0A4F4F9BD490A749D5437F821CF06DF1
Opinion No. 54: Post Mortem Removal of Human Body Material for Human Medical Applicataions or for Scientific Research Purposes (2012)
https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/opinion_54_web.pdf
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / Criminal Convictions
Searching for indicator prisoners:
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p.000022: light of the essential importance of public health.
p.000022:
p.000022: 4) Practical effects of the opt-out regime
p.000022:
p.000022: As well as sending a clear signal about the social significance of participation in research, the opt-out scheme is one
p.000022: of the most direct ways, though not the only one, to ensure that enough body material is removed. This seems entirely
p.000022: ethically justified as a goal on the part of legislators for the following reasons:
p.000022:
p.000022: The effect of ethical regulation on the sources of human body material
p.000022:
p.000022: Using legal provisions and social structures in a country to ensure that researchers have enough material
p.000022: available is a way of combating the trafficking and black market practices to which demand for human body material
p.000022: worldwide gives rise, although it is not enough in itself to put a stop to those practices.55 By creating the
p.000022: conditions for the collection of sufficient (though not unlimited: on this point see the recommendations
p.000022: of the members supporting this position) amounts of material, legislators can ensure, among other things, the ethical
p.000022: regulation of the demand for and use of human body material by researchers. When the needs for human body
p.000022: material are met through official channels in a country, there is less risk of "unofficial" circuits
p.000022: controlled by criminal gangs developing to meet those needs. This indirectly protects socially vulnerable
p.000022: categories of people (such as prisoners) who are the regular victims of these networks in some countries.
p.000022:
p.000022: A simplifying and clarifying effect on rules and structures
p.000022:
p.000022: The rules for the regulation and control of human body material in an enormous variety of contexts (transplantation,
p.000022: fertilisation, development of treatments, removal, analysis, research, storage, transportation, etc.)
p.000022: are becoming increasingly complex and require multiple regulatory or inspection bodies. This causes delays,
p.000022: increases costs and leads to confusion of responsibilities and categorisation. The current system, which
p.000022: encompasses the post mortem donation of organs, tissues and cells for transplantation and/or scientific
p.000022: research in a single model (the opt-out regime), concentrates responsibilities for the issue of human body material
p.000022: within human biomaterial institutions and biobanks and reduces the quantity of records and the number of stages in the
p.000022: process. This constitutes a guarantee of
p.000022:
p.000022:
p.000022: 55 See the report published in Le Monde on 22 July 2012.
p.000022:
p.000023: 23
p.000023: FINAL VERSION
p.000023:
p.000023: safety and practicality.
p.000023:
p.000023: The clarity of the system is one of the factors that have led to a consensus in France, where the opt-out system for
p.000023: the removal of tissue or organs has existed since 2003, apparently without having caused any particular problems
p.000023: so far. The creation of the National Committee for Biovigilance, whose work is coordinated by the National Agency
p.000023: for Medicines and Health Products Safety (MSNA), has enabled collection and other activities relating to
...
Political / criminal
Searching for indicator criminal:
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p.000017: consciousness of the person concerned.
p.000017:
p.000017: Of course, it may be objected that in this case, the (legal) person is still alive and that this is a fundamental
p.000017: difference. However, various authors argue that, like a person who has died, a person who is no longer capable has
p.000017: undergone a crucial (though less drastic) change to his or her personal identity, which leads us to conclude that
p.000017: even in the case of a persistent vegetative state, the person who was previously capable is regarded as
p.000017: the person who incurs the harm, rather than the subsequently incapable person.46
p.000017:
p.000017: Joel Feinberg, well known for his analysis of the concept of harm, stresses that:
p.000017:
p.000017: All interests are the interests of some person or other and a person’s surviving interests are simply
p.000017: the ones that we identify by naming him, the person whose interests they were. He is of course at that moment
p.000017: dead but that does not prevent us from referring now, in the present tense, to his interests, if they are still capable
p.000017: of being blocked or fulfilled, just as we refer to his outstanding debts or claims, as if they are still capable of
p.000017: being paid.47
p.000017:
p.000017:
p.000017: 44 See e.g. R.A. Belliotti. Posthumous Harm: Why the Dead Are Still Vulnerable. Lanham, Md.: Lexington
p.000017: Books, 2012.
p.000017: 45 J. Feinberg. The Moral Limits of the Criminal Law, Vol. I, Harm to Others. Oxford University Press, 1984.
p.000017: 46 See for example A. Buchanan, “Advance directives and the personal identity problem” Philosophy and Public
p.000017: Affairs 1988; 17(4): 277-302; H. Kuhse, “Some reflections on the problem of advance directives, personhood and personal
p.000017: identity” Kennedy Institute of Ethics Journal 1999; 9(4): 347- 364.
p.000017: 47 J. Feinberg. The Moral Limits of the Criminal Law, Vol. I, Harm to Others. Oxford University Press, 1984, 83.
p.000017:
p.000018: 18
p.000018: FINAL VERSION
p.000018:
p.000018: He argues that it is absurd to think that as soon as the person to whom we have promised something dies, an
p.000018: unfulfilled promise which was made while that person was still alive ceases to be a serious injustice to him
p.000018: or her.48 Such an outlook seems far from counter- intuitive or controversial.
p.000018:
p.000018: It might be objected that even if the existence of "surviving interests" and "posthumous harm" is
p.000018: conceded, the deceased is in any case no longer able to assert any rights, and that surviving interests are thus
p.000018: completely devoid of substance. However, this argument can be countered with the point that the obligation to uphold
p.000018: such interests is based on the rights that the person was able to exercise ante mortem and that while the rights
p.000018: themselves may have lapsed, some of the duties associated with them survive post mortem. In this light,
p.000018: surviving duties may very well exist without there being any surviving rights.
p.000018:
p.000018: Wellmann stresses, for example, that although rights cannot survive the death of their holder, certain
p.000018: duties arising from these rights may continue to exist and therefore imply future duties for others. He adds: “But
p.000018: this need not be to ascribe rights to the dead; it can and should be to assert that the rights of the living continue
p.000018: to impose duties even after the persons who possessed those rights have ceased to exist.”49 The same reasoning,
...
p.000018: nevertheless exists.
p.000018:
p.000018: According to these Committee members, scientists and clinicians do not have the right to take the decision to use
p.000018: body material post mortem for research purposes in lieu of the person concerned. The potential donor must
p.000018: have had the opportunity to make sure that he or she was willing to contribute to biomedical research by
p.000018: donating body material post mortem, and, if so, to explain what type of research he or she would regard as
p.000018: acceptable in the light of his or her moral values (see also below).
p.000018:
p.000018: If this opportunity to give specific authorisation is not provided, and if consent is simply assumed "in
p.000018: the interests of science", it is perfectly conceivable that the body material will be used in a way that is completely
p.000018: incompatible with the person’s values, which amounts to unacceptable exploitation. Regarding the use of
p.000018: leftover body material for research purposes, this reasoning is developed convincingly by bioethicist Julian
p.000018: Savulescu:
p.000018:
p.000018: Each mature person should be the author of his or her own life. Each person has values, plans,
p.000018: aspirations, and feelings about how that life should go. People have values which may collide with research
p.000018: goals [...]. To ask a person’s permission to do something to that person is to involve her actively and to give her the
p.000018: opportunity to make the project a part of her plans. When we involve people in our projects without
p.000018:
p.000018:
p.000018: 48 J. Feinberg. The Moral Limits of the Criminal Law, Vol. I, Harm to Others. Oxford University Press, 1984, 95. See
p.000018: also D. Price. Human Tissue in Transplantation and Research: A Model Legal and Ethical Donation Framework.
p.000018: Cambridge: Cambridge University Press, 2010: 61.
