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

Tag: future prospects (Page 6 of 10)

How to listen to (the right) patient voices? (By Ulrik Kihlbom)

Ulrik Kihlbom, Academic co-lead of PREFER's methodology work packageWe all think patients’ voices are important. But how do we make sure we listen to the right ones? Patient engagement and patient perspectives have come into focus in health care in recent years. Though this is especially true for the clinical setting, this development can be expected to continue for decision-makers at other levels.

We are just starting to research these questions in a project called PREFER. The aim is to establish which methods to use to bring in patient perspectives into important decisions regarding medical drugs; decisions made by different stakeholders, such as physicians, regulatory and reimbursement authorities, and the industry. In short: how and when should decision makers listen to the patients?

But, how can we make sure that the methods enable decision-makers to listen to the right patient voices?

Now, the expression “the right patient voices” should plausibly be understood as comprising several aspects such as being representative of the actual views patients have, being adequately informed, and as being non-biased. Each of these aspects require thorough consideration and also methodological development. I am myself responsible for one task that will specifically address these questions. One of the many intriguing issues here is when, during the process of falling ill, coming under treatment, and hopefully convalescing, a patient’s voice should be listened to? The patient’s preferences will probably change during the trajectory of illness. Imagine that you fall seriously ill, are treated and recover, and suppose also that your preferences for a risky treatment change during this period of time. Do you know when your preferences are such that your physician should listen to them? And when they merit less attention? I am myself far from sure how to answer this question.

Another set of questions concerns how the (right) patient perspective should be incorporated into the decision making. How, for example should a reimbursement authority weigh the patient perspective against cost-effectiveness when making a decision of subsidising a medical drug? Or how should a regulatory authority, such as EMA in Europe, FDA in the US, and Läkemedelsverket in Sweden, weigh patient effectiveness against safety concerns? It seems fair to say that everybody agrees that the patient perspective should have a weight, but no one has an established scale.

These are some of the very hard and intriguing questions that the PREFER project will address over the coming five years. 33 partners from academic institutions, patient organisations, health technology assessment bodies, small companies and the pharmaceutical industry are putting their heads, competence and resources together. Uppsala University is coordinating the project, with CRB’s director Mats G. Hansson at the helm. Apart from me and Mats, Josepine Fernow, Elisabeth Furberg, Jorien Veldwijk and Karin Schölin Bywall at CRB are involved in PREFER. We are looking forward to interesting research questions, but also to learning by working in, and leading, a public-private partnership of this size.

In the autumn of 2021, the project will issue recommendations. By then we will know better how decision makers may find and listen to the (right) patient voices. And how patients’ voices can make themselves heard in the decisions of regulators, health technology assessment bodies, reimbursement agencies, and pharmaceutical companies.

Ulrik Kihlbom

About PREFER: The Patient Preferences in Benefit-Risk Assessments during the Drug Life Cycle (PREFER) project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 115966. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA. The contents of this text reflects the author’s view and not the view of IMI, the European Union or EFPIA.

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More biobank perspectives

If you did not get your fill during the Europe biobank week in Vienna, we give you more biobank related news in the latest issue of Biobank Perspectives, our newsletter on current issues in biobank ethics and law.

This time, Moa Kindström Dahlin describes what BBMRI-ERIC’s new federated Helpdesk for ELSI-issues can offer. We also invite you discuss public-private partnerships in research at a workshop in Uppsala on 7-8 November.

The legislative process on data protection in the EU might be over for now but there is still activity in government offices. Anna-Sara Lind gives you her view on the consequences for Sweden. We are also happy to announce that the guidelines for informed consent in collaborative rare disease research have received the IRDiRC Recognized Resources label.

You can read the newsletter on our website, or download a pdf version.

Josepine Fernow & Anna-Sara Lind

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Identifying individuals while protecting privacy

Pär SegerdahlResearch ethics is complex and requires considering issues from several perspectives simultaneously. I’ve written about the temptation to reduce research ethics to pure protection ethics. Then not as much needs to be kept in mind. Protection is the sole aim, and thinking begins to resemble the plot of an adventure film where the hero finally sets the hostages free.

Protection is of course central to research ethics and there are cases where one is tempted to say that research participants are taken hostage by unscrupulous scientists. Like when a group of African-American men with syphilis were recruited to a research study, but weren’t treated because the researchers wanted to study the natural course of the disease.

