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Ethics and research

Leading researchers debate the latest challenges

The second day of the 11th Egozcue Lectures was dedicated to the subject of ethics in research. Such activity aims to improve human health, and the participants in any study are a means to achieving this goal. However, if people are used to this end and no significant benefits are obtained, then the result is exploitation. The role of ethics is to minimize such risks.

 

According to Ezekiel Emanuel, Chair of Medical Ethics at the University of Pennsylvania, ethics in research needs to be given far higher priority, instead of its current limited role, and it needs to be more rigorous. Ethics committees have many guidelines to help them analyze whether research is ethical – the Nuremberg Code, the Helsinki Declaration, the Belmont Report, CIOs, Common Rule, etc. – but these agreements are often contradictory and, having been created to address specific situations, frequently lack a general perspective.

 

Ezekiel Emanuel's team has worked over recent years to develop a series of ethical principles that should be considered before undertaking any research procedure: studies should contribute value to society; their results should have significant scientific value; the fair selection of trial participants is essential; the risk–benefit ratio must clearly favour the benefits; the informed consent of patients is essential; and participants must be respected. Emanuel argues that only if all of these principles are satisfied should the research go ahead.

 

The most important principle is the one that refers to the risk–benefit ratio. He argues that it is essential not to base the risk analysis for any study on intuition, and that it should instead be subject to systematic evaluation. To achieve this, he proposes a detailed data analysis from which to extract risk–benefit conclusions for any research project. To analyze these variables, the group has established a set of guidelines which stipulate that an investigation project with minimum risks is one in which the difficulty or harm it may pose for participants is no greater than what might be encountered in daily living. Risk is a part of daily life (domestic accidents, traffic accidents, sporting injuries etc.). This statistical analysis should then be used to determine the percentage of daily risk in the specific environment, and to compare it with the objective risks of the research. If the risk this entails is equal to or lower than the minimum daily risk of the environment in which the study is to be performed, the research can be conducted; otherwise, it should be ruled out.

 

Biomedical research in Spain

 

The final event was a penal discussion with leading researchers Manel Esteller (researcher at Bellvitge Institute of Biomedical Research), Bonaventura Clotet (director of IrsiCaixa), Mercè Boada (medical director at Fundació Ace) and Joan MV Pons (scientific coordinator at Aquas health evaluation and quality agency). They all agreed on the importance of research as a generator of knowledge, wealth and health. In general, the outlook is positive, with Spain boasting plenty of world-class research talent. However, researchers emphasize the need for public bodies to back research and not to reduce budgets in the face of crises such as that seen in recent years. They also argue for continued support for projects such as ICREA, which attracts talent from across the globe but in recent years has suffered budget cuts.

 

Participants in the panel discussion advocated the need to promote a culture of research, which should start by teaching people about the benefits of such activity for the territory where it is located. We also need to promote fundraising at the individual and corporate level, explaining the economic benefits that may derive from the research. These practices are commonplace in some countries, but there is little tradition of them in Spain. Finally, researchers noted the need to take a more balanced approach to the issue of publication, as recent years have seen the withdrawal of numerous publications as a result of failure to satisfy scientific research standards. It is important to find other ways of recognizing the work of doctors and scientists, ensuring that such recognition does not take the exclusive form of the number of publications in prestigious journals and mentions in the literature.

 

 


Ezequiel Emanuel identifies six health trends for the next ten years

They will significantly improve healthcare throughout the world, although speed of implementation will vary from country to country

Watch the video about his lecture

Ezekiel Emanuel, North American oncologist and specialist in bioethics, was the guest speaker at the 11th edition of the Josep Egozcue Lectures, held in Barcelona on 13 and 14 April. In the first of his two lectures, Emanuel identified six trends that will influence health and clinical research over the next 10 years. In his opinion, these trends will significantly improve healthcare throughout the world, although speed of implementation will vary from country to country.

 

Emanuel, chair of clinical bioethics at the University of Pennsylvania, believes that over the coming decade more efforts will be focused on chronic diseases. The progressive ageing of the population will require changes in our approach to a category of diseases which, in the USA, already account for the majority of health spending. This will require us to identify people at risk of suffering from chronic diseases, and will mean that doctors have to give managers responsibility for monitoring patients, to identify their needs and to control the treatments prescribed. It is therefore very important to educate people about their illness and what they can expect of it.

