Use of GPP3 for ethical guidance - Pubrica
                     USE OF GPP3 FOR  
ETHICAL 
GUIDANCE
An Academic presentation by
Dr. Nancy Agnes, Head, Technical Operations, Pubrica 
 Group: www.pubrica.com
Email: [email protected]
Today's Discussion
Outline
In-Brief
Introduction
GPP Historical Archive 
 What is New in GPP3 
 Role of ISMPP
Future Scopes 
 Conclusion
In-Brief
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.
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 p
eer-reviewed journal publications  and oral and 
poster presentations at science conferences.
Contd...
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.
GPP 
GPP3 FOR ETHICAL GUIDELINES, 2015
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...
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...
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...

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...
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 p
eer-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...
"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...

Role 
of  
ISMPP was the energetic force behind the adoption 
ISMPP 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...
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.
Future Scopes
We hope that GPP3 will add the valuabl
  to  mthaanty are  e  
guidelin an arsectohmosmeendatitohe alread
eWsr iters A sdsociafrtnoiosmn, American  y  
aCvoauminlmacbiiltlete(esuc on Publicaotf ioSncienceEthMicse,dic
EofuropeanhAssEodciitaotrios,n European Medical aWl riters 
SAcsiseonccieation ICMJE, International FederaEtdioitnors
,Pharmaceuticaol f Manufacturers & Associa,tions), 
ISMPP,  Medical Publishing Insights and Practices, 
and the World  Association of Medical Editors) all 
promote responsible  publishing practices and 
research.
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...
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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