3/2/23, 3:32 PM The ethics of case reports - PMC

Paediatr Child Health. 2004 Feb; 9(2): 83–84. PMCID: PMC2720465

doi: 10.1093/pch/9.2.83 PMID: 19654984

The ethics of case reports

Michael I Shevell, MD CM FRCPC

The unfettered exchange and dissemination of information is a necessary precondition to ad‐

vancement 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 scien‐
tific 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 his‐

tory with a disease presentation and progress (1). The impetus to write and publish a case re‐
port rests on the insight that a particular case offers with respect to issues relating to diagno‐
sis, 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 be‐
ing a building block of clinical care and research, case reports are, for many health profes‐
sional 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 ele‐
ments of successful caregiving with respect to health and disease include reciprocal informa‐
tion 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 con‐
sidered. It should be emphasized that the individual writing the case report has a primary obli‐
gation, 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 experimen‐
tal 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 in‐
formed and free way to the course of action reported.

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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 propri‐
etary 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 feasi‐
ble, 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 ob‐
tained directly, and preferably in writing, from the individual affected, with (ideally) the in‐
volved 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 appro‐
priate to their age or development, as is now done in clinical research efforts (7). Most individ‐
uals will enthusiastically consent if the approach is made on the basis that reporting their par‐
ticular 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 includ‐
ing, 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 mat‐
ters of a personal nature, and health is a most intimate one, are disclosed. Access to the medi‐
cal literature is unfettered and unrestricted, especially in the electronic age. Personal identi‐
fiers 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 over‐
lapping 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 re‐
port 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 insti‐
tutional 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 is‐

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sues 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 confiden‐
tiality, the authors of case reports serve the twin pillars of ethics and science, which properly
support and govern our practice of medicine.

Acknowledgments

The author would like to acknowledge the secretarial assistance of Alba Rinaldi in the prepara‐
tion of this manuscript and the Montreal Children’s Hospital Foundation for support during
the writing of this manuscript. MIS is a Chercheur Boursier Clinicien (Clinical Research
Scholar) of the Fonds de Recherche en Sante du Quebec.

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