© 2006 American Thoracic Society doi: 10.1164/rccm.2603003
Do All Types of Human Research Need Ethics Committee Approval?Hôpital Henri Mondor, Creteil, France In February 2005, as a new associate editor for the AJRCCM, I was assigned a manuscript from France. It was a sound pathophysiology study dealing with data obtained through routine care, in a rather rare subset of patients for whom the authors have unique experience. The authors did not seek approval from a research ethics committee. They only said in their Methods section: "All tests were performed for clinical purposes using routine techniques, thus ethical approval was not sought. The patients and their families received written information on methods." This is perfectly acceptable in France. However, two American reviewers argued that this study could not have been performed in the United States without institutional review board (IRB) approval. The first one said that "the authors have neglected to obtain informed consent from patients, purportedly because the test is ‘routine,’ an omission that raises ethical concerns," and further, "If ... the data were gathered ... prospectively ... ethical approval should have been sought, even if the techniques used were considered routine." The second reviewer commented, "The way as written may be acceptable in France, but I am positive that it will not be acceptable in the US without receiving approval from the institutional review board. The IRB may or may not waive informed consent. When a test is used routinely with low risk–benefit ratio, the IRB will waive consent." With rejection recommended by both reviewers, the paper could not be sent for revision. This is not a unique occurrence. In 2004, another group from Paris sent to a prominent North American journal a study done in the very same context, using data obtained during routine care, where French regulations do not make approval of an ethics committee necessary. In that case, the chief editor informed the authors' hospital director of their alleged ethical misconduct, asking for a formal inquiry of the case. The French Society of Critical Care convened a blue-ribbon panel, which concluded that the French legislation had indeed been enforced, but that the authors should have obtained an approval from another existing ethical review board. The paper was also ultimately rejected. In these two cases, the United States' reviewers and editors did not accept the possibility that French investigators use different—and, more importantly, more lenient—ethical rules. Such a "double standard" concept has been extensively discussed, criticized, and finally rejected, during the drafting of the last version of the Helsinki Declaration in 2000 (1). In addition, one cannot with certainty exclude the possibility that the United States' reviewers were tough on both papers because they felt it unfair that investigators from abroad could have freedom to do research that they could not themselves perform at home. It may be useful to try to explain why French investigators may occasionally find it so difficult to obtain approval from their local ethics committee. I focus here on the French situation because it is obviously the one I know best, even though similar problems do exist in other countries. Since 1988, French legislation has made it necessary to submit research protocols to specially designated local research ethics committees. However, when a clinical trial does not fall within the scope of the law—for example, when it intends to compare current practices or to use data obtained during usual routine care, as in the cases discussed above—most of the committees would refuse to examine protocols, arguing it is not the mission they have been given by law. What can the unfortunate investigator do in this case? An inadequate answer—or, at least, a hazardous one—is to tell the American reviewers and editors that it is not the way things are done in the authors' country. The worst solution is to claim in the manuscript that an approval was granted by a local committee, when it is not true. This apparently happened recently to a group of French surgeons, who were obliged to retract two papers they had previously published, as described in an editors' "Comment on Notice of Retraction" (2). At present, the only possibility that remains is to solicit approval from a research ethics committee other than the "legal" one. In most European university hospitals, clinical ethics committees are established bodies, which are able to review clinical trials protocols when they do not fall within the scope of the law. Another possibility for the investigators is to submit protocols to the ethics committees of relevant scientific societies. For at least 15 years, the French Society of Critical Care has had such a committee, which examined more than 100 research protocols dealing with critical care (3). When their results were submitted to journals, including the AJRCCM, the mention by authors of approval by this ethics committee was accepted by reviewers and editors. However, the current situation is certainly confusing, and it is worth trying to improve. All European Union member states now have legislation on clinical research after the implementation in their national laws of a Brussels' directive of 2001 (4), which became effective in 2004 (5) and which makes submission of research protocols to ethics committees mandatory. However, in most of the E.U. countries, these new legal requirements deal only with research on drugs, leaving large areas of clinical research, including research on surgery, medical devices, pathophysiology, and epidemiology, in a kind of regulatory vacuum. This is especially true for research using data obtained during routine care. A European directive from 1995 and all of the resulting national legislation on the protection of patients' privacy do not require IRB approval. Research on the products or components of the human body, like blood or bronchoalveolar lavage, has often not been specifically addressed by European national legislatures. When such issues are addressed, new regulations are often excessively protective or bureaucratic: for example, Norwegians are not currently allowed to sample blood from incompetent patients (6). The Helsinki Declaration is the cornerstone of all rules and regulations concerning clinical research. It says that "The protocol should be submitted for consideration, comment, guidance, and where appropriate, approval to a specially appointed ethical review committee, which must be independent of the investigator, the sponsor or any other kind of undue influence." Investigators outside the United States, including the French, do certainly have to convince themselves that submission to an independent body, such as an institutional review board or research ethics committee, of any research protocol concerning human beings is not simply adding red tape on top of existing bureaucratic hurdles. It is the fundamental condition for society at large to authorize research on patients. As said once by George Annas, "The average person wants treatment, not an opportunity to be researched on." When the editors of medical journals (the so-called Group of Vancouver), with John Murray representing the American Review of Respiratory Diseases, convened in 1978, they decided to enforce this rule and stated that acceptance for publication of any research manuscript would be conditional on formal approval by a research ethics committee: "When reporting experiments on human subjects, authors should indicate whether the procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975." Despite the huge diversity in national regulations, and sometimes a legal vacuum, as far as publication in international scientific journals is concerned, investigators should therefore know that approval by a research ethics committee will be required for consideration of their manuscript. Do we believe, though, that approval by an ethics committee is a guarantee that research is ethically sound? There is no need to argue that no system is perfect and that the medical literature is full of stories documenting shortcomings and failures of the review process (7–11). The process for reviewing clinical research includes the assessment of its ethical components, and this process is, worldwide, in continuous modification and, it is hoped, undergoing improvement (12). FOOTNOTES Conflict of Interest Statement: F.L. does not have a financial relationship with a commercial entity that has an interest in the subject of this manuscript. REFERENCES
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