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The case for consent: a primer on patient privacy and informed consent

September 15, 2021 | 7 min read

By Katie Eve, Catriona Fennell, Margaret Rees

Patient health records folder with a confidential stamp

© istockphoto.com/zimmytws

Exploring why informed patient consent is always required to publish a case report or case study

Isn’t it handy – and astounding – how the image software on one’s ‘phone can connect photographs of loved ones through the years as they grow and change? But what happens when those connections are made online and an old photograph you would rather forget is connected to your current persona? In the era of social media, facial recognition, and increasingly sophisticated software, privacy is an illusion.

This becomes even more serious when we consider medical case reports, which describe clinical observations for a single patient (or a small group of similar patients). Such studies can provide a timely way of advancing scientific knowledge of rare medical conditions and complications, inform clinical study design(opens in new tab/window), and support pharmacovigilance decisions(opens in new tab/window). Professor Margaret Rees, Editor in Chief of Case Reports in Women’s Health, commented “Patients consenting to publication are providing the gift of their unique experience to science.” However, by their very nature they report on individuals, often tying photographs together with additional identifiable clinical information, and they therefore present challenges around privacy and consent.

Basic principles

Patient privacy and consent are subject to guidance such as the CARE guidelines(opens in new tab/window) and COPE(opens in new tab/window), which cover two key aspects: informed consent and removal of patient identifiers(opens in new tab/window) from manuscripts as well as clinical images, figures and datasets.

If you take one thing away from this article, let it be this: informed patient consent is always required to publish a case report or case series. Would you be happy if your physician made your private medical details public forever, without asking? Even if your name and photograph were excluded, the answer is likely still a resounding “no”.

Authors must obtain appropriate consents and permissions from a patient or their legal representative in order to include case details or other personal information or images of the patient in their article, and must include a statement on their paper confirming that informed consent was obtained. However, authors should not provide copies of consent forms, and nor should the editor or publisher request them because of the additional security levels required to receive and store consent forms, which are considered sensitive.

Informed consent to publish means that the patient must enter into the agreement to publish voluntarily and with a full understanding of the implications for the subject; a copy of the proposed manuscript should be shared with the patient before it is published.

Elsevier’s patient consent policy requires that, even where consent has been given, identifying details should be omitted if they are not essential. With growth in use of preprints, authors should also be mindful of de-identification in any prior preprint publications.

Finally, before going ahead authors should consider the value of publishing versus respect for the privacy of the patient’s family and the risk of harm and distress to them should the case be published, since anonymity cannot be absolutely guaranteed. “An editor considering a case report containing photographs or personal details that have the potential to cause distress to the patient, their family or readers, but provide limited or no educational value, should proceed with extreme caution,” added Professor Rees.

Did they really consent?

Authors and editors must critically assess whether consent for publication (distinct from consent for treatment) was truly given prior to writing or considering a case report for publication. When the patient is considered particularly vulnerable e.g. from a minority group, a child, a prisoner, having disabilities or diminished mental capacity etc. extra vigilance is needed. This similarly applies to medical emergency situations and when the patient is temporarily incapacitated, such as if they are placed in an induced coma.

Authors and editors should consider carefully:

  • The age of the patient: The age of consent for medical treatment varies worldwide and cannot be equated to consent for publication. A parent or legal guardian would need to provide consent for the patient but, if available, the views of a child under the legal age should still be taken into account.

  • If the patient has diminished mental capacity or a fluctuating/deteriorating condition:

    If the patient consented, it is valid only if and when they had the capacity to do so. In changing conditions, the patient might be able to give consent during a remission or in the early stages of the disease, but it is uncertain whether they would have done so at a later stage. The reason for a legal representative signing a consent form should be detailed in the submission.

  • If the patient is deceased, including autopsy(opens in new tab/window) reports, or untraceable: Bodily autonomy extends beyond death, which is to say that what the patient themselves would have wanted should be guiding. Of course, if they did not leave express instructions, and crucially if there is clinical benefit to publishing the research, the patient’s family or other legal representative is best placed to advocate for them and provide consent if they feel it is appropriate to do so. For exceptional situations where neither the patient nor a legal representative is available to provide consent, but the findings have the potential to greatly benefit society, approval for publication should be provided in accordance with local legislation. This should involve the author’s organisation/institution, its legal representative and an ethics committee, and relevant details confirming the approval should be provided with the submission.

  • Consent for reports of treatments or complications of treatments that are illegal in the patient’s home/treatment country: Publication of such reports could lead to harm or legal action against patients (and their families). It is important for the author to be certain that the patient had consented to publication and not just treatment.

What happens when things go wrong?

If a paper was published without appropriate consent and it cannot be obtained retroactively, this is an extremely serious matter and the paper may need to be retracted or withdrawn/removed depending on the sensitivity of the content and publication stage. Even where a case report is retracted for reasons unrelated to consent, it would still be good practice to inform the patient about the retraction prior to it being issued, not least because this could have implications for the patient’s care.

There is also the issue of patients changing their minds. Patients may not intuitively realise when they consent to publication in an academic publication that their image could be found from any computer and not confined to the shelves of medical libraries. COPE guidance(opens in new tab/window) is that consent cannot be withdrawn after publication, but taking that right away from a patient who changes their mind, or for whom the impact of publication only becomes clear later, creates a moral dilemma for authors and journals especially when taking into account the “right to be forgotten(opens in new tab/window)”. There are examples where papers are retracted upon patient request, however images shared previously can, and do, live on.

Few things can be considered more sensitive than the details of one’s medical history. In these situations, authors, editors and publishers share a collective responsibility to safeguard the privacy of patients to ensure they can continue to trust their practitioners, and so readers can trust the research is presented ethically and consensually.

Further reading:

Contributors

Catriona Fennell

CF

Catriona Fennell

Margaret Rees

MR

Margaret Rees