Medical writing: vigilance for ethics

3 min read
First Published: 
Mar 2009

Key Learnings contained in this article:

As of the beginning of this year, the American Medical Writers Association (AMWA) has added its code of ethics to membership application and renewal materials. New and renewing members are asked to indicate that they have read and accepted the principles of the code. The goal is to increase awareness of ethical principles and, it is hoped, to contribute to maintenance of high ethical standards among medical writers.

AMWA, despite its name, is an organisation of medical writers from not only the United States but also around the world. Its members come from a variety of disciplines, including academic, pharmaceutical, marketing and regulatory.

The code of ethics itself is not new. It was first developed in 1973 and revised in 1989, 1994, and 2008. The 1994 revision came in response to a Food and Drug Administration (FDA) guideline that proposed severe restrictions on industry-sponsored medical writers. AMWA worked with the regulators to educate them on what medical communicators actually do and also strengthened the code of ethics by adding wording about “scientific rigour” and “fair balance.”

The code, intentionally brief, consists of a preamble that explains the role of AMWA in promoting excellence in medical communication, followed by eight principles to be applied in developing materials in the various media in which medical writers work. Among the principles are recognition and observance of applicable statutes and regulations; application of objectivity, scientific accuracy and rigour; maintenance of the highest professional standards, whether or not the materials they develop fall under the purview of any regulatory agency; and insistence on conditions that allow them to properly apply their own judgment and skills, with refusal to participate in assignments that require unethical or questionable practices. Additional principles include professional development, respect for the confidentiality of materials provided by clients, and expectation and acceptance of fair remuneration of and acknowledgment for their services.

AMWA will not enforce adherence to the code of ethics, and the organisation does not encourage individuals to become “ethics police.” Its goal is rather to increase awareness of ethical issues and principles.

Ethical issues are also addressed by AMWA’s sister organisation, the European Medical Writers Association (EMWA, EMWA includes on its website its own guidelines on the role of medical writers in developing peer-reviewed publications. The guidelines include the importance of respecting and acknowledging the role of medical writers in the development of scientific publications.

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Robert Hand
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