| 1. |
- Budin-Ljøsne, Isabelle, et al.
(författare)
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Feedback of Individual Genetic Results to Research Participants : Is It Feasible in Europe?
- 2016
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Ingår i: Biopreservation and Biobanking. - : Mary Ann Liebert Inc. - 1947-5535 .- 1947-5543. ; 14:3, s. 241-248
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: There is growing consensus that individual genetic research results that are scientifically robust, analytically valid, and clinically actionable should be offered to research participants. However, the general practice in European research projects is that results are usually not provided to research participants for many reasons. This article reports on the views of European experts and scholars who are members of the European COST Action CHIP ME IS1303 (Citizen's Health through public-private Initiatives: Public health, Market and Ethical perspectives) regarding challenges to the feedback of individual genetic results to research participants in Europe and potential strategies to address these challenges.MATERIALS AND METHODS: A consultation of the COST Action members was conducted through an email survey and a workshop. The results from the consultation were analyzed following a conventional content analysis approach.RESULTS: Legal frameworks, professional guidelines, and financial, organizational, and human resources to support the feedback of results are largely missing in Europe. Necessary steps to facilitate the feedback process include clarifying legal requirements to the feedback of results, developing harmonized European best practices, promoting interdisciplinary and cross-institutional collaboration, designing educational programs and cost-efficient IT-based platforms, involving research ethics committees, and documenting the health benefits and risks of the feedback process.CONCLUSIONS: Coordinated efforts at pan-European level are needed to enable equitable, scientifically sound, and socially robust feedback of results to research participants.
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| 2. |
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| 3. |
- Friberg-Fernros, Henrik, 1972
(författare)
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Hit but not down. The substance view in light of the criticism of Lovering and Simkulet
- 2018
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Ingår i: Bioethics. - : Wiley. - 0269-9702 .- 1467-8519. ; 32:6, s. 388-394
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Tidskriftsartikel (refereegranskat)abstract
- In his article The substance view: A critique', Rob Lovering argues that the substance view -according to which a human person comes into existence at the moment of conception - leads to such implausible implications that this view should be abandoned. I responded to his reductio arguments in A critique of Rob Lovering's criticism of the substance view' and concluded that his arguments did not justify a rejection of the substance view. Now Lowering and William Simkulet have both responded to my criticism, claiming that my criticism of Lovering's article did not refute his original arguments. In this article I respond to their criticism and conclude that, while the substance view has some less plausible implications, none of them justify a complete refutation of this view.
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| 4. |
- Helms, Karey, 1985-
(författare)
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A Speculative Ethics for Designing with Bodily Fluids
- 2022
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Konferensbidrag (refereegranskat)abstract
- This essay performs a speculative ethics in designing with a researcher's own bodily fluids. This is through the creation of "performative texts", which are autoethnographic accounts of past experiences in which written words perform through visual and spatial compositions alongside verbal readings aloud. I present three performative texts about moments of discomfort in designing with milk from my own breastfeeding relationship. They are to reflect upon felt experiences of potential harm and to understand social and material relations of care. From these I offer three possibilities for how HCI might consider the ethics of first-person research in attending to more-than-human entanglements: unsafe spaces, situated escapes, and censored inclusion. These possibilities and the approach of performative texts contribute to research for more sustainable futures by exploring the decentering of humans through an intimate engagement with the self.
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| 5. |
- Klingström, Tomas, et al.
(författare)
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Legal & ethical compliance when sharing biospecimen
- 2018
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Ingår i: Briefings in Functional Genomics & Proteomics. - Oxford : Oxford University Press. - 2041-2649 .- 2041-2657. ; 17:1, s. 1-7
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Forskningsöversikt (refereegranskat)abstract
- When obtaining samples from biobanks, resolving ethical and legal concerns is a time-consuming task where researchers need to balance the needs of privacy, trust and scientific progress. The Biobanking and Biomolecular Resources Research Infrastructure-large Prospective Cohorts project has resolved numerous such issues through intense ommunication between involved researchers and experts in its mission to unite large rospective study sets in Europe. To facilitate efficient communication, it is useful for onexperts to have an at least basic understanding of the regulatory systemformanaging biological samples. Laws regulating research oversight are based on national law and normally share core principles founded on international charters. In interview studies among donors, chief concerns are privacy, efficient sample utilization and access to information generated fromtheir samples. Despite a lack of clear evidence regarding which concern takes precedence, scientific as well as public discourse has largely focused on privacy concerns and the right of donors to control the usage of their samples. It is therefore important to roactively deal with ethical and legal issues to avoid complications that delay or prevent samples from being accessed. To help biobank professionals avoid making unnecessary mistakes, we have developed this basic primer covering the relationship between ethics and law, the concept of informed consent and considerations for returning findings to donors.
