The Ethics Blog

A blog from the Centre for Research Ethics & Bioethics (CRB)

Tag: guidelines

World Health Organization outlines guidelines for the use of genomic data

DNA chain link. Photo: Warren Umoh, Unsplash.
26 November, 2024 / / 1 Comment

Human genomics has potential to improve the health of individuals and populations for generations to come. It also requires the collection, use and sharing of data from people all over the world. There is therefore an accompanying need for a globally fair distribution of genomic technology, data and results. As the databases and infrastructures will be in operation for a long time, ethical, legal, social and cultural issues need to be taken into account from the outset, considering the entire life cycle of the data.

To promote such an ethical, equitable and responsible use of genomic data, the World Health Organization (WHO) recently issued globally applicable guidelines for human genome data collection, access, use and sharing. The guidelines are formulated as 8 principles with associated practical recommendations. The principles were developed step by step, first through review of existing documents and virtual consultation with experts from different parts of the world, then through a workshop in Geneva where experts met on site. Finally, the draft was discussed through public consultations.

The purpose of the WHO document is to create globally applicable principles that can complement local legislation. This is to promote, among other things, social and cultural inclusiveness as well as justice in the use of human genome data.

Read the important document here: Guidance for human genome data collection, access, use and sharing.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

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Approaching future issues

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Questions about evidence and guidelines in healthcare

orthoses, photo by ThisIsEngineering på Pexels
12 December, 2023 / / 1 Comment

Finding your way through the complex web of guidelines and requirements for evidence in healthcare can be challenging. It is easy to imagine that these guidelines are downloaded from above, like a collection of commandments, but the truth is that they are shaped and changed in a complex process of negotiation and deliberation.

My colleagues and I in prosthetics and orthotics in Region Uppsala in Sweden are involved in the procurement of orthopedic devices for patients, such as prostheses, orthoses, splints, sitting frames, medical corsets, orthopedic shoes and insoles. We often ask ourselves an important question: Who should receive tax-funded prosthetics and orthotics devices and how expensive should they be? Where do we find guidelines for our decisions? An example of a guiding document is the general guidelines for the prescription of assistive devices in the County Council of Uppsala (from 2015). This document is based on the laws and guidelines of the parliament, UN conventions and the Council’s own plans. It becomes clear that guidelines are not isolated rules, but rather an interweaving of different norms and values that guide healthcare decisions.

Despite clear priority levels and demands for individual assessment of health effects, we find that patients today are denied orthopedic devices with the argument that there is a lack of evidence that the aid works for the type of diagnosis in question. Is this argument as strong when it comes to orthopedic devices as it is when it comes to drug treatments? In the search for evidence in healthcare, randomized controlled trials (RCTs) are often required. But must all treatments be measured by the same yardstick? Applying an arm cast or using an assistive device that enables walking does not necessarily require the same level of evidence as more complex internal medicine treatments. Sometimes it should be enough to see with your own eyes and observe improvements, such as a better gait or reduced pain.

In addition to this possibly unfair situation, where a small patient group has to suffer from requirements that are reasonable for the majority but not for all patients, the availability and scope of assistive device prescription varies between different regions in Sweden. This variation raises questions about how guidelines and principles for prioritization in healthcare are interpreted in different regions. Although the overarching principles for priority setting are the same (the principle that all humans have equal value and the same right to care, the principle of need and solidarity, and of the principle of cost-effectiveness), the interpretation and application of these principles can apparently differ. Why is it like that? In some regions, a more comprehensive and individually adapted prescription of devices is given, while other regions are more restrictive. This variation raises important questions about fair and equal care. Providing fair and equal care does not just require following rules. It also requires that we deepen our understanding of how these rules are interpreted and applied in different parts of the country, as well as assess which requirements are reasonable in different practices. It is a complex balancing act between ensuring people’s equal value and right to health while managing resources efficiently. Prescription of assistive devices as a tool to support health and participation is emphasized in the guidelines in Uppsala, but it is important to reflect on how this tool is implemented in practice and what impact it has on people’s quality of life. A common basis in the WHO’s international classification of functional status, disability and health is a good starting point (as in the National Board of Health and Welfare’s support for prescribing assistive devices). But continued discussion and reflection is required to ensure that the patient’s individual health condition is taken into account (not just the patient group), and that devices are prescribed fairly across the country.

