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Recent eLetters

Displaying 1-10 letters out of 423 published

  1. Does the pragmatic model undermine the importance of the ethical obligations involved in information process? A defence of continuous genetic counselling for research participants.

    Hallowell et al. advocate an interesting pragmatic approach to the disclosure of genetic information in research settings. Furthermore, they present a useful framework which explicitly addresses advantages and disadvantages linked to different feedback policies researchers could pursue (Hallowell et al. 2014, table 1).

    We agree with the authors that the feedback of findings from whole- genome sequencing (WGS) or whole-exome sequencing (WES) technologies cannot be considered as automated processes of data disclosure. Since we have to take into account the research participant's autonomy as well as the prevention of possible harms related to the disclosure of genetic information, feedback policies have to be carefully chosen and thought over.

    In its evaluation of feedback policies, the authors state that no feedback undermines participant autonomy (policy A) and choosing their feedback option maximizes it (policy E) (Hallowell et al. 2014, table 1). However, more freedom to choose feedback options is not necessarily related to a more autonomous choice of the participant. It could be argued against Hallowell et al. that if in the information platforms suggested by Kaye et al. (2012) research participants were responsible to select on their own what level of research participation they consent to and which results they would access, this would not necessarily represent a more autonomous decision. This one-dimensional view of autonomy undermines the importance of intelligible communicative information transmission (Manson and O'Neill 2007) an essential and ethically demanded dimension of research participants' autonomous decision making (Eyal 2012).

    As an alternative to Hallowell et al. interpretation of autonomy, Manson and O'Neill (2007) suggest an agency-based approach that is based on informational and communicative obligations between the parties of counsellors and patients in a clinical context that could be extended to the process of information disclosure in genetic research. Assuming that the researcher's interest does not primarily focus on the information submission to the participants but on the generation of scientific knowledge, the agency-based approach between counsellor and participant could provide a better framework for assuring intelligible communicative information for the research participant. Autonomy should not refer only to more options to choose from, but also to an enhanced comprehension of information on possible harms and benefits of WGS/WES technologies.

    Hallowell et al. state that feedback of genetic findings goes hand in hand with extensive resources consumed due to the information costs arising in the communication process. Nonetheless, it can be objected that information costs should not exceed the normal information costs of a clinical setting. E.g. after receiving the research results and counselling the participant, the counsellor may initiate a personalized genetic test in order to correctly approve the general finding in the participant's personal context. Thus, the counsellor who stays in close contact with the participant is responsible for the information disclosure and information revealing is part of the counsellor-participant relationship. The counsellor therefore can be considered as the link between research (research results are usually published in journals or data bases) and the participant.

    Furthermore, it would be incorrect to consider researchers and sponsors as the only responsible agents for the costs of informational and communicative obligations. As it occurs with other ethical requirements in research settings such as post-trial obligations of access to beneficial information and interventions (WMA 2013 paragraphs 26 and 34, Mastroleo 2014), other agents -e.g. host country governments- have interests in and bear responsibility for the participants' health needs. So, following commonly held principles for conducting human health research, it could be argued that in advance of a clinical trial, sponsors, researchers and governments (among other agents) should make provisions and bear the economic costs of continuous genetic counselling for participants who may need it.

    Finally, besides discussing obligations of researchers towards participants and pointing out the numerous problems arising in this case (information costs, data quality, communication restrictions etc.), we should also focus on the communication process between counsellor and research participant as well as the counsellor's obligations towards potential participants prior to the participation in research projects. If we are taking seriously ethical obligation of genetic information process towards research participants, the consequences of data revealing should be discussed before samples are collected. Moreover, data disclosure should be a continuous process underlying the "nature" of genetic information: research on genetic data is an ongoing process; ideally it should be moderated by a counsellor to grant research participants truly informed and autonomous decisions.

