Transcript Uniform Requirements for Manuscripts (URM)

Uniform Requirements for
Manuscripts (URM)
• 1978: editors of general medical
journals meet in Vancouver BC
– Focus on format of manuscripts
– Reduce wasted time
– Published in 1979
• International Committee of Medical
Journal Editors
– Broader concerns, to include the ethics
of authorship and medical publishing
Rashomon: the investigators’ tale
• I want to be part of a big trial, and I
need the money to run my program.
• The drug companies can go to
Contract Research Organizations to
get the study done cheaply.
Rashomon: the investigators’ tale
• I want to be part of a big trial, and I need
the money to run my program.
• The drug companies can go to Contract
Research Organizations to get the study
done cheaply.
• They can drive a very hard bargain
• They design the study, do the analysis,
and decide whether to publish and
what to say. I get my name on the
paper.
Antecedents
Authors
Scientists have an ethical obligation to submit credible
research results for publication. Moreover, as the
persons directly responsible for their work, scientists
should not enter into agreements that interfere with
their control over the decision to publish the papers
they write.
ICMJE requirements May 2000 revision
Uniform Requirements :
as revised May 2001
Authors
Scientists have an ethical obligation to submit credible
research results for publication. Moreover, as the
persons directly responsible for their work, scientists
should not enter into agreements that interfere with
their control over the decision to publish the papers
they write access to the data or their ability to analyze
the data independently, to prepare manuscripts, and
to publish them. Authors should describe the role of
study sponsor(s), if any, in study design…..
Ann Intern Med. 2001;135:463-6
Words into action
• “We can help to solve this problem if
we act together”
Uniform Requirements :
as revised May 2001
Authors
Scientists have an ethical obligation to submit credible
research results for publication. Moreover, as the
persons directly responsible for their work, scientists
should not enter into agreements that interfere with
their (control over the decision to publish the papers
they write) access to the data or their ability to analyze
the data independently, to prepare manuscripts, and
to publish them. Authors should describe the role of
study sponsor(s), if any, in study design……. Editors
may choose not to consider an article if a sponsor has
asserted control over the authors’ right to publish.
Ann Intern Med. 2001;135:463-6
Words into action
• “We can help to solve this problem if we
act together”
“Editors may choose not to consider an article if a
sponsor has asserted control over the authors’ right
to publish.”
“We should tell our authors what we are
going to do.”
An editorial: Sponsorship, Authorship, and Accountability
From “Sponsorship, Authorship,
and Accountability”
“Authorship means both accountability and independence.
A submitted manuscript is the intellectual property of its
authors, not the study sponsor. We will not review or
publish articles based on studies that are conducted under
conditions that allow the sponsor to have sole control of
the data or to withhold publication.”
Ann Intern Med. 2001;135:463-6
Conflict of interest
For Sponsored Work
The following information applies to sponsored work, regardless of the
source of the funding. The cover letter must describe sources of outside
support for the research, including funding, equipment, and drugs. In the
Methods section of the text, the authors must describe the role(s) of the
funding organization in the design of the study; the collection, analysis, and
interpretation of the data; and the decision to approve publication of the
finished manuscript. If the funding source had no such involvement, the
authors should state that. The corresponding author must indicate on the
Conflict of Interest Notification page (also available in the first issues of
January and July each year) that the authors had access to all the study
data, take responsibility for the accuracy of the analysis, and had authority
over manuscript preparation and the decision to submit the manuscript for
publication. Annals will not consider an article unless the authors make this
attestation.
Information for authors. Ann Intern Med. 2002
Annals of Internal Medicine
Conflict Notification Page
Attestation of author independence/accountability
Did the authors have full access to all study data,
take full responsibility for accuracy of the data
analysis, and have full authority over manuscript
preparation and the decision to publish?
____ Yes
____ No (please explain)
Information for authors. Ann Intern Med. 2002
Rashomon: the company’s tale
• We need tight control when FDA
approval is at stake (Phase III trials).
– The abuses occur in marketing trials.
• Study design:
– At best: Investigators contribute
– Too often: too busy to help
Rashomon: the company’s tale
• Analysis:
– At best: The investigators don’t handle
the data, but they do specify the tables
– Too often: they don’t seem to care
• Writing the article
– At best: we write it; authors edit and
approve
– Too often: too busy to review the draft