In my work, I reflect daily on guidelines and requirements for evidence. I think it is valuable if we who work with the prescription of orthopedic devices reflect on the origin of the guidelines and the requirements for evidence that we use in healthcare. Understanding the context around why the guidelines look the way they do is crucial for us to be able to understand and apply them in our practices. For example, how should we interpret the requirement for evidence when working with prosthetics and orthotics?

I will return to discuss possible answers to these questions in future blog posts. With this post I just wanted to raise the questions.

Written by…

Jennifer Viberg Johansson, Associate Professor in Medical Ethics at Uppsala University’s Centre for Research Ethics & Bioethics.

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We want to be just

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An ethical strategy for improving the healthcare of brain-damaged patients

Brain, image by OpenClipart-Vectors
31 May, 2022 / / 1 Comment

How can we improve the clinical care of brain-damaged patients? Individual clinicians, professional and patient associations, and other relevant stakeholders are struggling with this huge challenge.

A crucial step towards a better treatment of these very fragile patients is the elaboration and adoption of agreed-upon recommendations for their clinical treatment, both in emergency and intensive care settings. These recommendations should cover different aspects, from diagnosis to prognosis and rehabilitation plan. Both Europe and the US have issued relevant guidelines on Disorders of Consciousness (DoCs) in order to make clinical practice consistent and ultimately more beneficial to patients.

Nevertheless, these documents risk becoming ineffective or not having sufficient impact if they are not complemented with a clear strategy for operationalizing them. In other words, it is necessary to develop an adequate translation of the guidelines into actual clinical practice.

In a recent article that I wrote with Arleen Salles, we argue that ethics plays a crucial role in elaborating and implementing this strategy. The application of the guidelines is ethically very relevant, as it can directly impact the patients’ well-being, their right to the best possible care, communication between clinicians and family members, and overall shared decision-making. Failure to apply the guidelines in an ethically sound manner may inadvertently lead to unequal and unfair treatment of certain patients.

To illustrate, both documents recommend integrating behavioural and instrumental approaches to improve the diagnostic accuracy of DoCs (such as vegetative state/unresponsive wakefulness syndrome, minimally conscious state, and cognitive-motor dissociation). This recommendation is commendable, but not easy to follow because of a number of shortcomings and limitations in the actual clinical settings where patients with DoCs are diagnosed and treated. For instance, not all “ordinary,” non-research oriented hospitals have the necessary financial, human, and technical resources to afford the dual approach recommended by the guidelines. The implementation of the guidelines is arguably a complex process, involving several actors at different levels of action (from the administration to the clinical staff, from the finances to the therapy, etc.). Therefore, it is crucial to clearly identify “who is responsible for what” at each level of the implementation process.

For this reason, we propose that a strategy is built up to operationalize the guidelines, based on a clarification of the notion of responsibility. We introduce a Distributed Responsibility Model (DRM), which frames responsibility as multi-level and multi-dimensional. The main tenet of DRM is a shift from an individualistic to a modular understanding of responsibility, where several agents share professional and/or moral obligations across time. Moreover, specific responsibilities are assigned depending on the different areas of activity. In this way, each agent is assigned a specific autonomy in relation to their field of activity, and the mutual interaction between different agents is clearly defined. As a result, DRM promotes trust between the various agents.

Neither the European nor the US guidelines explicitly address the issue of implementation in terms of responsibility. We argue that this is a problem, because in situations of scarce resources and financial and technological constraints, it is important to explicitly conceptualize responsibility as a distributed ethical imperative that involves several actors. This will make it easier to identify possible failures at different levels and to implement adequate corrective action.

