First European biobank for research on breast milk and medicines
A new large European research project will fill the knowledge gaps when it comes to medical treatments of pregnant and nursing women. To be able to evaluate the effects of drugs during pregnancy and breast feeding, Uppsala biobank will collect and store breast milk and blood samples form pregnant and nursing women currently under medical treatment. The samples will be collected from women around Europe. In addition, the drug analysis platform UDOPP at the SciLifeLab’s Uppsala site will develop methods and technology to analyze drug residues in milk and blood.
On 1-April 2019 a landmark public private partnership called ConcePTION was awarded a 5-year grant by the Innovative Medicines Initiative (IMI2) to tackle many of the research gaps related to medicine used by pregnant and breastfeeding women.Uppsala University takes on an important role, developing infrastrucures to enable research, and its Centre for Research Ethics & Bioethics (CRB) has a leading role in this work.
The project unites an unprecedented 88 organizations from 22 countries, including the European Medicines Agency, drug manufacturers, academia, public health organizations, and teratology networks to innovate new solutions to a decades-long public health issue. With a shared vision that there is a societal obligation to radically and rapidly reduce uncertainty about the safety of medication use in pregnancy and breastfeeding, the ConcePTION team will work to create sustainable solutions to the problem. Through better use of existing health data from routine, daily practice together with enhanced methods to collect patient-reported data, and with new research capabilities to predict and measure maternal medication in breastmilk, the team hopes to close the information gap.
Pregnant and breastfeeding women have long been overlooked in the medical research community because there have been few avenues available for conducting research; the fear of legal liability has overshadowed the need for reliable information to benefit these women and their families. Nonetheless, up to 90% of women are exposed to a prescription medication at some point during their pregnancy. Women and their healthcare providers face difficult choices before, during, and after pregnancy, due to a widespread lack of information. Physicians help women to select the safest medication, but they seldom have robust evidence to allow them to make informed decisions.
Today, only about 5% of medications have adequate safety information on use in pregnant or breastfeeding women. Obtaining reliable safety information can take 20 or more years to collect after a medicines on the market.
ConcePTION aims to profoundly change this paradigm by improving and unifying currently uncoordinated approaches to data collection, and through the re-use of existing and de-identified health data that is generated during the routine care of patients, this is also called ‘Big Data’. These data can be systematically and securely analysed to provide useful information about the effects of medicines on pregnancy outcomes in real life. ConcePTION does this by forming a networked system bringing together the major data sources dispersed across Europe. ConcePTION researchers also aim to create new pathways and methods for understanding medication transfer to breastmilk by creating the first Europe-wide breast milk biobank for research purposes. The team will also develop new models that can predict medication transfer into human breastmilk.
ConcePTION will create a trusted biomedical ecosystem that can efficiently, systematically, and in an ethically responsible manner, generate reliable evidence-based information regarding the safety of medications used during pregnancy and breastfeeding. ConcePTION aims to provide that information in a form that is usable by both healthcare providers and women to facilitate informed decision making.
ConcePTION is a 5-year, €28.6 million project supported by the Innovative Medicines Initiative (IMI), a public-private partnership between the European Union and the European pharmaceutical industry. The pharmaceutical industry contributes €13.3 million to the project through in-kind contributions, whereas the European Commission funds €15.3 million in cash. The consortium, comprising close to 200 researchers, is governed and managed by a balanced 50/50 split of public and private partners, and is jointly led by Novartis and the University Medical Center Utrecht.The Management team comprises representatives from Novartis, UCB Biopharma and University Medical Center Utrecht.
The Management Board (work package leaders) has representatives from: European Institute of Innovation through Health Data, European Institute of Women's Health (non-voting contributor), GSK, Janssen Pharmaceutica, LAREB, Katholieke Universiteit Leuven, Novartis, Sanofi Aventis, Takeda, UCB Biopharma, University Medical Center Utrecht, University of KwaZulu-Natal, Ulster University and Uppsala Universitet.