 

Another issue that Emanuel believes will grow in importance in the future concerns our approach to mental illness. Currently, almost all countries treat such conditions separately, often in facilities that are completely independent of those where physical diseases are treated. Over the next 10 years, this separation will have to be reduced so that patients can receive combined care. Many patients affected by other diseases also suffer from mental conditions caused by their physical illness (for example, depression in cancer patients). It is essential for doctors to work in coordination with psychiatric specialists and for there to be closer coordination between them to improve the health system.

 

Outpatient care will become more common. The trend is towards reducing interventions at medical centres, providing them in patients' homes, instead. Emanuel noted that, in the field of oncology, many treatments are now available in this way. This is a slow process, as politicians are reluctant to close hospitals, but the shift from hospital- to home-based treatment will save money and improve care. In addition to improvements in quality and comfort, according to the statistics, home-based care also reduces mortality and increases patient satisfaction.

 

At the same time, there will be greater measurement of the performance of hospitals and doctors, comparing their activities and practices. This will generate competitiveness, which will bring benefits in mutual learning and the sharing of best practice. There will also be changes in payment systems. At present, treatments are paid for on a fragmented basis: initial visit, analysis, pre-surgery, etc. The trend will be towards block pricing with adjusted fixed amounts. This will save money and increase the efficiency of treatment.

 

Finally, with respect to drug costs, Ezekiel Emanuel is not optimistic. Forecasts suggest that these will continue to rise. This is because in countries such as the USA monopolies continue to be granted for certain drugs and competition is not allowed. Research is not as expensive as final drug prices imply, but the greatest research effort is concentrated in areas where a lot of money can be made. In the USA, work is currently in progress on 631 cancer drugs, but there are very few projects in the development of antibiotics. This is because, although antibiotics are absolutely vital for people's health, they are not as profitable as cancer drugs.

 

 


Winners of BIYSC Awards 2017

Víctor Torrecillas and David Belda are the winners of the awards given by the Victor Grifols i Lucas Foundation and Catalunya la Pedrera Foundation.

Senior high school students Víctor Torrecillas and David Belda are the winners of the BIYSC Awards 2017, a prize given by the Victor Grifols i Lucas Foundation and Fundación Catalunya la Pedrera to recognize research projects presented at the Barcelona International Youth Science Challenge (BIYSC) 2017. This international programme is designed to promote interest in science and educational excellence among young people aged from 16 to 18, across the world. The winners received a grant to enable them to participate in the London International Youth Science Forum (LIYSF), a scientific event for students from different countries, to be held in London this summer.

 

Víctor Torrecillas is in his second year of the baccalaureate at Centre d'Estudis Montseny-Poblenou, Barcelona. Torrecillas' entry for BIYSC 2017 was an essay titled "Mutating LAE5 through bioinformatics tools to obtain a source for high-yield geraniol production". David Belda studies at Kings College, Alicante, and submitted a project on biomedicine and ethics with the title "Is animal immunostaining efficient and ethical?"

 


How advertising influences our health

The Foundation promotes ethical debate in a world in which our communication processes are being transformed

The transformation we have witnessed in the world of communication over the last two decades – which affects information sources, formats, distribution channels, access devices and participants in the communication process – means we need to review the role of advertising and its impact on health, not only from the perspective of health and medicines (drugs, care services and providers, different treatment options and therapies, institutional health promotion campaigns) but also any campaign that could have an impact on people's health or is related to diet and lifestyle. To address these topics and stimulate dialogue, on 5 June – in partnership with Pompeu Fabra University (UPF) – we held a seminar that brought together experts and professionals from a wide range of backgrounds to consider the impact of advertising on health.

 

The opening address was given by Gema Revuelta, director of the Centre for the Study of Science, Communication and Society at UPF,  in which she provided an overview of the new media landscape and the transformation the sector has undergone.  She argued that our consumption of media content is not just passive but is also an active process. These changes mean that further regulation is required in the field of health, and this in turn entails far-reaching ethical considerations.

 

Jordi Pérez, a member of the Scientific Educational Research Group at UPF, reflected on the influence of advertising on attitudes and behaviours. Pérez looked at how advertising messages are constructed, starting with a persuasive intention, based on a message's credibility and attractiveness and its capacity to connect with the potential audience.