Everyday life is not one big hostage drama, however, which immediately makes the issues more complex. The researcher is typically not the villain, the participant is not the victim, and the ethicist is not the hero who saves the victim from the villain. What is research ethics in everyday situations?

There is currently a growing concern that coding of personal data and biospecimens doesn’t sufficiently protect research participants from privacy invasions. Hackers hired to test the security of research databases have in some cases been able to identify the individuals who provided their personal data to research (in the belief that the link to them had been made inaccessible to outsiders through advanced coding procedures). Such re-identified information can obviously harm participants, if it falls into the wrong hands.

What is the task of research ethics here? Suddenly we can begin to discern the outlines of a drama in which the participant risks becoming the victim, the researcher risks becoming the villain’s accomplice, and the ethicist rushes onto the scene and rescues the victim by making personal data in research databases completely anonymous, impossible to identify even for researchers.

But everyday life hasn’t collapsed yet. Perhaps we should keep a cool head and ask: Why are personal data and biological samples not fully anonymized, but coded so that researchers can identify individual patients/research participants? The answer is that it’s necessary to achieve scientific results (and to provide individual patients the right care). Discovering relationships between genetics, lifestyle and disease requires running several registries together. Genetic data from the biobank may need to be linked to patient records in healthcare. The link is the individual, who therefore must be identifiable to the research, through the use of advanced code keys.

The need to identify participants is particularly evident in research on rare diseases. Obviously, there is only scant data on these diseases. The data needs to be shared between research groups, often in different countries, in order to collect enough data for patterns to appear, which can lead to diagnoses and treatments.

An overly dramatic heroic effort to protect privacy would have its own victims.

In an article in the European Journal of Human Genetics, Mats G. Hansson and co-authors develop a different, more sustainable ethical response to the risk of re-identification.

Respecting and protecting participants’ privacy is, of course, a central concern in the article. But protection isn’t the only perspective, since science and health care are ethical values too. And here you need to be able to identify participants. The task the authors assume, then, is that of discussing the risks of re-identification, while simultaneously considering the needs for identifiable data.

The authors are, in other words, looking for a balance between different values: simply because identifiable data are associated with both risks and benefits.

You can read a summary of the article on the CRB website. What I focus on in this post is the authors’ overall approach to research ethics, which doesn’t emphasize the hero/villain/victim opposition of certain dramatic situations.

The public image of research ethics is very much shaped by its function in response to research scandals. But research ethics is usually, and less dramatically, about making everyday life function ethically in a society which contains research. Making everyday life run smoothly is a more complex and important task than playing the hero when everyday life breaks down. In this work, more values and challenges need to be taken into account simultaneously than in emergency scenarios where ethicists, very naturally, focus on protection.

Everyday life may not be as exciting as a research scandal, but if we don’t first and foremost take responsibility for making everyday life work smoothly, as a complex whole, then we can expect more drama.

Keep a cool head and consider the issues from a variety of perspectives!

Pär Segerdahl

Hansson, M. G. et al. The risk of re-identification versus the need to identify individuals in rare disease research. European Journal of Human Genetics, advance online publication, 25 May 2016; doi: 10.1038/ejhg.2016.52

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Genetic screening before pregnancy?

Pär SegerdahlGenetic diseases can arise in strange ways. So-called recessive diseases require that both parents have the gene for the disease. The parents can be healthy and unaware that they are carriers of the same non-dominant disease gene. In these cases, the risk that the child develops the disease is 25 percent.

In families with a history of some recessive disease, as well as in communities where some serious recessive disease is common, genetic screening before pregnancy is already used – to determine whether couples that are planning a child are, so to speak, genetically compatible.

As these genetic tests have become more reliable and affordable, one has begun to consider offering preconception genetic screening to whole populations. Since one doesn’t know then exactly which genes to look for, it’s not just about screening more people, but also about testing for more recessive traits. This approach has been termed expanded carrier screening (ECS).

In the Netherlands, a pilot project is underway, but the ethical questions are many. One concerns medicalization, the risk that people begin to think of themselves as being more or less genetically compatible with each other, and feel a demand to test themselves before they form a couple and plan children.