p.000018: 49 C. Wellmann. Real Rights. Oxford: Oxford University Press, 1995: 156.
p.000018:
p.000019: 19
p.000019: FINAL VERSION
p.000019:
p.000019: their consent we use them as a means to our own ends.50
p.000019:
p.000019: It should also be noted in passing that making body material anonymous or coding it does not undermine this argument at
p.000019: all, as such procedures only provide protection in the area of privacy,51 but in no way guarantee respect for the
p.000019: values of the deceased.
p.000019:
p.000019: It should further be borne in mind that a person can be held morally complicit if his or her body material is used
p.000019: for a purpose to which he or she has moral objections. Moral complicity means that we can do something
p.000019: wrong just by being linked to unjust acts committed by others. This is obviously the case where a
p.000019: person has helped cause the injustice, but there can also be moral complicity if a person has made an
p.000019: injustice more likely to occur, even without making a strictly causal contribution.52
p.000019:
p.000019: The importance of enabling people to avoid posthumous moral complicity is, in the view of these members of the
p.000019: Committee, an additional reason for not accepting the system of presumed consent for the post mortem use of
p.000019: body material.
p.000019:
p.000019:
...
p.000019: why they consider the 2008 Law as satisfactory on this point, since it provides the opportunity to rebut
p.000019: the presumption. However, they consider it regrettable that the population is not more aware of this possibility, and
p.000019: think that this lack of information should be remedied by all appropriate means (see recommendations): citizens
p.000019: have the right to know the arrangements that the legislators have made in this area, which may have a direct
p.000019: impact on their bodies after their
p.000019:
p.000019: 50 J. Savulescu, “For and Against: No Consent Should Be Needed for Using Leftover Body Material for Scientific
p.000019: Purposes – Against” British Medical Journal 2000; 325: 648, 649. A comparable view is found in, for example, R. Rhodes,
p.000019: “Rethinking Research Ethics” American Journal of Bioethics 2005; 7: 16-17.
p.000019: 51 Moreover, various studies have shown that even such protection cannot be guaranteed. See e.g. McGuire,
p.000019: A.L. & Gibbs, R.A. (2006), “Genetics. No longer de-identified”, Science 312, pp. 370–371. See also Schmidt, H. &
p.000019: Callier, S. (2012), “How anonymous is 'anonymous'? Some suggestions towards a coherent universal coding system
p.000019: for genetic samples”, Journal of Medical Ethics 38(5), pp. 304-309. See also Lowrance, W.W. & Collins, F.S. (2007),
p.000019: “Identifiability in genomic research”, Science 317, pp. 600–602.
p.000019: 52 As examples of the interesting literature on moral complicity, see John Gardner, “Complicity and Causality”
p.000019: Criminal Law and Philosophy 2007; 1: 127-141; Ronald M. Green, “Benefiting from ‘Evil’: An Incipient Moral Problem in
p.000019: Human Stem Cell Research” Bioethics 2002; 16: 544-556; Christopher Kutz, Complicity: Ethics and Law for a Collective
p.000019: Age. Cambridge: Cambridge University Press, 2000; and Helen Watt, ed., Cooperation, Complicity & Conscience – Problems
p.000019: in Healthcare, Science, Law and Public Policy. London: The Linacre Centre, 2006.
p.000019:
p.000020: 20
p.000020: FINAL VERSION
p.000020:
p.000020: death, and to be told the reasons for these measures and the ways of registering an objection to them.
p.000020: They argue that it is under these conditions of clarity, publicity and education that the profoundly
p.000020: ethical significance of this system can be preserved.
p.000020:
p.000020: These members stress that the opt-out system must involve transparency and honesty with the general public – and hence
p.000020: the repeated provision of comprehensive explanations of its principle, its purpose and how it works. This is required
p.000020: firstly because of the sensitive area to which it relates – the use of body material after death – but
p.000020: also because it reflects a certain climate of trust: in return for the limitation of individual autonomy that the
p.000020: scheme involves, for reasons relating to the public interest and the public good, as will be explained below, the legal
p.000020: regime in this area must be perfectly transparent.
p.000020:
...
p.000022: objection.
p.000022:
p.000022: The restriction that it potentially introduces to individual autonomy does not seem here to be disproportionate in
p.000022: light of the essential importance of public health.
p.000022:
p.000022: 4) Practical effects of the opt-out regime
p.000022:
p.000022: As well as sending a clear signal about the social significance of participation in research, the opt-out scheme is one
p.000022: of the most direct ways, though not the only one, to ensure that enough body material is removed. This seems entirely
p.000022: ethically justified as a goal on the part of legislators for the following reasons:
p.000022:
p.000022: The effect of ethical regulation on the sources of human body material
p.000022:
p.000022: Using legal provisions and social structures in a country to ensure that researchers have enough material
p.000022: available is a way of combating the trafficking and black market practices to which demand for human body material
p.000022: worldwide gives rise, although it is not enough in itself to put a stop to those practices.55 By creating the
p.000022: conditions for the collection of sufficient (though not unlimited: on this point see the recommendations
p.000022: of the members supporting this position) amounts of material, legislators can ensure, among other things, the ethical
p.000022: regulation of the demand for and use of human body material by researchers. When the needs for human body
p.000022: material are met through official channels in a country, there is less risk of "unofficial" circuits
p.000022: controlled by criminal gangs developing to meet those needs. This indirectly protects socially vulnerable
p.000022: categories of people (such as prisoners) who are the regular victims of these networks in some countries.
p.000022:
p.000022: A simplifying and clarifying effect on rules and structures
p.000022:
p.000022: The rules for the regulation and control of human body material in an enormous variety of contexts (transplantation,
p.000022: fertilisation, development of treatments, removal, analysis, research, storage, transportation, etc.)
p.000022: are becoming increasingly complex and require multiple regulatory or inspection bodies. This causes delays,
p.000022: increases costs and leads to confusion of responsibilities and categorisation. The current system, which
p.000022: encompasses the post mortem donation of organs, tissues and cells for transplantation and/or scientific
p.000022: research in a single model (the opt-out regime), concentrates responsibilities for the issue of human body material
p.000022: within human biomaterial institutions and biobanks and reduces the quantity of records and the number of stages in the
p.000022: process. This constitutes a guarantee of
p.000022:
p.000022:
p.000022: 55 See the report published in Le Monde on 22 July 2012.
p.000022:
p.000023: 23
p.000023: FINAL VERSION
p.000023:
p.000023: safety and practicality.
p.000023:
p.000023: The clarity of the system is one of the factors that have led to a consensus in France, where the opt-out system for
p.000023: the removal of tissue or organs has existed since 2003, apparently without having caused any particular problems
...