 

Patrici Calvo, lecturer in bioethics at Universitat Jaume I, Castellón, summarized the current digital transformation. In particular, he warned of the potential dangers – particularly with regard to health issues – for vulnerable groups in this new scenario. The use of techniques based on artificial intelligence offers huge benefits but also poses considerable risks such as undermining privacy or the possibility of algorithm-based decision-making which, in the case of marketing and advertising, can give rise to serious errors and to aggressive and inappropriate campaigns. To address this issue, Calvo argued that we need to strengthen our control systems, promoting mechanisms based on systems to monitor ethical compliance in advertising, the creation of codes of ethics, and the expansion of ethical audits.

 

Legislation was a key focus of discussion throughout the day. Nuria Amarilla, senior partner at Eupharlaw, summarized the legislation that currently governs advertising activity. She stressed that there is already adequate legislation to regulate advertising activity, but argued that it is essential to keep this under constant review to fill any legal vacuums that may arise as a result of ongoing changes.

 


The discussion also covered the issues of self-regulation and control. Charo Fernández, assistant directory general of Autocontrol, explained what her organization does. This is a nonprofit body created by the industry in response to society's calls for guarantees to ensure that advertising is accurate and trustworthy. It brings together advertisers, advertising agencies and media organizations, and is designed to ensure compliance with advertising legislation. Fernández argued that "it is precisely the stakeholders in the advertising industry who have the biggest interest in ensuring that the rules are respected." The number of inquiries from companies, agencies and media organizations continues to grow and, during the course of 2018, Autocontrol expects to receive almost 5,000 requests to review campaigns, the majority of which correspond to advertising for healthcare, health products and food. 

 

Carlos Mateos, coordinator of the platform #SaludSinBulos (#HealthWithoutRumours) used some examples to demonstrate how easily fake news can spread. This is particularly dangerous when it affects people's health, as it can give rise to beliefs and behaviours which harm people's health. To address this problem, Mateos explained the various initiatives promoted by his platform, which involve developing materials to encourage people to take a critical approach to information, revealing the sources of fake news, sharing knowledge of credible sources and, more generally, promoting a more sophisticated knowledge culture.

 

The seminar ended with a session dedicated to analyzing advertising's influence on the construction of people's self-image. Mónika Jiménez of the UPF's Observatorio MediaCorp explained the research activity of this organization in recent years, to empirically demonstrate that advertising offers a distorted image of the body. Jiménez pointed out that advertising aimed at adults is also consumed by minors, who absorb stereotypes that do not reflect reality. According to a study conducted in 2015 analyzing the 150 adverts with the highest viewing figures among children in Spain, 72% of these featured people with near-perfect bodies. This has a major effect, as it generates a distorted body image and the pursuit of impossible aesthetic ideals. Jiménez explained that MediaCorp, in addition to research, also promotes materials to encourage children to read information critically and organizes workshops to help counter-act the false body image often offered by advertising.

 

The final contribution of the day came from Begoña Román, lecturer in Ethics at the School of Philosophy (UB) and Chair of the Social Services Ethics Committee of Catalonia, who offered some philosophical reflections on the contents of the seminar. She argued that we need an ethical commitment to underpin the stance that advertising should not be a free-for-all. "Health-related advertising does not generate self-confidence, respect and self-esteem, despite the fact that this is precisely what its proponents often claim."


Ezekiel Emanuel to deliver Egozcue Lectures

 13 and 14 June, Barcelona

Ezekiel Emanuel, oncologist and specialist in bioethics, is Chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania. He advised the White House on health policy from 2009 to 2011.

 

His lectures will consider, among other issues, megatrends in medicine and ethics in clinical research with human beings, focusing on developing countries.

 

June 13, "Megatrends in Medicine"

June 14, "The Ethics of ‘Second-Best' Care: conducting research in Developing Countries"

 

The lecture will be followed by the panel discussion "Biomedical research in our society" with: Manel Esteller, Director of the Epigenetics and Biology of Cancer Programme, Institute of Biomedical Research, Bellvitge (IDIBELL); Bonaventura Clotet, director of IrsiCaixa; Mercè Boada, medical director of the ACE Foundation and Joan Pons, scientific coordinator of Health Quality and Evaluation Agency (Aquas).

 

Caixaforum
Av. de Francesc Ferrer i Guàrdia, 6-8
08038 Barcelona

Free registration.


