Eline M Bunnik

Eline M Bunnik
Erasmus MC | Erasmus MC · Medical Ethics Philosophy of Medicine

PhD
Examining ethical issues in personalised medicine, stem cell technology and transplantable bioartificial organs.

About

85
Publications
7,443
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944
Citations
Citations since 2017
72 Research Items
777 Citations
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Introduction
As an Associate Professor at the Medical Ethics department of Erasmus MC, I run research projects investigating the ethical implications of new technological developments for healthcare systems and the practice of medicine. My current projects focus on (epi)genetics and genomics, regenerative medicine, organ transplantation, and (expanded) access to novel pharmaceutical interventions in oncology. I teach medical students and doctors-in-training about ethical dilemmas in clinical care.
Additional affiliations
September 2017 - present
Erasmus MC
Position
  • Professor (Assistant)
June 2014 - September 2017
Erasmus MC
Position
  • PostDoc Position
November 2008 - present
Education
August 2007 - July 2008
Erasmus MC
Field of study
  • Medicine
August 2000 - June 2005
University of Amsterdam
Field of study
  • Philosophy

Publications

Publications (85)
Article
Full-text available
Organoids are 3D structures grown from pluripotent stem cells derived from human tissue and serve as in vitro miniature models of human organs. Organoids are expected to revolutionize biomedical research and clinical care. However, organoids are not seen as morally neutral. For instance, tissue donors may perceive enduring personal connections with...
Article
The development of new effective but expensive medical treatments leads to discussions about whether and how such treatments should be funded in solidarity-based healthcare systems. Solidarity is often seen as an elusive concept; it appears to be used to refer to different sets of concerns, and its interrelations with the concept of justice are not...
Article
More and more frequently, clinical trials for Alzheimer disease (AD) are targeting cognitively unimpaired individuals who are at increased risk of developing the disease. It is not always clear whether AD biomarker information should be disclosed to research participants: on the one hand, research participants may be interested in learning this inf...
Article
Full-text available
Regenerative medicine has emerged as a novel alternative solution to organ failure which circumvents the issue of organ shortage. In preclinical research settings bio-artificial organs are being developed. It is anticipated that eventually it will be possible to launch first-in-human transplantation trials to test safety and efficacy in human recip...
Article
Full-text available
Background When anti-cancer treatments have been given market authorization, but are not (yet) reimbursed within a healthcare system, physicians are confronted with ethical dilemmas. Arranging access through other channels, e.g., hospital budgets or out-of-pocket payments by patients, may benefit patients, but leads to unequal access. Until now, li...
Article
Full-text available
When seriously ill patients reach the end of the standard treatment trajectory for their condition, they may qualify for the use of unapproved, investigational drugs regulated via expanded access programs. In medical-ethical discourse, it is often argued that expanded access to investigational drugs raises ‘false hope’ among patients and is therefo...
Article
Full-text available
Organoids are 3D structures grown from pluripotent stem cells derived from human tissue and serve as in vitrominiature models of human organs. Organoids are expected to revolutionize biomedical research and clinical care. However, organoids are not seen as morally neutral. For instance, tissue donors may perceive enduring personal connections with...
Article
Full-text available
Regenerative medicine is the new frontier in the field of organ transplantation. Research groups around the world are using regenerative medicine technologies to develop bio-artificial organs for transplantation into human patients. While most of this research is still at the preclinical stage, bio-artificial organ technologies are gearing up for f...
Conference Paper
Full-text available
Objective In the Netherlands, an increasing number of effective but extremely expensive cancer treatments are (temporarily) not reimbursed through mandatory basic health insurance. It seems that access to such treatments is currently limited: patients are often not allowed to pay out of pocket, and health insurers do not offer voluntary additional...
Conference Paper
Full-text available
Objective Personalized medicine is an increasingly prominent approach in many disease areas, including oncology and rare (genetic) disorders, but is often associated with high costs. The development of effective but (very) expensive medical treatments leads to discussions about whether and how such treatments should be allocated in solidarity-based...
