how they were measured? What problems were found? Make the question specific i.e. How effective are medicated bandages? He further stated that science cannot exist without writing. Only writing allows science to be recorded, evaluated, reproduced, systematic, cumulative and public. Publication Tom Lang opined is the final stage of research and evidence based medicine is literature based medicine. The quality of medical care is affected by the quality of published articles. Follow the instructions for authors of the journal you are writing for was extremely important and will determine whether it is accepted for publication or not.During the discussion it was stated that one should do something which need to be studied than what can be studied. One does not have to cure cancer but just find something that makes medicine better. If the topic selected is of local interest, such manuscripts cannot be published in an international journal. Editors want new research which is important and is clearly reported. One should ask timely and important questions. If the selection of the journal is wrong, topic selection is wrong, something has already been published on that topic and the journal has high Impact Factor, your manuscript will not be published.Dr. Bashair Musa from Research Center for Diabetes and Research Ajman highlighted the factors affecting academic writing skills and mentioned time, motivation, language, texting culture, knowledge, training i.e. Underestimating the importance of good writing and disregard the principles of good writing. One should convey the thoughts clearly and professionally. Good communication skills, career progress, Research and Publishing are important. Always use full words, provide accurate detailed information, provide facts, numbers, never use abbreviation in title and first time write full with abbreviation in bracket and then one can use these abbreviations. Writing of course has to be learnt, he added.Dr. Amena Sadiya from RCDR Ajman described UAE experience regarding conducting randomized controlled trials in clinical practice. Speaking about the planning phase in clinical trial she mentioned the hypothesis i.e. plans of the study, team formation for the study, study protocol and case report Form, budget and the ethics committee approval. In phase two the clinical trial should be registered in public database, prepare the essential documents, arrange for study medications, train the study team and then start subject’s recruitment. It is just like directing a Play. ICMJE in 2005 decided that no trial will be published unless it is registered in a public database. As regards informed consent of the patients, study subjects it is essential that they are explained everything in detail otherwise there will be drop out. Patients can be in control or in placebo group. The trial procedure should be strictly followed. Explain the possible benefits and adverse effects if any. The whole record should be kept confidential. The duration of the trial should be explained. The research subjects should have the liberty to withdraw at any time if they wish to and it must not affect the medical treatment. She further stated that the quality of data determines the quality of study. She also referred to missing data or feeding of wrong data which are some of the problems which are encountered sometime.Research subjects should have the liberty to withdraw at any time if they wish to and it must not affect the medical treatment-Dr. Amena Sadiya.Speaking about the reasons for non-compliance she mentioned the study subjects forget, development of side effects hence they do not want to continue. Some might change their mind to participate in the study. Short duration of study, simplicity of intervention like single dose drug, careful selection of study subjects who are likely to follow study protocol, explaining in detail about the study and what is expected from them and staying in contact with the participants will minimize the chances of non-compliance. She then talked about the termination procedure, breaking the code and monitoring possible toxicity. The evaluation phase consists of data management, statistical evaluation, finalization and archiving. It is extremely important the study should be reported and published even if the results are negative.Mr. Shaukat Ali Jawaid from Pakistan made his presentation on How to write Medico Legal report and said that it comes under the domain of Forensic Medicine which is both an Art and a Science. Forensic Medicine is a branch of medicine which deals with application of principles of medical knowledge for the purpose of law and for furthering Justice.Writing medico legal reports is a highly specialized job which should not be undertaken by some one who has no experience or training in Forensic Medicine. In case of difficulty or inability to frame opinion, it is advisable to refer the matter to senior colleagues who are well trained for advice. Final opinion in the medico legal report, he said, should contain comments about nature of causative agent, estimation of time lapsed, gravity of damage inclusive of incapacity produced by trauma or intoxication. The possibility of injury being