    References

    Eyal, N. (2012). "Informed Consent", The Stanford Encyclopedia of Philosophy (Fall 2012 Edition), Edward N. Zalta (ed.), http://plato.stanford.edu/entries/informed-consent/#VolCon

    Hallowell, N., Hall, A., Alberg, C., Zimmern, R. (2014). "Revealing the results of whole-genome sequencing and whole-exome sequencing in research and clinical investigations: some ethical issues". JME; 0:1-5.

    WMA Declaration of Helsinki (2013). "Ethical Principles for Medical Research Involving Human Subjects.", http://www.wma.net/en/30publications/10policies/b3/

    Kaye, J., Curren, L., Anderson, N. (2012). From patients to partners: participant-centric initiatives in biomedical research. Nat Rev Genet; 3: 371-6.

    Manson, N., O'Neill, O. (2007). Rethinking informed consent in bioethics. Cambridge University Press, New York.

    Mastroleo, I. (2014). "Consideraciones sobre las obligaciones posinvestigaci?n en la Declaraci?n de Helsinki 2013." Revista de bio?tica y derecho; 31: 51-65, http://revistes.ub.edu/index.php/RBD/article/view/10438

    Acknowledgments

    We would like to thank Prof. Mertelsmann for helpful comments on this letter.

    Contributors

    Both authors were involved in the drafting and writing of this piece. Both authors approved the final version of the manuscript and are accountable for all aspects included in it.

    Conflict of Interest:

    None declared

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  2. Re:' Good Death'?

    Every person's death will be unique and their response to treatment not altogether predictable. The recent degrading way a man on 'death row' in USA was put to death, using drugs which prolonged his dying by around two hours was obviously grotesque . Doctors gave the injections. The limits of responsibility by prescribing doctors in UK if assisted dying becomes law, must be made clear to both persons receiving 'help' and prescribers so that s/he does not necessarily become liable of possible legal consequences should things 'go wrong'- the emotional pain of involvement in a bungled death would be difficult to handle to say the least.

    Conflict of Interest:

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  3. Headline-grabbing entertainment

    Honestly, this is one of the silliest articles I have ever read in the Journal of Medical Ethics. Apart from a host of other objections, I wonder if the author has investigated whether IVF actually raises the birth-rate, an essential consideration if she is to prove that the pitter- patter of little carbon footprints is environmentally unsustainable.

    I suspect that the net effect of IVF is to depress the birth-rate. One of the few studies of this issue was done in 2007 by Rand Europe http://goo.gl/U4VkVj. It pointed out that the availability of IVF leads women to delay child-bearing. For some of them it will be too late for them to have a child, even with IVF. If this is true, says the report, "then it may actually have a negative effect on the [total fertility rate] and consequently lead to further ageing of the population".

    Good theology, like good bioethics, is based on facts.

    Conflict of Interest:

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  4. Asking the Right Autonomy Question about Genomic Tests

    Eline Bunnik's comment(1) concludes with the observation that not all existing direct-to-consumer genetic tests enhance the autonomy of their consumers, not if autonomy is understood in the Razian sense employed in my article.(2) This is a demanding sense of autonomy, one that requires the presence of an adequate range of valuable options from which to choose. Bunnik's conclusion is difficult to disagree with, but that's because it is sheer commonsense. No existing services of any kind are guaranteed to enhance their consumers' autonomy. It all depends on various factors such as the nature and quality of the service, the conditions under which it is delivered, and the use made of it by consumers. What is surprising is that Bunnik reads me as disagreeing with this banal truth.

    Contrary to Bunnik's interpretation, in the article I explicitly stated that '[my] defence of DTC genomics in principle is not to be confused with the defence of existing DTC genomic services, which may be deficient in various ways. The point is that these deficiencies are not inherent and ineradicable' (p.4). So, contra Bunnik, I was not engaged in the na?ve, cheerleading enterprise of defending all existing forms of DTC genomic services, many of which are problematic in ways identified in the article. Instead, I argued that such services can, in principle, enhance autonomy if they meet certain conditions, and that this fact is sufficient to yield a pro tanto case for the legal permissibility of services that do in fact satisfy those conditions.

