The current research publishing environment is a confusing place for both native and nonnative users of English. Researcher-authors must somehow reconcile pressures to publish as much and as rapidly as possible with conflicting advice from reviewers about the language, writing, and reporting, and with differences among journals and publishers in the quality of the peer review and editing services they provide (or advise authors to seek). An additional challenge is meeting the sometimes conflicting expectations of different stakeholders (coauthors, institutions, journal editors and reviewers, publishers, public and private research funders) without breaking the rules of ethical research publishing.
Researchers must communicate the results of their work efficiently; however, they are often unskilled in writing and other forms of communication.1,2 Most published research articles have attained some fuzzily defined threshold of acceptability in terms of the content and writing, yet even after peer review and editing, these articles rarely linger in the memory as shining examples of reader-friendly information transfer. Clients who can afford it turn to translators, language editors, author’s editors, and medical writers to produce manuscripts with the best possible chance of avoiding rejection because of language, writing, or reporting flaws. Yet misunderstandings about the roles of different communication professionals are widespread, and as a result, the ethics of communication professionals, particularly medical writers, have been questioned.3–9
WHAT DO MEDICAL WRITERS DO?
Actual practices vary somewhat, but the following description summarizes the general process of manuscript development with input from medical writers.4,10,11 After the study is complete and the data have been obtained, the medical writer meets with researchers to query them about the aims of the study, the hypothesis that was tested, and the main results. The medical writer may also search the literature to identify relevant studies that should be considered in the introduction and discussion sections. Then, the medical writer produces a first draft of the manuscript, which is revised by the investigators in the course of subsequent meetings or correspondence. The medical writer coordinates the revision process and incorporates the authors’ suggestions and corrections into subsequent drafts, which are reviewed and revised as many times as necessary until the authors are satisfied that the manuscript reports the research accurately and effectively.
Like other types of technical writing, good medical writing is, in essence, good reporting. Writing well to ensure that the content is accurate and clear is not the same as deciding what to write about, so medical writers are usually not authors as defined by the International Committee of Medical Journal Editors (ICMJE) criteria.12 Rather, they are technicians likely to be more skilled than the named authors in writing, reporting, and using the English language. Good medical writers can produce manuscripts more likely to be ready for submission in less time and with fewer errors than if the authors prepared the manuscript themselves.2,13
Medical writers are usually not responsible for final decisions about the content of the manuscript. The authors must reconcile disagreements about the content among themselves, just as they would if they were writing and revising the manuscript themselves. Medical writers who are not responsible for the entire final content of a manuscript are naturally reluctant to go on the record as having approved it,14 although authors who are identified as such in the byline may have fewer compunctions about this. In fact, skilled medical writers are likely to raise concerns over possible spin and underreporting of relevant findings in the course of their duties. When their clients overrule these concerns and opt for language that is more flattering to the product under investigation, this can make medical writers uncomfortable enough to refuse to work for certain clients or even leave the profession entirely.15
Medical writers are not ghostwriters if they are named and their contribution is disclosed clearly. Current professional guidelines strongly urge medical writers and their clients to let readers know who contributed to the published material, and encourage medical writers to resist efforts by their clients to hide their role.3,16–32
GUIDELINES DEVELOPED BY MEDICAL WRITERS AND OTHER STAKEHOLDERS
Medical writers, in collaboration with journal editors, industry sponsors, and ethics consultants, have developed a number of professional practice guidelines (Table 1). These documents explain in detail the steps medical writers have taken to ensure that their work is presented professionally and their contributions are reported accurately.
GHOST AND GUEST AUTHORS, AUTHOR’S EDITORS, AND MEDICAL WRITERS
Although calls for greater transparency in disclosing the roles of paid communication professionals have been justified, general attacks on the professional ethics of medical writers7,8 are misdirected. Interestingly, politicians’ ghostwriters33 have not been criticized for their ability to make their clients’ support for unjust social policies, weapons of mass destruction, and activities that damage the environment sound logical, convincing, and sincere, even though some of these policies may result in harm to human health. Also overlooked by many critics of medical writing is the phenomenon of guest authorship: when prestigious academics, often in exchange for some tangible form of compensation, knowingly allow their name to be used as an author even when they do not meet the ICMJE criteria for authorship.5–7,27 In this connection, it may be worth asking why peer reviewers’ substantial contributions are almost never acknowledged in print. Feedback from peer reviewers may turn an unpublishable manuscript into a publishable one, yet reviewers are rarely asked to accept public responsibility for their contribution, and when offered this option, they often decline.
