AMWA Ethics FAQs
"Because the integrity of the medical writing profession is built on the ethical practices of its members, AMWA continues to seek ways to improve members' awareness and understanding of the ethical issues inherent in their work." (1)
1. Alexander LL, Hudson S. Ghostbusting [editorial]. AMWA J 2008;23(2)54-55
The Importance of Ethics in Medical Communication
Q: Why are the issues of ethics (1) in medical communication so important to the community as a whole?
A: "...all the medical information you read and hear about comes originally from [medical] journals. It's not being overly dramatic to say that public trust in clinical research, and in medicine in general, is at stake here. Unless we can be confident that research results and review articles are unbiased, we can't know if doctors are giving and the public is getting correct advice and care." (2)
Medical communicators who adhere to ethical practices contribute to strengthening the integrity of the medical literature, improving medical treatment and fostering confidence and trust in and respect for the undertaking of medical research and communication.
1. "Conforming to accepted standards of professional conduct." From Merriam Webster's Collegiate Dictionary, 11th edition.
2. Kamerow D. Medical Journals' Ethics on Authors Questioned. Originally broadcast April 16, 2008. Available at <www.npr.org/templates/story/story.php?storyId=89695722>. Accessed September 14, 2009.
Publication Practices of Particular Concern to Medical Communicators
Q: What do "ghost authoring," "guest authoring," and "ghostwriting" mean?
A: "Ghost authoring" refers to making substantial contributions without being identified as an author. "Guest authoring" refers to being named as an author without having made substantial contributions. "Ghostwriting" refers to assisting in presenting the author's work without being acknowledged. The term "ghostwriting" is often used to encompass all three of these practices.
Medical journal editors worldwide (1) and medical schools (2) have been issuing statements and policies proscribing these unethical publication practices.
1. International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals (Updated October 2008). Available at <www.icmje.org>. Accessed September 14, 2009.
2. Emory University School of Medicine: Policy on Industry and Other External Professional Relationships. Available at <http://www.med.emory.edu/dean/facultyaffairs_policies_industryrelations.pdf>. Accessed September 14, 2009.
Ethical Responsibilities of Medical Communicators
Q: How can medical communicators and authors work ethically with each other?
A: Medical communicators "have a responsibility to hold authors to the principle that...the physician-scientist must truly be the author of the ideas, the data, and the conclusions if he or she is to claim authorship." (1)
To promote an ethical working relationship that aligns well with efficient document preparation, a medical communicator could consider having standard operating procedures requiring that the author and the medical communicator work collaboratively throughout the process. The standard operating procedures could mandate that authors control the content, retain responsibility for approving the final version of the manuscript, and submit the article for publication. The medical communicator should ensure that his or her involvement and funding source are acknowledged in the publication. (2)
1. Eastwood S, Liberthson D. The Author-Editor Relationship. In: Witte FM, Taylor ND, eds. Essays for Biomedical Communicators: Volume 1 of Selected AMWA Workshops. Bethesda MD: American Medical Writers Association; 2001:79-91. Available for purchase from AMWA at <www.amwa.org/default.asp?id=181>.
2. Woolley KL. Goodbye ghostwriters! how to work ethically and efficiently With professional medical writers. Chest 2006;130:921-923. Available at <www.chestjournal.org/content/130/3/921.full.html>. Accessed September 14, 2009.
Appropriate Credit for Authors and for Medical Communicators
Q: What are criteria for determining authorship credit?
A: The International Committee of Medical Journal Editors' (ICMJE's) highly regarded and often cited Uniform Requirements for Manuscripts (1) states the following: "Authorship credit should be based on 1) substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; 2) drafting the article or revising it critically for important intellectual content; and 3) final approval of the version to be published. Authors should meet conditions 1, 2, and 3." Those who make substantial contributions but who do not fulfill all 3 criteria should be identified in the acknowledgments. Other ethical guidelines have different criteria for authorship.
Q: What does the phrase, substantial contribution, mean?