    Putting aside this radical misunderstanding, I turn now to the three 'crucial considerations' Bunnik claims that I overlook in supposedly rejecting her truistic conclusion.

    The first consideration is that 'genomic testing' is very heterogeneous, and that this limits our ability to make general moral assessments of such tests, including judgments about their utility. Again, it is odd that Bunnik reads me as disagreeing with this further truism. On the contrary, I emphasized that the medical actionability of DTC genomics depends on variables such as which kind of test is employed and which sort of condition is being investigated. Indeed, precisely because DTC genomic services exhibit considerable variety, I argued, it is wrong to endorse a sweeping skepticism about their utility, clinical or non-clinical.

    From the fact that DTC genomic services exhibit this variation, does it follow that it is impossible to identify general principles bearing on their legal permissibility? This is what Bunnik suggests, but provides no argument. Many of the phenomena regulated by law exhibit a similar variability, but it does not mean that we have to resort to a case-by-case assessment of their permissibility, one that does not draw on more general considerations. Indeed, Bunnik herself, in offering an alternative approach to autonomy-based arguments for DTC genomic services in her final paragraph, seems committed to the possibility of the sort of general moral assessments regarding which she expresses skepticism. If the heterogeneity of DTC genomic services stands in the way of a general assessment based on Razian autonomy, why is such an assessment suddenly possible when we substitute Bunnik's favoured concepts of agency, control and freedom? Inexplicably, she seems to want to have it both ways: denying the possibility of a general moral assessment while simultaneously offering one.

    Second, Bunnik claims that I 'confound' two distinct senses of autonomy, asking whether I argue 'that DTC genomic testing generates valuable options or that it is a valuable option'. Although there is a genuine distinction here, Bunnik does not explain why she thinks I overlook it and, if so, what trouble this causes for my argument. For the record, I believe that under certain conditions, DTC genomic testing can enhance autonomy in both ways: acquisition of the information it provides can itself be a valuable option, e.g. acquiring ones' raw data, knowledge of one's genealogy or the likely course of one's future health, and possession of this information can generate additional valuable options, e.g. to pursue family connections, or even to seek medical care, etc.(3,4)

    Third, I come to perhaps Bunnik's key criticism, i.e. 'most of these tests do not generate (actionable) options at all, medical or non- medical'. Everything here depends on the slippery qualification 'most'. The success of my argument does not depend on showing that all or most existing DTC genomic services generate valuable options. It only requires a plausible case for believing that DTC genomic services are capable of generating such valuable options under feasibly attainable circumstances. In the article, I enumerated a number of valuable options such services are able to generate beyond clinical utility: enhanced knowledge of one's genetic constitution, participation in medical research, information about ancestry, and so on. Bunnik asserts that these options lack the value necessary for Razian autonomy, but in the absence of an adequate supporting argument, this remains an assertion. At one point, Bunnik appears to dismiss such utilities by saying there is a difference between perceived utility and actual utility. However, this distinction does not license the somber conclusion that the enjoyment people derive from DTC genomic services, e.g. by participating in research, fails to enhance their well-being. (5,6) Enjoyment, knowledge and accomplishment, which can be achieved through such participation, are familiar elements of human well-being.(7)

    Finally, it is worth noting Bunnik's claim that autonomy-based arguments for a liberal regulatory approach to DTC genomic services should appeal to a narrow sense of autonomy, rather than the 'thick' Razian employed in my article. This narrow sense would, among other things, dispense with the requirement of an adequate range of valuable options. Bunnik's contention, summarily delivered in the final paragraph, is that autonomy-based arguments should instead rely on the less demanding 'values' of agency, control, and freedom to decide. Bunnik is certainly right that this would be an easier way of defending DTC genomic services. But the real question is whether it is so easy that it provides no real defence. Such a defence will be made out only if bare agency, control and freedom to decide are truly 'values' and, moreover, values with a claim to be respected and promoted through law and public policy. Yet this is precisely what leading philosophical critics of the narrow sense of autonomy, such as O'Neill and Raz, have called into questioned. In the absence of a response to such critics, Bunnik's alternative approach to autonomy remains under-motivated.