Some researchers and editors are unclear about the differences in the roles of author’s editors and medical writers.1 The contributions of these 2 types of communication professionals are not the same, although practitioners who self-identify as one or the other may provide either type of service depending on the client. Unlike medical writers, author’s editors34,35 do not usually draft material “for” or “instead of” the authors. Author’s editors work directly with researchers, usually in the latter’s own institutional setting, and usually try to improve researchers’ writing and publishing skills as a part of the service they provide.34–37 In contrast, medical writers liaise with authors through intermediaries such as pharmaceutical firms, medical communications agencies, and contract research organizations, so their opportunities to educate or train authors may be limited.
WHAT CAN STAKEHOLDERS DO TO SUPPORT ETHICAL PUBLISHING PRACTICES?
Education and transparency are keys to responsible, professional publishing. The roles of all contributors should be documented and disclosed transparently, so that any issues raised about writing or editorial assistance can be resolved promptly.
- Whenever possible, researchers should find a good mentor who abides by ethical publishing practices. Authors should take the time to read and follow the journal’s instructions for manuscript preparation and publication ethics. Before submitting a manuscript, the checklist to discourage ghostwriting should be consulted.24–26
- Editors and peer reviewers should understand that most researchers work in an environment that does not do enough to encourage good behavior or discourage bad behavior. Pressure to publish, competition for research jobs, and weak enforcement of the rules for professional conduct can motivate some to cheat. Moreover, the perceived intrinsic unfairness and lack of transparency in manuscript and grant peer review may lead researchers to feel that cheating is justified to compensate them for biases in a dysfunctional system.38
- Journal editors should explain their authorship and contributorship policies clearly, as in the Guide for Authors of Anesthesia & Analgesia.39 The journal’s instructions to authors should include the checklist to discourage ghostwriting.24–26 Shortening and simplifying the instructions (or perhaps translating them into other languages) might improve comprehension and compliance by authors whose first language is not English. Journal editors should also resist the temptation to blame researchers or their communication service providers for ethical issues that will require changes in the big picture (commercially sponsored health research and publication) to resolve.3,8 When editors suspect inaccurate authorship disclosure, they should consult the appropriate Committee on Publication Ethics flowchart and advice on authorship problems.40 Honest errors discovered during manuscript review create opportunities to educate authors. If knowingly dishonest behavior with the intention to deceive is documented, appropriate measures should be taken to discourage unacceptable behavior in the future.
- The ICMJE needs to update its authorship criteria to reflect current practices in academic and commercial health research.14,41,42 The Good Publication Practices Guidelines strongly support a switch to contributorship instead of authorship,16,17,23 a change that would facilitate transparent reporting of the roles of communication professionals, guest authors, and industry employees. But because nominal authorship remains a valuable commodity, researchers, institutions, journals, and indexing services have been slow to support this change.
- Communication professionals have understood the need for transparency, and, as explained above, medical writers have taken steps to make their roles known. Academic institutions as well as public and private funders of health research, however, sometimes seem reluctant to publicize their roles. These stakeholders should make parallel efforts to ensure that contributions by their employees and staff members are also disclosed honestly and transparently.
Name: Karen Shashok, BA.
Contribution: This author wrote the manuscript.
Attestation: Karen Shashok approved the final manuscript and is the archival author.
This manuscript was handled by: Steven L. Shafer, MD.
My appreciation goes to Patricia Rohrs, formerly Medical Writer/Editor at the Department of Anesthesia, Stanford University, and to Dr. Lawrence Saidman, for their useful feedback on improving the organization of the manuscript.