Sweden has not yet considered offering expanded carrier screening to the population and the ethical issues have not been discussed. Amal Matar, PhD student at CRB, decided to start investigating the issues in advance. So that we are prepared and can reason well, if preconception expanded carrier screening is suggested.

The first study in the PhD project was recently published in the Journal of Community Genetics. Interviews were made with clinicians and geneticists, as well as with a midwife and a genetic counselor, to examine how this type of genetic screening can be perceived from a Swedish health care perspective.

Ethical issues raised during the interviews included medicalization, effects on human reproductive freedom, parental responsibility, discrimination against diseased and carriers, prioritization of resources in health care, as well as uncertainties about what to test for and how to interpret results.

The study serves as an empirical exploration of the ethical issues. Some of these issues will be examined philosophically further on in Amal Matar’s project.

(Read more about Amal Matar and her work at CRB here.)

Pär Segerdahl

Matar, A., Kihlbom, U., Höglund, A.T. Swedish healthcare providers’ perceptions of preconception expanded carrier screening (ECS) – a qualitative study. Journal of Community Genetics, DOI 10.1007/s12687-016-0268-2

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Distance between media representations and public perceptions of synthetic biology (by Mirko Ancillotti)

Mirko AncillottiMedia do not generally represent the general public’s views on synthetic biology nor, regrettably, render a balanced or thoughtful picture of the field. Until now media cannot represent a starting point nor can they facilitate a public debate on synthetic biology, which would be desirable for a responsible and responsive development of the field.

In a previous post, written together with Josepine Fernow, I expressed some concerns about the way mainstream media report synthetic biology. Stories told by the journalists are often obviously adhering to the versions of their sources, mainly synthetic biologists. As a consequence, the broad majority of the reports are uncritically positive and optimistic about the field and its potentials.

In a recent article I investigated, together with researchers from The Netherlands, Austria, and Germany, whether this sort of journalistic passivity is specific to Swedish media or if this is a common trend. Well, in case some of you may wonder, the answer is that it is a common trend. Although I cannot claim that it is a global trend, it is a trend in at least 13 European countries and in the US.

But how do different audiences react to what synthetic biology does and can potentially do? Are they also as supportive and progressive as the stories told by the journalists (or, rather, recycled by the journalists)? This is what we tried to understand.

The Meeting of Young Minds is an event which was organized by the Rathenau Instituut in 2011 and 2012, where young synthetic biologists (students) met and debated with spokespersons of Dutch political youth organizations. The analysis of the event showed that positive expectations and an open attitude towards synthetic biology could certainly be found among the prospective politicians. However, concerns about the environment were expressed, as well as about the concept of designing new forms of life.

But of course, political organizations are not neutral and cannot be assumed to mirror general public views.

What happens when we turn our attention to the general public? Participants in citizens’ panels in Austria tended to focus primarily on the challenges and risks presented by synthetic biology and expressed only a mild enthusiasm for its potential applications. Noteworthy is that support for synthetic biology was always conditional to a number of demands, primarily transparency and information, which were defined as essential. Austrian citizens’ experiment of public engagement revealed also a rather worrisome distrust towards scientists and policy makers, coupled with a sense of resignation towards the inevitability of scientific and technological progress. Similar studies in the UK, Austria, and the US showed that public attitudes are either balanced or mainly negative towards synthetic biology.

These differences between media representations and public perceptions indicate a need for more responsible journalism about synthetic biology.

Mirko Ancillotti

(You can read more about Mirko’s work at CRB here.)

Ancillotti M., Rerimassie V., Seitz S. and Steurer W. 2016 “An update of public perceptions of synthetic biology: still undecided?” NanoEthics, DOI: 10.1007/s11569-016-0256-3

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Global bioethics: each culture its own “ethnobioethics”?

Pär SegerdahlWith globalization bioethics is spread over the world. The process isn’t without friction, since bioethics is associated with Western philosophy. Is that thinking applicable to other cultures? Parts of the world where bioethics is spread may also have a colonial history, such as Africa. Should they now once again come under Western influence?

In an article in the Cambridge Quarterly of Healthcare Ethics, Sirkku K. Hellsten discusses the role of philosophy in global bioethics. She uses the example of Africa, where discussions about a unique African philosophy have been intense. But she also quotes Henry Odera Oruka, wondering why so much time is spent discussing what distinguishes African philosophy, when so little time is devoted to actually practicing it.