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| 6. |
- Klingström, Tomas, et al.
(författare)
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Supporting the Development of Biobanks in Low and Medium Income Countries
- 2016
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Ingår i: 2016 IST-AFRICA WEEK CONFERENCE. - 9781905824557
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Konferensbidrag (refereegranskat)abstract
- Biobanks are an organized collection of biological material and associated data. They are a fundamental resource for life science research and contribute to the development of pharmaceutical drugs, diagnostic markers and to a deeper understanding of the genetics that regulate the development of all life on earth. Biobanks are well established in High Income Countries (HIC) and are rapidly emerging in Low and Middle Income Countries (LMIC). Surveys among biobanks operating in a LMIC setting indicate that limited resources and short term funding tied to specific projects threaten the sustainability of the biobanks. Fit-for-purpose biobanks targeting major societal challenges such as HIV and Malaria provide an excellent basis for integrating biobanks with the available research communities in LMIC regions. But to become sustainable for the future it is important that biobanks become an integrated part of local research communities. To achieve this, the cost of operating biobanks must be lowered, templates must be developed to support local ethics committees and researchers must be given the opportunity to build experience in successfully operating biobank based research projects. The B3Africa consortium is based on these conclusions and set up to support biobank based research by creating a cost efficient Laboratory Information Management System (LIMS) for developing biobanks and also contribute to the training and capacity building in the local research community. The technical platform called the eB3Kit is open source and consists of a LIMS and a bioinformatics module based on the eBiokit that allow researchers to take control over the analysis of their own data. Along with the technical platform the consortium will also contribute training and support for the associated infrastructures necessary to regulate the ethical and legal implications of biobank based research.
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| 7. |
- McCormack, Pauline, et al.
(författare)
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'You should at least ask'. The expectations, hopes and fears of rare disease patients on large-scale data and biomaterial sharing for genomics research.
- 2016
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Ingår i: European Journal of Human Genetics. - : Springer Science and Business Media LLC. - 1018-4813 .- 1476-5438. ; 24:10, s. 1403-1408
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Tidskriftsartikel (refereegranskat)abstract
- Within the myriad articles about participants' opinions of genomics research, the views of a distinct group - people with a rare disease (RD) - are unknown. It is important to understand if their opinions differ from the general public by dint of having a rare disease and vulnerabilities inherent in this. Here we document RD patients' attitudes to participation in genomics research, particularly around large-scale, international data and biosample sharing. This work is unique in exploring the views of people with a range of rare disorders from many different countries. The authors work within an international, multidisciplinary consortium, RD-Connect, which has developed an integrated platform connecting databases, registries, biobanks and clinical bioinformatics for RD research. Focus groups were conducted with 52 RD patients from 16 countries. Using a scenario-based approach, participants were encouraged to raise topics relevant to their own experiences, rather than these being determined by the researcher. Issues include wide data sharing, and consent for new uses of historic samples and for children. Focus group members are positively disposed towards research and towards allowing data and biosamples to be shared internationally. Expressions of trust and attitudes to risk are often affected by the nature of the RD which they have experience of, as well as regulatory and cultural practices in their home country. Participants are concerned about data security and misuse. There is an acute recognition of the vulnerability inherent in having a RD and the possibility that open knowledge of this could lead to discrimination.