1. Bailey M. Science editing and its effect on manuscript acceptance time. J Am Writers Assoc. 2011;26:147–52
3. Mansi BA, Clark J, David FS, Gesell TM, Glasser S, Gonzalez J, Haller DG, Laine C, Miller CL, Mooney LA, Zecevic M. Ten recommendations for closing the credibility gap in reporting industry-sponsored clinical research: a joint journal and pharmaceutical industry perspective. Mayo Clin Proc. 2012;87:424–9. Available at: http://www.mayoclinicproceedings.org/article/S0025-6196(12)00298-4/fulltext
. Accessed May 16, 2012
8. Shashok K, Jacobs A. Who’s watching whose ethics? Slanted reporting of the medical writer’s role in the Neuropsychopharmacology-Cyberonics case. The Write Stuff. 2007;16:33–5
12. International Committee of Medical Journal Editors (ICMJE). . Uniform requirements for manuscripts submitted to biomedical journals: ethical considerations in the conduct and reporting of research—authorship and contributorship. Available at: http://www.icmje.org/ethical_1author.html
. Accessed June 1, 2012
13. Jacobs A. Adherence to the CONSORT guideline in papers written by professional medical writers. The Write Stuff. 2010;19:196–200
17. Graf C, Battisti WP, Bridges D, Bruce-Winkler V, Conaty JM, Ellison JM, Field EA, Gurr JA, Marx ME, Patel M, Sanes-Miller C, Yarker YEfor the International Society for Medical Publication Professionals. . Good publication practice for communicating company sponsored medical research: the GPP2 guidelines. BMJ. 2009;339:b4330 Available at: http://www.bmj.com/content/339/bmj.b4330
. Accessed June 8, 2012
19. Jacobs A, Wager E. European Medical Writers Association (EMWA) guidelines on the role of medical writers in developing peer-reviewed publications. Curr Med Res Opin. 2005;21:317–21. Available at: http://www.emwa.org/Mum/EMWAguidelines.pdf
. Accessed June 1, 2012
21. American Medical Writers Association (AMWA). . Home: about AMWA. AMWA guidelines/ethics: AMWA position statement on the contribution of medical writers to scientific publications. Available at: http://www.amwa.org/default.asp?id=308
. Accessed June 1, 2012
27. Woolley KL, Wang M-Y, Matheis R. Re-building trust in medical journal publications. What can professional medical writers, journal editors and industry sponsors do? Global Forum. 2011;3:24–7 Available at: http://espace.library.uq.edu.au/view/UQ:263552
(click on: g20113624to27.pdf). Accessed June 11, 2012
28. Chipperfield L, Citrome L, Clark J, David FS, Enck R, Evangelista M, Gonzalez J, Groves T, Magrann J, Mansi B, Miller C, Mooney LA, Murphy A, Shelton J, Walson PD, Weigel A. Authors’ Submission Toolkit: a practical guide to getting your research published. Curr Med Res Opin. 2010;26:1967–82 Available at: http://www.cmrojournal.com/ipi/ih/MPIP-author-toolkit.jsp
. Accessed June 11, 2012
34. Tacker MM. Author’s editors: catalysts of scientific publishing. CBE Views. 1980;3:3–11
36. Burrough-Boenisch J. Authors’ editors: their procedures and interaction with authors. Eur Sci Edit. 2001;27:90–1
37. Kerans ME. Readers, writers and editors: looking at our ecosystem. Eur Sci Edit. 2001;27:93–4
39. Anesthesia & Analgesia, 2009–2010 Editorial Board. . 2010 Anesthesia & Analgesia guide for authors. Anesth Analg. 2010;11:525–39
41. Ivaniš A, Hren D, Sambunjak D, Marušić M, Marušić A. Quantification of authors’ contributions and eligibility for authorship: randomized study in a general medical journal. J Gen Intern Med. 2008;23:1303–10 Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2518038/
. Accessed June 12, 2010
42. Marušić A, Bošnjak L, Jerončić A. A systematic review of research on the meaning, ethics and practices of authorship across scholarly disciplines. PLoS One. 2011;6:e23477 Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3169533/
. Accessed June 12, 2012