Political / political affiliation
Searching for indicator party:
(return to top)
p.000017:
p.000018: 18
p.000018: FINAL VERSION
p.000018:
p.000018: He argues that it is absurd to think that as soon as the person to whom we have promised something dies, an
p.000018: unfulfilled promise which was made while that person was still alive ceases to be a serious injustice to him
p.000018: or her.48 Such an outlook seems far from counter- intuitive or controversial.
p.000018:
p.000018: It might be objected that even if the existence of "surviving interests" and "posthumous harm" is
p.000018: conceded, the deceased is in any case no longer able to assert any rights, and that surviving interests are thus
p.000018: completely devoid of substance. However, this argument can be countered with the point that the obligation to uphold
p.000018: such interests is based on the rights that the person was able to exercise ante mortem and that while the rights
p.000018: themselves may have lapsed, some of the duties associated with them survive post mortem. In this light,
p.000018: surviving duties may very well exist without there being any surviving rights.
p.000018:
p.000018: Wellmann stresses, for example, that although rights cannot survive the death of their holder, certain
p.000018: duties arising from these rights may continue to exist and therefore imply future duties for others. He adds: “But
p.000018: this need not be to ascribe rights to the dead; it can and should be to assert that the rights of the living continue
p.000018: to impose duties even after the persons who possessed those rights have ceased to exist.”49 The same reasoning,
p.000018: incidentally, lies behind the continuation of certain contractual obligations after the death of the other party to the
p.000018: contract.
p.000018:
p.000018: 3. The need to be able to avoid moral complicity with the achievement of goals one finds morally
p.000018: objectionable
p.000018:
p.000018: A final reason that members of the Committee opposed to the extension of the system of presumed consent as provided for
p.000018: in the Law of 19 December 2008 wish to expound relates to the importance of being able to avoid moral
p.000018: complicity with behaviour that we find objectionable.
p.000018:
p.000018: Each of us has certain moral values that are reflected in life plans. These values may conflict with the methods and/or
p.000018: goals of certain types of biomedical research. Even in the case of post mortem research on body material, where
p.000018: health risks and threats to privacy can no longer be a concern for the donor, a risk of non-pecuniary harm
p.000018: nevertheless exists.
p.000018:
p.000018: According to these Committee members, scientists and clinicians do not have the right to take the decision to use
p.000018: body material post mortem for research purposes in lieu of the person concerned. The potential donor must
p.000018: have had the opportunity to make sure that he or she was willing to contribute to biomedical research by
p.000018: donating body material post mortem, and, if so, to explain what type of research he or she would regard as
p.000018: acceptable in the light of his or her moral values (see also below).
p.000018:
p.000018: If this opportunity to give specific authorisation is not provided, and if consent is simply assumed "in
...
Political / vulnerable
Searching for indicator vulnerable:
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p.000017: that are ignored. The principle that such wishes must be respected 'survives' the loss of mental abilities and
p.000017: consciousness of the person concerned.
p.000017:
p.000017: Of course, it may be objected that in this case, the (legal) person is still alive and that this is a fundamental
p.000017: difference. However, various authors argue that, like a person who has died, a person who is no longer capable has
p.000017: undergone a crucial (though less drastic) change to his or her personal identity, which leads us to conclude that
p.000017: even in the case of a persistent vegetative state, the person who was previously capable is regarded as
p.000017: the person who incurs the harm, rather than the subsequently incapable person.46
p.000017:
p.000017: Joel Feinberg, well known for his analysis of the concept of harm, stresses that:
p.000017:
p.000017: All interests are the interests of some person or other and a person’s surviving interests are simply
p.000017: the ones that we identify by naming him, the person whose interests they were. He is of course at that moment
p.000017: dead but that does not prevent us from referring now, in the present tense, to his interests, if they are still capable
p.000017: of being blocked or fulfilled, just as we refer to his outstanding debts or claims, as if they are still capable of
p.000017: being paid.47
p.000017:
p.000017:
p.000017: 44 See e.g. R.A. Belliotti. Posthumous Harm: Why the Dead Are Still Vulnerable. Lanham, Md.: Lexington
p.000017: Books, 2012.
p.000017: 45 J. Feinberg. The Moral Limits of the Criminal Law, Vol. I, Harm to Others. Oxford University Press, 1984.
p.000017: 46 See for example A. Buchanan, “Advance directives and the personal identity problem” Philosophy and Public
p.000017: Affairs 1988; 17(4): 277-302; H. Kuhse, “Some reflections on the problem of advance directives, personhood and personal
p.000017: identity” Kennedy Institute of Ethics Journal 1999; 9(4): 347- 364.
p.000017: 47 J. Feinberg. The Moral Limits of the Criminal Law, Vol. I, Harm to Others. Oxford University Press, 1984, 83.
p.000017:
p.000018: 18
p.000018: FINAL VERSION
p.000018:
p.000018: He argues that it is absurd to think that as soon as the person to whom we have promised something dies, an
p.000018: unfulfilled promise which was made while that person was still alive ceases to be a serious injustice to him
p.000018: or her.48 Such an outlook seems far from counter- intuitive or controversial.
p.000018:
p.000018: It might be objected that even if the existence of "surviving interests" and "posthumous harm" is
p.000018: conceded, the deceased is in any case no longer able to assert any rights, and that surviving interests are thus
p.000018: completely devoid of substance. However, this argument can be countered with the point that the obligation to uphold
...
p.000022: light of the essential importance of public health.
p.000022:
p.000022: 4) Practical effects of the opt-out regime
p.000022:
p.000022: As well as sending a clear signal about the social significance of participation in research, the opt-out scheme is one
p.000022: of the most direct ways, though not the only one, to ensure that enough body material is removed. This seems entirely
p.000022: ethically justified as a goal on the part of legislators for the following reasons:
p.000022:
p.000022: The effect of ethical regulation on the sources of human body material
p.000022:
p.000022: Using legal provisions and social structures in a country to ensure that researchers have enough material
p.000022: available is a way of combating the trafficking and black market practices to which demand for human body material
p.000022: worldwide gives rise, although it is not enough in itself to put a stop to those practices.55 By creating the
p.000022: conditions for the collection of sufficient (though not unlimited: on this point see the recommendations
p.000022: of the members supporting this position) amounts of material, legislators can ensure, among other things, the ethical
p.000022: regulation of the demand for and use of human body material by researchers. When the needs for human body
p.000022: material are met through official channels in a country, there is less risk of "unofficial" circuits
p.000022: controlled by criminal gangs developing to meet those needs. This indirectly protects socially vulnerable
p.000022: categories of people (such as prisoners) who are the regular victims of these networks in some countries.
p.000022:
p.000022: A simplifying and clarifying effect on rules and structures
p.000022:
p.000022: The rules for the regulation and control of human body material in an enormous variety of contexts (transplantation,
p.000022: fertilisation, development of treatments, removal, analysis, research, storage, transportation, etc.)
p.000022: are becoming increasingly complex and require multiple regulatory or inspection bodies. This causes delays,
p.000022: increases costs and leads to confusion of responsibilities and categorisation. The current system, which
p.000022: encompasses the post mortem donation of organs, tissues and cells for transplantation and/or scientific
p.000022: research in a single model (the opt-out regime), concentrates responsibilities for the issue of human body material
p.000022: within human biomaterial institutions and biobanks and reduces the quantity of records and the number of stages in the
p.000022: process. This constitutes a guarantee of
p.000022:
p.000022:
p.000022: 55 See the report published in Le Monde on 22 July 2012.
p.000022:
p.000023: 23
p.000023: FINAL VERSION
p.000023:
p.000023: safety and practicality.
p.000023:
p.000023: The clarity of the system is one of the factors that have led to a consensus in France, where the opt-out system for
p.000023: the removal of tissue or organs has existed since 2003, apparently without having caused any particular problems
p.000023: so far. The creation of the National Committee for Biovigilance, whose work is coordinated by the National Agency
...
