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

Tag: data sharing (Page 1 of 3)

Return of health data from clinical trials to the patients

During a clinical trial, large amounts of health data are generated that can be useful not only within the current study. If the trial data are made available for sharing, they can be reused within other research projects. Moreover, if the research participants’ individual health data are returned to them, this may benefit the patients in the study.

The opportunities to increase the usefulness of data from clinical trials in these two ways are not being exploited as well as today’s technology allows. The European project FACILITATE will therefore contribute to improved availability of data from clinical trials for other research purposes and strengthen the position of participating patients and their opportunity to gain access to their individual health data.

A policy brief article in Frontiers in Medicine presents the project’s work and recommendations regarding the position of patients in clinical studies and the possibility of communicating their health data back to them. The project develops an ethical framework that will put patients more at the center and increase their influence over the studies they participate in. For example, it tries to make it easier for patients to dynamically design and modify their consent, access information about the study and retrieve individual health data.

An extended number of ethical principles are identified within the project as essential for clinical trials. For example, one should not only respect the patients’ autonomy, but also strengthen their opportunities to make informed decisions about their own care on the basis of returned health data. Returned data must be judged to be of some kind of benefit to the individuals and the data must be communicated in such a way that they as effectively as possible strengthen the patients’ ability to make informed decisions about their care.

If you are interested in greater opportunities to use health data from clinical trials, mainly opportunities for the participating patients themselves, read the article here: Ethical framework for FACILITATE: a foundation for the return of clinical trial data to participants.

Pär Segerdahl

Written by…

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

Ciara Staunton, Johanna M. C. Blom and Deborah Mascalzoni on behalf of the IMI FACILITATE Consortium. Ethical framework for FACILITATE: a foundation for the return of clinical trial data to participants. Frontiers in Medicine, 17 July 2024. https://doi.org/10.3389/fmed.2024.1408600

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Neuroimaging the brain without revealing the person

Three contemporary trends create great challenges for researchers. First, science is expected to become increasingly open, among other things by making collected data available to new users and new purposes. At the same time, data protection laws are being strengthened to protect privacy. Finally, artificial intelligence finds new ways to reveal the individuals behind data, where this was previously impossible.

Neuroimaging is an example of how open science, stronger data protection legislation and more powerful AI challenge the research community. You may not think that you can identify the person whose brain is imaged by using a magnetic camera? But the image actually also depicts the shape of the skull and face, including any scars. You could thus recognize the person. In order to be able to share neuroimaging data without revealing the person, it has hitherto been assumed sufficient to remove the shape of the skull and face in the images, or to make the contours blurry. The problem is the third trend: more powerful AI.

AI can learn to identify people, where human eyes fail. Brain images where the shape of the skull and face has been made unrecognizable often turn out to contain enough information for self-learning face recognition programs to be able to identify people in the defaced images. AI can thus re-identify what had been de-identified. In addition, the anatomy of the brain itself is individual. Just as our fingers have unique fingerprints, our brains have unique “brainprints.” This makes it possible to link neuroimaging data to a person, namely, if you have previously identified neuroimaging data from the person. For example, via another database, or if the person has spread their brain images via social media so that “brainprint” and person are connected.

Making the persons completely unidentifiable would change the images so drastically that they would lose their value for research. The three contemporary trends – open science, stronger data protection legislation and more powerful AI – thus seem to be on a collision course. Is it at all possible to share scientifically useful neuroimaging data in a responsible way, when AI seems to be able to reveal the people whose brains have been imaged?

Well, everything unwanted that can happen does not have to happen. If the world were as insidiously constructed as in a conspiracy theory, no safety measures in the world could save us from the imminent end of the world. On the contrary, such totalized safety measures would definitely undermine safety, which I recently blogged about.

So what should researchers do in practice, when building international research infrastructures to share neuroimaging data (according to the first trend above)? A new article in Neuroimage: Reports, presents a constructive proposal. The authors emphasize, among other things, increased and continuously updated awareness among researchers about realistic data protection risks. Researchers doing neuroimaging need to be trained to think in terms of data protection and see this as a natural part of their research.

