Professional codes of ethics for medical writers
A professional association's code of ethics sets out the conduct its members agree to. For medical writers this covers the American Medical Writers Association (AMWA) code with its preamble and eight principles, where it sits among the association's other ethics resources, how it was written and revised, what a code does for a profession and its members, and the codes of the neighbouring professions that apply to other kinds of work.
What AMWA's code says
A professional association's code of ethics is a shorter and blunter instrument than a publication-ethics guideline, and it is worth reading in full for what it does not attempt. AMWA's, in the revision current in 2008, is a preamble and eight principles of conduct. The preamble describes the association as an educational organisation that promotes excellence in medical communication and recommends principles of conduct for its members, grounding them in the role medical communicators play in writing, editing and developing materials in various media and in the potential of what they produce to inform, educate and influence audiences. The eight are: recognise and observe the statutes and regulations pertaining to the materials you write, edit or otherwise develop; apply objectivity, scientific accuracy and rigour, and fair balance while conveying pertinent information in all media; write, edit or participate in developing information that meets the highest professional standards whether or not it falls under any regulatory agency's purview, attempt to prevent the perpetuation of incorrect information, and accept assignments only when collaborating with a qualified specialist in the area or when adequately prepared by training, experience or ongoing study; work only under conditions or terms that allow proper application of your judgment and skills, refusing assignments that require unethical or questionable practices; expand and perfect your professional knowledge and communication skills; respect the confidential nature of materials provided to you, divulging no patent, proprietary, patient or otherwise confidential information without permission; expect and accept fair and reasonable remuneration and acknowledgment for your services, and honour the terms of any contract or agreement entered into; and consider association membership an honour and a trust, conducting yourself accordingly in professional interactions.
Where the code sits among the association's resources
Tamara Ball, principal medical writer at a contract research organisation and the AMWA Journal's Everyday Ethics editor, reprinted AMWA's code in full when she opened that column in the Fall 2017 issue, and her account adds what the code is for to what it says. The Fall 2017 AMWA Journal issue (volume 32, number 3) was converted from its PDF by layout-aware Poppler XML conversion and admitted without content repair, in which figure labels can be inlined into prose, cover and contents columns can interleave, and reference URLs can be malformed or truncated. Her starting point is that ethics already pervades the association. On its website the joint position statement of AMWA, EMWA and ISMPP on the role of professional medical writers is foundational — it opens with the claim that professional medical writing support helps authors and sponsors to disclose their research in peer-reviewed journals and at scientific congresses in an ethical, accurate and timely manner, with the ultimate aim of advancing patient care — and the code sits beneath it. Ethics runs through nearly every part of the education programme, from workshops and the essential-skills programme to online learning and self-study workbooks; members can draw attention to it in their profile or freelance directory listing; the certification examination's content outline includes it; it is a frequent topic on the online community; and a search of the website for "ethic" returned 166 hits, 81 of them journal entries. Her table of those resources and their web addresses was published as an online supplement. Her answer to why a column is still needed is that ethics is not a list of facts or guidelines to be memorised but the embodiment of core values that manifest beliefs and guide actions, and so a living, evolving part of who members are that warrants continued attention.
Where such a code sits relative to everything else is worth establishing before leaning on it. The association carried it on its website alongside its position statement on the contribution of medical writers to scientific publications, background information on that statement, and links to ethical guidelines and statements from other organisations, with a bibliography of relevant publications — including journal articles about ghostwriting and the association's responses to them — being added. A code is the shortest document in that stack and the one least able to settle a particular case; its function is to be agreed to rather than to be applied.
How the code came to be written and revised
The past president credited with that code has a name and a motive, and both are worth carrying. Cindy W. Hamilton, delivering the association's Swanberg address at its 73rd annual conference in Columbus on 8 November 2013, identifies Eric Martin as the member responsible for the code, and records that he lobbied for one for at least a decade before the association formally approved it in 1973, each principle worded and reworded in between. The position he argued from, written in 1963 while he was director of medical communication at Lederle Laboratories, is a claim about equivalence rather than about etiquette: the printed word can be very dangerous, false claims for medicines cause great harm, the quality of medical information is just as important as the quality of the product being prescribed, and control of medical communication is just as important as control of the potency, purity and stability of drugs.
The association introduced the code in 1973 not only to promote excellence in medical communication but also to recommend principles of conduct for its members. In 2003 it issued its Position Statement on the Contribution of Medical Writers to Scientific Publications, in response to the ongoing controversy over ghostwriting.