Health / Comatose
Searching for indicator coma:
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p.000016: 40 M. Wicclair, “Ethics and research with deceased patients” Cambridge Quarterly of Healthcare Ethics
p.000016: 2008; 17(1): 87-97.
p.000016: 41 Law Reform Commission of Canada. Procurement and transfer of human tissues and organs, working paper
p.000016: 66, 1992: 45.
p.000016: 42 For an analysis of these principles, see e.g. D. Price. Human Tissue in Transplantation and
p.000016: Research: A Model Legal and Ethical Donation Framework. Cambridge: Cambridge University Press, 2010. The summary of the
p.000016: arguments that we present here is largely drawn from this impressive work.
p.000016: 43 R. Dworkin. Life’s Dominion. London: Harper Collins, 1993: 199-217.
p.000016:
p.000017: 17
p.000017: FINAL VERSION
p.000017:
p.000017: character and moral values most closely. Unlike experiential interests, critical interests may be harmed after death.44
p.000017:
p.000017: A remark frequently heard regarding the determination of what happens to one’s own body material after death is
p.000017: that it may be a matter of critical interest while the person is still alive, but not subsequently,
p.000017: because (as stated earlier), there is no longer a subject and hence no longer the possibility of regressive
p.000017: causality of the negation of this critical interest.
p.000017:
p.000017: It may be objected to the point on the lack of a subject that it is generally recognised in other contexts that
p.000017: individuals’ interests may be harmed without their being aware of it at the time or in the future. For example, one may
p.000017: be the victim of theft or defamation without being aware of it, or fall into a coma, meaning that others have to make
p.000017: crucial decisions that fundamentally affect one’s welfare. It is therefore wrong to believe that we can only have an
p.000017: interest in things of which we are conscious. In short, the "mental state account of harm,"
p.000017: i.e. the idea that one must be aware of harm for there to be any harm at all, is inadequate.
p.000017:
p.000017: Wishes can be fulfilled by events after the death of the person concerned just as they can by events during his or her
p.000017: lifetime. Fulfilment of wishes in the former case is just as positive as in the latter. It is true that the dead may
p.000017: never know whether their wishes have actually been fulfilled or have been ignored, but it is not clear why a simple
p.000017: lack of knowledge of what has happened would imply that they have not been harmed by their wishes being ignored.45
p.000017:
p.000017: In short, regardless of whether a person is aware of the fulfilment or non-fulfilment of his or her wishes, harm can be
p.000017: caused simply by non-fulfilment of those wishes. Such a concept of harm that is unrelated to one’s experience of it
p.000017: adequately captures the very essence of the problem that arises when prior manifestations of wishes (advance
p.000017: directives) are not respected. For example, if the wishes of persons in a persistent vegetative state that have been
p.000017: expressed independently beforehand are ignored, it is the wishes of the previously mentally capable person
...
Health / Drug Usage
Searching for indicator influence:
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p.000015: because it manifests and protects the moral autonomy of persons … [and] it is a barrier to exploitation and
p.000015: harm. These purposes are no longer relevant to the cadaver, which has no autonomy and cannot be harmed.”35 Some
p.000015: people who have similar views on the issue stress that posthumous interests, if they exist, are in any
p.000015: case easily ousted by the interests of the living, who need the body material of the deceased for their health.36
p.000015:
p.000015: The claim that posthumous interests do not exist and that we can do whatever we like with the body of the deceased – at
p.000015: least if we are solely taking the position of the previously living person as our basis and we disregard the possible
p.000015: impact on the relatives and on society – is based on two combined assumptions:
p.000015:
p.000015: 1) Lack of subject: After death, there is no longer a subject who has interests and there is therefore no one to be
p.000015: harmed. Partridge, for example, argues that the concept of interests that survive death is totally
p.000015: incoherent, “as there is no … one who can be harmed at the point that any wrongful setback of interest
p.000015: occurs”.37 Glannon takes the view that the concept of "harm" involves a comparison between anterior and posterior
p.000015: bodily or mental states, and that an action occurring after death cannot cause a real change because it no
p.000015: longer has any influence on the person’s intrinsic
p.000015:
p.000015: 34 See e.g. A. Spital & C. Erin, “Conscription of cadaveric organs for transplantation: Let’s at least talk about it”
p.000015: American Journal of Kidney Diseases 2002; 39(3): 611-615; and J.S. Taylor, “The Myth of Posthumous Harm” American
p.000015: Philosophical Quarterly 2005; 42(4): 311-322.
p.000015: 35 A. Jonsen, “Transplantation of fetal tissue: An ethicist’s viewpoint” Clinical Research 1988; 36: 215.
p.000015: 36 See e.g. A. Spital & J.S. Taylor, “Routine recovery of cadaveric organs for transplantation: Consistent, fair, and
p.000015: life-saving” Clinical Journal of the American Society of Nephrology 2007; 2(2): 302.
p.000015: 37 E. Partridge, “Posthumous interests and posthumous respect” Ethics 1981; 91: 243.
p.000015:
p.000016: 16
p.000016: FINAL VERSION
p.000016:
p.000016: characteristics.38
p.000016:
p.000016: 2) The impossibility of regressive causality: Even if a person had interests before death that are adversely affected
p.000016: by events occurring after his death, such harm cannot have retrospective effects.39 In short, whatever happens
p.000016: to the body post mortem cannot have any influence on the person ante mortem.
p.000016:
p.000016: A third group in the debate on whether posthumous interests exist claims that the dead cannot incur any
p.000016: harm from posthumous events, but that people do have interests that survive death and thus can be harmed
p.000016: when these interests are violated. The existence of such surviving interests seems consistent with strong intuitions
p.000016: shared by many people on this subject, and therefore deserves further analysis.
p.000016:
p.000016: The fact that in our society we show respect for people's wishes about what should happen to their estate after their
p.000016: death and to their body (e.g. funeral preferences; donation of body to science; opt-out from organ donation) shows that
p.000016: there is a widely shared intuition (which is often upheld by the law) that certain personal wishes must be respected
p.000016: after death. Death cannot be regarded as completely destroying all moral traces of the person as he or she was when
p.000016: alive.40 As we noted earlier, some commentators speak in this regard of "interests". The Law Reform Commission in
p.000016: Canada, for example, held that:
p.000016:
p.000016: The utter disregard of one’s burial wishes, or the failure to honour one’s express wishes on the
p.000016: post-mortem uses of one’s body, lend credence to the claim that people have interests that survive their deaths
p.000016: and that they may be harmed when the interests are violated.41
p.000016:
p.000016: According to many bioethicists, this feeling is much more than an intuition, and is in fact based on clear ethical
p.000016: principles.42 They believe that the right to respect post mortem for the wishes of the person expressed ante
...
p.000027: (national register number – see the back of your identity card:)…………………………………..
p.000027:
p.000027: (1) agree to the removal of body material after my death:
p.000027:
p.000027: (a) for therapeutic purposes, i.e. for the benefit of another patient (note that in this case, an independent body
p.000027: will decide which patient will receive the material);
p.000027:
p.000027: (b) for scientific purposes (in order to find treatments for diseases); in this case, any specific research
p.000027: project in which the body material might be used will be subject to the approval of the hospital’s medical ethics
p.000027: committee; this committee will ensure in particular that the rules on the protection of privacy and confidentiality are
p.000027: respected;
p.000027:
p.000027: (c) for both therapeutic (a) and scientific (b) purposes.
p.000027:
p.000027: (2) withhold permission for any removal of body material after my death, for any purpose whatsoever.
p.000027:
p.000027: (date:).………………………………………………………….
p.000027:
p.000027: (signature:)…..………………………………………………..
p.000027:
p.000027:
p.000027: If you would like more information in order to make your choice, do not hesitate to contact your
p.000027:
p.000027:
p.000028: 28
p.000028: FINAL VERSION
p.000028:
p.000028: doctor. It is essential to understand that you can change your mind at any time. If you do, you can simply ask for
p.000028: a new form, either from the reception desk at the hospital where you are staying, or from your doctor,
p.000028: and return the completed form to the reception desk or your doctor.
p.000028:
p.000028: We also wish to emphasise that whatever choice you make, it will not in any way influence the care that you will be
p.000028: given. However, if you do not specify any choice, the law states that you will be deemed to agree with option
p.000028: 1.c. (i.e. use for therapeutic and scientific purposes).
p.000028:
p.000028: Thank you for reading this document.
p.000028:
p.000028:
p.000028: Each of us has values that are reflected in aspirations and life plans. These values may conflict with
p.000028: the methods and/or goals of certain types of scientific research. If scientists think they have good reasons
p.000028: to use such human body material for research either ante mortem or post mortem, they have every right to
p.000028: explain to the person concerned, while he or she is alive, why this research is valuable and why his or
p.000028: her participation in it (by providing the material in question) is very important. However, they do not have the
p.000028: right to decide in the person's place whether or not the material can be used. The person must be able to ensure that
p.000028: the way the material is used for research, including posthumously, will be consistent with his or her moral values. If
p.000028: we deprive people of this possibility and decide for them "in the interests of science", we are using them as a means
p.000028: to achieve a goal that is not necessarily theirs and are therefore violating their dignity.
p.000028:
p.000028: With regard to the material that is already stored in biobanks and for which no authorisation regarding use can now
p.000028: be sought, since the people concerned are already dead, these Committee members do not claim that this
p.000028: material should be destroyed, given the massive implications this would have for research projects already in progress.