To investigate the role of philosophy in global bioethics, Hellsten distinguishes (inspired by Odera Oruka) four forms of philosophy. I reproduce two of them here:

  1. Ethnophilosophy: Here it is assumed that different cultures often have incommensurable conceptions and worldviews. Bioethical key concepts – personhood, rationality, autonomy, consent, human nature, human well-being – have as many interpretations as there are cultures. The aim seems to be to develop these interpretations of Western ethical concepts and principles, to develop culture specific “ethnobioethics.”
  2. Professional philosophy: Professional philosophers, says Hellsten, are academically trained in critical, impartial, logical argument. (She distinguishes professional philosophy from the ideological tendencies of Peter Singer and John Harris). Although professional philosophers are influenced by their culture, they can recognize these biases and subject them to self-critical examination. Professional philosophy is self-correcting.

Hellsten points out that ethnophilosophical thinking, in its quest to carve out culture specific “ethnophilosophies,” on the contrary tends to make sweeping generalizations about cultural views, creating false oppositions. Moreover, ethnophilosophical thinking is at risk justifying double standards in biomedical practices. It can make it seem reasonable to ask for individual consent in individualistic cultures but not in collectivist.

Hellsten suggest that what global bioethics needs is professional philosophy. It can impartially scrutinize arguments and reveal contradictions and unclear thinking, and it can keep ethics at arm’s length from politics and rhetoric. It is a universal form of human thought that should be accessible to all cultures. Through professional philosophy, global bioethics can become universal bioethics.

What do think about this? I believe that Hellsten’s emphasis of “universality” does not quite strikingly describe the point I think she actually has. In order to understand in what sense she has a point, I believe we need to understand that bioethics is not only as a form of “thinking,” but also a concrete component of contemporary social structure.

Law (to take another example) isn’t just a form of “thinking” but also an organized part of the social structure: a legal system. During the twentieth century, we saw the birth of bioethics as another part of the social structure: as an organized way to deal with certain issues of health care and biomedical research (other parts of the social structure). Bioethics therefore has an obvious place in the social structure, and that place is: the university, with its resources for research and education.

So where do I locate Hellsten’s point when she claims professional philosophy’s role in global bioethics? Not in the view that professional philosophy supposedly is “universal thinking,” but in the fact that the university is the place of bioethics in the social structure. If we build hospitals and invest in advanced medical research and education, and if we develop legislation for these activities, it is in the university that bioethics finds the resources it needs to play its role.

So why is “professional philosophy” relevant for bioethics in Africa? In my view, precisely because one builds hospitals and makes investments in medical research and education. It would be odd if the efforts to build such a society were combined with an emphasis on tradition-bound “ethnophilosophy.”

We need to be clear about where we are: in the midst of an ongoing construction of society. And we need to be clear about the fact that ethics, in addition to being a personal concern, also has become an important “apparatus” in the social structure. In Africa, and elsewhere, it will certainly be faced with unique bioethical issues, like the legal system is faced with unique problems in different parts of the world.

At the same time, it is important to emphasize, as Hellsten does, the open and self-critical nature of global bioethics.

(I want to thank the Global Bioethics Blog for drawing my attention to Hellsten’s article.)

Pär Segerdahl

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Online course in research ethics, spring 2016

Pär SegerdahlAnyone who manages research also needs to be able to reflect on research. Not only the researchers themselves, but also funding bodies, journal editors, members of research ethics committees, administrators, journalists, organizations, politicians, and others.

How do you act if you suspect research misconduct, and what is it? What are the ethical and legal regulations governing data management or research on humans and animals?

If you want to learn more about these issues, or perhaps about publication ethics and authorship rules, conflicts of interest, mentor/trainee responsibilities, biosecurity and more – then we can help you. We give an online course in research ethics for medicine and the life sciences.

The course runs for ten weeks, from April 4 to June 10, every week with its own theme (the last week is devoted to sharing what you learned with your home institution). The course includes video lectures and texts to read, but also interactive exercises and regular e-meetings with other students and with the teacher.

The course is given in English and is open to students from all over the world. If you want to know what some of the former students have to say about the course, you can read more here. And if you want to know who the course is aimed at, read more here.

