Patient and family consent for publication: A bibliographic and ethical analysis of recent case reports from a single institution

Abstract

The objective of this study was to identify compliance with journal policies on documenting consent to publish case studies and to discuss the ethical framework specific to the creation and publication of case studies. Textual analysis of case studies published between 2019 and 2024 at a single institution and evaluation of their compliance with journal policies and emerging ethical standards. 229 case reports were published between 2019 and 2024 in 107 journals. The majority of articles remain uncited at this time and were published in low-impact journals. Almost 20% of articles evaluated did not comply with journal policies on documenting consent, and, in an additional 30%, it was not possible to document compliance because journal policies did not require documentation within the manuscript. Journal policies on documentation of consent to publish, where they exist, are inconsistently applied at every stage of case study production and publication. This may reflect a broader lack of understanding of the ethical context of case studies and their increasing risk to patient privacy.

Keywords

single case studies as topic patient rights confidentiality research ethics case reports

Introduction

For most of medicine’s history, knowledge and practice was rooted in case studies, simple reports describing presentations and treatments. From its beginnings in African antiquity to the current day, the format of case studies remains recognizable and until relatively recently, were the most published format in medical journals (Nissen and Wynn, 2014; Zeng et al., 2021). In the modern era case studies communicated the discovery of Cushing’s Disease, Acquired Immune Deficiency Syndrome, and many rare conditions (Cabán-Martinez and García-Beltrán, 2012; Graffeo et al., 2017). Within the past few years, this format was critical in the global response to COVID-19 (Huppert, 2022).

As Evidence-Based Medicine (EBM) became fundamental to practice, the case study became a “mere bystander” (Akers, 2016) suffering from both its inherent scientific limitations and business pressures from an evolving publishing market. A 2001 editorial in the journal Anaesthesia claimed that the case report “is now almost extinct” (Mason, 2001). However, two decades later, Neuroradiology Journal celebrated case studies in an editorial celebrating their “key role in sharing knowledge” and unique ability to “bring humanity to medicine” (Saba, 2023).

By 2015 most major publishers had created new Open Access journals solely for publishing case reports in most specialties, commonly presented as companion journals to established titles (Akers, 2016). With the renewed increase in case report publication and delineated publication locations in the medical literature, it is worthwhile to explore the specific and unique ethical considerations of this perennial method of medical research.

The ethical context of case studies

Generally, a write up of the history, treatment, and outcomes of a small handful of subjects is exempt from Institutional Review Board (IRB) oversight due to the interpretation of the Common Rule’s definition of research (Johns Hopkins Institutional Review Board, 2021; Office for Human Research Protections, 2018). This light regulation and absence of rigorous methodology increases the attraction of case reports as a rite of passage, resume booster, and gateway into publication, especially for junior clinicians (Saba, 2023; Shevell, 2004). Case reports are included in the publication options required as evidence of scholarly activity for the almost 150,000 doctors in residency programs each year evaluated by the Accreditation Council for Graduate Medical Education (AGCME), the credentialing body for Medical Doctor (MD) residency programs in America.

While there is research and discussion about the value of case studies as a format for driving medical discovery and treatment options, by comparison to the robust ethical debate about the rights and responsibilities of researchers to study participants, little is to be found regarding the ethical aspects of case studies. This is especially surprising given the risk of harm from the violation of the subject’s right to privacy due to the increasingly digital and open publishing ecosystem. The potential for patients or those without access to medical literature to access this knowledge has been remote until recently. Due in part to tradition and the absence of regulatory drivers, consideration of a case study subject’s rights and vulnerabilities has had few stakeholders, so the sparse ethical consideration of the topic is unsurprising. It should be remembered that the current version of the Hippocratic Oath used ceremonially in many United States medical schools commits a physician to “respect the privacy of my patients, for their problems are not disclosed to me that the world may know” (Tyson, 2001), underscoring the central ethical expectation of research publication as well as that of a clinician’s professional conduct that patient privacy must be protected to the greatest extent possible.

Several well-known cases have documented harmful unintended consequences of nonconsensual publication of patient information in case studies, such as the one discussed by Antommaria, where the subject of a psychiatric case study was discovered by a journalist and “outed,” with severe personal and professional consequences which resulted in her complaining to the British Medical Council and charges of professional misconduct being placed against the authors (Antommaria, 2004). Antommaria’s note that “medical knowledge is no longer confined to the profession” is even more true in 2024 than it was 20 years ago, and other editorialists and ethicists have discussed the problems and potential harms of unexpected discovery. Most recently this was demonstrated with the widespread availability of potentially identifiable patient images from case reports in Google Images (Marshall et al., 2024). The discussions between Isaacs and BMJ editors concerning their reluctant to publish a rare disease case report crystallize the inherent conflicts between promoting medical knowledge, protecting patient rights, and ensuring legal compliance (Isaacs et al., 2008). New risks to patient privacy and autonomy emerge in an era of expanding digital surveillance, merging data in the interests of government efficiency, and generative artificial intelligence.

