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Resolving Unreported Conflicts of Interest
Catherine D. DeAngelis, MD, MPH;
Phil B. Fontanarosa, MD, MBA
JAMA. 2009;302(2):198-199.
Conflicts of interest have taken an increasingly prominent role in politics, business, and medicine. High-profile examples of undisclosed or incompletely reported financial conflicts of interest have been well publicized. There have been recent investigations by academic centers and lawmakers into unreported conflicts of interest by physicians1-2 and recommendations for more transparent reporting of potential conflicts of interest by faculty and researchers.3-5
Despite this increased attention, episodes of unreported financial conflicts of interest continue to occur. JAMA editors take issues of undisclosed conflicts of interest very seriously and investigate such allegations rigorously. In investigating such allegations, we follow our standard policies and procedures, which involve conducting our own independent investigation and contacting the authors whose disclosures are challenged. We require the authors to verify or refute the allegations and to provide a detailed explanation to support their position. In addition, we also ask all other authors listed on the article to verify that their published disclosure information was complete and accurate. Once the investigation is complete, when appropriate (not all allegations prove to be accurate) we publish a letter in JAMA that reflects the results of the investigation, including the authors' explanation for why the conflicts were not initially reported as well as an apology from the authors, along with a formal correction, and thereby correct the record and the medical literature. We have never hesitated to do this and have published several such letters6-9 following these same procedures.
However, these investigations require due diligence to ensure that the allegations are evaluated fairly and the record is corrected as necessary. This approach is important to ensure due process and also to ensure that no one's reputation is unfairly damaged due to inaccurate charges and at the same time to make certain that all relevant disclosures—including those that might not have been included in the original allegation—have been identified and addressed. Moreover, because of the sensitive nature of these investigations, we have conducted them confidentially and ordinarily have not revealed the identity of the individual bringing the allegations to the person being accused of failing to report conflicts of interest. The results of the investigation ordinarily are not revealed to any third parties until the letter of explanation and the formal correction are published. Clearly, with this level of diligence, these investigations into undisclosed conflicts of interest are time-intensive and require careful attention.
To avoid misunderstanding about our policies and procedures, we are clarifying certain aspects regarding our approach for investigations into allegations of unreported potential conflicts of interest. JAMA requires that the individual bringing the allegations provide a written detailed explanation of the unreported conflicts of interest and provide documentation to support the allegation. We will explain to the person bringing the allegation that gaining full cooperation of all parties with knowledge of the facts is likely to be enhanced by maintaining confidentiality while the investigation is under way. This approach has proven to be vital in delicate situations, such as those requiring the assistance of deans.10 Furthermore, the person making the allegation will be informed about progress of the investigation and will be notified when the investigation is completed. In addition, once the investigation into unreported conflicts of interest is completed and the letter of explanation and the correction (if necessary) are finalized, those documents will be immediately posted online and linked from the article, and then subsequently published in the print journal.
The duty to disclose and report potential conflicts of interest hinges on trust and patience, and a common bond among authors, deans, editors, and readers recognizing that reporting the best available biomedical science matters most. Pressures to publish rapidly, reports in the news media, and comments on blogs and advocacy sites must not overwhelm the process of thorough and fair investigation when reputations are at stake. A rush to judgment may spark heat and controversy, but rarely sheds light or advances medical discourse.
JAMA has been a leader in developing and enforcing policies on conflicts of interest.11-13 We have dedicated our professional efforts to doing all we can to ensure that articles published in JAMA meet the highest scientific and ethical standards and will continue to put forth the efforts necessary to do so.
AUTHOR INFORMATION
Financial Disclosures: None reported.
Editorials represent the opinions of the authors and JAMA and not those of the American Medical Association.
Author Affiliations: Dr DeAngelis (cathy.deangelis{at}jama-archives.org) is Editor in Chief and Dr Fontanarosa is Executive Deputy Editor, JAMA.
REFERENCES
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1. Harris G. Top psychiatrist didn't report drug makers' pay. New York Times. October 3, 2008.
2. Giles J. Exposing the links between doctors and big pharma. New Scientist. February 2009.3. Institute of Medicine. Conflict of Interest in Medical Research, Education, and Practice. Washington, DC: National Academies Press; 2009.4. AAMC. Protecting Patients, Preserving Integrity, Advancing Health: Accelerating the Implementation of COI Policies in Human Subjects Research. https://services.aamc.org/Publications/showfile.cfm?file=version107.pdf&prd_id=220&prv_id=268&pdf_id=107. February 2008. Accessed March 20, 2009.5. Steinbrook R. On-line disclosure of physician-industry relationships. N Engl J Med. 2009;360(4):325-327.
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6. Robinson RG, Arndt S. Incomplete financial disclosure in a study of escitalopram and problem-solving therapy for prevention of poststroke depression. JAMA. 2009;301(10):1023-1024.
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7. Ridker PM. Incomplete financial disclosure for study of funding and outcomes in major cardiovascular trials. JAMA. 2006;295(23):2725-2726.
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8. Natanson C. Incomplete financial disclosure in a study of cell-free hemoglobin-based blood substitutes and risks of myocardial infarction and death. JAMA. 2008;300(11):1300.
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9. Yao GL, Albertson P, Shih W, Yao SL. Failure to report financial disclosure information. JAMA. 2009;301(1):35-36.
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10. DeAngelis CD, Fontanarosa PB. Retraction: Cheng B-Q, et al. Chemoembolization combined with radiofrequency ablation for patients with hepatocellular carcinoma larger than 3 cm: a randomized controlled trial [published online April 20, 2009]. JAMA. 2008;299(14):1669-1677. JAMA. doi:10.1001/jama.2009.640. 2009;301(18):1931.
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11. Flanagin A, Fontanarosa PB, DeAngelis CD. Update on JAMA's conflict of interest policy. JAMA. 2006;296(2):220-221.
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12. Fontanarosa PB, Flanagin A, DeAngelis CD. Reporting conflicts of interest, financial aspects of research, and role of sponsors in funded studies. JAMA. 2005;294(1):110-111.
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13. DeAngelis CD, Fontanarosa PB. Impugning the integrity of medical science: the adverse effects of industry influence. JAMA. 2008;299(15):1833-1835.
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