Research ethical responsibility is vital and it is important that ethics education reaches out. The course fee is € 1.125 (including tax), and to students who cannot receive financial support from their home institution we offer a limited number of scholarships for which application deadline is February 15.

If you don’t need a scholarship you can apply for the course until course start.

Pär Segerdahl

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Gene editing: a threat to the moral ecosystem?

Pär SegerdahlA few years ago it was discovered that bacteria can protect themselves against viruses by cutting the viruses’ DNA at specific positions. The discovery is the basis for new, easier and more precise ways to make changes in the genome. Researchers have begun to talk about “cutting and pasting” in the genome; about “editing” the genome.

The new gene-editing technique has been applied to plant breeding. But it can, of course, be applied elsewhere too. And as often is the case, the issues appear extra controversial when applications to humans are considered.

I read an intellectual debate between a proponent of therapeutic use of the technique on humans (Julian Savulescu), and an opponent (Margaret Somerville). (You find it here.) The opponent used an analogy to summarize her position, which I cannot resist commenting upon here on the Ethics Blog. Here is the analogy (as I render it):

  • Today we are acutely aware that we must take responsibility for our environment, for the physical ecosystem. But the same can be said of our metaphysical or moral ecosystem. We must care about our values, beliefs, attitudes, principles and narratives. Genetically editing a human embryo, perhaps to remove a disease gene, may have good consequences from an individual perspective. But it threatens the moral ecosystem at its roots: it contradicts the respect for human life.

Say what you want, but it is a dramatic analogy! Maybe a little too dramatic. For essentially the same threat has been depicted many times before, when new forms of biotechnology appeared on the horizon. If this kind of threat was real, morality should lie in ruins since long ago. But we quickly forget and it is always only the latest techniques that Threaten Morality at its Foundation.

I believe that the idea of ​​a major technological threat to morality is based on intellectualizing both technology and morality. One attaches enormous significance to the fact that aspects of the technology can be described with certain words, such as “editing” or “designing.” The description, ​​”designing a child,” sounds like it logically clashed with another intellectualization – of morality as a system of propositions about what a “person” is, about what “respect” is, and about what is “right and wrong.”

The idea of an apocalyptic threat is thus based on reading the new technique and morality literally, so that it sounds as if the technique contradicted the basic tenets of morality.

Is there nothing to worry about, then? Should we not care about important values? Of course we should. My point is that in practice this looks differently than it verbally sounds like.

When new biotechnologies are implemented in society and put to use, this occurs in specific practical contexts where there are recognized problems that one wants to solve or treat. These applications are regulated, ethically and legally.

In vitro fertilization (IVF), another technique, is embedded in its specific contexts. Within these contexts, the technique solves problems for people. But it hardly threatens morality by, on some general and verbal level, contradicting the basic tenets of a moral system – such as “the respect for human life.” Rather, the technology has become a new way to concretely respect people and take their problems seriously.

The practical aspects disappear in the intellectualization of the issues, with its focus on words and theses. But it is the living contexts we have to take responsibility for. That is where we find the respect and the disrespect. That is where the problem lies.

Some moral problems are just false readings, overinterpretations of words.

Pär Segerdahl

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Trust, responsibility and the Volkswagen scandal

Jessica Nihlén FahlquistVolkswagen’s cheating with carbon emissions attracted a lot of attention this autumn. It has been suggested that the cheating will lead to a decrease in trust for the company, but also for the industry at large. That is probably true. But, we need to reflect on the value of trust, what it is and why it is needed. Is trust a means or a result?

It would seem that trust has a strong instrumental value since it is usually discussed in business-related contexts. Volkswagen allegedly needs people’s trust to avoid losing money. If customers abandon the brand due to distrust, fewer cars will be sold.

This discussion potentially hides the real issue. Trust is not merely a means to create or maintain a brand name, or to make sure that money keeps coming in. Trust is the result of ethically responsible behaviour. The only companies that deserve our trust are the ones that behave responsibly. Trust, in this sense, is closely related to responsibility.

What is responsibility then? One important distinction to make is the one between backward-looking and forward-looking responsibility. We are now looking for the one who caused the problem, who is to blame and therefore responsible for what happened. But responsibility is not only about blame. It is also a matter of looking ahead, preventing wrongful actions in the future and doing one’s utmost to make sure the organisation, of which one is a member, behaves responsibly.