 

 

 



Autonomy and treatment

Article by Núria Terribas in La Vanguardia


Víctor Grífols i Lucas Foundation rated highly for transparency

The Foundation ranks fourth in an evaluation of the leading Spanish foundations.

The report "Construir Confianza 2017" (building trust), compiled by Fundación Compromiso y Transparencia, puts the Víctor Grífols i Lucas Foundation in fourth place in its ranking of the most transparent organizations in the family foundation category. This report evaluates the transparency and governance of Spanish foundations, based on the information published on their websites.


The foundation's position has improved over the last year. However, it is not included in the top rankings because it does not publish an auditor's report, which this study deems essential, although none of the circumstances specified by the legislation in this area would require the foundation to produce audited accounts.
 


http://www.compromisoytransparencia.com/


Awards and grants

Online submission of applications.

Applications are now open for the Foundation's science awards and grants, 2017-18. You can register online and submit projects via our website.


Grants
 

Secondary high school prizes
 

Ethics and science prize
 

Audiovisual awards

 



Ester Busquets, coordinator of training and research for the Chair in Bioethics

This appointment will support the activities of the Grífols Foundation Chair of Bioethics 

Busquets holds a PhD in philosophy and is a qualified nurse. She is also a professor of ethics at the School of Health Sciences at University of Vic-Central University of Catalonia. She is a member of the Professional Ethics Committee of the Official College of Nurses of Barcelona, secretary of the Research Ethics Committee at UVic-UCC, and an advisor to a number of ethics committees in Catalonia. She has also worked with the Borja Institute of Bioethics (URL) and has directed the journal, Bioètica & Debat.

 

She will combine her teaching duties with coordinating the chair in bioethics, including responsibility for promoting training activities and research projects.


 


"Although the debate around CRISPR has to be rooted in the scientific community, society as a whole must also participate"

Interview with Salvador Macip

He delivered the Josep Egozcue lecture on advances in CRISPR, a subject on which the Foundation recently published a monograph.

Salvador Macip is a research doctor and senior lecturer in the Department of Molecular and Cellular Biology at the University of Leicester. In May 2017 he delivered the Josep Egozcue lecture on advances in CRISPR, a subject on which the Foundation recently published a monograph. And on 20 December he gave the keynote address at the Ethics and Science Awards Ceremony, with the title: "Playing at being God: the ethical and social challenges of 21st century medicine."

 

What applications does CRISPR currently have in humans?

The CRISPR technique is a method for editing genetic material in a huge variety of ways. Although there is still a lot of work to be done before this goal can be achieved, its potential applications are clear. Research is currently focusing on editing animal cells. In humans, research is more complicated as – in addition to the technical challenges – such work entails ethical considerations, but the first steps towards what could become genome editing in embryos have already been taken. Although we are still very much in the early stages and we need a thorough debate before the technique can be used to treat human embryos, CRISPR already has a number of potential therapeutic applications. These would involve extracting cells from an organism, modifying them genetically, and injecting them back into the body to reactivate the immune system or to cause cells to start functioning again when, for various reasons, they have ceased to do so. This approach is very promising and should be the first step when modifying cells within the human body.

 

How do you think the application of the technique will develop over the short, medium and long term?

It's difficult to make precise predictions, because progress is exponential and the developments of the last few years have been dramatic.  It's possible that within the next five years we will see the standardized application of CRISPR in hospitals based on the cell extraction and modification technique mentioned above. The next breakthrough, perhaps a decade away, would enable treatment within the body, while a challenge for the future is genome editing of embryos. However, as noted above, this is not solely a scientific question but also entails an ethical debate for which we are not yet fully prepared.

 

Who do you think should lead this ethical debate?

The debate should start with the scientific community, as they have the best understanding of the opportunities the technique offers and the tools available for its application. However, there is a difference between leading and monopolizing. This is a discussion that must involve society as a whole. Although the technical details are complex, the challenge for scientists is how to make this comprehensible. Once this challenge has been overcome, the debate should be opened up, bringing together experts in bioethics, politicians, civil society organizations and so on. It may also be necessary to conduct this debate locally, as it will be very difficult to reach a global consensus.

 

When should this debate begin?

