Uniform Requirements for Manuscripts (URM)

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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

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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.

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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.

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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
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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. 2001135463-6
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Words into action

• We can help to solve this problem if we act
  together

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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. 2001135463-6
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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
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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. 2001135463-6
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Conflict of interest
Information for authors. Ann Intern Med. 2002
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Annals of Internal MedicineConflict 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
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Rashomon the companys 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

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Rashomon the companys tale

• Analysis
• At best The investigators dont handle the data,
  but they do specify the tables
• Too often they dont seem to care
• Writing the article
• At best we write it authors edit and approve
• Too often too busy to review the draft