Additional partners by country: AT: BBMRI-MUG, Biobanking and BioMolecular ResourcesResearch Infrastructure – ERIC BE: Bionotus, European Forum for Good Clinical Practice, Provinciaal Instituut voor Hygiene, The Synergist, CH: Arcades Sage-Femme, Groupement des sages-femmes indépendantes vaudoises, Registre Vaudois des Malformations, Division Autonome de Genetique Medicale, Universite de Geneve, University Hospital Geneva, University Hospital Lausanne, Pharmacology service, Pharmacometry unit, University Hospital Lausanne, Service of Obstetrics CZ: Masaryk University DE: Leibniz Institute for Prevention Research and Epidemiology, Merck Kommanditgesellschaft auf Aktien, Otto-von-Guericke University, Malformation Monitoring Centre Saxony-Anhalt Medical Faculty, Univeristy of Leipzig, Universitatskinderklinik Mainz, DK: Ellegaard Göttingen Minipigs A/S, Hospital Lillebaelt, Novo Nordisk A/S, Odense Universitetshospital, University of Aarhus, University of Copenhagen ES: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana, IDIAP Jordi Gol FI: National Institute for Health and Welfare FR: Centre Hospitalier Universitaire de Toulouse, Institut National de la Santé Et de la Recherche Médicale, Registre des Malformations Congenitales de la Reunion, Rennes University Hospital, Department of Neonatology, Universite de Bordeaux HR: Klinicka bolnica Sestre milosrdnice, Klinika za djecje bolesti Zagreb IE: European Institute for Women’s Health IL: Jerusalem (Ministery of Health), Teva Pharmaceutical Industries Ltd. IT: Agenzia regionale di Sanità, Alma Mater Studiorum - Università di Bologna, Consiglio Nazionale delle Ricerche – Institute of Clinical Physiology, Università degli Studi di Ferrara, University of Florence, University of Messina MT: Malta Congenital Anomalies Registry NL: Academisch Ziekenhuis Groningen, Elevate, Orcion, PHARMO Institute, Rijksinstituut voor Volksgezondheid en Milieu, Teratology Information Service networks, The European Medicines Agency, Ttopstart, NO: University of Oslo PL: Poznan University of Medical Science, Dept of Medical Genetics, Wroclaw Medical University SE: Karolinska Institutet, Stockholms Lans Landsting SW: University of Lund TR: Izmir Katip Celebi Universitesi UK: Covance Laboratories Ltd., Eli Lilly and Company Ltd., Health Service Executive, Dept of Public Health, St Finbarr's Hospital, Medicines and Healthcare products Regulatory Agency, Pfizer Ltd., Public Health England, St. George's Hospital Medical School, Swansea University, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, The University of Manchester, University of Bath, University of Dundee US: AbbVie Inc, Bristol-Myers Squibb Company Corp.
The ConcePTION project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 821520. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA.
More news from CRB
Are you our new communications officer?
Our centre is a multidisciplinary research environment with a clear communications profile. We lead the communications work in several international research projects and run two research blogs. We are looking for a driven writer, who likes teamwork and appreciates high tempo. You will be working in projects, producing content for web, social media and newsletters, to fit different project channels.
Responsibility key to implementing guidelines for treating disorders of consciousness
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We’re hiring! Looking for a PhD student in medical ethics
Uppsala University’s Centre for Research Ethics & Bioethics is looking for a PhD student for a project on the ethical foundations for assessment of severity as a priority criterion in health care. Swedish required, apply before 22 April!
Indicators and criteria of consciousness for behaviourally unresponsive patients
Identifying and quantifying residual consciousness in patients with disorders of consciousness is notoriously challenging but increasingly urgent. There is a high rate of misdiagnosis among patients suffering from these disorders, particularly between vegetative states/unresponsive wakefulness syndrome and minimally conscious states. A recent BMC Medical Ethics publication explores how operational indicators previously introduced to assess consciousness in non-human animals and artificial intelligence can be relevant and have an ethical impact on the diagnosis and care of patients with disorders of consciousness.