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Searching for indicator substance:
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p.000017: Books, 2012.
p.000017: 45 J. Feinberg. The Moral Limits of the Criminal Law, Vol. I, Harm to Others. Oxford University Press, 1984.
p.000017: 46 See for example A. Buchanan, “Advance directives and the personal identity problem” Philosophy and Public
p.000017: Affairs 1988; 17(4): 277-302; H. Kuhse, “Some reflections on the problem of advance directives, personhood and personal
p.000017: identity” Kennedy Institute of Ethics Journal 1999; 9(4): 347- 364.
p.000017: 47 J. Feinberg. The Moral Limits of the Criminal Law, Vol. I, Harm to Others. Oxford University Press, 1984, 83.
p.000017:
p.000018: 18
p.000018: FINAL VERSION
p.000018:
p.000018: He argues that it is absurd to think that as soon as the person to whom we have promised something dies, an
p.000018: unfulfilled promise which was made while that person was still alive ceases to be a serious injustice to him
p.000018: or her.48 Such an outlook seems far from counter- intuitive or controversial.
p.000018:
p.000018: It might be objected that even if the existence of "surviving interests" and "posthumous harm" is
p.000018: conceded, the deceased is in any case no longer able to assert any rights, and that surviving interests are thus
p.000018: completely devoid of substance. However, this argument can be countered with the point that the obligation to uphold
p.000018: such interests is based on the rights that the person was able to exercise ante mortem and that while the rights
p.000018: themselves may have lapsed, some of the duties associated with them survive post mortem. In this light,
p.000018: surviving duties may very well exist without there being any surviving rights.
p.000018:
p.000018: Wellmann stresses, for example, that although rights cannot survive the death of their holder, certain
p.000018: duties arising from these rights may continue to exist and therefore imply future duties for others. He adds: “But
p.000018: this need not be to ascribe rights to the dead; it can and should be to assert that the rights of the living continue
p.000018: to impose duties even after the persons who possessed those rights have ceased to exist.”49 The same reasoning,
p.000018: incidentally, lies behind the continuation of certain contractual obligations after the death of the other party to the
p.000018: contract.
p.000018:
p.000018: 3. The need to be able to avoid moral complicity with the achievement of goals one finds morally
p.000018: objectionable
p.000018:
p.000018: A final reason that members of the Committee opposed to the extension of the system of presumed consent as provided for
p.000018: in the Law of 19 December 2008 wish to expound relates to the importance of being able to avoid moral
p.000018: complicity with behaviour that we find objectionable.
p.000018:
p.000018: Each of us has certain moral values that are reflected in life plans. These values may conflict with the methods and/or
...
Health / Healthy People
Searching for indicator volunteers:
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p.000020: merely means allowing that certain values can only be understood at the specific level of the community.
p.000020:
p.000020:
p.000021: 21
p.000021: FINAL VERSION
p.000021:
p.000021: Thus certain values acquire rectitude and legitimacy at the community level even in the absence of any
p.000021: real moral obligation on the part of individuals.
p.000021:
p.000021: It is in this respect that, despite the absence of an individual moral duty to participate in scientific research,
p.000021: the opt-out system may be regarded as morally and ethically justified at the social level: the point is to establish
p.000021: collectively a mechanism that makes an essential contribution to citizens’ participation in research, without
p.000021: this mechanism removing any freedom on their part or creating any inequality in principle. It is important to stress
p.000021: that the opt-out scheme does not oblige anyone to participate in research posthumously, since it is always possible to
p.000021: object to the scheme and rebut the presumption. On the other hand, it draws attention to the value of participation in
p.000021: research at the collective level and the fact that such research is regarded as a “common good under certain
p.000021: conditions.”
p.000021:
p.000021: 2) Scientific research as a “common good under certain conditions”
p.000021:
p.000021: For the members who support this position, the point is not to engage in smug scientism or to lose sight of reality.
p.000021: Research can, if its regulation is non-existent or insufficient, be an activity with particularly deleterious effects,
p.000021: for those who participate in it (healthy or sick volunteers and those from whom samples and/or personal data
p.000021: are taken) and/or their families, but also for society as a whole53 when it sees its core values being flouted.
p.000021: To be convinced of this, one only has to consider the many tragedies that marked the 20th century in particular in this
p.000021: context.
p.000021:
p.000021: Research acquires the status of a common good when it is the subject of scientific and ethical
p.000021: evaluation according to international54 and local ethical standards. When a research protocol involves clinical
p.000021: research, i.e. when it involves people and/or human samples and/or personal data, such research can be
p.000021: implemented only under strict conditions, which must be adhered to throughout the investigation.
p.000021:
p.000021: In the view of these members, research involving people, human samples or personal data is only a good when (1) it
p.000021: satisfies the ethical and regulatory requirements of international and local ethical standards, and (2) it leads to an
p.000021: increase in scientific knowledge which (3) in the short, medium or long term produces a better understanding of disease
p.000021: and contributes to the medical care of individuals. When these conditions are met, it is reasonable and justified for
p.000021: legislators to encourage the public to participate in research, because of the benefits that it is likely to bring to
p.000021: the community.
p.000021:
p.000021: The reason why this is so is that research is the best way – if not the only way – to enable a hypothesis associated
p.000021: with an individual case to be turned into a relevant scientific fact at the level of a population or population group.
p.000021: In other words, the scientific approach makes possible a process of objectivisation and generalisation with
...
Health / Mentally Disabled
Searching for indicator mentally:
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p.000017: crucial decisions that fundamentally affect one’s welfare. It is therefore wrong to believe that we can only have an
p.000017: interest in things of which we are conscious. In short, the "mental state account of harm,"
p.000017: i.e. the idea that one must be aware of harm for there to be any harm at all, is inadequate.
p.000017:
p.000017: Wishes can be fulfilled by events after the death of the person concerned just as they can by events during his or her
p.000017: lifetime. Fulfilment of wishes in the former case is just as positive as in the latter. It is true that the dead may
p.000017: never know whether their wishes have actually been fulfilled or have been ignored, but it is not clear why a simple
p.000017: lack of knowledge of what has happened would imply that they have not been harmed by their wishes being ignored.45
p.000017:
p.000017: In short, regardless of whether a person is aware of the fulfilment or non-fulfilment of his or her wishes, harm can be
p.000017: caused simply by non-fulfilment of those wishes. Such a concept of harm that is unrelated to one’s experience of it
p.000017: adequately captures the very essence of the problem that arises when prior manifestations of wishes (advance
p.000017: directives) are not respected. For example, if the wishes of persons in a persistent vegetative state that have been
p.000017: expressed independently beforehand are ignored, it is the wishes of the previously mentally capable person
p.000017: that are ignored. The principle that such wishes must be respected 'survives' the loss of mental abilities and
p.000017: consciousness of the person concerned.