    In short, for the greater part of her response, Bunnik wrestles with an opponent of her own imagining. To the extent that she genuinely engages with claims that I make, her contentions - about clinical/non-clinical utility and the proper understanding of autonomy - ultimately beg the question.

    References:

    1. Bunnik E. Do genomic tests enhance autonomy? J Med Ethics. 2014 Jun 30. pii: medethics-2014-102171.

    2. Vayena E. Direct-to-consumer genomics on the scales of autonomy. J Med Ethics. 2014 May 5. doi: 10.1136/medethics-2014-102026.

    3. Roberts ME, Riegert-Johnson DL, Thomas BC. Self diagnosis of Lynch syndrome using direct to consumer genetic testing: a case study. J Genet Couns. 2011 Aug;20(4):327-9. doi: 10.1007/s10897-011-9356-y.

    4. Francke U, Dijamco C, Kiefer AK, Eriksson N, Moiseff B et al. Dealing with the unexpected: consumer responses to direct-access BRCA mutation testing. PeerJ 2013 1:e8 http://dx.doi.org/10.7717/peerj.8

    5. Vayena E, Ineichen C, Stoupka E, Hafen E. Playing a part in research? University students' attitudes to direct-to-consumer genomics. Public Health Genomics. 2014;17(3):158-68. doi: 10.1159/000360257.

    6. Vayena E, Gourna E, Streuli J, Hafen E, Prainsack B. Experiences of early users of direct-to-consumer genomics in Switzerland: an exploratory study. Public Health Genomics. 2012;15(6):352-62. doi: 10.1159/000343792.

    7. Griffin J. Value Judgment: Improving our Ethical Beliefs (Oxford University Press, 1996), pp.29-30

    Conflict of Interest:

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  5. Re:PROFESSIONAL JEALOUSY IS HIGH AMONG DOCTORS

    Cannot agree more than this title. This "Live and Let die" attitude is probably highest amongst doctors, whether in academic or non academic set up. You send a manuscript for publication; You will find a jealous reviewer colleague (often donot even know you personally, but have competing interest) will turn it down as "reject" only to publish his similar work in a short time by clever means of planted peer review. So, "offence is the best defence"? This disgustingly painful attitude of grown ups, often called Gods by their patients act in so demeaning way that one needs to think how to purify these souls. I think the so called "publish or perish" culture is responsible for it. One more reason is the rat race of making science more complex and complicated ( and you must know for sure that information not understood easily is far from truth, as all truths are simple) by basic science without clear clinical correlate and industry driven, so called "evidence based medicine". True personalised medicine (and that is true basic science of medicine) may be the answer . Respect for clinical science also needs be preserved at the earliest. Just imagine, there is no nobel prize for true Clinical medicine. Why not - if it can be there for economics and peace? Will the childish behaviour in the form of professional jealousy ever disappear? If only they understand the real ethos of a physician which is forgotten by most of us.

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  6. Neuberger review evidence

    You seem to have based your article on the evidence contained in the Neuberger Review [NR]. I note myself with some dismay that the actual evidence submitted to it was never published in full (names redacted of course), so we'll never know what complaints were actually received or considered by this panel. John Ellershaw (who wrote the LCP) was permitted to use his complaints databases in Liverpool as examples, according to the 'Rapid Evidence Review' published with the NR itself.

    According to this review, the methodology was approved by the panel, but involved a search of a database specifically using the Key Word 'Liverpool Care Pathway' for a tiny tiny period of time. In the area used for the review, covered by the CNG for Wirral and Cheshire, the End of Life care pathway was called variously 'The Vigil Pathway' and other descriptors. One complaint about its use at the HQ of the LCP appears to have been missed out completely - it is this case: http://www.dailymail.co.uk/news/article-1219853/My-husband-beaten-cancer- doctors-wrongly-told-returned-let-die.html - the case involved someone who was in charge of the Liverpool Deanery and training for the Joint Royal Colleges - perverse to blame 'poor training' therefore when the authors cannot even use it safely themselves!

