How to overcome regulatory and ethical challenges regarding medical device? – Pubrica
Use of ICMJE URM for ethical guidance – Pubrica
-
Upload
pubricahealthcare -
Category
Services
-
view
0 -
download
0
description
Transcript of Use of ICMJE URM for ethical guidance – Pubrica
-
Copyright © 2021 pubrica. All rights reserved 1
Use of ICMJE URM for Ethical Guidance
Dr. Nancy Agnes, Head,
Technical Operations, Pubrica
In-Brief
The guidelines were established by the
International Committee of Medical
Journal Editors (ICMJE). To investigate
best practises and ethical principles in the
conduct and reporting of research and
other content presented in medical journals
and assist publishers, editors, and those
interested in peer review and biomedical
publication in developing and
disseminating reliable, transparent,
reproducible, and impartial medical
journal articles.
I. INTRODUCTION
These guidelines are specifically for writers
who consider sending their work to one of
the ICMJE's members papers. Many non-
ICMJE publications use these guidelines on
their initiative. The ICMJE publication
supports this practice, but it lacks the power
to oversee or execute it. In both cases,
authors may combine these guidelines with
the guidance for authors provided by
specific journals. The ICMJE supports the
widespread distribution of these guidelines
and full reuse of this document for
educational and non-profit purposes without
respect for copyright. However, all the
recommendations and document can guide
readers to www.icmje.org for the official,
most recent edition. The ICMJE updates the
recommendations regularly as new problems
emerge.
This paper, formerly known as the Uniform
Requirements for Manuscripts Submitted to
Biomedical Journals, has been published in
several editions by the ICMJE (URMs). The
URM was created in 1978 to standardize
manuscript publication support formatting
and planning through journals.
"Recommendations for Scholarly Work in
Medical Journals: Conduct, Reporting,
Editing, and Publication"
II. USE OF ICMJE URM FOR ETHICAL
GUIDANCE
A. Defining the Role of Authors and Contributors
Authorship bears a lot of weight in the
intellectual, social, and financial realms.
Authorship also requires liability and
transparency for work that has been written.
The following suggestions are meant to
ensure that contributors who have made
significant intellectual contributions to a
paper are given authorship credit. The
contributors who are credited as authors are
aware of their responsibilities and
accountability for what is written. Since
authorship does not specify what
contributions qualify a person to be an
author, some publications are now
requesting and publishing information about
each person's contributions identified as a
participant in a submitted report, at least for
original research.
B. Financial and non-financial partnerships and practices, as well as
possible conflicts of interest.
The transparency in which an author's
interactions and activities, specifically or
topically relevant to work, are treated during
https://pubrica.com/services/publication-support/?utm_source=Organic&utm_medium=Gpp3&utm_campaign=Gpp3
-
Copyright © 2021 pubrica. All rights reserved 2
the preparation, execution, publishing, peer
review, editing, and publishing of scientific
work affects a public interest in the
scientific process quality of published
medical publication support. A clinical
opinion on a primary objective (such as
patients' health or the validity of research) is
affected by a secondary interest. There is a
risk of conflict of interest and prejudice
(such as financial gain). Conflicts of interest
beliefs are almost as important as actual
conflicts of interest.
Financial links (such as jobs, consultancies,
equity ownership or options, honoraria,
trademarks, and paid expert testimony) are
the easiest to spot, the ones that are more
commonly viewed as possible conflicts of
interest.
Those other interests, such as personal
relationships or rivalries, academic rivalry,
and intellectual values, can also reflect or be
viewed as disputes.
C. Responsibilities in the Submission and Peer-Review Process
An increasing number of organizations
claim to be "scholarly medical journals" but
do not operate as such. These journals (also
known as "predatory" or "pseudo-journals")
accept and print almost all submissions and
charge article processing (or "publication")
fees, which are only disclosed to authors
after a paper is accepted for publication.
They sometimes tend to do peer review but
do not, and they can have titles that are
confusingly similar to well-known journals.
D. Journal Owners and Editorial Freedom
The appointment and firing of editors is the
responsibility of medical journal members.
Owners should provide editors with a
contract that explicitly outlines their rights
and liabilities, jurisdiction, the basic terms
of their appointment, and dispute resolution
mechanisms at the time of their
appointment. The editor's output can
generally be measured using agreed-upon
measures such as readership, manuscript
submissions and handling times, and
different journal metrics, among others.
E. Protection of Research Participants
https://pubrica.com/services/publication-support/?utm_source=Organic&utm_medium=Gpp3&utm_campaign=Gpp3https://pubrica.com/academy/journal-selection/publishing-in-a-reputed-medical-journal/https://pubrica.com/academy/journal-selection/publishing-in-a-reputed-medical-journal/
-
Copyright © 2021 pubrica. All rights reserved 3
Both inspectors can ensure that human
research is prepared, performed, and
documented in compliance with the Helsinki
Declaration, as amended in 2013. All
authors should request approval from an
independent local, state, or national review
body (e.g., ethics committee, institutional
review board). The analysis was done in
compliance with the Helsinki Declaration,
the authors must clarify their reasoning and
show that the study's questionable aspects
were accepted explicitly by a local, state, or
national review authority.
The provision for informed consent should
be included in the journal's author
guidelines. It should be stated in the written
article where informed consent has been
received.
III. CONCLUSION
The ICMJE Recommendations have a
limited ability to avoid market prejudice.
Still, they provide helpful safeguards against
the most severe possible commercial
violations of literature, such as poor
statistical requirements, guest authorship,
and nondisclosure of industry participation.
The Recommendations have since been used
to develop research practices, such as study
registration and evolving guidance on data
sharing. The ICMJE must bear a particular
responsibility for weaknesses in the content
of medical literature, to the degree that these
flaws are ignored or even promoted by the
ICMJE's criteria. By urging their continued
evolution and asserting the validity of these
flawed but necessary guidelines, beneficial
effects on science and publishing standards,
including in commercial literature. Avail
Publication support services from Pubrica.
REFERENCES
1. Fugh-Berman, AJ. The haunting of medical journals:
how ghostwriting sold "HRT". PLoS Med.
2010;7:e1000335.
2. Matheson A. Corporate science and the husbandry of
scientific and medical knowledge by the pharmaceutical
industry. BioSocieties. 2008;3:355–82.
3. Sismondo S. Ghost management: how much of the
medical literature is shaped behind the scenes by the
pharmaceutical industry? PLoS Med. 2007;4:e286.
4. Fugh-Berman A, McDonald CP, Bell AM, Bethards EC,
Scialli AR. Promotional tone in reviews of menopausal
hormone therapy after the Women's Health Initiative: an
analysis of published articles. PLoS Med.
2011;8:e1000425.
https://pubrica.com/services/publication-support/?utm_source=Organic&utm_medium=Gpp3&utm_campaign=Gpp3