While patient and research subject rights have been minimized or marginalized throughout most of the history of medicine, positive trends in advocacy, philosophy, and the publication industry suggest that there is ongoing evolution in research, case study creation, and publication processes. The recent revisions to the Helsinki Declaration, for instance, removed all mentions of patient as “subjects,” replacing this word throughout the document with “participants,” reflecting the increased attention paid to patients’ enhanced role in all aspects of clinical research (Bloom, 2025; Resneck, 2024).

Most academic journal publication policies now typically state that a specific person should not be identifiable from the details and data included in an article, and the International Committee of Medical Journal Editors (ICMJE) provides recommendations on how to protect patient privacy, including when consent to publish should be obtained from the patient (ICMJE, 2024). Some journal publishers require documentation regarding this consent process from case study subjects. This documentation ranges from a self-reported author affirmation to a separate form submitted with the manuscript or the inclusion of specific statements in the manuscript indicating that consent to publish from the was obtained from the patient or proxy.

Other organizations, notably the CARE group (CAse REports, https://www.care-statement.org/) have developed extensive EQUATOR-recommended guidelines based on the ethical duty of the case report author to the subject. This includes the recommendation that the subject’s own perspective be included where feasible (Gagnier et al., 2013; Geppert, 2022). While there are multiple practical and ethical models for protecting the identity and autonomy of case report subjects, strong recommendations by professional associations and expert groups, as well as specific policies at the publisher and journal levels are widely variable and inconsistently applied.

In the setting of this historical background, the question of compliance with guidelines regarding patient consent has been previously examined. In 2003, a cross-sectional analysis of all publications in the BMJ, The New England Journal of Medicine, Annals of Internal Medicine, and JAMA over a 3-month time period was performed specifically assessing overall rates of subject consent. (Schroter et al., 2006) This work had built on prior studies of similar publications (Yank and Rennie, 2002). While the trend noted in Schroder’s work showed improvement in overall rates of consent obtainment, this was only noted for publications of formal research. The consent rates for case report publications and case series publications remained abysmally low at 8% and 17% respectively.

With this background understanding of the ethical rationale for subject consent in case report publication, and initial inklings of overall improvement in consent rates at the turn of the last century, we performed the following analysis of case report publications from our hospital system and provide a deeper discussion as to further needs in this topic.

Goals

In this publication we will explore the ethical considerations that have evolved to govern this format and provide a current example based on the publications of a single institution to illustrate its complications. We analyze case studies published within the past 5 years by clinicians associated with a single academically affiliated institution to assess and evaluate compliance with organizational and publisher guidelines, best practice recommendations, and ethical frameworks around privacy and consent. Given anecdotal experience, familiarity with the format, and findings from relevant literature, we hypothesized that compliance would be poor and that differences between specialties might emerge.

Methods

A cross-sectional analysis of case studies published by researchers employed at a suburban based, academic affiliated, pediatric hospital within the past 5 years was performed using the Scopus and PubMed databases, with searches limited by relevant affiliation statements and publication type. Out of 400 results, 229 case studies were identified after review and analyzed using the Covidence review platform. Extracted data included: journal title and publisher; publication date; clinical specialty; impact factor; permission-related text such as publication consent, informed consent, and institutional review. For our study, authors considered permissions-related text as: any mention in the full text of the study regarding IRB oversight; management of personally identifiable information; seeking for or granting of permission to publish from the patient or their family; acknowledgment of patient or family contribution. To assess compliance with journal policy, we searched journal websites for author instructions related to patient privacy, permission to publish, and any relevant ethical guidelines.

Of Note, articles published in the open-access journal Cureus were excluded from the analysis. Within the study period, this journal had merged several state-specific journals with unclear peer-review status and has an online-only continuous publication model offering “rapid review” and other innovative features that were not shared by other journals included in this corpus. This totaled 47 case reports.

Results

Bibliographic analysis

Case reports were published in 107 individual journals. Twenty-eight journals published more than one case report, with 3/4 of the journals represented publishing only one report. 43% (n = 77) of total articles were published Open Access.

Average journal impact factor varied widely with a mean of 3.7 (range 0–40) and a median of 2. 40% of articles were published in 29 journals in the lowest quartile of impact, and 20% of articles were published in 23 journals in the highest quartile.

35% of published articles were in general medical/pediatric journals. Cardiology, Hematology/Oncology, Neurology, Otolaryngology, Urology, general surgery, and Orthopedics comprised another 45%. The remaining 20% of articles were in other specialties. Thirty-seven articles were in 23 case report-only journals. More than half of the case studies (56%) included in this analysis were uncited, and the median citation of papers was 1, with a range of 0–22 citations.

