The following are some of the latest subjects discussed in GPP3:
• The most recent ICMJE authorship conditions are explained (2013)
• Authorship problems that are frequently found
• Author payment and repayment are now more explicitly described.
• Clarification of the words "ghost fiction" and "guest authorship."
• Professional medical writers: what they do and how they help
• Advice on how to exchange data acceptably.
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Use of gpp3 for ethical guidance - Pubrica
1. USE OF GPP3 FOR
ETHICAL GUIDANCE
An Academic presentation by
Dr. Nancy Agnes, Head, Technical Operations, Pubrica
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Email: sales@pubrica.com
3. GPP3 is a revision of the original Good Publication Practice (GPP)
standards, which were first published in 2003 and last revised in 2009. The
ISMPP GPP3 Steering Committee has revised the 2009 edition of the Good
Publication Practice Guidelines (GPP2) to emphasise integrity and
transparency in industry-sponsored publication planning and development in
today's environment.
In-Brief
4. Introduction
GPP3 is a revised version of the Good Publishing Practice
(GPP) guideline that offers guidelines for persons and
organisations involved in disseminating research findings
funded or assisted by pharmaceutical, medical device,
diagnostics, and biotechnology industries.
The guidelines are meant to help individuals and
organisations adhere to legal and regulatory standards while
ensuring fair and open publishing activities.
These guidelines apply to peer-reviewed journal publications
and oral and poster presentations at science conferences.
Contd...
5. The following are some of the latest subjects discussed in GPP3:
The most recent ICMJE authorship conditions are explained (2013)
Authorship problems that are frequently found
Author payment and repayment are now more explicitly described.
Clarification of the words "ghost fiction" and "guest authorship."
Professional medical writers: what they do and how they help
Advice on how to exchange data acceptably.
6. GPP Historical
Archive
The resulting guideline adds new parts (Principles of
Good Publication Practice for Company-Sponsored
Medical Research, Data Sharing, Studies That
Should Be Published, and Plagiarism).
It builds on authorship requirements and widespread
authorship concerns established by the International
Committee of Medical Journal Editors., Expand details
on the position of medical writers and explain
appropriate author payment and reimbursement.
Contd...
GPP3 FOR ETHICAL GUIDELINES, 2015
7. Individuals and organisations can embody honesty, transparency, and obligation
for reliable, complete, and transparent reporting in their publications and
presentations by adopting good publishing practices (including GPP3).
Step 1: ISMPP
Step 2: Publication Steering Committee
Step 3: Reviewer Panel
Step 4: Steering Committee
Contd...
8. GPP2 GUIDELINES, 2009
International Society for Medical Publication Professionals (ISMPP) assembled
a Steering Committee to produce an updated Good Publication Practice guide, now
known as "GPP2," to discuss regulatory, guidance, and ethical changes since 2003
and to affirm the goals of the initial 2003 publication.
GPP GUIDELINES, 2003
The critical Good Publication Practice (GPP) guidelines, released in 2003, aimed to
ensure that "clinical trials funded by pharmaceutical firms are published responsibly
and ethically."
Contd...
9.
10. What is New
in GPP3
Guidance on updated ICMJE 2013 authorship criteria
Advice on everyday issues about authorship
Author payment and compensation guidance and clarification
Further definitions of what creates guest or ghost invention
Information on the position and benefits of licenced medical
authors has been expanded
Contd...
11. Advice for appropriate data sharing.
Overall simplification of language and format with a new guiding principles section
and quick reference tables addressing guidance on authorship criteria and joint
authorship issues.
We use the terms "publications" and "presentations" interchangeably in the
guideline to refer to the wide variety of formats presented in peer-reviewed
journals (for example, original research papers, brief reports, analyses, or letters
to the editor) and "abstracts," "posters," and slides for oral presentations at
scientific congresses.
Contd...
12. "Sponsors" are organisations that offer primary resources for a study, such
as funding.
Professional medical researchers, publishing designers, and publication
administrators are known as "publication practitioners," and they work in or
with businesses.
Regulatory documents, medical education services, and marketing and
promotional materials are governed or accredited by various national or state
bodies and are not protected by this guideline.
Contd...
13.
14. Role of
ISMPP
ISMPP was the energetic force behind the adoption of the
GPP3 guideline.
By supplying logistical research paper support, giving access
to the mailing list of ISMPP participants, sending out e-mails to
members and prospective reviewers, maintaining the
database of respondents, setting up the reviewer Web site,
and reviewing the GPP3 steering committee, the sponsor was
able to assist in the formation of the GPP3 steering committee.
Contd...
15. Several members of the steering committee also sit on the ISMPP Board of Trustees.
They did, however, contribute to GPP3 as entities, not on behalf of ISMPP.
The quality of this guideline was not guided or regulated by the ISMPP employees.
16. Future Scopes
We hope
guidelines
available
that
and
(such
the many
GPP3 will add to
recommendations
valuable
already
Medical
Editors,
that are
the American
of Science
as those from
Writers Association, Council
Committee on Publication Ethics, European Association
of Science
Association,
Editors, European Medical Writers
ICMJE, International Federation of
Pharmaceutical Manufacturers & Associations), ISMPP,
Medical Publishing Insights and Practices, and the World
Association of Medical Editors) all promote responsible
publishing practices and research.
17. Conclusion
Because of advancements in regulatory, medical, and
journal standards, our understanding of the publishing
environment has changed.
The GPP3 guideline has been amended to keep up with
the changes.
The role, reimbursements, and increased responsibility of
MWs in the process have been identified and elaborated
to a greater extent.
Contd...
18. Necessitates MW staying current with current trends and undergoing specialised
training from known institutions to improve understanding and formulate a
proper strategy.
It is required to produce high-quality documentation and the bridging of the gap
between research conduct and reporting.
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