p.000017:
p.000017: Of course, it may be objected that in this case, the (legal) person is still alive and that this is a fundamental
p.000017: difference. However, various authors argue that, like a person who has died, a person who is no longer capable has
p.000017: undergone a crucial (though less drastic) change to his or her personal identity, which leads us to conclude that
p.000017: even in the case of a persistent vegetative state, the person who was previously capable is regarded as
p.000017: the person who incurs the harm, rather than the subsequently incapable person.46
p.000017:
p.000017: Joel Feinberg, well known for his analysis of the concept of harm, stresses that:
p.000017:
p.000017: All interests are the interests of some person or other and a person’s surviving interests are simply
p.000017: the ones that we identify by naming him, the person whose interests they were. He is of course at that moment
p.000017: dead but that does not prevent us from referring now, in the present tense, to his interests, if they are still capable
p.000017: of being blocked or fulfilled, just as we refer to his outstanding debts or claims, as if they are still capable of
p.000017: being paid.47
p.000017:
p.000017:
p.000017: 44 See e.g. R.A. Belliotti. Posthumous Harm: Why the Dead Are Still Vulnerable. Lanham, Md.: Lexington
p.000017: Books, 2012.
...
Health / Mentally Incapacitated
Searching for indicator incapable:
(return to top)
p.000017: never know whether their wishes have actually been fulfilled or have been ignored, but it is not clear why a simple
p.000017: lack of knowledge of what has happened would imply that they have not been harmed by their wishes being ignored.45
p.000017:
p.000017: In short, regardless of whether a person is aware of the fulfilment or non-fulfilment of his or her wishes, harm can be
p.000017: caused simply by non-fulfilment of those wishes. Such a concept of harm that is unrelated to one’s experience of it
p.000017: adequately captures the very essence of the problem that arises when prior manifestations of wishes (advance
p.000017: directives) are not respected. For example, if the wishes of persons in a persistent vegetative state that have been
p.000017: expressed independently beforehand are ignored, it is the wishes of the previously mentally capable person
p.000017: that are ignored. The principle that such wishes must be respected 'survives' the loss of mental abilities and
p.000017: consciousness of the person concerned.
p.000017:
p.000017: Of course, it may be objected that in this case, the (legal) person is still alive and that this is a fundamental
p.000017: difference. However, various authors argue that, like a person who has died, a person who is no longer capable has
p.000017: undergone a crucial (though less drastic) change to his or her personal identity, which leads us to conclude that
p.000017: even in the case of a persistent vegetative state, the person who was previously capable is regarded as
p.000017: the person who incurs the harm, rather than the subsequently incapable person.46
p.000017:
p.000017: Joel Feinberg, well known for his analysis of the concept of harm, stresses that:
p.000017:
p.000017: All interests are the interests of some person or other and a person’s surviving interests are simply
p.000017: the ones that we identify by naming him, the person whose interests they were. He is of course at that moment
p.000017: dead but that does not prevent us from referring now, in the present tense, to his interests, if they are still capable
p.000017: of being blocked or fulfilled, just as we refer to his outstanding debts or claims, as if they are still capable of
p.000017: being paid.47
p.000017:
p.000017:
p.000017: 44 See e.g. R.A. Belliotti. Posthumous Harm: Why the Dead Are Still Vulnerable. Lanham, Md.: Lexington
p.000017: Books, 2012.
p.000017: 45 J. Feinberg. The Moral Limits of the Criminal Law, Vol. I, Harm to Others. Oxford University Press, 1984.
p.000017: 46 See for example A. Buchanan, “Advance directives and the personal identity problem” Philosophy and Public
p.000017: Affairs 1988; 17(4): 277-302; H. Kuhse, “Some reflections on the problem of advance directives, personhood and personal
p.000017: identity” Kennedy Institute of Ethics Journal 1999; 9(4): 347- 364.
p.000017: 47 J. Feinberg. The Moral Limits of the Criminal Law, Vol. I, Harm to Others. Oxford University Press, 1984, 83.
p.000017:
p.000018: 18
...
Health / Motherhood/Family
Searching for indicator family:
(return to top)
p.000012: morally binding duty.30 Some authors go even further than postulating a serious moral obligation here, and
p.000012: take the view that the imposition of a legally binding obligation to donate is justified (i.e. pure conscription),
p.000012: since the benefits for people
p.000012:
p.000012: 28 T.L. Beauchamp & J.F. Childress. Principles of biomedical ethics. New York: Oxford University Press, 1994: 264.
p.000012: 29 J. Feinberg. Freedom and fulfillment. Princeton, NJ: Princeton University Press, 1992: 175.
p.000012: 30 See e.g. D.A Peters, “A unified approach to organ donor recruitment, organ procurement, and
p.000012: distribution” Journal of Law and Health 1989-90; 3: 157-187, 168.
p.000012:
p.000013: 13
p.000013: FINAL VERSION
p.000013:
p.000013: experiencing a serious medical condition are very significant (organs can usually save lives) and the disadvantages for
p.000013: the dead, the relatives and society as a whole are very slight.
p.000013:
p.000013: For the sake of clarity, it should be mentioned that these members of the Committee are not proponents of pure
p.000013: conscription (without any possible opt-out) for post mortem organ transplants, but think that presumed consent
p.000013: is ethically defensible in this context, given the particularly important and direct therapeutic benefits of such post
p.000013: mortem organ removal, which normally saves lives.31 Further, these members believe that if an organ posthumously
p.000013: removed for transplantation proves unsuitable, it should be available for use in scientific research
p.000013: related to transplantation. Except in exceptional circumstances, the family must be informed.
p.000013:
p.000013: As we shall see, the relative value of the benefits and drawbacks of a system of presumed consent for posthumous
p.000013: removal of body material for research purposes is totally different from the relative value of the benefits and
p.000013: drawbacks of a system of presumed consent for posthumous removal of organs for transplantation. The balance tips in the
p.000013: latter case on the negative side.
p.000013:
p.000013:
p.000013: b) Posthumous removal of body material: the benefits are less certain and, although they exist, often
p.000013: less important
p.000013:
p.000013: The aim of the law – to ensure enough body material can be obtained so that biomedical research can be performed
p.000013: – is less important and urgent than the aim of organ transplantation. The posthumous removal of human body
p.000013: material from a specific deceased person cannot directly save a life.
p.000013:
p.000013:
p.000013: 31 Naturally, these members are aware that some people have objections to a system of presumed consent
p.000013: for posthumous organ donation. However, they believe that these objections are not decisive. We cannot go
p.000013: into this debate in detail, since it is not essential to the question which this opinion is supposed to answer;
p.000013: however, we will make some brief remarks. Opponents of a system of presumed consent for posthumous organ donation
p.000013: often remark that such a system leads to organs sometimes being removed from people who did not wish to be
...
p.000014: differing positions in terms of objecting or consenting to the removal of body material and the removal
p.000014: of organs. In other words, a system which is ethically problematic (or perceived as such) for the posthumous removal
p.000014: of body material for research could undermine the system of presumed consent for posthumous organ
p.000014: donation with which we are familiar in Belgium.32
p.000014:
p.000014: More generally, it could even lead to a collapse in the confidence that many citizens have towards the government and
p.000014: biomedical research. While the population remains unaware of what is permitted by the 2008 law in terms of the post
p.000014: mortem collection and use of body material, the risk of a strong reaction is probably very slight, but the Alder Hey
p.000014: scandal in the United Kingdom,33 which still arouses emotion many years after the events concerned, demonstrates the
p.000014: scale of the trauma that can result from a "leak" in a single case.