Concordance with publisher policy was variable. Policies on informed consent and consent to publish were extracted from journal websites and compliance was evaluated for 178 articles (see Figure 1).

Figure 1.

Compliance of case studies with journal policies (green, compliant; yellow, not determined; red, not compliant).

In total, 87 articles (49%) were published in 60 journals where it was possible to establish compliance with publisher/journal policies on informed consent/consent to publish. This included journals where there was no requirement to document or describe subject consent or where the published policy only specified requirements around describing Institutional Review Board (IRB) oversight.

Fifty-nine articles (33%) were published in 29 journals where it was not possible to establish compliance because policies required authors assent during the editorial process that they had obtained permission but not to use any particular text in their manuscript. Thirty-two articles (18%) were published in 18 journals where there was no indication that authors had followed the current journal policies or that the policies currently in place had been enforced by the publisher during the editorial process.

Of the three studies published in Annals of Thoracic Surgery, an Elsevier journal, the publisher’s policy requiring an in-text written statement documenting consent had not been followed by the authors or editors (Alloah et al., 2022; Hurtado et al., 2022; Nelson et al., 2020).¹ Six of eight case reports published in Progress in Pediatric Cardiology did not follow the journal’s author guidelines, either in their recommendation that CaRE guidelines be followed, or that specific statements on IRB oversight be included in the text of the article (DiLillo and Nunlist, 2020; Griffith and Nunlist, 2020; Hinds and Nunlist, 2020; Krivenko et al., 2022; Matoq et al., 2020; Vari et al., 2020).² Three studies out of three published in Radiology Case Reports did not appear to follow the journal policy that case reports must report that written informed consent be acquired³ (Albrecht et al., 2021; Rivas et al., 2019; Singh et al., 2019). None of the five articles published in Child’s Nervous System complied with the current journal policy on providing information in a declarations statement regarding documenting consent to publish⁴ (Ahluwalia et al., 2020a, 2020b; Ahluwalia and Scherer, 2019; Kim et al., 2021; Krafft et al., 2021). Only one of five articles in Journal of Pediatric Surgery Case Reports complied with the current policy on documenting subject consent according to CARE guidelines⁵ (Williams et al., 2023).

Whether or not a journal policy required in-text documentation of subject permission, more than half of all articles (52%, n = 119) did not include any text related directly or inferentially to seeking informed consent or permission to publish, consistent with the 2022 study by Kumar (2022).

Thirty articles in this group did include statements specifically noting that case studies are exempt from IRB oversight per institutional policy, or that informed consent, or permission was not required for reasons including: anonymization; absence of identifying or protected health information; subject being lost to follow-up.

Of the 110 articles that did include qualifying text, 52 specifically and directly noted that patients and family members gave permission to have their case published. This comprises 23% of the total articles reviewed in this study.

Some disciplinary differences may be suggested, although small numbers of articles in any category and multi-disciplinary authorship precludes formal statistical analysis in this regard. In 28 articles affiliated to radiology or medical imaging, only 25% complied with journal requirements, and only 14% included any text indicating consent from subjects. Of 32 articles affiliated to non-orthopedic surgery, there was 50% compliance, and 25% included consent-related text. In 11 articles in orthopedic surgery, 80% of articles complied with publisher policies and 68% included consent-related text. Orthopedic surgery and medical genetics had similar figures for compliance and consent and had the highest scores of any category identified and analyzed.

Limitations

This study reflects the clinical and institutional practice of a single pediatric institution which may not be representative of other types of hospitals. It was not possible to assess compliance of almost a third of articles included in the analysis because most journals included in this group did not require that documentation of publication consent/assent be included in the manuscript text. Finally, while the narrow temporal scope of the study was chosen to hopefully exclude widespread policy changes at the journal level, it is possible that policies on obtaining and documenting consent had changed at some journals within the 5-year time frame.

Discussion

While the easier availability of medical articles on the internet is generally seen as a conditional good, it increases the likelihood that a patient or family could come across their story told without their consent. Many case reports in the corpus analyzed here, while anonymized per policy, nevertheless reported cases with rare or uncommon conditions, treated at a specific institution, by named physicians, sometimes including photographs. In addition, journal guidelines, recommendations, and editorial oversight on documentation and in-text consent statements were followed inconsistently, or at some journals, not at all. This strongly suggests a lack of attention at all levels to the ethical context of case reports and to their potential to violate ethical principles.

