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

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

By Katie Eve, Catriona Fennell and Margaret Rees - September 15, 2021  7 mins
An image of a confidential file
© istockphoto.com/zimmytws

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, and support pharmacovigilance decisions. 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 and COPE, which cover two key aspects: informed consent and removal of patient identifiers 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 study. 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 autopsyreports, 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 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”. 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


Katie Eve
Written by

Katie Eve

Written by

Katie Eve

Katie Eve is a Communications Manager in Elsevier’s Global Publishing Development department. She joined Elsevier in 2010 and worked as a Publisher for journals across earth sciences and energy before moving into her communications position in 2017. She is currently supporting communications for Elsevier’s ethics, open science and inclusion & diversity programmes.

Catriona Fennell
Written by

Catriona Fennell

Written by

Catriona Fennell

Following graduation from the National University of Galway, Ireland, Catriona Fennell joined Elsevier as a Journal Manager in 1999. She later had the opportunity to learn about the intricacies of peer review while supporting and training hundreds of editors during the introduction of Elsevier Editorial System (EES). Since then, she has worked in various management roles in STM Journals Publishing, and as Director of Publishing Services, she is now responsible for its publishing integrity and reproducibility programs.

Margaret Rees
Written by

Margaret Rees

Written by

Margaret Rees

Professor Margaret Rees MA, DPhil, FRCOG  

Margaret Rees has an international reputation of leadership in women's midlife health and is the Executive Director of the European Menopause and Andropause Society. A gynaecologist, she is Editor-in-Chief of Case Reports in Women’s Health and Emeritus Editor of Maturitas.

Margaret Rees has a long-standing, unique, portfolio of experience of research and publication ethics. She is currently on the advisory board of the UK Research Integrity office and a member of the Open University Research Ethics Committee (REC). She has also chaired a National Health Service REC, was on the Oxford University and Northumbria University RECs, and was on the Council of the Committee on Publication Ethics (COPE).

Her expertise has been recognized nationally and internationally, by appointments to a Readership in Reproductive Medicine at Oxford University; and visiting Professorships at Glasgow University and at the Karolinska Institute in Sweden and the University of Turku in Finland, and an Adjunct Associate Professorship at Rutgers Robert Wood Johnson Medical School, New Jersey. In 2020, she received the Women's Health Institute's Woman of Distinction Award from Rutgers Robert Wood Johnson Medical School.

The case for consent: a primer on patient privacy and informed consent
What is a Clinical Decision Support? Dispelling the myths and defining the purpose
Reducing CO2 impact with carbon capture, utilization and storage

Comments


comments powered by Disqus