Above all, the article proposes several concrete measures to technically and organizationally build research infrastructures where data protection is included from the beginning, by design and by default. Because completely anonymized neuroimaging data is an impossibility (such data would lose its scientific value), pseudonymization and encryption are emphasized instead. Furthermore, technical systems of access control are proposed, as well as clear data use agreements that limit what the user may do with the data. Moreover, of course, informed consent from participants in the studies is part of the proposed measures.

Taken together, these safety measures, built-in from the beginning, would make it possible to construct research infrastructures that satisfy stronger data protection rules, even in a world where artificial intelligence can in principle see what human eyes cannot see. The three contemporary trends may not be on a collision course, after all. If data protection is built in from the beginning, by design and by default, researchers can share data without being forced to destroy the scientific value of the images, and people may continue to want to participate in research.

Pär Segerdahl

Written by…

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

Damian Eke, Ida E.J. Aasebø, Simisola Akintoye, William Knight, Alexandros Karakasidis, Ezequiel Mikulan, Paschal Ochang, George Ogoh, Robert Oostenveld, Andrea Pigorini, Bernd Carsten Stahl, Tonya White, Lyuba Zehl. “Pseudonymisation of neuroimages and data protection: Increasing access to data while retaining scientific utility,” Neuroimage: Reports, 2021,Volume 1, Issue 4

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Approaching future issues

Research for responsible governance of our health data

Do you use your smartphone to collect and analyse your performance at the gym? This is one example of how new health-related technologies are being integrated into our lives. This development leads to a growing need to collect, use and share health data electronically. Healthcare, medical research, as well as technological and pharmaceutical companies are increasingly dependent on collecting and sharing electronic health data, to develop healthcare and new medical and technical products.

This trend towards more and more sharing of personal health information raises several privacy issues. Previous studies suggest that people are willing to share their health information if the overall purpose is improved health. However, they are less willing to share their information with commercial enterprises and insurance companies, whose purposes may be unclear or do not meet people’s expectations. It is therefore important to investigate how individuals’ perceptions and attitudes change depending on the context in which their health data is used, what type of information is collected and which control mechanisms are in place to govern data sharing. In addition, there is a difference between what people say is important and what is revealed in their actual behaviour. In surveys, individuals often indicate that they value their personal information. At the same time, individuals share their personal information online despite little or no benefit to them or society.

Do you recognise yourself, do you just click on the “I agree” button when installing a health app that you want to use? This behaviour may at first glance suggest that people do not value their personal information very much. Is that a correct conclusion? Previous studies may not have taken into account the complexity of decisions about integrity where context-specific factors play a major role. For example, people may value sharing health data via a physical activity app on the phone differently. We have therefore chosen to conduct a study that uses a sophisticated multi-method approach that takes context-specific factors into account. It is an advantage in cybersecurity and privacy research, we believe, to combine qualitative methods with a quantitative stated preference method, such a discrete choice experiment (DCE). Such a mixed method approach can contribute to ethically improved practices and governance mechanisms in the digital world, where people’s health data are shared for multiple purposes.

You can read more about our research if you visit the website of our research team. Currently, we are analysing survey data from 2,000 participants from Sweden, Norway, Iceland, and the UK. The research group has expertise in law, philosophy, ethics and social sciences. On this broad basis, we  explore people’s expectations and preferences, while identifying possible gaps within the ethical and legal frameworks. In this way, we want to contribute to making the growing use and sharing of electronic health data ethically informed, socially acceptable and in line with people’s expectations.  

Written by…

Jennifer Viberg Johansson, Postdoc researcher at the Centre for Research Ethics & Bioethics, working in the projects Governance of health data in cyberspace and PREFER.

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Part of international collaborations

Global sharing of genomic data requires perspicuous research communication

To understand how our genes affect health and disease, drug reactions, and much more, researchers need to share vast amounts of data from people in different parts of the world. This makes genomic research dependent on public trust and support.

Do people in general trust research? Are we willing to donate DNA and health information to researchers? Are we prepared to let researchers share the information with other researchers, perhaps in other parts of the world? Even with researchers at for-profit companies? These and other issues were recently examined in the largest study to date about the public’s attitudes to participating in research and sharing genetic information. The questionnaire was translated into 15 languages ​​and answered by 36,268 people in 22 countries.