It is reasonable to question who “owns” a case report. They have been seen historically as under the exclusive agency of the physician as the sole protagonist in the story, told by them, with the patient as the passive subject whose experience is solely reported through the physician’s perspective. This is arguably rooted in antiquated hierarchical and coercive views of the physician-patient relationship. As shared decision making is increasingly an expectation, perhaps shared story telling should be as well. In addition, it would be equally unethical to ignore the impact an unintended violation of a patient’s privacy could have on them regardless of “ownership.” This could certainly be argued in case reports on child abuse, where the likelihood of obtaining consent seems limited and where there is potential clinical significance. An editorial in Journal of Medical Toxicology noted the presence of this “perilous balance” (Neavyn and Murphy, 2014). However, the particular vulnerability of the subject, the risk of their double victimization through future retraumatization if they were to come across an account of their abuse, and the inherent “newsworthiness” of child abuse cases in the media where privacy protection is not prioritized, may in fact argue for even stricter scrutiny.

It is, however, fortuitous that such a renewal in focus on the patient’s perspective would be included in the early medical education of so many physicians through their publication requirements. Indeed, doing away with the subjecthood of the patient entirely in these narrative case reports, at a particularly crucial time of becoming a physician, seems to be a useful and positive step in seeding these behaviors. This echoes an ongoing discussion around the nomenclature of patient participants in research studies (Weiss, 2023). A move toward universalizing consent to publish and encouraging the inclusion of patient narratives could make a small contribution to keeping respect for patients and respect for privacy at the center of the physician-patient relationship.

In pediatrics in particular, it is well documented that participation in clinical trials is often strongly or predominantly motivated by altruism (Hillson et al., 2023; Truong et al., 2011) and so it seems likely that making the case to guardians about the value of case studies, for instance in cases of rare diseases where case reports may be a primary source of evidence, might draw upon the same proven motivations and fulfill the joint goals of promoting knowledge and respecting the rights of patients. Indeed, since the publication of a case report cannot reasonably be argued to ever be in the patient’s best interests, clinicians must rely on altruism and trust. Isaacs provides an example in a brief 2013 editorial where authors intended to publish a case study on a rare disease without parental consent (having assumed it would not be granted): on being rejected by the journal because of the lack of consent and potential for identification, the authors returned to the caregiver who gave unhesitating consent because of her trust and appreciation of the clinicians who had cared for her child (Isaacs and Kilham, 2013).

With only 1% of studies analyzed in our study mentioning best practices for patient/family publishing permission, it seems likely that this reflects a persistent general and widespread lack of awareness among residents and their mentors regarding the ethical frameworks around case study publication. Opportunities to promote awareness of ICMJE and CARE guidelines in residency education and other professional and publishing education should be considered, and greater promotion of author tools such as CARE’s CARE-writer online application might help with more widespread adoption of best practices (https://care-writer.com/). Institutionally, compliance could be improved by creating case study oversight pathways in residency education and fellowship.

In many countries, emerging legal standards around broader issues of patient privacy may encompass case studies. In Canada, the Canadian Journal of Anesthesia responded to interpretations of the federal Personal Information Protection Act of 2000 by requiring the documentation of subject consent in most case studies (Bevan and Hardy, 2004). Moreover, in the multinational world of medical journal publishing, where authors might find themselves subject to legal standards outside of their country of practice and residency, it may be more efficient as well as more ethical to proactively secure consent as a standard of practice for the writing of a case report.

Conclusion

In 2023 The journal American Surgeon published a case about facial reconstruction in a hunter attacked by a Grizzly bear in Wyoming and no record of consent was published (Ingram et al., 2023) Given the extremely low incidence of bear attacks in the United States, it would seem possible that the victim in this case could be identified easily using other sources. At the turn of the 21st century, data suggested that patient consent rates across various journals had improved but with consent rates for case reports still lagging greatly behind. Our single center study suggests a tiny, if any, improvement from 17% to 23% in the intervening 20 years. Journals should be consistently improving, applying, and enforcing their own policies on documentation of consent and should be proactive in regard to emerging technology. As a pragmatic measure for authors, the variation in publisher and journal policies argues that proactively securing consent from case study subjects may save time and provide expanded opportunities for publication. Regardless, it will also help attenuate the growing risk of harm to the patient living in the modern age of electronic based information dissemination and satisfying the ethical demand.

These concerns about potential harm, violations of the physician-patient contract, and evolving legal frameworks about information privacy and ownership of personal data, particularly in the European context, all lead to what Elaine Gibson noted as the “bottom line”: that subject consent is obligatory from both confidentiality and autonomy analyses when seeking to publish a case report (Gibson, 2008).

Footnotes

Acknowledgements

The authors thank Olivia Di Leonardo, Susan Harnett, and Ann Ferrari for their assistance in extracting the data used in this analysis.

ORCID iDs

Richard James

Kristina M. Flathers

Ethical considerations

Not applicable.

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Publication made possible in part by support from the Nemours Children’s Health Grants for Open Access from Library Services (GOALS).

Declaration of conflicting interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Data availability statement

All data generated or analyzed during this study are included in this article and its supplementary information files.

Notes

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