A: The phrase substantial contribution is often used with respect to determining authorship credit. A helpful explanation of what substantial contribution means is in the authoritative AMA Manual of Style: "A substantial contribution is an important intellectual contribution, without which the work, or an important part of the work, could not have been completed or the manuscript could not have been written and submitted for publication." (2)
Q: Does assistance from a medical communicator constitute a substantial contribution so as to earn authorship credit?
A: It depends. If the contribution from the medical communicator fulfills all three ICMJE criteria (1), then the medical communicator should be included as an author. Otherwise, the medical communicator should be included in the acknowledgments.
Q: How can assistance from medical communicators be acknowledged?
A: The acknowledgment should explain what the medical communicator did and by whom he or she was paid. The instructions to authors of some journals provide guidance about preparing acknowledgments. Acknowledgments can be looked for in recent issues of the journal to which an article is to be submitted for publication. A poster (3) about acknowledging biomedical communicators lists the sorts of contributions that are appropriate for acknowledgment.
Q: How can a medical communicator respond to a situation in which a journal does not acknowledge the contributions of medical communicators?
A: AMWA provides a draft letter (4) that can be used to write to the editor of a journal that does not acknowledge the contributions of medical communicators.
1. International Committee of Medical Journal Editors. Uniform Requirements for Manuscripts Submitted to Biomedical Journals (Updated October 2008). Available at <www.icmje.org>>. Accessed September 14, 2009.
2. Flanagin, Annette. "Authorship Responsibility" in Iverson C, Christiansen S, Flanagin A, et al. AMA Manual of Style: A Guide for Authors and Editors. 10th ed. New York, NY: Oxford University Press; 2007, p. 127-140.
3. Mitrany D, Phillips SG, Foote MA, Berman K, Hamilton C, Mallia M, Schwedel B. How to acknowledge a biomedical communicator. Poster presented at: 63rd Annual Conference of the American Medical Writers Association; September 2003; Miami, FL. Available at <www.amwa.org/DEFAULT/Conference/2003Poster/AcknowledeMedicalWriter.pdf>. Accessed September 14, 2009.
4. Anonymous. Letter to the editor. Available at <www.amwa.org/default/letter%20to%20editor%2012.22.03.doc>. Accessed September 14, 2009.
AMWA's Commitment to Ethical Codes and Practices
A: AMWA's Code of Ethics (1) calls upon AMWA members to adhere to its 8 principles guiding the professional activities of medical communicators so as to engage only in activities that bring credit to their profession, to AMWA, and to themselves.
Q: What is the history of AMWA's Code of Ethics?
A: Eric W. Martin, PhD, AMWA president in 1971, is credited with developing the Code of Ethics in 1973. The Code was revised in 1989. Later, in response to a 1991 US Food and Drug Administration guideline that proposed severe restrictions on industry-sponsored medical writers, AMWA strengthened the Code by adding "scientific rigor" and "fair balance" to Principle 2 in 1994. Minor editorial changes were made in 2008 (2)
A: AMWA's Position Statement on the Contribution of Medical Writers to Scientific Publications (3) calls for acknowledgment of medical communicators for their contributions to writing and editing manuscripts. The acknowledgment should disclose any of the communicator's pertinent professional or financial relationships.
A: In December 2001, AMWA created the Task Force on the Contribution of Medical Writers to Scientific Publications to develop a position statement about the controversial issue of the unacknowledged contributions of professional medical writers to the preparation of manuscripts for publication (4, 5). During AMWA's 2002 annual conference, the position statement was approved unanimously by the AMWA's Board of Directors and was presented to the membership at an open discussion session. (6)
Q: How should AMWA members use AMWA's Position Statement?
A: AMWA members should be aware of the Position Statement and educate others about it. Members are invited to comment on the Position Statement on AMWA's e-mail discussion lists. (7)
Q: How are AMWA's Code of Ethics and Position Statement being promulgated to members and publicized to the general community?
A: As of January 1, 2009, AMWA added its Code of Ethics to the membership application and renewal forms. Prospective and renewing members are asked to indicate that they have read and agree with the code (8).