The majority of respondents are unwilling or unsure about donating DNA and health information to research. In general, the respondents are most willing to donate to research physicians, and least willing to donate to for-profit researchers. Less than half of the respondents say they trust data sharing between several users. The study also reveals differences between countries. In Germany, Poland, Russia and Egypt, for example, trust in data sharing between several users is significantly lower than in China, India, the United Kingdom and Pakistan.

The study contains many more results that are interesting. For example, people who claim to be familiar with genetics are more willing to donate DNA and health data. Especially those with personal experience of genetics, for example, as patients or as members of families with hereditary disease, or through one’s profession. However, a clear majority say they are unfamiliar with the concepts of DNA, genetics and genomics. You can read all the results in the article, which was recently published in The American Journal of Human Genetics.

What practical conclusions can we draw from the study? The authors of the article emphasize the importance of increasing the public’s familiarity with genomic research. Researchers need to build trust in data collection and sharing. They need to participate in dialogues that make it clear why they share large amounts of data globally. Why is it so important? It also needs to become more understandable why not only physicians can carry out the research. Why are collaborations with for-profit companies needed? Moreover, what significance can genetic techniques have for future patients?

Well-functioning genomic research thus needs well-functioning research communication. What then is good research communication? According to the article, it is not about pedagogically illustrating the molecular structure of DNA. Rather, it is about understanding the conditions and significance of genomic research for healthcare, patients, and society, as well as the role of industry in research and development.

Personally, I want to put it this way. Good research communication helps us see things more perspicuously. We need continuous overviews of interrelated parts of our own societies. We need to see our roles and relationships with each other in complex societies with different but intertwined activities, such as research, healthcare, industry, and much more. The need for perspicuous overviews also applies to the experts, whose specialties easily create one-sidedness.

In this context, let me cautiously warn against the instinctive reaction to believe that debate is the obvious form of research-communicative exchange of thoughts. Although debates have a role to play, they often serve as arenas for competing perspectives, all of which want to narrow our field of view. This is probably the last thing we need, if we want to open up for perspicuous understandings of ourselves as human beings, researchers, donors, entrepreneurs, healthcare professionals and patients. How do we relate to each other? How do I, as a donor of DNA to researchers, relate to the patients I want to help?

We need to think carefully about what it means to think freely, together, about common issues, such as the global sharing of genomic data.

Pär Segerdahl

Written by…

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

Middleton A., Milne R. and Almarri M.A. et al. (2020). Global public perceptions of genomic data sharing: what shapes the willingness to donate DNA and health data? American Journal of Human Genetics. DOI:https://doi.org/10.1016/j.ajhg.2020.08.023

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We like broad perspectives

Neuroethical reflection in the Human Brain Project

Arleen SallesThe emergence of several national level brain initiatives and the priority given to neuroscientific research make it important to examine the values underpinning the research, and to address the ethical, social, legal, philosophical, and regulatory issues that it raises.

Neuroscientific insights allow us to understand more about the human brain: about its dynamic nature and about its disorders. These insights also provide the basis for potentially manipulating the brain through neurotechnology and pharmacotherapy. Research in neuroscience thus raises multiple concerns: From questions about the ethical significance of natural and engineered neural circuitry, to the issue of how a biological model or a neuroscientific account of brain disease might impact individuals, communities, and societies at large. From how to protect human brain data to how to determine and guard against possible misuses of neuroscientific findings.

Furthermore, the development and applications of neuro-technology to alleviate symptoms or even enhance the human brain raise further concerns, such as their potential impact on the personality, agency, and autonomy of some users. Indeed, some empirical findings appear to even challenge long held conceptions about who we are, the capacity to choose freely, consciousness, and moral responsibility.

Neuroethics is the field of study devoted to examining these critical issues. Unfortunately, it has sometimes been reduced to a subfield of applied ethics understood as a merely procedural approach. However, in our understanding, neuroethics is methodologically much richer. It is concerned not just with using ethical theory to address normative issues about right and wrong, but notably with providing needed conceptual clarification of the relevant neuroscientific and philosophical notions. Only by having conceptual clarity about the challenges presented will we be able to address and adequately manage them.