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  7. ' Good Death'?

    Since the first version was published in 2003, up until the LCP renal prescribing guidelines were issued in 2008, versions of the Liverpool Care Pathway issued to staff in Acute Hospitals mandated the use of Diamorphine for relief of both 'pain' and 'breathlessness'.

    Administering these drugs to anyone in renal compromise must have led to thousands of appalling and undiginified bad deaths - delirium and hallucinations are as dreadful for the patient and those witnessing their demise.

    I appreciate that the owners of the copyright to this pathway will have to shed a few of their better paid senior staff if the new NHS Commissioners don't use it, but they really are flogging a dead horse.

    And paying the RCP to produce a selective audit relating to 'poor implementation' doesn't really constitute the kind of evidence needed to convince a public to consent to being put on this pathway.

    Conflict of Interest:

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  8. Which version of Liverpool Care Pathway are you referring to?

    Seems odd that you gloss over the fact that there were two versions of this copyright-owned 'care' pathway, and that you only cite 'evidence' from a review that examined only one of them, whilst neatly skirting around the other.

    Version 11 had no consent process attached. Version 11 did not even inquire whether the patient and their family could speak English until after a decision to put them on the pathway had been taken. Version 11 was still in use AFTER the Code of Conduct accompanying the Mental Capacity Act came into force (1st October 2008) - this demanded 'Informed Consent' for ALL medical treatment recommended.

    I would have thought someone with an interest in 'Medical Ethics' would have spotted that!

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  9. Forced circumcision of children also unethical

    This is a very telling paper, for if it is true that forced circumcision of an adult male is a violation of his human rights, it must follow that forced circumcision of a male minor - a boy or an infant - is a violation of his human rights and equally wrong. The age at which it is done does not matter - as you can see from a simple thought experiment.

    It is held by many people in Australia and the United States that parents have the right to circumcise their (male) children, and by even more people in the Middle East, North Africa and South East Asia that they have the right to circumcise their female children as well. How old do the children have to be before parents lose this right? Would it be OK for parents to forcibly circumcise a 25-year-old, male or female? Most people would probably say No, but what about an 18-year old? A 15-year-old? Ten years? Five years? Two years? Six months? Six weeks? We may predict that the number of people answering Yes will increase as we go down the age scale, but what is the basis for their judgement? Where is the dividing line where circumcision without consent becomes unacceptable (going up), or acceptable (going down)? And what are the criteria for placing it there? The fact is that it really makes no difference when a boy or girl is circumcised; whatever the age, it is just as much a violation of his (or her) physical integrity and personal autonomy, and the result is just the same: permanent loss and/or disfigurement of a functional body part. No matter when it is done the result is the same: for the rest of his life he will be deprived of his foreskin, and she will bear the scars of whatever operation was performed on her.

    The reason that circumcision advocates insist on circumcision in infancy or early childhood is not because circumcision at that age is safer or attended by fewer complications, despite their claims to the contrary, and certainly not because it has to be done that early for the full extent of the "benefits" to be available. The real reason advocates demand infant circumcision is that early circumcision is simpler and more convenient for the adults because the infant or child has little or no power to object or resist. The older he or she is, the greater his/her powers of resistance.

    Conflict of Interest:

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  10. Moral Enhancement

    Technology they say is manipulation of Nature. It is now the time for manipulation of behavior and even morality. Drugs will make in future a more morally responsible person. Exogenous chemicals will influence human behavior. Science and scientific inquiry seem to touch areas that are sensitive for manipulation.

    Morality is developed behavior through family, culture and customs. It is spontaneous and not drug induced. Oxytocin can be a marker of love and it cannot replicate love.

    We are humans we feel and respond to environment naturally. Even if it is led to the corridors of research to be dissected the uniqueness of what makes us human will be lost in the dissecting table.

    Conflict of Interest:

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