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Journal of Clinical Oncology, Vol 25, No 36 (December 20), 2007: pp. 5835-5836 © 2007 American Society of Clinical Oncology. DOI: 10.1200/JCO.2007.14.5250
Informed Consent: True Information or Institutional Review Board–Approved Disinformation?Ethics Committee, Faculty of Medicine, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland
Clinical Research Unit, Multidisciplinary Oncology Center, Centre Hospitalier Universitaire Vaudois and University of Lausanne, Lausanne, Switzerland To the Editor: Increasing attention is given to investigators' real or potential conflicts of interest when enrolling patients in research protocols. In a study on how patients would perceive financial and intrinsic (eg, publication, career, recognition by peers) conflicts of interest, Gray and colleagues1 report, after interviewing over 100 phase I trial participants, that patients are more preoccupied by intrinsic rather than financial conflicts of interest (65% v 45%), and that just more than half of the patients desired disclosure. At the same time, two thirds of the patients estimate that full disclosure would not affect their trial participation. The authors conclude that the impact of conflicts of interest disclosure needs to be evaluated carefully. Would their investigation of disclosure in actual existing conflicts of interest of the trials in which they are participating have revealed the same results? We do not know, given that the interviews were based on a hypothetical context only. Logically, this should be studied further in a randomized trial comparing different variants of the informed consent process and documentation. However, is this really the way we should investigate further? In a similar study, Hampson et al2 interviewed more than 250 participants in phase I-III oncology trials on hypothetical conflicts of interest. Ninety percent of patients indicated that they were not concerned about investigators' financial conflicts of interest, and about one third of the patients wished to receive detailed disclosure. In a qualitative study in patients with various chronic diseases (HIV, arthritis, cancer),3 again only a minority of patients requested full disclosure. Some global information on the relationship with the pharmaceutical industry and an assurance that mechanisms are in place to oversee potential conflicts of interest seem to suffice. In addition, when the same question was investigated again with focus groups of patients who, in their great majority, have never participated in any clinical trial,4 it turned out that the patients already had difficulties understanding the problem and were largely unable to recognize that their physician may actually have a conflict of interest. We are currently conducting a longitudinal study on the psychological impact of the informed consent process. Consistent with other observations, our study confirms that patients—at different stages of a live-threatening disease—have many other and more burning preoccupations than the physicians' potential conflicts of interest. Adequate information of potential research subjects with regard to investigators' conflicts of interest is integral part of the recommendation by several bodies governing biomedical research (Department of Health and Human Services, Association of American Colleges, World Medical Association5-8). It is interesting, however, that the Institutional Review Board for the study by Gray et al actually mandated that the interrogation should be based on fictitious conflicts of interest, specifically excluding the actual current role and potential conflicts of interest their physician may have in the trials in which they were participating. Was this to avoid a negative impact on the patient-physician relationship? Interpreting the available data, one may just as easily conclude that a majority of patients do not want to be informed in detail about the investigators potential conflicts of interests. By insisting on extensive disclosure and information, are we not burdening the patient with a responsibility he or she might not be able or willing to assume? Consideration of potential conflicting interests and providing care always directed in the patients best interest are responsibilities that need to be part of every investigator's or physician's minimal moral and ethical codex. It is possible that oversight by internal or external governing bodies may be of value, but it does not replace the individual physician's personal vigilance. Gray and colleagues have clearly shown that recognition of intrinsic conflicts of interests may be just as important as the much more easily quantified financial interests. Perhaps more attention needs to be directed to identify occult but significant intrinsic conflicts of interest.
The question is not if, but rather how patients should be appropriately informed while respecting their autonomy. This means respecting the patients right of knowing as much as the right of not wanting to know. The patient information sheet (and oral information) is already becoming more and more complex, including an ever increasing amount of mandatory (who is mandating?) information, often not really contributory for decision making (or is the fact that liver toxicity was observed with a drug x in a rat model truly going to affect patients willingness to participate?). After analysis of 149 patient information sheets submitted to our Ethics Committee in 2004 to 2005,9 using several validated readability scales, we concluded that the intelligibility of most documents was poor or not adapted to the patient. As an example, the median Flesch-Kincaid score indicating the number of school years required to understand a text was 11.2 (interquartile range [IQR], 2.1). The Gunning FOG score, for which values We believe it is time to redefine what type of information, and in what detail, should be given to a patient approached for trial participation. Pertinent data need to be adequate in relation to the individual's potential to truly assimilate the information, in particular because the patient is often confronted with these data in a situation of personal stress (cancer diagnosis or progression). Patients right of autonomy would thus be much better respected. AUTHORS' DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The author(s) indicated no potential conflicts of interest. REFERENCES
1. Gray SW, Hlubocky FJ, Ratain MJ, et al: Attitudes toward research participation and investigator conflicts of interest among advance cancer patients participating in early-phase clinical trials. J Clin Oncol 25:3488-3494, 2007 2. Hampson LA, Agrawal M, Joffe S, et al: Patients' views on financial conflicts of interest in cancer research trials. N Engl J Med 355:2330-2337, 2006 3. Grady C, Ostmann E, Sussman JS, et al: The limits of disclosure: What research subjects want to know about investigator financial interests. J Law Med Ethics 34:592-599, 2006 4. Weinfurt KP, Friedman JY, Allsbrook JS, et al: Views of potential research participants on financial conflicts of interest: Barriers and opportunities for effective disclosure. J Gen Intern Med 21:901-906, 2006[Medline] 5. US Department of Health and Human Services (DHHS): Financial relationships and interests in research Involving human subjects: Guidance for human subject protection. http://www.hhs.gov/ohrp/humansubjects/finreltn/fguid.pdf 6. AAMC: Protecting subjects, preserving trust, promoting progress: I. Policy and guidelines for the oversight of individual financial interests in human subjects research. Acad Med 78:225-236, 2003[Medline] 7. World Medical Association: Declaration of Helsinki, 1964, amended in 1975, 1983, 1989, 1996, and 2000. http://www.wma.net/e/policy/b3.htm 8. Weinfurt KP, Dinan MA, Allsbrook JS, et al: Policies of academic medical centers for disclosing financial conflicts of interest to potential research participants. Acad Med 80:113-118, 2006 9. Rossel M: Readibility of patient information sheets [Lisibilité des formulaires d'information]. Oral communication: 3rd meeting of Ethics Committee members of the French part of Switzerland, Geneva. November 2006 Related Article
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Copyright © 2007 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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6 are considered very easy to understand and values 
12 are considered very difficult to understand, remained at a median of 14.8 (IQR, 2.3), even after inclusion of modifications requested by the Ethics Committee. 