The neuroethics contribution to AI ethics and regulation
The AI ethics research field is growing rapidly. So is the number of guidelines issued to provide operational recommendations to manage the ethical issues raised by AI design, development and implementation. In a recent Neuroethics publication, Michele Farisco, Kathinka Evers and Arleen Salles suggest some of the applied issues covered by these guidelines can in fact be properly assessed only on the basis of a preliminary conceptual analysis. And that embracing neuroethical methodology can help tackle the practical ethical challenges of AI.
Empirical ethics to explore the acceptability of AI in healthcare
Breast cancer is the leading cause of cancer-related death among women worldwide. Early detection is key for successful treatment and researchers are now exploring how artificial intelligence (AI) can be used to interpret mammogram scans. As part of the newly launched project AICare, Uppsala University’s Centre for Research Ethics & Bioethics are using empirical research to support ethical discussion about using AI-based tools in the health care system.
Being at risk for heart disease affects perceived importance of own risk factors
How someone understands an illness also affects their attitudes to taking preventive action. A recent study investigated how Swedes aged 40 to 70 perceive the cause of heart infarctions and their beliefs about how much they can influence their own personal risk. Results show a high level of awareness among the participants about the causal impact of risk factors such as obesity, hypertension, smoking, and lack of exercise, on heart disease. However, people having those risk factors were less convinced about the casual link between their own risk factor and having a heart attack.
New professor "I want to vitalise research in clinical medical ethics"
On 1 February 2022, Niklas Juth joins the Department of Public Health & Carin Sciences and the Centre for Research Ethics & Bioethics in his new role as professor in medical ehics. With the ambition to vitalise research in clinical medical ethics.
Niklas Juth new chair in Medical Ethics at Uppsala University & Region Uppsala
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Anna T. Höglund new professor in Care Ethics
The asymmetrical relationship between patients and health care professionals raises ethical concern: Bringing the ethics of nursing and care to the fore in health care settings. On 1 December 2021, Anna T. Höglund was promoted to Professor in Care Ethics and Gender Studies, strengthening our profile on clinical ethical issues.
Policy brief on fighting antibiotic resistance
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Scientific evidence for treatment of resignation syndrome
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Screen4Care: Accelerating Diagnosis for Rare Disease Patients Through Genetic Newborn Screening & AI
Today an international public-private consortium of 35 partners announced the launch of Screen4Care – a research project that aims to significantly shorten the time required for rare disease diagnosis and efficient intervention by utilising genetic newborn screening and advanced analysis methods such as machine learning. The project will run for a period of five years with a total budget of EUR 25 million provided by the Innovative Medicines Initiative (IMI 2 JU), a joint undertaking of the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
European Academic Integrity Week 2021
To support the occasion of the Global Ethics Day 2021 on Wednesday 20 October 2021, ENAI together with Uppsala University has organised European Academic Integrity Week 2021 (EAIW) which takes place from 18 October to 22 October 2021. European Academic Integrity Week 2021 will be celebrated in the same way as last year: With a series of lunch-time webinars, starting at 12:00 CEST, each lasting 90 minutes. There will be no webinar on Wednesday as this day will be free for your national or institutional activities. The webinars are free and everybody is welcome to register!
Many underestimate their own risk of cardiovascular disease
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7 medical faculties agree on compulsory research ethics course
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YouTube videos about clinical trials for children with cancer fall short
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51 percent of researchers sometimes cheat
A recent study shows 51% of researchers in the Netherlands are occasionally guilty of questionable research practices. Some by being insufficient as mentors or supervisors, others by only citing research that supports their own findings. 8% are guilty of misconduct, like fabricating or manipulating results. This is alarming, says Stefan Eriksson, Director of Uppsala University’s Centre for research ethics & bioethics.
When are we willing to share our health data?
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Policy brief: Informing the public about cardiovascular risk
Any health care interventions should be made after careful consideration of the benefits and risks for the individual. But experts and the general public sometimes have different views on what the benefit actually is. By examining which groups benefit from health care efforts, they can be directed towards particularly vulnerable groups and individuals. In a newly issued policy brief, Åsa Grauman reveals her recommendations for how best to inform the public about cardiovascular risk.