AMWA leaders refer to Code of Ethics and Position Statement in letters to media outlets and to professional organizations when explaining AMWA's commitment to ethical practices.
Q: How have other organizations responded to AMWA's Position Statement?
A: The responses have been favorable. Two examples are those from the Council of Science Editors (9) and the Association of Regulatory and Clinical Scientists (10).
Q: Do other organizations have position statements like AMWA's?
A: Yes. Many other organizations concerned with the communication of medical information have publication and ethics guidelines. A list is available on AMWA's Web site (11).
1. AMWA Code of Ethics. Third revision, June 2008. Available at <www.amwa.org/default.asp?id=114>. Accessed September 14, 2009.
2. Hamilton CW, Hudson S, Gegeny T. AMWA Code of Ethics Added to Membership Application and Renewal Forms. AMWA Journal 2008;23(4):177–179.
3. AMWA Position Statement on the Contribution of Medical Writers to Scientific Publications. Available at <www.amwa.org/default.asp?id=308>. Accessed September 14, 2009.
4. Royer MG, Hamilton CW. The story behind the AMWA Task Force on the Contribution of Medical Writers to Scientific Publications. AMWA J 2002;17(3):5-6.
5. Hamilton CW, Royer MG, for the AMWA 2002 Task Force on the Contributions of Medical Writers to Scientific Publications. AMWA Position Statement on the Contributions of Medical Writers to Scientific Publications. AMWA Journal 2003;18(1):13-16.
6. Foote M, Hamilton CW, Royer MG. Contributions of medical writers to scientific publications. AMWA Journal 2002;17(4):48.
7. De Bellis D, for the AMWA Task Force on the Contributions of Medical Writers to Scientific Publications. Facts about the AMWA Task Force on the Contributions of Medical Writers to Scientific Publications. Available at <www.amwa.org/default/fact%20sheet%20draft%205%20arial.pdf>. Accessed September 14, 2009.
8. Hamilton CW, Hudson S, Gegeny T. AMWA Code of Ethics added to membership application and renewal forms. AMWA Journal 2008;23(4):177–179.
9. Flanagin A, Lang T, Held M, McLellan F, Bozuwa P, Prudhomme S, Iverson C, Bruce L, Niyo K, Scott-Lichter D. Letter to the editor. AMWA J 2003;18(1):40.
10. Anonymous. Endorsement Statement, ARCS (Association of Regulatory and Clinical Scientists). The Write Stuff (The Journal of the European Medical Writers Association) 2006;15(4):138. Available at <www.emwa.org/JournalPDFs/J_V15_I4.pdf>.
11. Anonymous. Other publication and ethical guidelines and statements. Available at <www.amwa.org/default.asp?id=461>. Accessed September 14, 2009.
Participating in Discussions of Ethics in Medical Communication
Q: How can medical communicators take part in discussions of ethics in medical communication?
A: AMWA members can participate in AMWA's e-mail discussion lists, which are available in the members-only section of the AMWA's Web site. AMWA's annual conference, which is open to nonmembers, has workshops and other sessions about ethics in medical communication.
Contributorship: Michael S. Altus, PhD, ELS, who is chiefly responsible for content and direction, prepared the first and revised drafts. Cindy W. Hamilton, PharmD, ELS, reviewed and provided substantial comments and suggestions. Nancy D. Taylor, PhD, ELS, commented on the drafts and provided editorial corrections.
Disclosures: Dr. Altus has been paid by individual clients and by medical education and communication companies for preparing and polishing manuscripts to be suitable for submission for publication. Dr. Hamilton has been paid by pharmaceutical and device companies to help authors prepare manuscripts for submission to medical journals. Dr. Taylor has been paid by a pharmaceutical company to edit a newsletter.
Reviewed and accepted by AMWA's nationally elected officers, September 2009.
Recommended citation: Altus MS. AMWA's Ethics FAQs. Available at <www.amwa.org/default.asp?id=466>.