Ethical Integrity is the Sine Qua Non of Scientific Reporting

SLEEP IS THE OFFICIAL BIOMEDICAL JOURNAL OF THE ASSOCIATED PROFESSIONAL SLEEP SOCIETIES (APSS), A JOINT VENTURE OF THE AMERICAN Academy of Sleep Medicine and the Sleep Research Society. The APSS Board of Directors and the Editors of the journal are committed to ethical integrity and professionalism in scientific reporting. SLEEP has a comprehensive policy on Responsible Conduct Regarding Scientific Communication that is based on the leading ethical standards for the conduct and publication of science.^1–4 The policy provides detailed ethical guidelines for virtually all aspects of manuscript preparation, submission, review, publication, citation, and use. These formal ethical standards and procedures have been used to ensure that a wide range of issues were handled appropriately in the past 4 years (e.g., attestation of authorship, conflicts of interest, manuscript withdrawal, etc.). The standards are updated regularly to ensure they meet the latest recommendations of the U.S. National Institutes of Health³ and the International Committee of Medical Journal Editors (ICMJE).⁴

One area that continues to evolve and that affects virtually every manuscript submitted to SLEEP is the issue of disclosure of all potential conflicts of interest. Science requires objectivity of observation and honesty in reporting, both of which depend upon an ethical commitment to intellectual rigor and freedom from bias. Science is costly, and investments in it are squandered when bias and doubt pervade the integrity of either scientific methods or scientific reporting. Consequently, deciding what constitutes bias, and under what conditions a significant risk of bias may be present from a conflict of interest, have been major focuses in the ethics of science and scientific reporting during the past decade.

ICMJE states that “conflict of interest exists when an author (or the author's institution), reviewer, or editor has financial or personal relationships that inappropriately influence (bias) his or her actions (such relationships are also known as dual commitments, competing interests, or competing loyalties).”⁴ All authors of a manuscript and all those involved in the peer-review and publication process must disclose all relationships that could be viewed as potential conflicts of interest. Among the most important points to be aware of regarding disclosure of conflicts of interest in scientific publications are that: 1) conflicts of interest may be potential, or perceived, or factual; 2) conflicts must be disclosed regardless of whether they are potential, perceived, or factual; and 3) conflicts are neither inherently wrong nor an admission of wrongdoing, but rather intended to fully inform readers. Consequently, authors should disclose all potential conflicts of interest, whether or not some of them are seen as irrelevant by the authors. When someone knowingly fails to clearly and accurately disclose a potentially significant conflict of interest, it can compromise the integrity of the science reported.

It is recognized that conflicts of interest are perhaps inevitable in today's highly competitive and demanding research environment in which investigators often face competing obligations and interests. The U.S. National Institutes of Health Office of Research Integrity document observes that “Researchers are expected to serve on committees, to train young researchers, to teach, and to review grants and manuscripts at the same time they pursue their own research. Conflicts of interest cannot and need not be avoided. However, in three crucial areas: financial gain, work commitments, and intellectual and personal matters, special steps are needed to assure that conflicts do not interfere with the responsible practice of research.”³ Foremost among these special steps is disclosure, especially of financial conflicts of interest, which have been at the center of many of the scandals regarding the credibility of scientific reports.

SLEEP's current conflict of interest disclosure policy primarily focuses on significant financial conflicts of interest, because these are among the most pervasive sources of influence in sleep research and sleep medicine, and they are seen as particularly important to disclose to readers. “Significant financial interest” is defined as anything of monetary value.⁵ This disclosure policy applies to all areas of sleep research (basic and human experimental research, clinical trials, population science, etc.). It applies to all sources of private financial influence (pharmaceuticals, therapeutic devices, monitoring and measurement technologies, diagnostic devices, etc.). It applies to all types of personal financial gain (industry grants, patents, copyrights, royalties, equity of any kind, unrestricted gifts, educational stipends, employment, salary support, development fees, advisory positions, consulting, paid lectures, honoraria, travel, accommodations, etc.). Importantly, disclosure includes the financial interests of all authors and their immediate family members when conflicts of interest involve them.^2–4

Prospective authors are required to complete the Conflict of Interest form for SLEEP when a manuscript is submitted. If it is uncertain whether a potential conflict of interest exists, authors are encouraged to report it nonetheless. Substantive changes to the disclosure must be reported as they occur between the time of initial manuscript submission and its publication. Disclosures are reviewed by the Editor-in-Chief and the journal staff. The disclosed information is listed within the article, but dollar amounts are not included. SLEEP now follows the guidelines of the ICMJE, which state that “Editors may use information disclosed in conflict-of-interest and financial-interest statements as a basis for editorial decisions”⁴ and for judging manuscripts.

Beginning in 2010, authors are also required to explicitly highlight in their disclosure statements, connections between what is disclosed and what they are reporting scientifically. For example, when an author of a report on a pharmaceutical agent or a therapeutic device discloses consulting for multiple companies, the author must also state clearly in the disclosure of the manuscript which (if any) of these companies manufactures and/or markets the drug or devise studied in the publication. Currently readers cannot discern this information from disclosures in which many different companies are listed and only the generic name of a drug or device is used in the publication. Henceforth, when applicable, the disclosure statement should begin with the statement that the drug/device studied in the report is manufactured and/or marketed by company X, for whom authors A, B, and C have…(e.g., consulted, received grants, served on the advisory board). This will allow readers to better understand the conflicts of interest most germane to the publication.

In coming months, SLEEP will further update its policies regarding the disclosure of conflicts of interest and other aspects of responsible conduct in scientific communication. These will include adoption of the new uniform disclosure forms of ICMJE.⁴ We will also begin enforcing disclosure requirements. If it is discovered during manuscript review and processing that an author neglected to disclose a relevant conflict of interest, whether or not it is financial in nature, the manuscript will be withdrawn from consideration. If the discovery occurs after the paper is published, the Editors will follow the guidelines of ICMJE⁴ regarding expressions of concern and retraction of manuscripts.

SLEEP now requires that all clinical trials, regardless of when they were completed, and all partial and secondary analyses of original clinical trials must be registered before submission of a manuscript based on the trial. Trials must have been registered at or before the onset of patient enrollment for any clinical trial that began patient enrollment on or after February 1, 2007. The trial name, URL, and registration number should be included at the end of the manuscript abstract. Acceptable clinical trial registries can be found at the SLEEP website, under instructions to authors.

Integrity in scientific reporting is the responsibility of everyone involved in sleep research, manuscript development, submission, review, and evaluation. All scientists should be aware of these standards, which continue to evolve and cover a wide range of issues relevant to ethical scientific publishing. As has been noted by the Council of Science Editors,² scientific journals have responsibilities to the public, the scientific community as a whole, the owners/publishers, the authors of published papers, the peer reviewers, and to the readers. Thus, prospective authors should proactively and conscientiously assume their vital role in the preservation of scientific integrity and the unique value of their intellectual contributions to humankind.

DISCLOSURE STATEMENT

Dr. Dinges is compensated by the Associated Professional Sleep Societies for his time and effort as Editor-in-Chief of SLEEP. He has received compensation for consulting and advisory board service from Eli Lilly, Inc., Mars, Inc., Merck & Co., and Sanofi-Aventis. His scientific reports in SLEEP and all other reports for which he has a conflict of interest (e.g., manuscripts from his institution) are handled by independent Editors and reviewers, without his involvement.