One problem in our time is that so many activities take place in such large contexts. Organisations are global and complex and it is hard to pinpoint who is responsible for what. All the individuals involved only do a small part, like cogs in a wheel. When a gigantic actor like Volkswagen causes damage to health or the environment, it is almost impossible to know who caused what and who should have acted otherwise. In order to avoid this, we need individuals who take responsibility and feel responsible. We should not conceive of people as powerless cogs in a wheel. The only companies who deserve our trust are the ones in which individuals at all levels take responsibility.

What is most important now is not that the company regains trust. Instead, we should demand that the individuals at Volkswagen raise their ethical awareness and start acting responsibly towards people, society and the environment. If they do that, trust will eventually be a result of their responsible behaviour.

Jessica Nihlén Fahlquist

(This text was originally published in Swedish, in the magazine, Unionen, industri och teknik, December 2015.)

Further reading:

Nihlén Fahlquist, J. 2015. “Responsibility as a virtue and the problem of many hands,” In: Ibo van de Poel, Lambèr Royakkers, Sjoerd Zwart. Moral Responsibility in Innovation Networks. Routledge.

Nihlén Fahlquist J. 2006. “Responsibility ascriptions and Vision Zero,” Accident Analysis and Prevention 38, pp. 1113-1118.

Van de Poel, I. and Nihlén Fahlquist J. 2012. “Risk and responsibility.” In: Sabine Roeser, Rafaela Hillerbrand, Martin Peterson, Per Sandin Handbook of Risk Theory, 2012, Springer, Dordrecht.

Nihlén Fahlquist J. 2009. “Moral responsibility for environmental problems – individual or institutional?” Journal of Agricultural and Environmental Ethics 22(2), pp. 109-124.

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Scientists shape how the media portray synthetic biology (by Mirko Ancillotti)

mirko-ancillotti2 Most of us learn about scientific developments through the media. Journalists and newspaper editors not only select what to bring to public attention but also the way the contents are conveyed. But how can we be sure that what they report is well researched?

There are some new studies on how media portray synthetic biology in different countries. It turns out that reports are both unbalanced and uncritical. Most of the stories use the same terminology, figures of speech and envision the same fields of application. This is because they rely on the same sources: press releases, press conferences or interviews with a few prolific American scientists, with Craig Venter doing the lion’s share. Stories are often optimistic and future oriented. The promising applications of synthetic biology are connected to subjects that people already prioritize like health and environment. But it also means that the possible risks are omitted or presented in a few choice words close to the end.

josepine-fernow2Scientists have a public role and a duty to perform science outreach and science communication in a responsible way. This duty is amplified by the interaction with mass media. Indeed, there are a number of national and international regulations and guidelines that provide indications on what kind of relationship and communication scientists should entertain with the media and what pitfalls they should avoid. Is it a problem that the media copy their framing and present the field with their words? If scientists can reach the public directly, does that mean that we should increase our demand on their communication? Maybe not. Managing to popularize and frame science in a way that attracts media’s attention and an inattentive and unengaged public is already a communications feat.

Journalists have ethical responsibilities and a strong professional ethics. This resounds in a remarkable amount of national and international guidelines and regulations. Did the journalists do a good job when they kept the message and vision the scientists provided and spread that to the public? Should we ask journalists to be more critical and filter the voice of the scientists involved?

Well, we would of course prefer to receive balanced information filtered by knowledgeable science journalists. But science news is not always handled by them. Perhaps the real problem is the logic of the current media landscape. There is no time to research a press-release: the news have to go out, otherwise someone will beat you to it.  In the extreme, this logic allows for hoax press releases to become news (like the one that made the Emulex stock plummet in 2000). If we want journalists to do a good job, we have to give them time. Because the idea that media basically “retweet” what a few scientists and entrepreneurs decide is of course a bit disturbing.

If you are interested to read more about this topic have a look at Mirko Ancillotti’s recent publications:Uncritical and unbalanced coverage of synthetic biology in the Nordic press that was just published in Public Understanding of Science, or Synthetic Biology in the Press: Media Portrayal in Sweden and Italy.

Mirko Ancillotti and Josepine Fernow

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