The ethics of case reports

The unfettered exchange and dissemination of information is a necessary precondition to advancement and progress in both medical practice and science. The forum for such an exchange is frequently within the confines of the ever-expanding medical literature and relevant scientific journals. Case reports are an essential element of this information exchange. Case reports can be conceptualized as a formulized description of a particular individual’s history with a disease presentation and progress (1). The impetus to write and publish a case report rests on the insight that a particular case offers with respect to issues relating to diagnosis, therapy, evolution, pathogenesis or outcome. To warrant publication, such observations must be in some way novel and serve to advance our understanding of the disease reported. Frequently, the case report may serve as a catalyst to adjust our thinking regarding a disease and, thus, precipitate new approaches either clinically or in research efforts. In addition to being a building block of clinical care and research, case reports are, for many health professional trainees, the initial foray into the academic world. A rewarding introduction can lead to a career featuring inquisitiveness and ongoing effort to expand our knowledge base. Case reports bridge the often arbitrary separation between caregiving and research. Key elements of successful caregiving with respect to health and disease include reciprocal information exchange, respect, support, partnership and enablement (2). These elements should guide the process of the case report and are the context in which the relevant ethical issues are considered. It should be emphasized that the individual writing the case report has a primary obligation, as a health care provider, to the subject of the case report. The professional obligations of this role are paramount and should never be compromised by expediency or academic gain. Ethical issues that arise from writing a case report are basically twofold: informed consent and confidentiality. Since the postwar Nuremberg trials, which exposed hideous human experimental abuses and resulted in the formulation of the Nuremberg Code, informed consent has been the cornerstone of human research ethics (3). Informed consent is premised on the autonomy of the individual as an agent in charge of his or her own destiny (4). The competent individual is best positioned to uniquely determine what is best for himself or herself. Consent for either a clinical course of action or research participation must be freely given and based on full prior knowledge of potential benefits and risks. Case reports are derived from clinical practice and, thus, the observations reported must be based on the subjects having consented in an informed and free way to the course of action reported. Furthermore, what is unique about the case report is the externalization and dissemination of what is typically a very private matter – an individual’s medical condition. This personal ‘story’ does not belong to the caregiver, and it is assumed that the patient or subject retains proprietary rights. It is the individual subject who possesses the original ‘copyright’. This premise is reflected throughout our medical care system by carefully established privacy controls that protect against dissemination of patient information to third parties without the consent of the affected individual. Such privacy concerns are at the forefront when a caregiver is considering undertaking a case report. The subject of the case report should, wherever possible and feasible, be aware of both the premise and the undertaking. Consent to use a patient’s story should be obtained a priori to publishing the report whenever possible. This consent should be obtained directly, and preferably in writing, from the individual affected, with (ideally) the involved caregiver obtaining the actual consent (5). Others in the literature have argued against obtaining consent, so a clear consensus on this issue is not universal (6). Where consent is not possible (ie, due to incompetence or age) it should be obtained from the proper guardian. Children pose an additional challenge, as their assent should be obtained in a manner appropriate to their age or development, as is now done in clinical research efforts (7). Most individuals will enthusiastically consent if the approach is made on the basis that reporting their particular case would aid others with the same disease process and would not involve additional interventions. Altruism can be a powerful motivator in human behaviour. Difficulty in obtaining informed consent well after care is provided may be avoided by including, in the standard consent for care notation, that patient information, properly anonymized, may be used in the future. A corollary to an individual’s ‘copyright’, which requires informed consent before publication, is the need for preserving confidentiality (8). This corollary also reflects our societal valuation on the right to privacy and respect for persons. Individual autonomy determines to whom matters of a personal nature, and health is a most intimate one, are disclosed. Access to the medical literature is unfettered and unrestricted, especially in the electronic age. Personal identifiers must be stricken from any case report, with particular care taken when ancillary data is presented (ie, an imaging study) which may inadvertently contain traceable information (ie, hospital/Medicare number, birth date, initials or name), or when the individual being reported on comes from a small or restricted community where personal identity can be deduced from standard details of the medical story (ie, age, family history, job status). Ethical concerns about informed consent and confidentiality are best protected by four overlapping and non-mutually exclusive sources (9): the individual, the caregiver and/or author of the case report, the institution where care is provided, and the journal to which the case report is submitted for publication. Wherever possible, the case report should be reviewed by the individual to permit editing or removal of any confidential or compromising material, thus respecting ‘copyright’ overtly. The caregiver and/or author should be constantly aware of the need for informed consent and the protection of confidentiality, thus, providing an additional level of protection. Additional institutional protection may be provided through the mechanism of a research ethics board. Although not obliged to oversee case reports at present, this institutional structure may provide guidance to investigators and, where necessary, oversight. A reasonable approach may be to designate a member of the research ethics board to review case reports written by members of an institution to ensure that consent and confidentiality issues are respected. This ‘seal of approval’ could be used to ensure ethical conduct at the time of submission of a case report to a journal for publication. Journals may add an additional final measure of protection by requesting prior local review before consideration. Case reports can be good science. Good science is by necessity predicated on a respect for best ethical practice. Such respect should not be perceived as a barrier to science, and, should be considered a precondition of scientific practice. By respecting informed consent and confidentiality, the authors of case reports serve the twin pillars of ethics and science, which properly support and govern our practice of medicine.

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