From protection to participation: involving patients with reduced capacity in decision making about publication

Simone Ragavooloo and Cat Chatfield look at how we can promote appropriate inclusion of vulnerable individuals in the publication process

Obtaining consent from individuals so you can publish their personal data is an integral legal and ethical step in the publication process. It ensures the journal has legal permission to publish, and that the individual(s) reported are aware of any implications of information relating to themselves being publicly available. For this reason, publishers have strict policies in place for ensuring consent has been obtained before publication to protect individuals from harm. But these policies are not always inclusive for all the individuals they are designed to protect. 

Perpetuating research inequities

For authors who wish to publish information about vulnerable individuals—for example, when a patient is identified as lacking capacity to consent on their own behalf—a journal cannot accept a signed consent form alone. In this case, authors must also assess a range of factors, including how the consent was obtained and from who (e.g appropriate proxy consent, the benefits and harms of the publication, and any person centred support provided to the individual during the consent process). These complex issues are not routinely assessed in most standard journal policies or procedures, suggesting we are not adequately protecting these individuals—or we are excluding them from participating in research and publication altogether.

Anonymising manuscripts where an individual cannot consent to publication is often seen as the best solution. The aim is to anonymise the manuscript to satisfy data protection requirements and ensure the patient is not identifiable. It is BMJ’s view that full anonymity can never be guaranteed and, for some cases, particularly in areas like mental health where personal history may be highly relevant, it can be extremely difficult to meet these requirements. Adopting an anonymisation approach also denies individuals the opportunity to engage meaningfully in the publication decision making process, whatever their capacity.  

Another common solution is rejection if manuscripts can’t pass ethics checks for consent. This risks publishers contributing to a hidden source of bias in our scientific record, widening the inequity between physical health and mental health in terms of reporting. If authors and publishers take the easy option and avoid publishing these papers under the guise of protecting individuals from harm, rather than seeking to find a way through the minefield of obtaining consent, we will continue to observe a poorer quality of published research for vulnerable patient groups, such as patients with learning disabilities. This may lead to a reduced quality of care and poorer outcomes for these patients, ultimately, harming individuals we originally sought to protect. 

BMJ’s roundtable discussion on capacity to consent

BMJ’s mission for a healthier world includes protecting the quality of the scientific record and seeking to address any bias that is within our scope of influence. Given this, we felt that there was a role for us to do something about the lack of significant guidance for authors or publishers on appropriate methods to obtain consent for publication from vulnerable individuals, including adults who may lack capacity. While the Committee on Publication Ethics (COPE) guidance does address the issue briefly, it lacks detail for use in practice. It suggests, for example, obtaining “proxy” consent in scenarios where a patient may lack capacity, but does not advise in what circumstances to seek proxy consent or who an appropriate proxy may be. We sought to address this by making the consent process clearer for authors, researchers, and other publishers, as well as finding a way to make the consent process more inclusive.

To assist in this journey, BMJ’s Research Integrity team held a roundtable on capacity to consent with the aim of seeking diverse views and inputs beyond the publisher perspective. We included a diverse group of key opinion leaders, including experts in medical ethics, mental health support, law, and patient perspectives. 

It was the roundtable’s view that the law should be a baseline rather than a ceiling, and there is both a legal and ethical duty for publishers to consider their consent policies closely. For this reason, BMJ has since clearly outlined internally our ethical principles that we wish to uphold even when legal requirements have been met. These include a commitment to:

(1) Consider the needs of the individual as our first priority, including involving them in decision making wherever possible
(2) Assess the contribution of the publication to the scientific literature, including considering other ways to share the same knowledge without identifying an individual
(3) Understand that the public good is only likely to outweigh individual needs in exceptional circumstances
(4) Support authors to implement this best practice
       (a) Reduce harm and increase benefits to the individual
       (b) Contribute to the public good and to aid scientific progress
       (C) To ensure patient and public safety
       (D) To support authors

Another key point agreed was that while it is the authors’ responsibility to obtain consent, publishers could do more to support authors. BMJ agrees that ensuring the protection of individuals is a collective responsibility. Authors must ensure all necessary steps have been taken to support the individual in understanding the content of the publication, the process, and the implications. Meanwhile, publishers also have a duty to ensure these steps have been undertaken and to educate and support authors to seek consent respectfully and thoroughly. 

A step towards inclusion

We appreciate that obtaining consent can be a challenging task for authors and we take our role in supporting authors seriously. Following the roundtable, we created best practice guidance for authors on obtaining consent for publication. The guidance covers all the key aspects of consent for publication, but more importantly, it also addresses those areas that we have observed authors find the most difficult, including consent for minors, those with diminished capacity, and anonymisation. 

Scientific publication helps to advance knowledge and improve healthcare outcomes for all members of society. Vulnerable individuals must be equally represented in the scientific literature to obtain these same benefits. Current journal policies for obtaining consent for publication are contributing to a gap in the scientific literature and these individuals are not routinely being engaged in the publication process. BMJ have taken the important step to promote appropriate inclusion of vulnerable individuals, particularly adults with diminished capacity, in the publication process in an effort to reduce publication bias. An important aspect of addressing this bias is to support authors more in the consent process to ensure this is not just another hoop for authors to jump through and a barrier to research, but a meaningful process for all involved.

Simone Ragavooloo, research integrity manager, BMJ. Twitter @s_ragavooloo

Cat Chatfield, research integrity editor, The BMJ. Twitter @drcatchatfield