1. Uniform Requirements for Manuscripts (URM) 1978: editors of general medical journals meet in Vancouver BC1978: 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 EditorsInternational Committee of Medical Journal Editors –Broader concerns, to include the ethics of authorship and medical publishing

2. Rashomon: the investigators’ tale I want to be part of a big trial, and I need the money to run my program.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.The drug companies can go to Contract Research Organizations to get the study done cheaply.

3. 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 bargainThey 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.They design the study, do the analysis, and decide whether to publish and what to say. I get my name on the paper.

4. 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

5. 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

6. Words into action “We can help to solve this problem if we act together”“We can help to solve this problem if we act together”

7. 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

8. Words into action “We can help to solve this problem if we act together”“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

9. 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

10. Conflict of interest 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. Conflict of Interest Notification For Sponsored Work Information for authors. Ann Intern Med. 2002

11. 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

12. Rashomon: the company’s tale We need tight control when FDA approval is at stake (Phase III trials).We need tight control when FDA approval is at stake (Phase III trials). –The abuses occur in marketing trials. Study design:Study design: –At best: Investigators contribute –Too often: too busy to help

13. Rashomon: the company’s tale Analysis: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 articleWriting the article –At best: we write it; authors edit and approve –Too often: too busy to review the draft