So understood, neuroethics plays a key role in the Human Brain Project (HBP). The HBP is a European Community Flagship Project of Information and Computing Technologies (ICT). It proposes that to achieve a fuller understanding of the brain, it is necessary to integrate the massive volumes of both already available data and new data coming from labs around the world. Expected outcomes include the creation and operation of an ICT infrastructure for neuroscience and brain related research in medicine and computing. The goal is to achieve a multilevel understanding of the brain (from genes to cognition), its diseases and the effects of drugs (allowing early diagnoses and personalised treatments), and to capture the brain’s computational capabilities.

The HBP is funded by the European Commission in the framework of the EU’s Horizon 2020 research-funding programme. The programme promotes responsible research and innovation (RRI). RRI is generally understood as an interactive process that engages social actors, researchers, and innovators who must be mutually responsive and work towards the ethical permissibility of the relevant research and its products. The goal is to ensure that scientific progress and innovation are responsible and sustainable: that they increase individual and societal flourishing and maximize the common good.

To develop, broaden, and enhance RRI within the project, the HBP established the Ethics and Society subproject. Ethics and Society  is structured around a number of RRI activities such as foresight analysis (to identify at an early stage ethical and social concerns), citizens’ engagement (to promote involvement with different points of view and to strengthen public dialogue), and ethics support (to carry out research in applied ethics and to develop principles and mechanisms that ensure that ethical issues raised by research subprojects are communicated and managed and that HBP researchers comply with ethical codes and legal norms).

Neuroethical reflection plays a key role in this integration of social, scientific, and ethical inquiry. Notably, in the HBP such reflection includes conceptual and philosophical analysis. Insofar as it does, neuroethics aims to offer more than assistance to neuroscientists and social scientists in identifying the social, political, and cultural components of the research. Via conceptual analysis, neuroethics attempts to open a productive space within the HBP for examining the relevant issues, carrying out self-critical analysis, and providing the necessary background to examine potential impacts and issues raised. Neuroethical reflection in the HBP does not exclusively focus on ethical applications and normative guidance. Rather, it takes as a starting point the view that the full range of issues raised by neuroscience cannot be adequately dealt with without also focusing on the construction of knowledge, the meaning of the relevant notions, and the legitimacy of the various interpretations of relevant scientific findings.

At present, the importance of neuroethics is not in question. It is a key concern of the International Brain Initiative, and the different international brain projects are trying to integrate neuroethics into their research in different ways. What continues to be unique to neuroethics in the HBP, however, is its commitment to the idea that making progress in addressing the host of ethical, social, legal, regulatory and philosophical issues raised by brain research to a great extent depends on a conceptual neuroethical approach. It enables constructive critical alertness and a thought-out methodology that can achieve both substantial scientific ground and conceptual clarity.

If you want to read more, see below a list of publications on which this post is based.

Arleen Salles

Delegates eaGNS. Neuroethics Questions to Guide Ethical Research in the International Brain Initiatives. Neuron. 2018.

Evers K, Salles A, Farisco M. Theoretical Framing for Neuroethics: The Need for a Conceptual Aproach. In: Racine E, Aspler, J., editor. Debates About Neuroethics: Springer; 2017.

Salles A, Evers K. Social Neuroscience and Neuroethics: A Fruitful Synergy. In: Ibanez A, Sedeno, L., Garcia, A., editor. Social Neuroscience and Social Science: The Missing Link: Springer; 2017. p. 531-46.

Farisco M, Salles A, Evers K. Neuroethics: A Conceptual Approach. Camb Q Healthc Ethics. 2018;27(4):717-27.

Salles A, Evers K, Farisco M. Neuroethics and Philosophy in Responsible Research and Innovation: The Case of the Human Brain Project. Neuroethics. 2018.

Salles A, Bjaalie JG, Evers K, Farisco M, Fothergill BT, Guerrero M, et al. The Human Brain Project: Responsible Brain Research for the Benefit of Society. Neuron. 2019;101(3):380-4.