Her history puts the code's approval in 1973, when after a decade of urging the board approved the Code for Medical Communicators proposed by Eric Martin, and then speaks of the code's "introduction in 1976", since when it has been reviewed and modified three times — 1989, 1994 and 2008 — with the greatest change in 1994, when scientific rigour and fair balance were added to the second principle in response to changes in emphasis at the FDA, the other changes being editorial. The column does not reconcile the two dates; the printed code itself gives Martin's original as 1973. Her timeline supplies the rest. Through the 1980s the use of medical communicators was debated, advocates crediting them with better and more efficient documents and opponents saying they encouraged bias where their contribution went unacknowledged or their financial relationship with industry undisclosed — practices then common. The FDA's 1991 draft guidelines, which she calls career-threatening, drew a vigorous response that ended in a review of the code and an expansion of ethics teaching: ethics workshops proliferated, ethics presentations entered the annual conference and workshop leaders were encouraged to consider professional ethics in all their presentations. The FDA's 1997 guidelines on industry-supported publications did not mention writers; a task force formed in 2001 to develop a position paper on the role of medical writers; the code went onto the membership application and renewal forms in 2009; and the RIGHT model for ethical situations appeared in the journal in 2012. Membership awareness had improved, she judges, with much still to be done.
Its revision history shows a code responding to external pressure rather than to internal drift. A past president is credited with developing it in 1973; it was revised in 1989, again in 1994, and a third time in 2008. The 1994 revision is the consequential one, and it followed a 1991 draft US regulatory policy proposing severe restrictions on industry-sponsored medical writers: the association strengthened the second principle by adding scientific rigour and fair balance to it. The 2008 changes were minor editorial ones. A professional body that answers a proposed restriction by tightening its own standard is making an argument about who should be doing the regulating, and it is the same argument the profession has been making ever since.
The 1991-1992 episode behind that revision is worth having in full, because it is the clearest case in this corpus of a professional body answering a regulator. Elizabeth L Smith, installed as president of the American Medical Writers Association in November 1991 and recalling the events in an award address delivered at the association's annual conference in Jacksonville on 21 October 2011, was told by a former president immediately after her installation that the US Food and Drug Administration had drafted a proposed concept paper that would effectively restrict the role of medical writers in the writing and dissemination of scientific information. The executive director's first position was that the association could not respond; Smith and several other members argued that the livelihood of most of the then membership would be affected negatively if the proposal were approved, and she agreed. Smith then established a task force on medical writing composed of active members inside the pharmaceutical industry — MaryAnn Foote of Amgen, Harriet Layne of Lederle, Sandra Purrenhage of Ciba-Geigy, and Bob Orsetti of Ciba-Geigy as an ex officio member — together with Jean Dolan from journal publishing and the gynaecologist Jane E Hodgson, who was renowned for her activities in federal legislation.
The sequence that followed is the useful part. In November 1991 the association wrote to the agency urging it to recognise the professional contributions of medical writers and rescind the proposed prohibitions, and received a form letter thanking it for the comment and nothing more. Because the agency remained adamant about advancing its proposal, the association invited agency representatives to a closed-door executive board meeting in spring 1992 with the entire board present; five people from the agency attended and talked about the need for scientific rigour, fair balance, full disclosure and other issues. The association then requested and was granted a two-hour meeting at the agency's headquarters in September 1992, at which it presented — using overheads, at the agency's request, with binders of the slides and the past three years' annual conference brochures highlighting its growing education programme — a synopsis of its history and its members, the various areas where medical writers work, the types of project medical writers prepare including submissions to the agency, an overview of the writing process, and how the writer is part of a team gathered for a given project.
The three commitments offered in place of the restriction are what the profession has been offering ever since. The association would refine its code of ethics to include specific standards ensuring fair balance, scientific rigour and objectivity in writing all scientific materials; it would establish a course on ethics in medical writing, which has been given at least once a year since 1992 and had reached four ethics courses at the 2011 annual conference; and it would create a disclosure statement to accompany every published article stating that writing assistance was provided by a professional medical writer. No formal action was ever taken on the original concept paper — in Smith's words, it died a natural death — and she believes the association's commitment helped produce that outcome.
What a later review of the code found is as instructive as the revisions themselves. A task force appointed in 2001, combining representatives of the leadership group that had dealt with the regulator in the 1990s with newcomers, began by researching the ghostwriting controversy and the relevant resources, and concluded that the code as it stood remained comprehensive, generalisable and relevant to members providing many different kinds of communication service — so it recommended no major revision at all. What it recommended instead were tactics for making the code visible: placing it on the membership form, developing new ethics workshops, and requiring an ethics workshop for the completion of each of the association's certificates. It also prepared a position statement on the contributions of medical writers to manuscripts submitted to scientific journals, recommending disclosure both of substantial contributions and of any potential conflicts of interest by non-author contributors. Hamilton's measure of what that last document cost is the detail to keep: 218 e-mails and eleven drafts for the task force to agree one paragraph fit to go to the board of directors.
What the code's principles ask in practice
The preamble's reach is what the rest of her address is built on. Martin wrote that the code takes into account the important role of medical communicators in writing, editing and developing materials in various media and the potential of the products of their efforts to inform, educate and influence audiences, and Hamilton reads that last word at full width. The audiences she lists are the pharmaceutical industry, medical communication and education companies, contract research organisations, universities and medical schools, health care facilities, research institutes, government agencies and contractors, journal offices and other publishers, advertising agencies and public relations firms, health information services, non-profit organisations and professional societies — and, beyond all of them, the public, including healthy individuals and patients, their families and carers. Her arithmetic for the 5,000 members then in the association is that they collaborate with tens of thousands of scientists to convey words to billions of readers, which is the scale at which a code either does something or does not.