self inflicted, homicidal or accidental should also be recorded. Working in the medico legal section of a healthcare facility is a very dangerous job and one must be careful of all these consequences which at times could be too harsh, he remarked.The practice of forensic medicine Mr. Shaukat Ali Jawaid stated extends beyond the premises of hospitals into the courts of law in continuation of work which has already been done in the hospital to help further justice. A Medical Jurist has to present, authenticate, interpret and justify his work done in the hospital as factual and true. All this requires efficiency, precision, neatness and full concentration. Forensic Medicine work must reflect respect for human being victim or accused.It is extremely difficult while dealing with dead bodies under putrefaction. Besides legal, moral consideration, the job may become hazardous endangering safety of workers while they are medically examining the injured or dead. As such it requires recognition of risk and identification of hazards beforehand. Medico legal certification is highly technical hence it should not be attempted half heartedly. Only trained, qualified forensic medicine examiners should perform and make their opinion reliable and creditable.Writing medico legal reports is a highly specialized job which should not be undertaken by some one who has no experience or trainingin Forensic Medicine - Shaukat Ali JawaidDespite the fact that examination of living and dead are similar but it differs in technical details and status of the examinee. Autopsy is more specific with additional objectives i.e. determining cause and manner of death, estimation of fatal and postmortem periods. Medico legal examination requires purpose built centers supported with proper and specific implements in medico legal clinics for living and autopsy suits are required for the Dead.Workload of forensic medicine includes physical and sexual assaults, intoxication resultant from self or criminal poisoning with drugs, accidental trauma on the road, rail, air and industry. Medical certificates may also be required for life insurance, police recruits, and drivers, age certification for schooling and fitness for job, marriage, election as well as capital punishment.There are certain pre-exam formalities. In sexual assault, he said, one has to determine whether the injury has produced any damage to private parts of the victim, injury resulted in damage or defect in private parts. Information about weapons used, number of persons involved, circumstances i.e. place of occurrence is also extremely important in case of physical and sexual assault cases. In case of road traffic accidents, industrial accidents it is important to listen to the victim carefully and record history of occurrence. Of course professional ethics demands that one has to take consent of the victim before starting the examination.Physical examination of clothes Mr. Shaukat Ali Jawaid remarked has a special place in forensic medicine. They are preserved, searched to locate any foreign material present on them i.e. Stain, hair, fiber, stains of blood, semen, vomitus, excreta, oil, its position, colour and distribution should all be recorded in the medico legal certificate. Details about smell, feel, shape and texture must also be recorded. One should use naked eye as well as magnifying lens. Any damage, cut in clothes is an important finding in forensic medicine. One should note its position and relationship to the injury. Examination should include physical exam, mental status examination, clinical systematic examination, local examination of the affected part. Local examination means exam of body parts or any portion with pathology, wound caused during assault or accident. Examination also includes exam of body opening violated during sexual assault. Wound margins, walls bed whether smooth, cleanly cut or lacerated needs to be carefully noted.Body opening of vagina and anus if violated sexually must be examined. These openings are best examined in lithotomy and knee-elbow position respectively. Adequate illumination is essential for good results. In Forensic Medicine, solely relying on victim’s statement could be hazardous. As regards documentation and certification, written record, drawn sketches, photographs must be prepared and preserved. Close up photographs of injuries, damage, staining of clothes, full view of injured or intoxicated are all very essential. Fractures should be recorded with X-rays. The certificate should include result of investigations, reports on collected material and all other relevant documents such as receipts and dispatches. In case the injured is admitted to the hospital, treatment notes, duration of stay, date of discharge should be obtained and incorporated in certification to help verify full facts of the case. It is worthwhile to note that medical opinion or conclusions should only be based on observed facts. Opinions should not go beyond knowledge of the medical examiner. Sentiments, sympathy, personal theory must not influence the formulation of opinion. It is also essential to record whether the findings are consistent with sexual intercourse or otherwise. He also acknowledged