Article
An increasing number of people seek medical attention for mild cognitive symptoms at older age, worried that they might develop Alzheimer’s disease. Some clinical practice guidelines suggest offering biomarker testing in such cases, using a brain scan or a lumbar puncture, to improve diagnostic certainty about Alzheimer’s disease and enable an earl...
Article
Full-text available
Inequitable access to deceased donor organs for transplantation has received considerable scrutiny in recent years. Emerging evidence suggests patients with impaired decision-making capacity (IDC) face inequitable access to transplantation. The “Ethical and Legal Issues” working group of the European Society of Transplantation undertook an expert c...
Article
Full-text available
Background: Genomic sequencing is being used more frequently in the clinic, not only by clinical geneticists, but also by other specialists ("mainstreaming"). The use of genomic sequencing gives rise to challenges regarding informed consent, as it can yield more, and more complex results. Methods: This study maps the informed consent process for...
Article
Objectives The current study aims to investigate young adult research participants’ experiences with and preferences regarding the disclosure of MRI incidental findings (IFs) in brain imaging research, and to elucidate the impact and long-term effects of IF disclosure on these participants.Methods We conducted 11 semi-structured interviews with 10...
Article
Full-text available
New epigenomics technologies are being developed and used for the detection and prediction of various types of cancer. By allowing for timely intervention or preventive measures, epigenomics technologies show promise for public health, notably in population screening. In order to assess whether implementation of epigenomics technologies in populati...
Article
Full-text available
Seriously ill patients who have exhausted all approved treatment regimens and who cannot be enrolled in clinical trials may resort to expanded access programmes in order to gain access to unapproved, investigational drugs. It seems that in some countries, expanded access to investigational drugs is offered in clinical practice on a more routine bas...
Article
Full-text available
The research exemption implemented in the new EU General Data Protection Regulation (EU-GDPR) gives member states leeway in determining whether patient consent is required for secondary data use in medical research. However, even though broad consent has become common in data-rich medical research in many EU countries, giving up consent altogether...
Article
"The most effective treatment for type 1 diabetes is transplantation of either a whole pancreas from a deceased donor or islet cells derived from multiple deceased donors. However, transplantation has several limitations, including shortage of post-mortem donors and the need for post-transplant patients to use life-long immunosuppressive medication...
Article
Full-text available
Learning healthcare systems have recently emerged as a strategy to continuously use experiences and outcomes of clinical care for research purposes in precision medicine. Although it is known that learning healthcare transitions in general raise important ethical challenges, the ethical ramifications of such transitions in the specific context of p...
Article
Full-text available
The wider availability of genomic sequencing, notably gene panels, in cancer care allows for personalised medicine or the tailoring of clinical management to the genetic characteristics of tumours. While the primary aim of mainstream genomic sequencing of cancer patients is therapy-focussed, genomic testing may yield three types of results beyond t...
Article
Full-text available
Background Genomic research on neurodevelopmental disorders (NDDs), particularly involving minors, combines and amplifies existing research ethics issues for biomedical research. We performed a review of the literature on the ethical issues associated with genomic research involving children affected by NDDs as an aid to researchers to better antic...
Article
Full-text available
Making routine clinical-care-data available for medical research requires adequate consent to legitimize use and exchange. While, public interest in supporting medical research is increasing, individuals often find it difficult to actively enable researchers to access their data. In addition to broad consent, the idea of (consent-free) data-donatio...
Article
Organ donation after euthanasia is performed in an increasing number of countries. In this donation after circulatory death procedure, it has not been possible to donate the heart. Recent literature, however, reports positive results of heart donation after circulatory death. Therefore, patients who donate organs following euthanasia might be suita...
Article
Full-text available
Treating physicians have key roles to play in expanded access to investigational drugs, by identifying investigational treatment options, assessing the balance of risks and potential benefits, informing their patients, and applying to the regulatory authorities. This study is the first to explore physicians' experiences and moral views, with the ai...
Article
While the accumulation and increased circulation of genomic data have captured much attention over the past decade, privacy risks raised by the diversification and integration of omics have been largely overlooked. In this paper, we propose the outline of a framework for assessing privacy risks in multi-omic research and databases. Following a comp...