Her method for making the eight principles operational is to turn each one into a question about what would change if every member observed it, and three of those questions are concrete enough to use. On recognising and observing relevant statutes and regulations: how many of us honour copyright law by always obtaining permission to reproduce tables and graphs from other publications, and would being a stickler about it lead colleagues to look for the statutes and regulations that apply to their own work? — a gap between assent and practice that rights and permissions treats as a planning problem. On objectivity, scientific rigour and fair balance: how would encouraging colleagues to publish negative study findings affect the medical community's opinion of the pharmaceutical industry, and would journal editors and other sceptics then begin to recognise medical writers as ethical partners in the team that develops a product? And on accepting assignments only when adequately prepared: how would obtaining input from the authors before beginning to prepare outlines change the preparation of manuscripts, and would investigators come to understand their role as the scientific experts who determine content as distinct from the writer's role as the communication expert who conveys it?
Why a profession keeps a code, and what it does for its members
What a code does for a profession is the argument she adds. A profession, in the definition she quotes from medical education, is a disciplined group of individuals who adhere to ethical standards, possess special knowledge and skills in a widely recognised body of learning, and are recognised by the public as such; people with extensive training often want to be recognised as professionals rather than as technicians or workers, and the element that turns an occupation into a profession is a shared ethic. That ethic is usually expressed as a code setting the minimum acceptable moral behaviour, which can teach or remind members of their obligations and, shared with employers and consumers, enhance trust in and respect for the profession. Most such codes are self-defined, collectively accepted and regulated by a professional organisation through licensing; AMWA's focus has always been education and it has never licensed anyone to practise medical communication, so members who agree to its code on joining or renewing — because "membership in AMWA is an honor and a trust" — regulate their own adherence. The benefits she claims are practical. An employer overwhelmed by the parade of service providers on the internet can use exposure to professional ethics through an association as a filter against those who might violate ethical norms and become a liability; advocating professionalism may enhance employability and job longevity; the fifth principle's pledge to expand one's knowledge and skills is easier to keep as a member; and ethical behaviour is what earns a profession its recognition, respect and reward. Because the profession's growth had brought an influx of new members over 2014 to 2016, she argues that the code should be introduced to them early, citing a 2005 AMWA survey in which members' familiarity with guidelines was associated with compliance with them.
One view holds that every writer should embrace the AMWA Code of Ethics for Medical Writers: it will not address every ethical issue, but it can be the first step in assessing one and may give a writer a base from which to act when action is needed.
Reach for the neighbouring professions' codes
Medical communication sits across several professional communities, and a writer's situation will sometimes be better covered by one of their codes than by their own. The 2012 issue that carries Hamilton's article prints the short list of where they live: the Association of Health Care Journalists' statement of principles; the Council of Science Editors' white paper on promoting integrity in scientific journal publications; the Health and Science Communications Association's code of ethics; the National Association of Science Writers' code of ethics; the Public Relations Society of America's member code of ethics; and the Regulatory Affairs Professionals Society's code of ethics for regulatory affairs professionals. The retraction session's resource list names the AMWA Code of Ethics, the Committee on Publication Ethics, the Council of Science Editors' white paper in its 2012 update, and the Office of Research Integrity's guidance on handling misconduct.
Rappaz's prize-winning essay in the June 2022 issue of Medical Writing maps which codes apply to which work. AMWA's code of ethics serves as the basic code for all professional communicators; ISMPP's code guides those developing and disseminating publications, who also follow the ICMJE recommendations and Good Publication Practice; reporting guidelines from the EQUATOR network govern the presentation of research, COPE guides publication decisions, and the joint AMWA-EMWA-ISMPP statement on publication processes addresses data integrity and transparency. Regulatory writers follow authority guidelines grounded in ethical principles, helped by understanding the principles behind good clinical practice and by the RAPS code of ethics; writers of promotional and educational material follow the codes on industry interaction with healthcare professionals, such as the IFPMA and MedTech Europe codes; and writers for lay audiences can borrow the codes of health journalists' associations. Codes and compliance checklists set minimums, so she argues for going beyond them: defining personal standard operating procedures and sharing them with prospective contractors and clients, which is recommended for freelancers who often receive no compliance training from clients, and using the RIGHT model's five steps — recognise, investigate, gauge, handle, tailor — for decisions.
For a general treatment rather than a professional one, the AMWA ethics workshop leaders' own recommendation in 2012 was The Elements of Ethics for Professionals by W B Johnson and C R Ridley, which sets out 75 elements of ethics under eleven categories of behaviour: taking the high ground, meaning integrity; doing no harm; according dignity, meaning respect; benefiting others; exercising caution; caring for others; seeking fairness; promoting autonomy; being faithful; delivering your best; and making ethical decisions, meaning sound judgment. Rappaz's essay recommends practising the same eleven, which it calls virtue-based behaviours and words as working with integrity, doing no harm, being respectful, benefiting others, being cautious, being compassionate, promoting fairness, encouraging self-determination, being loyal, aiming for excellence and using sound judgment.