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| 8. |
- Munthe, Christian, 1962
(författare)
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A New Ethical Landscape of Prenatal Testing: Individualizing Choice to Serve Autonomy and Promote Public Health: A Radical Proposal
- 2015
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Ingår i: Bioethics. - : Wiley. - 0269-9702 .- 1467-8519. ; 29:1, s. 36-45
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Tidskriftsartikel (refereegranskat)abstract
- A new landscape of prenatal testing (PNT) is presently developing, including new techniques for risk-reducing, non-invasive sampling of foetal DNA and drastically enhanced possibilities of what may be rapidly and precisely analysed, surrounded by a growing commercial genetic testing industry and a general trend of individualization in healthcare policies. This article applies a set of established ethical notions from past debates on PNT for analysing PNT screening-programmes in this new situation. While some basic challenges of PNT stay untouched, the new development supports a radical individualization of how PNT screening is organized. This reformation is, at the same time, difficult to reconcile with responsible spending of resources in a publicly funded healthcare context. Thus, while the ethical imperative of individualization holds and applies to PNT, the new landscape of PNT provides reasons to start rolling back the type of mass-screening programmes currently established in many countries. Instead, more limited offers are suggested, based on considerations of severity of conditions and optimized to simultaneously serve reproductive autonomy and public health within an acceptable frame of priorities. The new landscape of PNT furthermore underscores the ethical importance of supporting and including people with disabilities. For the very same reason, no ban on what may be analysed using PNT in the new landscape should be applied, although private offers must, of course, conform to strict requirements of respecting reproductive autonomy and what that means in terms of counselling.
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| 9. |
- Munthe, Christian, 1962
(författare)
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Pragmatic Challenges in Practical Ethics
- 2023
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Ingår i: In: Garcia, A., Gunnemyr, M. & Werkmäster, J. Value, Morality & Social Reality: Essays dedicated to Dan Egonsson, Björn Petersson & Toni Rønnow-Rasmussen.. - Lund : Department of Philosophy, Lund University. - 9789189415669 ; , s. 275-285
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Bokkapitel (refereegranskat)abstract
- This brief essay traces a development of orthodox applied ethics into a present-day variant of practical ethics, where pragmatic reasons may upset ideal theoretically and empirically informed epistemically supported ethical prescriptions when these are to be implemented in a real context. This shift comes with a development where the applied ethicists of older days are nowadays aiming for much more specific and practically useful action-guidance, and for activist involvement to support feasible implementation of ethical prescriptions. This results in a strongly and moderately activist variant of practical ethics, both of which face specific challenges due to the necessity of considering pragmatic reasons. I argue that the radical variant has trouble managing these challenges. The moderate variant may manage them, but this may require substantial methodological development.
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| 10. |
- Munthe, Christian, 1962
(författare)
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Precautionary Principle
- 2013
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Ingår i: International Encyclopedia of Ethics. - Chichester : Blackwell. - 9781444367072
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Bokkapitel (refereegranskat)abstract
- Following the statement in the United Nations' Rio Declaration of 1992 that countries should apply a “precautionary approach” in policymaking on environmental and technological issues, the notion of a precautionary principle (PP) has gained ground in worldwide policymaking and regulation, thus catching the interest of ethics scholars. Although seldom explained in much detail, and resulting in quite different policy results in different countries and areas (O'Riordan et al. 2001; Sandin 1999; Trouwborst 2002; Zander 2010), PP is generally understood as a norm urging or permitting policymakers to take preventive action in the face of unknown, uncertain, or probable dangers, motivated by the experience of how seemingly valuable and promising practices may lead to seriously adverse consequences in spite of lack of solid evidence to this effect (Sandin 1999). In ethics debate, this idea has been applied not only to matters regarding the large-scale introduction and use of technology (e.g., regarding energy production, transport and communication, nano- or biotechnology, and so on) (see Biotechnology; Nanotechnology, Ethics of) with possible ensuing impact on the natural environment connecting to the notion of sustainability (see Sustainability), but also, for example, to abortion (see Abortion), medical genetics, embryo experimentation (see Embryo Research), the treatment of animals (see Animal Experimentation), terrorism (see Terrorism), and general research ethics (see Research Ethics) (Munthe 2011). Many of these applications advocate strong conclusions in spite of the fact that PP or its normative justification have not been made very clear. At the same time, PP has been the subject of criticism, much of which boils down to three points: lack of clarity, lack of practicality, and/or ethical implausibility. Curiously, these critical points have often been made in conjunction, in spite of the fact that a clear sense of what PP means seems necessary for backing up the other two objections.
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