p.000014:
p.000014: 2) Potential disadvantages for close relatives of the deceased
p.000014:
p.000014: If we examine the question from the perspective of the close relatives, it is fair to say that the disadvantages of
p.000014: biomedical research on body material from a deceased person may be more severe and are likely to affect a larger number
p.000014: of people than the removal of organs from a deceased person for transplantation. Alongside the comparable potential
p.000014: drawbacks – associated with the potential psychological disturbance that some family members may experience
p.000014: from the idea of the body being cut open, material removed, and the dead person’s body being exploited –
p.000014: there may also be disadvantages which are specific to the context of biomedical research on body material removed post
p.000014: mortem.
p.000014:
p.000014:
p.000014: 32 See e.g. Nys, H. (2009) “Bloed, zweet en tranen. Kritische ontleding van de wet van 19 december 2008 inzake
p.000014: het verkrijgen en het gebruik van menselijk lichaamsmateriaal”, Rechtskundig Weekblad, 2009-2010, p.
p.000014: 184, n° 26.
p.000014: 33 Royal Liverpool Children’s Inquiry Report (2001), available
p.000014: at
p.000014: http://www.ricinquiry.org.uk/download/index.htm [consulted on 23 August 2012].
p.000014:
p.000015: 15
p.000015: FINAL VERSION
p.000015:
p.000015: 3) Potential disadvantages from the point of view of the deceased: harm to posthumous "interests"?
p.000015:
p.000015: In the literature, it is sometimes assumed rather casually, without many supporting arguments being
p.000015: offered, that what happens to the body of someone who has died has no implications as far as that person is concerned.
p.000015: However, conclusions on this subject ought to be based on an analysis of the possible arguments, rather than
p.000015: on mere suppositions. One of the reasons why such an analysis is far from simple is that terms are sometimes used in
p.000015: this context that cannot be applicable (e.g. the "rights" of the deceased), or that may intuitively seem
p.000015: to be applicable, but require clarification and argumentation (e.g. the "interests" of the deceased), or that
...
p.000023: people’s natural tendency, when asked, to say that they would be willing to donate, and claim that it is
p.000023: hence unnecessary to establish a system of "presumption", one may answer that it is precisely because
p.000023: participation in research measures its specific value and legitimacy against the yardstick of society as a
p.000023: whole that it is up to the legislator to send a message about its importance and legitimacy, and to
p.000023: encourage participation, rather than allowing the unrestricted exercise of individual freedoms to define
p.000023: what such participation will be. However, the fact that some people are prepared to donate of their own free will
p.000023: ensures that this encouragement is a socially regulated amplification of natural traits within society, rather than a
p.000023: forcible appropriation of the individual by the collective.
p.000023:
p.000023: Moreover, the proponents of this position take the view that in itself, the use of human body material in the context
p.000023: of research which is properly supervised and assessed scientifically and ethically does not entail treating the body as
p.000023: a mere tool. In their view it cannot be seen as desecrating or disregarding the sacredness of the body, even though its
p.000023: physical integrity is affected. At the symbolic level, moreover, some advocates of keeping the opt-out system point
p.000023: out that removing human body material for research has the effect of delaying the body's natural decay
p.000023: after death, and giving it a potential symbolic "utility". Of course there are differing sensitivities, beliefs and
p.000023: attitudes vis-à-vis the body and the respect due to the mortal remains of the deceased, as well as to family members
p.000023: and to the social groups to which the deceased belonged. The Committee members in favour of retaining the opt-out
p.000023: system believe that, if accompanied by certain guarantees, it is a safe and transparent means of preventing corpses
p.000023: from being tampered with for the sake of research in an unjustified and potentially profane way.
p.000023:
p.000023: Some of these members also point out that all research, especially that involving human body material, is
p.000023: already regulated by safety, health and ethical rules. Thus any research on human body material must have received
p.000023: approval from a medical ethics committee and must be carried out in approved laboratories on material obtained,
p.000023: stored and transported according to specific rules.
p.000023:
p.000023: Some opponents of the opt-out system under certain conditions argue that it is not a moral duty for everyone to
p.000023: contribute to research, since not everyone has equal access to healthcare and hence to the benefits of
p.000023: scientific research. While it is unfortunately true that access to healthcare is not equal for all, the solution is to
p.000023: act to dispel this disparity. Non- participation on this ground will do nothing to solve this problem of unfairness. In
p.000023: addition,
p.000023:
p.000023: 56 However, the French expert who was heard by the select committee was highly critical of French law and the opt-out
p.000023: system.
p.000023:
p.000024: 24
p.000024: FINAL VERSION
p.000024:
p.000024: the knowledge gained through the development of research may help to reduce the cost of certain forms of care and thus
p.000024: make them accessible to a larger number of people.
...
p.000025: been defined at the time of collection (by contrast with the removal of material from living donors)
p.000025: makes a "regular" assessment by medical ethics committees impossible.
p.000025:
p.000025: This is why these members recommend that an agency – possibly the current Federal Agency for Medicines and Health
p.000025: Products – should, in liaison with the medical ethics committee of the hospital where the material is removed,
p.000025: verify the scientific reasons for doing so, regardless of how the collected material will be used. This would
p.000025: enable an assessment of all research needs for human body material.
p.000025:
p.000025: 2) Arrangements should be made to allow a differing response to the opt-out for therapeutic purposes and the opt-out
p.000025: for research purposes, so that if people wish to rebut the presumption of consent to the donation of
p.000025: material for research purposes, they are not therefore obliged to do so for donations for therapeutic purposes at
p.000025: the same time.
p.000025:
p.000025: 3) These members also call for the royal decrees implementing the Law of 19 December 2008 to include
p.000025: provisions specifying the establishment of an effective traceability system ranging from the collection of body
p.000025: material to its storage, transportation and final use, and ensuring that only authorised organisations can
p.000025: perform these tasks, in complete transparency.57
p.000025:
p.000025: 4) For the donor or his or her family: even after death, the collection of human body material can expose the donor,
p.000025: and by extension members of the family or genetic group from which he or she comes, to stigmatisation (e.g. in
p.000025: connection with genetic studies). Such a risk may be partially – but only partially – circumscribed by the
p.000025: requirement for material that is collected and studied to be treated anonymously. However, in the field of human
p.000025: genetics, total anonymity seems impossible. It would therefore be prudent to provide other security mechanisms to
p.000025: protect descendants and relatives of potential donors from any such abuses.
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025:
p.000025: 57 On traceability, see already Article 14 of the Law of 19 December 2008 and Article 6 of the Royal Decree of 28
p.000025: September 2009 setting quality and safety standards for the donation, removal, acquisition, testing,
p.000025: handling, storage and distribution of human body material, which human body material banks, intermediate human body
p.000025: material structures and production facilities must meet.
p.000025:
p.000026: 26
p.000026: FINAL VERSION
p.000026:
p.000026: 4. Recommendations and conclusions
p.000026: A. Recommendations made jointly by all Committee members
p.000026: The Committee unanimously deplores the lack of any ethical debate prior to the adoption of Article 12 of the Law of 19
p.000026: December 2008, which extends the opt-out system to all post mortem removal of human body material for human
p.000026: medical applications or scientific research purposes. None of its members defends this legal provision in its
p.000026: present form.
p.000026:
p.000026: The Committee unanimously stresses the need to allow citizens the possibility of expressing differing wishes with
...
p.000028: the methods and/or goals of certain types of scientific research. If scientists think they have good reasons
p.000028: to use such human body material for research either ante mortem or post mortem, they have every right to
p.000028: explain to the person concerned, while he or she is alive, why this research is valuable and why his or
p.000028: her participation in it (by providing the material in question) is very important. However, they do not have the
p.000028: right to decide in the person's place whether or not the material can be used. The person must be able to ensure that
p.000028: the way the material is used for research, including posthumously, will be consistent with his or her moral values. If
p.000028: we deprive people of this possibility and decide for them "in the interests of science", we are using them as a means
p.000028: to achieve a goal that is not necessarily theirs and are therefore violating their dignity.
