Newswise — San Francisco, CA. (February 24, 2010) – The recent retraction of a fabricated research paper has led to the introduction of new editorial safeguards to protect the integrity of research published by Anesthesia & Analgesia, official journal of the International Anesthesia Research Society (IARS).
In December 2009, Anesthesia & Analgesia published a paper by German anesthesiologist Joachim Boldt on the use of hydroxyethyl starch for fluid management of patients undergoing cardiac surgery. Readers immediately noticed some statistically unlikely findings, prompting a closer look at the study and its conduct. An investigation over the ensuring 10 months identified serious irregularities, including the absence of institutional review board (IRB) approval and written informed consent. Additionally, an investigating committee at the hospital, Klinikum Ludwigshafen, determined that there was no evidence that the study was performed at all.
The March issue of Anesthesia & Analgesia includes a series of editorials and articles on research misconduct and editorial steps to detect it prior to publication. In his editorial describing the fabricated research Dr. Steven L. Shafer of Columbia University, Editor-in-Chief of Anesthesia & Analgesia, writes, "My commitment to 'unimpeachable integrity' means that credible allegations of misconduct are not ignored or swept under the rug, but are pursued, relentlessly, and sometimes at considerable personal cost."
The lack of IRB approval for many of Dr. Boldt’s clinical studies went undetected for many years because of the complex system of research oversight in Germany. Two editorials in the March issue of Anesthesia & Analgesia explore the "safeguards and shortcomings" of research oversight in Germany. In Germany the institutions responsible for granting IRB approval for studies done in private hospitals do not have the right to audit research records to ensure compliance. Dr. Boldt exploited this loophole to conduct studies without IRB review.
Fabricated Study Prompts New Steps to Ensure Properly Conducted ResearchFollowing the announcement that many of Dr. Boldt’s studies did not have IRB approval, Dr. Shafer and the editorial board introduced a requirement that authors provide detailed information on the IRB responsible for informed consent, as well as a copy of IRB approval letter for all clinical trials.
Additionally, Dr. Boldt alleged that one of his studies that lacked IRB approval was an “audit”, and hence IRB approval was not required. In another editorial Dr. Shafer sets forth an explicit policy for Anesthesia & Analgesia that all human research published in Anesthesia & Analgesia undergo IRB review and approval prior to publication. This specifically includes audits. An accompanying editorial by Dr. Steven M. Yentis, editor of the British journal Anaesthesia, presents his journal's policies, which take a somewhat different approach to reach the same goal.
The aggressive editorial response reflects tough lessons learned by previous experience with fabricated studies at Anesthesia & Analgesia. In 2009, the discovery of scientific fraud by anesthesiologist Scott Reuben led to the retraction of a large body of research on the use of nonsteroidal anti-inflammatory drugs during surgery to prevent chronic postoperative pain. In that case, follow-up with other authors provided "substantial confirmatory evidence" that at least some of the author's previous research was legitimate.
A similar process will now be needed to scrutinize all of Dr. Boldt's previous research for evidence of possible misconduct. Dr. Shafer has reached out to the editors of other journals that have published the now-suspect research, and will coordinate efforts—along with the authors' hospital and the responsible German medical board—to work through the backlog of papers.
A separate editorial provides a preliminary evaluation on how the discrediting of Dr. Boldt’s research affects the current state of knowledge on the use of hydoxyethyl starches on fluid management during surgery. While the falsified research is a setback, Drs. Konrad Reinhart and Jukka Takala conclude that the loss of data doesn't have a major impact on this issue—which continues to be an active topic of scientific debate.
In assessing the damage wrought by falsified research, Dr. Shafer quotes Carl Sagan's characterization of science as "a candle in the dark." "The candlelight of science published in Anesthesia & Analgesia has been dimmed by the shadow cast by this fabrication," Dr. Shafer concludes. "It will take years to dispel. We are committed to the task."
Read the full articles in Anesthesia & Analgesia
About the IARSThe International Anesthesia Research Society is a nonpolitical, not-for-profit medical society founded in 1922 to advance and support scientific research and education related to anesthesia, and to improve patient care through basic research. The IARS contributes nearly $1 million annually to fund anesthesia research; sponsors an annual forum for anesthesiology leaders to share information and ideas; maintains a worldwide membership of more 15,000 physicians, physician residents, and others with doctoral degrees, as well as health professionals in anesthesia-related practice; sponsors the SAFEKIDS initiative; and publishes the journal Anesthesia & Analgesia. Additional information about the society and the journal may be found at www.iars.org and www.anesthesia-analgesia.org.
About Anesthesia & AnalgesiaAnesthesia & Analgesia was founded in 1922 and was issued bi-monthly until 1980, when it became a monthly publication. A&A is the leading journal for anesthesia clinicians and researchers and includes more than 500 articles annually in all areas related to anesthesia and analgesia, such as cardiovascular anesthesiology, patient safety, anesthetic pharmacology, and pain management. The journal is published on behalf of the IARS by Lippincott Williams & Wilkins (LWW), a division of Wolters Kluwer Health.
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