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LETTER TO THE EDITOR

The Ethical Role of Medical Journal Editors

Clinical Associate Professor, Anesthesiology, Affiliate Associate Professor, Biomedical History and Ethics, University of Washington, Seattle, WA, lbsparrow{at}yahoo.com (Van Norman) Department of Anesthesiology, Providence Milwaukie Hospital, Milwaukie, OR, (ASA Ethics Committee Member 1992–2005 and Chair 2004–5) (Palmer) Department of Anesthesiology, Good Samaritan Hospital, San Jose, CA (Jackson)

To the Editor:

We believe that the Editors (1) erred in publishing the clinical studies by Tucker et al., (2,3) and agree with Yaksh (4,5) that the "serendipitous" submission of the research of Johansen et al. (6) does not mitigate the ethical failures of Tucker’s studies.

The Helsinki Declaration regarding ethical principles for human subjects research (7) (also available on line: www.wma.net/e/policy/17-c) requires prior "adequate laboratory and animal experimentation," and that "publishers must not accept for publication any research that does not adhere to the principles in the declaration." Johansen et al.’s study (6) did not settle the human safety issues, and was not available to Tucker et al. during their research. It cannot be used post hoc as rationale that Tucker’s studies were safe or ethical.

Institutional Review Board (IRB) approval of Tucker’s studies is not reassuring (8). IRBs increasingly rely on scientific information provided solely by the investigators themselves, who have conflicts of interest with regard to accuracy, completeness, and balance. Editors and reviewers, therefore, have independent obligations to discourage unethical treatment of research subjects by refusing to publish studies with apparent ethical shortcomings. The Committee on Publication Ethics’ (COPE) Guidelines on Good Publication Practice mandates that editors seek an investigation by an appropriate body, such as the author’s employer, when unethical conduct is suspected (9,10) (also available on line: http://www.publicationethics.org.uk/cope1999/gpp/gpp.phtml#gpp).

We urge the Editors to obtain formal ethics consultation on questionable studies, including referral back to the originating IRB. The ASA Committee on Ethics is another potential consultative resource.

Note: While all authors have served on the American Society of Anesthesiologists’ Committee on Ethics, we wish to emphasize that the views presented in this letter are our own, and do not represent an official statement of the ASA.

References

1. Cousins MJ, Miller RD. Intrathecal midazolam: an ethical editorial dilemma. Anesth Analg 2004;98:1507–8.[Free Full Text]
2. Tucker AP, Lai C, Nadeson R, Goodchild CS. Intrathecal midazolam: I. A cohort study investigating safety. Anesth Analg 2004;98:1512–20.[Abstract/Free Full Text]
3. Tucker AP, Mezzatesta J, Nadeson R, Goodchild CS. Intrathecal midazolam: II. Combination with intrathecal fentanyl for labor pain. Anesth Analg 2004;98:1521–7.[Abstract/Free Full Text]
4. Yash T, Allen J. Preclinical insights into the implementation of intrathecal midazolam: a cautionary tale. Anesth Analg 2004;98:1509–11.[Free Full Text]
5. Yaksh T, Allen J. The use of intrathecal midazolam in humans: a case study of process. Anesth Analg 2004;98:1536–45.[Abstract/Free Full Text]
6. Johansen MJ, Gradert TL, Satterfield WC, et al. Safety of continuous intrathecal midazolam infusion in the sheep model. Anesth Analg 2004;98:1528–35.[Abstract/Free Full Text]
7. World Medical Association Declaration of Helsinki: Ethical Principles for Medical Research Involving Human Subjects. Last Amended by the 52nd WMA General Assembly, Edinburgh, Scotland, October 2000. WMA The World Medical Association. Ferney-Voltaire, France.
8. Weingarten MA, Paul M, Leibovici L. Assessing ethics of trials in systematic reviews. BMJ 2004;328:1013–4.[Free Full Text]
9. Committee on Publication Ethics. Guidelines on good publication practice. London: BMJ Publishing Group, 2003.
10. Giles J. Medical editors urged to accept ethical code. Nature 2004;428:3

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