Global data sharing, national oversight bodies

Pär SegerdahlScience has an international character and global research collaboration is common. For medical research, this means that health data and biological samples linked to people in one nation often are transferred to researchers in other nations.

At the same time, the development of new information and communication technology increases the importance of people’s data protection rights. To provide satisfying data protection in the new internet world, data protection regulations are tightening, especially within the EU.

In an article in Health and Technology, lawyer Jane Reichel discusses challenges that this development poses for biomedical research.

I am not a lawyer, but if I understand Reichel right, legislation can accompany personal data across national borders. For example, the EU requires that the foreign receiver of European data subjects’ personal data will handle the data in accordance with EU legislation – even if the receiver is a research group in the United States or Japan.

The fact that one nation may need to follow a foreign nation’s legislation not only challenges concepts of sovereignty and territoriality. It also challenges the responsibility of research ethics committees. These committees operate administratively at national level. Now it seems they might also need to monitor foreign rights and global standards. Do these national bodies have the expertise and authority for such an international task?

Read the article about these exciting and unexpected legal issues!

Pär Segerdahl

Reichel, J. Health Technol. (2017). https://doi.org/10.1007/s12553-017-0182-6

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Thinking about law - the Ethics Blog

Acknowledging the biobank and the people who built it

Pär SegerdahlBiomedical research increasingly often uses biological material and information collected in biobanks. In order for a biobank to work efficiently, it is important not only that the biological material is stored well. The material must also be made available to science so that researchers easily and responsibly can share samples and information.

Creating such a biobank is a huge effort. Researchers and clinicians who collect bioresources might even be reluctant to make the biobank openly available. Why make it easy for others to access to your biobank if they do not give you any recognition?

In an article in the Journal of Community Genetics, Heidi C. Howard and Deborah Mascalzoni, among others, discuss a system that would make it more attractive to develop well-functioning biobanks. It is a system for rewarding researchers and clinicians who create high quality bioresources by making their work properly acknowledged.

The system, presented in the article, is called the Bioresource Research Impact Factor (BRIF). If I understand it, the system may work the following way. A biobank is described in a permanent “marker” article published in a specific bioresource journal. Researchers who use the biobank then quote the article in their publications and funding grants. In this way, you can count citations of bioresources as you count citations of research articles.

The article also describes the results of a study of stakeholders’ awareness of BRIF, as well as an ethical analysis of how BRIF can contribute to more responsible biobanking.

If you are building a biobank, read the article and learn more about BRIF!

Pär Segerdahl

Howard, H.C., Mascalzoni, D., Mabile, L. et al. “How to responsibly acknowledge research work in the era of big data and biobanks: ethical aspects of the Bioresource Research Impact Factor (BRIF).” J Community Genet (2017). https://doi.org/10.1007/s12687-017-0332-6

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Research data, health cyberspace and direct-to-consumer genetic testing

josepine-fernow2We live in a global society, which means there are several actors that regulate both research and services directed at consumers. It is time again for our newsletter on current issues in biobank ethics and law. This time, Biobank Perspectives  lets you read about the legal aspects of direct-to-consumer genetic testing. Santa Slokenberga writes about her doctoral dissertation in law from Uppsala University and how the Council of Europe and the EU interact with each other and the legal systems in the member states. She believes direct-to-consumer genetic testing can be seen as a “test” of the European legal orders, showing us that there is need for formal cooperation and convergence as seemingly small matters can lead to large consequences.

We also follow up from a previous report on the General Data Protection Regulation in a Swedish perspective with more information about the Swedish Research Data Inquiry. We are also happy to announce that a group of researchers from the University of Oxford, University of Iceland, University of Oslo and the Centre for Research Ethics & Bioethics at Uppsala University received a Nordforsk grant to find solutions for governance of the “health cyberspace” that is emerging from assembling and using existing data for new purposes. To read more, download a pdf of the latest issue (4:2016), or visit the Biobank Perspectives site for more ethical and legal perspectives on biobank and registry research.

Josepine Fernow

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Approaching future issues - the Ethics Blog

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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