Full time position to look at preferences for newborn genetic screening
We are looking for a full time researcher to investigate the preferences that parents and healthcare professionals have in relation to screening and genetic testing of newborns. This is a full time position for two years, based at the centre, but working in an international research project. Application deadline 19 July 2021.
Bringing patients' views into medical approvals
Patients want to have a say in decisions that affect their health. But decision-makers have not had the tools to listen. Patient preference studies offers just that: a tool for decision-makers to collect, and for patients to give, representative and well-informed input. Karin Schölin Bywall’s dissertation reveals when and how including patient preferences in regulatory decision-making.
One in three underestimate their risk of heart infarction
One in three underestimate their own risk of cardiovascular disease. Many are good at understanding risks and risk factors when they pertain to other people. A recent study reveals that when it comes to our own risk, many of us appear to have a blind spot. In an interview, Åsa Grauman reveals how this finding could help improve risk communication in health care.
Looking for new preference studies postdoc!
We are looking for a postdoc researcher to work on an international project looking at parents' and health care professionals' preferences for screening and genetic testing for rare diseases in newborn children. And for attempting to identify patients by looking at the symptoms listed in their medical records using an algorithm. How this information is perceived will be explored using an instrument to measure Empowerment. Application deadline 12 July 2021!
Do educational tools influence what patients prefer?
Stakeholders across the medical product life cycle are eager to find out what patients prefer. From the pharmaceutical companies that develop new treatments, to the authorities that decide if they should become available to patients, and at what price. But to be useful in decision-making, the patient preferences collected need to be informed. A recent Patient Education and Counseling publication explores the use of educational tools in patient preference studies, and finds that sometimes, they influence patients’ preferences.
Fighting antibiotic resistance: We can do better!
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Launch of EU Research Project “ENLIGHTENme”: Exploring the Impact of Urban Lighting on Health and Wellbeing
An interdisciplinary consortium of 22 partners will perform in-depth studies in three European cities to develop innovative, evidence-based policies to improve citizens’ quality of life addressing indoor and outdoor lighting. Our Deborah Mascalzoni will contribute her expertise in research ethics and bioethics.
Are you our new Professor of Medical Ethics?
Medical ethics is an interdisciplinary subject of research and education that critically, analytically and empirically studies the ethical and moral aspects of biomedical research and clinical practice. Speak Swedish well enough to teach? We are looking for a new Professor of Medical Ethics to strenghten our clincal research profile. Application deadline 31 March 2020!
Neurotwin: New European project proposes a novel therapy for Alzheimer’s disease
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No data, no policy: New project promotes gender equality action in seven European research institutions
A new European research project prepares the ground for structural changes to promote gender equality in public and private research organisations. Led by the University of Turin, the four-year MINDtheGEPs project will identify good practice and help shape measures to reduce gender imbalances in seven research institutions and generate data to support the development of national and European policy for gender equality in research performing organisations. Uppsala University’s Centre for Research Ethics & Bioethics (CRB) contributes communications expertise, working together with Elsevier to support impact through communications and dissemination strategies for the project.
Season's Greetings from CRB
2020 was not what we expected. We are happy to have contributed expertise and skill to inform the discussion on vaccines and ethical guidance for intensive care. Now we look forward to new projects, new publications, new collaborations and a happy new 2021!! Want to stay connected? Follow our work on the Ethics Blog!
Pandemic – decision-making, communication & vaccination: See you at Smer’s ethics day 2020!
Ethical dilemmas are part of preparing for pandemics, and part of fighting contagion. The Swedish National Council on Medical Ethic’s (Smer) Ethics Day 2020 will consist of three webinars, all focusing on pandemics. Our Jessica Nihlén Fahlquist will participate in a panel discussion on vaccines against Covid-19.
Ethical, social and psychological impacts of genomic risk communication
Biomedical research is constantly finding new ways to detect genetic variation and link the findings to diseases and to the effects of various drug treatments. The amount of information that it produces keeps increasing, but we are still not sure how to manage it. Researchers who took part in the six-year Mind the Risk project coordinated from the Centre for Research Ethics & Bioethics have published their findings in an anthology focussed on genetic risk communication.