the help and guidance of Prof. Naseeb R. Awan an eminent Forensic Medicine specialist from Pakistan for preparing this presentation.Dr. Nader Lessan from UAE discussed writing the manuscript. One of the topics suggested by the participant for the study was why AMI is seen in young people in UAE. In this, one has to find out the reasons and also define what you mean by the young age. While writing on this topic, in the introduction one should give the global figures for AMI, its relevance, life style changes, risk factors in UAE, differences in prevalence in UAE and other countries and then justify why you wish to do this study. In the methods section, one can mention that it is a retrospective study for the last five years and the data in a particular hospital was looked at from Dubai Health Authority. The electronic data is used and the risk factors are reviewed. While writing the results, provide patients characteristics in the form of a table, it may also include figures and the overall number. Then you discuss your results with findings from other similar studies from UAE, from the region and globally in the discussion section and find out how and why they are different if at all.Mr.Habibur Ibrahim talked about pharmacy related open access journals from India. Open access encourages more citations. He also referred to the DOAJ which has two hundred journals from USA. During the Year 2011, 169 journals were included in DOAJ. He was of the view that one must check the validity of journals while looking at the open access journals.On third day of the conference Next presentation was on outsourcing medical writing services. It was pointed out that in this skilled medical writers are hired and they are cost effective and it also meets the guidelines. These professional writers work with mutual respect and trust. The sponsors of the study are always the owners of the data. In the beginning they sign agreement regarding confidentiality of study data. During the discussion it was pointed out that one should use editing services before making final submission. Universities and medical institutions use the services of professional medical writers because it is most cost effective.Markus Heinemann from Germany gave highlights of cardiac surgery reflected in one journal over a period of thirty four years. This was based on MD thesis. The journal named Thoracic and Cardiovascular surgery was founded in 1953. It became a university journal in 1972 and in 1974 it was converted into English and included in ISI. In 1953 its all issues were put online and they publish eight issues every year. So far the journal has published 3350 articles and now 78% of its manuscripts are related to cardiac surgery. Almost 15% of the papers were on congenital heart disease. Case reports are very popular and they are covered in the last in the journal. During 208-2011 there has been an increase in publication of case reports. Experimental research work accounted for 15%. It was further stated that case reports are extremely important in surgery; they are widely read but hardly cited. Dr. Markus further stated that now they have started a case reports journal, almost 60% of the submitted articles are rejected and there is 75% rejection in the main journal. He concluded his presentation by quoting Ibne Sina who had remarked that we should try to know the cause of the disease.Sam Mathews from India presented highlights of a decision support tool they have developed to determine the authorship in clinical publications which looked quite useful. During the discussion issues like listing of authors and credit criteria all figured prominently.Tom Lang from USA, Julia Donnelly from UK, Shaukat Ali Jawaid from Pakistan, Farhad Handjani from Iran and Gamela Nasr from Egypt. It was pointed out that each one of us should try to be a vehicle of change. All the information available on the net is not credible. Equator website has guidelines for reporting research findings. Then there is CONSORT statement for clinical trials. It was reiterated that one should carefully look at the credibility of the websites. Ethics Mr. Shaukat Ali Jawaid remarked has a lot to do with morality. Mr. Tom Lang said that at time manuscripts are rejected because of poor English and Grammar. Some of the journals are very large and some have part time staff that cannot help the authors. The easiest way is to reject such manuscripts because these journals do not have the resources to rewrite these manuscripts. Hence some commercial companies have come up who provide these services of improving English language. Some of these companies are very professional and do a quality job. It was also suggested that we should try to find an indigenous solution to indigenous problems which alone will be cost effective. Mr. Tom Lang said that he needs about seven to eight hours to correct a manuscript and it takes two three days. However some companies have acquired the services of professional writers who are asked to correct and edit fifty articles in a week hence how you can expect a quality job from them, he asked.The conference concluded with a panel discussion on Online Health Information. The panelists included