We don't have a lot of time, because the technique is almost ready to be applied. Without regulation, it is possible that some techniques will be applied before a consensus has been reached. At the same time, we cannot simply discard all the opportunities offered by such techniques, out of fear that they may not be used correctly. So we need to find a balance that allows us to enjoy the benefits while avoiding malpractice, and the only way to do this it through a thorough debate.

 

What should the starting point be?

We need to start by deciding who we need to involve in this debate, and by identifying what we can do to include those who are not yet ready to participate. It is essential for us to reach agreement on how far we want to go with genome editing techniques, and to prevent their misuse. It is vital that governments be able to establish guidelines and issue regulations with regard to their use. While we are not yet in a position to treat human embryos, we do need to make progress in other areas, where practical application is almost a reality.

 

As a researcher, what do you think has been the most important contribution of scientific advances in genome editing?

The major achievement of recent decades was the genome revolution. Since the start of this century, we have had a map of the whole human genome. Current research is advancing very rapidly due to the genetic information available in public databases.  This is what underpins the advances we are seeing in techniques such as CRISPR or in the field of personalized medicine.  This has transformed both the scientific and the medical scenario. It is becoming faster and cheaper to read genomes, and we are implementing this in medicine to offer patients the most suitable treatments.

 

And the negative side of all this progress?

The main threat is the one that has occurred throughout history, whenever there is major scientific progress: the exacerbation of the differences between rich and poor. This was what happened with antibiotics – perhaps the most dramatic scientific achievement in the history of humanity – which led to a significant increase in life expectancy in a very short time. Initially, however, these medicines were not available to the whole population and in many countries people continued to die of infectious diseases. The challenge, with regard to genome editing, is to ensure that this gap, while inevitable, is bridged in the shortest possible time. The solution is not simple, but nor should we refuse to apply a new technology unless it is accessible to everyone. That would not be just, either from an ethical or from a moral perspective. If we have the capacity to apply improvements then we are duty-bound to do so, but we need to avoid a scenario in which ‘post-humans' and traditional humans live side by side; where the inhabitants of some countries are still struggling to overcome diseases which have been eradicated in the developed world.

 

What role should young people play in this scenario?

I regularly give talks on bioethics, genetics, cancer and ageing to groups of young people aged between 11 and 18. We tend to shield and infantilize people of these ages, but the reality is that they are far more capable of making value judgements and expressing their opinions on these issues than we often assume. It's important to involve them in the debate as early as possible. If we educate young people both to understand problems and to evaluate opportunities, and we teach them to take reasoned decisions that go beyond the opinions to be found in their immediate family or sociocultural environments, humankind will benefit and we will take a step towards a better future.

 

 

 


Winners of the Ethics and Science prizes

The jury has selected this year's winning projects.

First prize: "Natural thought: kindness and hard work" Institut de Sentmenat, Barcelona.

 

Second prize: "Robo-ethics: learning robotics to help" Col·legi Mare de Déu dels Àngels, Barcelona.

 

Third prize: "Mission to Mars" IES A Xunqueira II, Pontevedra.

 

Special mention:

"Inter-generational solidarity and caring for the environment. Environmental ethics project" Escola Sant Gregori, Barcelona.

 


New genome editing techniques such as CRISPR/Cas9 open up a whole range of possibilities for human health. They can be used to correct genetic defects to cure disease, and also to modify individuals and entire plant or animal species. Who should be responsible for determining their use? Do we need to establish limits?


Júlia Martín and Oriol Yuguero featured in the latest bulletin of the Bioethics Committee of Catalonia (CBC)

The CBC has published two articles by researchers supported by Foundation research grants.

The most recent issue of the bulletin of the Bioethics Committee of Catalonia includes two articles by researchers supported by Foundation bioethics research grants.


 

The article by Júlia Martín, of the University of Barcelona, is titled La presa de decisions anticipades en adolescents (Taking advanced decisions in adolescents). Júlia received a bioethics grant in October to develop a project related to narrative bioethics and the model of humanizing care for hospitalized minors.


 

Oriol Yuguero, of the University of Lleida, published La promoció de la empatia, fonamental per reduir el burnout mèdic, element clau de la qualitat assistencial (Promoting empathy: fundamental for the reduction of medical burnout and a key element in the quality of care).  Oriol was awarded a grant in 2014 for a project exploring empathy in physicians and nursing staff in the Lleida Health Region.

 


Events organized by other institutions