Academic integrity series for European Academic Integrity Week
We are hosting four lunch webinars in association with European Network for Academic Integrity during European Academic Integrity Week, 19-23 October. One for each day of the week except Wednesday the 21st, Global Ethics Day, when we are encouraging everyone to organise events at their home organisations.
New way to tailor treatment of acute myologic leukaemia
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Culturally shaping developing minds
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Space, time: bridging the epistemic gap of brain & mind
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Corona vaccine(s) should not be a race to the finish line
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Genomic data sharing requires public trust
Genomics research relies on the ability for clinicians, and researchers to share genetic data with each other across the world. The largest ever survey on global public attitudes towards genomic research and data sharing was just published in American Journal of Human Genetics. Lack of trust in who data is shared with could significantly hinder genomic research. With less than half of the respondents saying they would be happy for their genetic information to be shared for more than one purpose, the results send a call to action for the genomic research community to build public trust.
Russian vaccine development raises important questions about transparency and trust
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Ethical choices in a pandemic
During the coronavirus pandemic, many ethical questions come to the fore. How should care services prioritise among severely ill patients? And how far should the rights of individuals be restricted? There are various ethical perspectives, think Anna T Höglund and Jessica Nihlén Fahlquist, researchers at the Centre for Research Ethics and Bioethics (CRB) in Uppsala.
Cancer treatment no better in clinical trials
Many belive cancer patients who take part in clinical trials receive better treatment than others. A recent study from researchers at Uppsala University, published in BMC Cancer, pokes a hole in that theory. The authors, concluding that there is no quality evidence to support the idea that patients who participate in clinical trials have better outcomes.
What demands can we place on physicians during the COVID-crisis?
Physicians have a responsibility to protect patients’ autonomy, do no harm, to do good and to divide resources fairly. But how these ethical principles are interpreted in practice can differ from physician to physicians. For whom are they supposed to do good, for example? For the patient, a patient group or society as a whole? With limited resources and large demand, these questions are more crucial than ever. And different interpretation can create conflict.
Research podcast on ethical crossroads in a pandemic
The corona pandemic brings a lot of ethical issues to the fore. For example about priorities in the health care system, or limiting individual's rights to protect those that are vulnerable. Episode 47 of Uppsala University’s' "Forskarpodden" talks about public health ethics with CRB's Anna T. Höglund and Jessica Nihlén Fahlquist (in Swedish).
What should we eat? An ethical framework for well-grounded food choices
Being an ethically aware consumer today is difficult. Partly because there are so many aspects to take into account, and partly because it is difficult to find trustworthy and reliable information to base your food choices on. But that does not mean there is no point in thinking about what could constitute an ethical choice of food. Anna T. Höglund explores ethical food choices in a recent publication.
Swedish obstetric routines changed after criticized study: Too soon?
Decisions to induce prolonged pregnancies in week 41 instead of 42 were made in two Swedish healthcare regions as a result of the Swepis study. Now, the study is facing criticism. External researchers are critical to conclusions drawn by the authors and that clinical routines have changed before the study has been reviewed in its entirety.
Governance and ethics of health care in focus
Governance and ethics was the theme at the Swedish National Council on Medical Ethics' Ethics Day 2019. Among the presenters was Anna T. Höglund, associate professor of ethics at the Centre for Research Ethics & Bioethics at Uppsala University. Together with Erika Falkenström, she presented on the subject of "Ethics in policy and governance: What ethical competence do health care decision-makers need?".
Connecting the brain and consciousness
What is consciousness? What does it mean to be ‘aware’, and how is our consciousness connected to the physical brain? A recent thesis from Uppsala University explores the philosophical aspects of the issue, and proposes a solution: the ‘intrinsic consciousness’ theory.
Egg donation for gene editing in embryos expose women to health risks
Current gene editing approaches allow for precise modification of DNA. These could potentially be used to correct disease-causing genes in human embryos.To evaluate the safety and efficacy of this approach, a large number of studies would be needed. To create embryos for this purpose, women have to donate eggs. In a recent Nature correspondence, CRB’s Emilia Niemiec and Heidi Howard draw attention to the health risks associated with egg donation in this context.