In short, we identify three main levels of responsibility: institutional, clinical, and interpersonal. At the institutional level, responsibility refers to the obligations of the relevant institution or organization (such as the hospital or the research centre). At the clinical level, responsibility refers to the obligations of the clinical staff. At the interpersonal level, responsibility refers to the involvement of different stakeholders with individual patients (more specifically, institutions, clinicians, and families/surrogates).

Our proposal in the article is thus to combine these three levels, as formalized in DRM, in order to operationalize the guidelines. This can help reduce the gap between the recommendations and actual clinical practice.

Written by…

Michele Farisco, Postdoc Researcher at Centre for Research Ethics & Bioethics, working in the EU Flagship Human Brain Project.

Farisco, Michele; Salles, Arleen. American and European Guidelines on Disorders of Consciousness: Ethical Challenges of Implementation, Journal of Head Trauma Rehabilitation: April 13, 2022. doi: 10.1097/HTR.0000000000000776

We want solid foundations

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Two measures against the culture of honorary authorships

13 March, 2018 / / 0 Comments

Pär SegerdahlIt is important in the academia to know who actually contributed as author to scientific publications. Partly because authorship is meritorious when researchers seek positions and funding. Partly to facilitate investigations of suspected research misconduct.

These are two important reasons why there are guidelines for academic authorship. These guidelines state that an author should not only contribute to design, data collection, or analysis behind the publication. An author should also contribute to writing and revising the text. An author should moreover approve the final version of the text, and agree to be accountable if there are issues of accuracy or integrity.

The number of authors listed on academic publications tends to increase. As an extreme example, I might mention that in 2011, 140 scientific articles were published listing more than 1,000 authors!

One reason for the larger numbers of listed authors is, of course, that research is becoming increasingly complex and requires collaborations that are more extensive. However, much suggests that the number of undeserving authors increases. One could speak of a culture of honorary authorships within the academia.

There are strong driving forces behind the culture of honorary authorships. It can be about supporting cohesion in a research group by avoiding the uncomfortable decision to exclude team members who contributed minimally to the work being published. It can be about creating good relationships with influential people in the research community by giving them authorship; which they sometimes demand. It can be about increasing the chances of being published by having a famous researcher’s name in the author list. And since big research projects are prestigious, a long author list looks good. It creates pressure on the journals to publish what apparently required the contribution of so many skilled researchers – one thinks.

What can we do about it? In a recent article with the, nowadays, modest number of four authors, it is emphasized that guidelines for academic authorship, which have been around for a long time and are well known, obviously do not suffice. In the journal Insights, Stefan Eriksson, Tove Godskesen, Lars Andersson and Gert Helgesson write that we probably need to create psychological incentives against the culture of honorary authorships.

More specifically, two simple measures are suggested that can reduce undeserving authorships within the academia:

  1. When researchers seek positions, interview them about their contributions to publications that they include in the list of qualifications. If they are only honorary authors, they may not be able to account for the articles or how they contributed to them. Knowing that this is part of the recruitment process can create a psychological pressure to avoid undeserving honorary authorships.
  2. Divide authorship and citations scores with the number of authors. Awareness that scores ​​are calculated in this way creates a psychological pressure not to include undeserving authors in the author list.

One might object that this proposal instead risks excluding collaborators from contributing as authors, although they could very well be invited to function as well-deserved co-authors. This objection is addressed in the article. Instead of explaining the authors’ defense, I hope that my silence on this point will motivate readers of the Ethics Blog to read the important article. So that I do not lure you into some sort of honorary readership! How often do we not intimate that we have read something very interesting, which we in fact only skimmed through or heard summarized?

The academic culture of honorary authorships will not disappear easily. Ethical guidelines are obviously not enough. Of course, the best thing would be if we all became saints. While waiting for it to happen, psychological incentives may be needed to behave well.

Pär Segerdahl

Eriksson, S., Godskesen, T., Andersson, L., Helgesson, G. (2018). How to counter undeserving authorship. Insights. 31(1), p.1. DOI: http://doi.org/10.1629/uksg.395

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We recommend readings - the Ethics Blog

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