Article
Full-text available
Epigenetic markers could potentially be used for risk assessment in risk-stratified population-based cancer screening programmes. Whereas current screening programmes generally aim to detect existing cancer, epigenetic markers could be used to provide risk estimates for not-yet-existing cancers. Epigenetic risk-predictive tests may thus allow for n...
Article
Full-text available
Background and Objectives: The meaning of Alzheimer's disease (AD) is changing in research. It now refers to a pathophysiological process, regardless of whether clinical symptoms are present. In the lay literature, on the other hand, AD is understood as a form of dementia. This raises the question of whether researchers and the lay audience are sti...
Article
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Background Including participants in patient and public involvement activities is increasingly acknowledged as a key pillar of successful research activity. Such activities can influence recruitment and retention, as well as researcher experience and contribute to decision making in research studies. However, there are few established methodologies...
Article
Full-text available
This interview study investigates the short- and long-term implications of incidental findings detected through brain imaging on research participants' lives and their surroundings. For this study, nine participants of the Rotterdam Scan Study with an incidental finding were approached and interviewed. When examining research participants' narrativ...
Article
Clinical studies have shown that up to 90% of patients with idiopathic rapid eye movement sleep behavior disorder (RBD) will eventually be diagnosed with a clinical α-synucleinopathy. Because of this high conversion rate, screening for RBD is often performed to identify eligible participants for studies aimed at elucidating the prodromal phase of α...
Article
The introduction of the accurate and procedurally easy non-invasive prenatal test (NIPT) raises ethical concerns that public attitudes towards prenatal screening may change, leading to societal pressure to participate in aneuploidy screening. This study examined Dutch citizens’ attitudes towards a pregnant woman’s decision to (1) decline NIPT in th...
Article
Full-text available
Informed consent is a key condition for prenatal screening programmes to reach their aim of promoting reproductive autonomy. Reaching this aim is currently being challenged with the introduction of non‐invasive prenatal testing (NIPT) in first‐trimester prenatal screening programmes: amongst others its procedural ease—it only requires a blood draw...
Preprint
Full-text available
Background: Including participants in patient and public involvement activities is increasingly acknowledged as a key pillar of successful research activity. Such activities can influence recruitment and retention, as well as researcher experience and contribute to decision making in research studies. However, there are few established methodologie...
Article
Full-text available
To date, few scholarly discussions on ethical implications of epigenetics and epigenomics technologies have focused on the current phase of research and development, in which researchers are confronted with real and practical ethical dilemmas. In this article, a responsible research and innovation approach, using interviews and an expert meeting, i...
Article
Full-text available
Asking pregnant women to (co)pay for non-invasive prenatal testing (NIPT) out of pocket leads to unequal access across socioeconomic strata. To avoid these social justice issues, first-trimester prenatal screening should be publicly funded in countries such as the Netherlands, with universal coverage healthcare systems that offer all other antenata...
Article
Full-text available
Background: Patients with unmet medical needs sometimes resort to non-standard treatment options, including the use of unapproved, investigational drugs in the context of clinical trials, compassionate use or named-patient programs. The views and experiences of patients with unmet medical needs regarding unapproved, investigational drugs have not...
Article
Full-text available
The noninvasive prenatal test (NIPT) as the first trimester prenatal screening (FTS) for trisomies 21, 18, and 13 is offered to all pregnant women in the Netherlands. NIPT using genome sequencing allows for an expansion of the scope of FTS and the introduction of NIPT gives rise to ethical and societal concerns about deliberated decision‐making, pr...
Article
Full-text available
The introduction of non-invasive prenatal testing (NIPT) in healthcare systems around the world offers an opportunity to reconsider funding policies for prenatal screening. In some countries with universal access healthcare systems, pregnant women and their partners are asked to (co)pay for NIPT. In this paper, we discuss two important rationales f...
Article
Full-text available
Background The introduction of non-invasive prenatal testing (NIPT) for foetal aneuploidies is currently changing the field of prenatal screening in many countries. As it is non-invasive, safe and accurate, this technique allows for a broad implementation of first-trimester prenatal screening, which raises ethical issues, related, for instance, to...
