The Good Publication Practice (GPP) guidelines define how medical writers and other contributors ensure ethical, transparent reporting of industry-sponsored research. For medical communicators who contribute to peer-reviewed publications reporting company-sponsored biomedical studies, the GPP guidelines provide a framework for authorship, disclosure, publication integrity, and transparent scientific communication.
This blog post describes what the GPP 2022 guidelines are, why they matter, and the role of professional medical writers and editors.
What Are Good Publication Practice (GPP) Guidelines?
The GPP guidelines provide recommendations for ethical publication practices involving pharmaceutical, biotechnology, medical device, and other commercially sponsored biomedical research. GPP 2022 is the current version of the guidelines and applies to peer-reviewed and peer-oriented biomedical communications, including manuscripts, abstracts, posters, conference presentations, and enhanced content such as plain language summaries.
The guidelines are intended to complement publication standards like the International Committee of Medical Journal Editors (ICMJE) recommendations and the Consolidated Standards of Reporting Trials (CONSORT) statement while addressing ethical practices specific to industry-sponsored research and publication development.
Why Does GPP 2022 Matter for Medical Writers?
GPP 2022 provides a framework for ethical collaboration among authors, sponsors, medical writers, editors, and publication professionals involved in industry-sponsored research communications. The guidelines support transparency, publication integrity, appropriate disclosure practices, and accurate reporting of clinical findings.
The updated guidance also reflects changes in biomedical publishing, including digital communication formats, plain language summaries, social media communications related to peer-reviewed research, and increasing expectations around inclusivity and accessibility in scientific communication.
How Does GPP 2022 Define the Role of Medical Writers and Publication Professionals?
GPP 2022 emphasizes transparency around the involvement of professional medical writers in publication development. The guidelines recommend disclosure of medical writing support and reinforce that authors retain responsibility for publication content and decision-making. The guidance also emphasizes that medical writers and other publication professionals should be treated ethically and supported in following good publication practices.
Research referenced in GPP 2022 suggests that professional medical writers can support publication quality and ethical research reporting. The guidelines note that publications developed with professional medical writing support have been associated with lower rates of misconduct-related retractions.
GPP 2022 also states that professional medical writers may qualify for authorship if they meet established authorship criteria, such as ICMJE recommendations.
Beyond manuscript development, GPP 2022 recognizes the broader role of publication professionals in areas such as publication planning, quality oversight, documentation, ethics education, and coordination among authors, sponsors, and publication teams.
What Are the Essential Elements of GPP 2022?
GPP 2022 addresses key principles related to ethical publication practices in biomedical research communications. These include
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Transparency and disclosure: Guidance on authorship, contributor acknowledgment, sponsor roles, and publication integrity
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Authorship and accountability: Clarification of responsibilities among authors, sponsors, medical writers, and publication professionals, including access to data and accountability for publication content
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Inclusivity and accessibility: Expanded discussion of inclusive publication practices, patient involvement, and accessible scientific communication
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Publication planning and processes: Guidance for publication planning, review, approval, documentation, and communication workflows
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Scientific communication practices: Recommendations related to enhanced content, plain language summaries, preprints, and other newer evolving publication formats
These principles have expanded over time as biomedical publishing and scientific communication practices have evolved.
How Have GPP Standards Evolved?
First introduced in 2003, the GPP guidelines established ethical recommendations for company-sponsored biomedical research, addressing authorship, relationships between study investigators and sponsors, duplicate publication, and medical writing support.
As outlined in the AMWA Journal article by Qing Zhou, PhD, ELS, “An Overview of the 2022 Update of Good Publication Practice (GPP) Guidelines: A Medical Writer’s Perspective”, the 2022 update expands ethical principles related to inclusivity, transparency, and scientific integrity, alongside practical guidance for medical communicators.
GPP 2022 reflects advances in biomedical publishing by expanding its scope to include translational and biomarker studies, nonclinical research, health economics and outcomes research, and real-world evidence, while also addressing evolving practices such as plain language summaries, preprints, and social media communications.
The update further emphasizes inclusive publication practices, including cultural and regional considerations, and patient involvement. It also points readers to complementary professional resources, such as the AMWA-EMWA-ISMPP Joint Position Statement on the Role of Professional Medical Writers.
What Standards and Resources Support GPP-Related Work?
GPP 2022 complements a number of publication guidelines and professional resources that support ethical biomedical publishing and medical communication practice.
Publication and Research Reporting Standards
- ICMJE Recommendations: Guidance on authorship, disclosure, manuscript preparation, and publication ethics
- CONSORT Statement: Standards for reporting randomized clinical trials
- Declaration of Helsinki: Ethical principles for research involving human participants
Professional Guidance for Medical Communicators
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AMWA-EMWA-ISMPP Joint Statement on the Role of Professional Medical Writers: Recommendations developed by AMWA, European Medical Writers Association (EMWA), and International Society for Medical Publication Professionals (ISMPP) for collaboration with professional medical writers in publication development
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AMWA Position Statement on the Contribution of Medical Writers to Scientific Publications: Professional guidance on the role and acknowledgment of medical writers
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AMWA Code of Ethics: Ethical standards for medical communicators
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EMWA Code of Conduct: Professional and ethical standards for medical writers
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ISMPP Code of Ethics: Ethical principles for publication professionals working in medical research publishing
Emerging Topics in Publication Practice
Emerging technologies and publication practices continue to shape biomedical communication. In addition to GPP guidance and other standards for publication and medical communication, current professional discussions increasingly focus on the ethical use of generative artificial intelligence (AI) in scientific publishing.
A recent AMWA Journal article “Current Guidelines on the Use of Generative Artificial Intelligence in Peer-Reviewed Scholarly Publications” by Hannah H. Chang, PhD, Anil Sindhurakar, PhD, and Qing Zhou, PhD, ELS, summarizes that AI chatbots cannot be listed as authors, the use of AI should be disclosed, and humans remain responsible for the peer review process. The article encourages medical communicators to stay informed about technological developments and support the ethical use of generative AI in medical publishing.
Conclusion: Supporting Ethical Scientific Communication
GPP 2022 provides a contemporary framework for ethical publication practices in industry-sponsored biomedical research. For medical communicators working in this area, the guidelines help clarify responsibilities, support transparent collaboration, and reinforce standards that contribute to the integrity of scientific communication.
As publication practices and technologies continue to evolve, staying informed about current guidance and professional standards can also support ongoing professional development in medical communication.
AMWA acknowledges the contributions of Nadine Odo, MPH, CCRC, ELS, FACRP, and Noelle Ochotny, PhD, CMPP, for peer review in the development of this AMWA resource.