Article
Many healthy volunteers choose to take part in Alzheimer’s disease (AD) prevention studies because they want to know whether they will develop dementia—and what they can do to reduce their risk—and are therefore interested in learning the results of AD biomarker tests. Proponents of AD biomarker disclosure often refer to the personal utility of AD...
Article
Background: Today, public and private bodies around the world are trying to facilitate and increase expanded access to unapproved, investigational drugs for patients with unmet medical needs. Methods: This paper discusses three major shifts in the field of expanded access and presents an argumentative account of ethical issues connected with tho...
Article
In the debate surrounding the introduction of non-invasive prenatal testing (NIPT) in prenatal screening programmes, the concept of routinisation is often used to refer to concerns and potential negative consequences of the test. A literature analysis shows that routinisation has many different meanings, which can be distinguished in three major ve...
Article
Biomedical research aimed at the development of therapies for chronic and late‐onset conditions increasingly concentrates on the early treatment of symptom‐less disease. This broad trend is evidenced in prominent shifts in contemporary dementia research. Revised diagnostic criteria and new approaches to clinical trials propose a focus on earlier st...
Article
Biomedical research aimed at the development of therapies for chronic and late-onset conditions increasingly concentrates on the early treatment of symptom-less disease. This broad trend is evidenced in prominent shifts in contemporary dementia research. Revised diagnostic criteria and new approaches to clinical trials propose a focus on earlier st...
Article
Full-text available
In clinical trials which target pathophysiological mechanisms associated with Alzheimer's disease, research participants who are recruited based on biomarker test results should be informed about their increased risk of developing Alzheimer's dementia. This paper presents the results of a qualitative focus group study of attitudes and concerns towa...
Article
The Netherlands awoke with a shock to some highly publicized cases of clients suffering second-degree burns from inadequate use of laser technology for hair removal in the beauty salon. Aestheticians are increasingly offering risky and sometimes irreversible skin-enhancing treatments. Because of the complexity and hazards of the beauty profession a...
Article
Full-text available
When patients are told that standard medical treatment options have been exhausted, their treating physicians may start looking for promising new drugs that are not yet approved, and still under investigation. Some patients can be included in clinical trials, but others cannot. It is not widely known that these patients might still be eligible for...
Article
The introduction of novel diagnostic techniques in clinical domains such as genomics and radiology has led to a rich ethical debate on how to handle unsolicited findings that result from these innovations. Yet while unsolicited findings arise in both genomics and radiology, most of the relevant literature to date has tended to focus on only one of...
Article
Full-text available
Developments in prenatal testing allow the detection of more findings. SNP arrays in prenatal diagnosis (PND) can be analyzed at 0.5 Mb resolution detecting more clinically relevant anomalies, or at 5 Mb resolution. We investigated whether women had sufficient knowledge to make informed choices regarding the scope of their prenatal test that were c...
Article
Genetic testing for personalizing diet and wellness programs is performed without extensive counseling that informs about the potential implications of knowing one's genotype status. Genetic counseling seems redundant for genes that impact the effect of diet on biomarkers such as cholesterol and blood pressure, but the same genes may have pleiotrop...
Article
There is growing interest in the development of novel approaches to secondary prevention trials in Alzheimer's disease to facilitate screening and recruitment of research participants and to reduce the time and costs associated with clinical trials. Several international research collaborations are setting up research infrastructures that link exis...
Article
Full-text available
Background As thousands of healthy research participants are being included in small and large imaging studies, it is essential that dilemmas raised by the detection of incidental findings are adequately handled. Current ethical guidance indicates that pathways for dealing with incidental findings should be in place, but does not specify what such...
Article
There is growing interest in the development of novel approaches to secondary prevention trials in Alzheimer's disease to facilitate screening and recruitment of research participants and to reduce the time and costs associated with clinical trials. Several international research collaborations are setting up research infrastructures that link exis...
Article
Full-text available
Background: Current Alzheimer's disease (AD) research initiatives focus on cognitively healthy individuals with biomarkers that are associated with the development of AD. It is unclear whether biomarker results should be returned to research participants and what the psychological, behavioral and social effects of disclosure are. This systematic r...
Article
Full-text available
Imaging techniques are deployed in human subjects research on an increasingly large scale. Worldwide, images of the brain, the abdomen or the whole body are acquired in clinical and population-based cohort studies, and in neuroscience, cognitive science and behavioural science studies. Many of these imaging studies are performed in volunteers who a...
Article
It is not a bad idea to assess whether direct-to-consumer (DTC) genomic tests are a threat to or instead an enhancement of autonomy, as is done in the article ‘Direct to consumer genomics on the scales of autonomy’ by Effy Vayena.1 Autonomy has played a starring role in ethical discussions surrounding DTC genomic testing, but has taken many differe...
Article
Full-text available
In ethical and regulatory discussions on new applications of genomic testing technologies, the notion of 'personal utility' has been mentioned repeatedly. It has been used to justify direct access to commercially offered genomic testing or feedback of individual research results to research or biobank participants. Sometimes research participants o...
Article
What's in a name? Terminology has the power to shape the ethical and regulatory debate surrounding commercially offered genomic testing. This article discusses the normative effects of naming and framing, and proposes that the medical frame, with its focus on the reduction of harm, should be used in the evaluation and regulation of predictive genom...
Article
The advent of new genetic and genomic technologies may cause friction with the principle of respect for autonomy and demands a rethinking of traditional interpretations of the concept of informed consent. Technologies such as whole-genome sequencing and micro-array based analysis enable genome-wide testing for many heterogeneous abnormalities and p...
Article
Full-text available
In recent years, developments in genomics technologies have led to the rise of commercial personal genome testing (PGT): broad genome-wide testing for multiple diseases simultaneously. While some commercial providers require physicians to order a personal genome test, others can be accessed directly. All providers advertise directly to consumers an...
Article
Broad genome-wide testing is increasingly finding its way to the public through the online direct-to-consumer marketing of so-called personal genome tests. Personal genome tests estimate genetic susceptibilities to multiple diseases and other phenotypic traits simultaneously. Providers commonly make use of Terms of Service agreements rather than in...
Article
Full-text available
Companies are currently marketing personal genome tests directly-to-consumer that provide genetic susceptibility testing for a range of multifactorial diseases simultaneously. As these tests comprise multiple risk analyses for multiple diseases, they may be difficult to evaluate. Insight into morally relevant differences between diseases will assis...
Article
Full-text available
As genetics technology proceeds, practices of genetic testing have become more heterogeneous: many different types of tests are finding their way to the public in different settings and for a variety of purposes. This diversification is relevant to the discourse on ethical, legal and societal issues (ELSI) surrounding genetic testing, which must ev...

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Projects (7)
Project
Dear highly appreciated specialists in prenatal diagnosis, your input is of high importance for the future of prenatal screening and diagnosis. We would like to investigate the acceptance of a cut off values for genetic testing in the current prenatal landscape, which was substantially changed by the introduction of techniques such as NIPT, microarray and prenatal exome sequencing. We hope that you can spend few minutes to share your opinions with us: This is link to the questionnaire: https://erasmusmcsurvey.erasmusmc.nl/nipt/ls/index.php/383489?newtest=Y Sharing the link with interested colleagues will be highly appreciated.
Project
For a very long time karyotyping was the only whole genome genetic test that was possible in pregnancy. With the recent rapid development and improvement of various techniques such as microarray, next generation sequencing, ultrasound imaging and genetic non-invasive prenatal testing more clinical research became possible. However what is technically available is not always directly clinically possible. Therefore not only a continuous development of techniques is challenging, but also implementation in clinical settings. Our multidisciplinary group covers all aspects of high resolution testing in pregnancy from making rapid testing possible and allowing informed choices to translating the results to patients and supporting decisions. Why we think the developments of the early diagnosis are important? The possibility of early diagnostics means the possibility of early interventions in pregnancy and after birth. Anyone interested in this topic is welcome to see what we have done so far or contact our group members. We are also looking forward to new national and international collaborations.