p.000028:
p.000028: With regard to the material that is already stored in biobanks and for which no authorisation regarding use can now
p.000028: be sought, since the people concerned are already dead, these Committee members do not claim that this
p.000028: material should be destroyed, given the massive implications this would have for research projects already in progress.
p.000028: However, they call for the rapid introduction of a new regime of explicit authorisation via an amendment to the Act of
p.000028: 19 December 2008 as outlined above.
p.000028:
p.000028: In addition, these members believe that if an organ removed post mortem for transplantation proves unsuitable, it
p.000028: should be available for use in scientific research purposes related to transplantation. Except in exceptional
p.000028: circumstances, the family must be informed.
p.000028:
p.000028:
p.000028: C. Recommendations and conclusions of members in favour of the opt-out system for post mortem removal of
p.000028: human body material
p.000028: In the view of these members, the current law can be kept, provided further conditions are added and control systems
p.000028: are reinforced.
p.000028:
p.000028: These members are in favour of keeping the opt-out regime for post mortem collection of human body material and wish to
p.000028: warn about the consequences of abandoning this regime – which they regard as morally and ethically justified
p.000028: – for the public health sector. Accordingly, they argue for the retention of Article 12 of the Law of
p.000028: 19 December 2008, which provides for an opt-out system for post mortem collection of human body material for
p.000028: scientific purposes. However, given the ethically sensitive nature of this material, they recommend that
p.000028: additional precautions be taken.
p.000028:
p.000028:
p.000028: 1. Improving public information
p.000028:
p.000028: It is important for citizens to be better informed about the provisions of the current legal framework and the
p.000028: reasons why this system was introduced. These members therefore recommend that in hospital admission
p.000028: booklets, as well as in the waiting rooms of healthcare facilities, concise and simply worded information
p.000028: should be provided in any medium deemed appropriate, mentioning the opt-out regime with regard to the post mortem
p.000028:
p.000029: 29
p.000029: FINAL VERSION
p.000029:
p.000029: collection of body material for therapeutic and scientific purposes, and the possibility of withholding
p.000029: permission for such collection, either completely or on a differentiated basis depending on the purpose
p.000029: (direct therapeutic/scientific purposes).
p.000029:
p.000029: Example of poster text or wording:
p.000029: "Under the current law, in the event of death, organs, cells and tissue may be removed from the body of the deceased,
p.000029: in a manner respectful of his or her dignity and that of his or her family. The collection of such organs and
p.000029: body material can save lives or contribute to research and development leading to the creation of new medicines.
p.000029: If you do not want body material to be removed after your death, or if you want material to be removed only to save
p.000029: lives through organ transplantation after your death, but not for use in a research setting, you can register your
p.000029: wishes by contacting ... "
p.000029:
p.000029:
p.000029: 2. Evaluating the ethical and scientific appropriateness of collecting human body material
p.000029:
p.000029: Under the current legislation, only the use of biological material must be approved by an ethics committee.
p.000029: However, the actual removal of this type of ethically sensitive material should be the subject of
p.000029: evaluation as to its need and appropriateness. It would be unacceptable for such material to be
p.000029: available in unlimited quantities and for it to be collected indiscriminately, without paying heed to the
p.000029: ethically sensitive nature of this material and without checking that there is a proven scientific need.
p.000029:
p.000029: It is true that such an evaluation cannot proceed in the same way as those currently performed by ethics
p.000029: committees, on the basis of a protocol and in the context of a specific research purpose. This is not possible for two
p.000029: reasons. Firstly, the material has often been collected in advance of the research and the drafting of a
p.000029: protocol. Secondly, for this evaluation to take place presupposes a comprehensive knowledge of the needs for human
p.000029: body material within each research institution and the country more generally, in order to determine whether, based on
p.000029: the type of material required (e.g. corneas or gastric cells) and the research field concerned, there is a shortage
p.000029: (which would permit more material of this type to be collected), a surplus (which would lead to a reduction in the
p.000029: amount of material collected) or a state of equilibrium.
p.000029:
p.000029: Given the specific characteristics of this evaluation, the Committee members who wish to keep the opt-out
p.000029: regime recommend that an agency should be created – or that this task should be entrusted to the current Federal
p.000029: Agency for Medicines and Health Products – to allow overall research needs for human body material to be assessed, and
p.000029: guidelines issued on how the collection of material should take place in order to be justified. This
p.000029: agency would first need to be able to draw up an inventory of present and future needs for human body material, in
p.000029: partnership with research institutions and human biobanks, as well as by cross-checking against the registers listing
p.000029: research in progress. Based on this inventory, it should be possible to determine the collection volume that
p.000029: is actually needed and hence justifiable.
p.000029:
p.000029:
p.000029: 3. Increased protection for individuals’ genetic material
p.000029:
p.000029: These members acknowledge that, even after the donor’s death, there may be a risk to his or her family if genetic
p.000029: information is disclosed that has been derived from the body material of the deceased, since it could be used for
p.000029: discriminatory or stigmatising purposes. The use of measures to maintain anonymity provides only limited
p.000029: protection in human genetics, because certain genetic information is always identifiable. A specific
p.000029: assessment should therefore be performed by the researchers in the research protocol of the risk
p.000029: of identification and stigmatisation of relatives, depending on the type of genetic investigation planned and the
p.000029: susceptibility to stigmatisation of the disease or physiological characteristic under investigation. The Ethics
p.000029: Committee which evaluates the protocol will need to check that adequate measures have been planned to 1) regulate the
p.000029: use and disclosure of identity-
p.000029:
p.000030: 30
p.000030: FINAL VERSION
p.000030:
p.000030: sensitive data/results in a research context, e.g. by stipulating that the results of these investigations
p.000030: will only be disclosed in databases that are subject to data-sharing policies58, and 2) prevent any disclosure or use
p.000030: of these results outside the context of the research.
p.000030:
p.000030: ***
p.000030:
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p.000030:
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p.000030:
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p.000030:
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p.000030:
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p.000030:
p.000030:
...
Health / Physically Ill
Searching for indicator sick:
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p.000020: the scope of individuals. Such a position does not amount to postulating the community as a "global" power: it
p.000020: merely means allowing that certain values can only be understood at the specific level of the community.
p.000020:
p.000020:
p.000021: 21
p.000021: FINAL VERSION
p.000021:
p.000021: Thus certain values acquire rectitude and legitimacy at the community level even in the absence of any
p.000021: real moral obligation on the part of individuals.
p.000021:
p.000021: It is in this respect that, despite the absence of an individual moral duty to participate in scientific research,
p.000021: the opt-out system may be regarded as morally and ethically justified at the social level: the point is to establish
p.000021: collectively a mechanism that makes an essential contribution to citizens’ participation in research, without
p.000021: this mechanism removing any freedom on their part or creating any inequality in principle. It is important to stress
p.000021: that the opt-out scheme does not oblige anyone to participate in research posthumously, since it is always possible to
p.000021: object to the scheme and rebut the presumption. On the other hand, it draws attention to the value of participation in
p.000021: research at the collective level and the fact that such research is regarded as a “common good under certain
p.000021: conditions.”
p.000021:
p.000021: 2) Scientific research as a “common good under certain conditions”
p.000021:
p.000021: For the members who support this position, the point is not to engage in smug scientism or to lose sight of reality.
p.000021: Research can, if its regulation is non-existent or insufficient, be an activity with particularly deleterious effects,
p.000021: for those who participate in it (healthy or sick volunteers and those from whom samples and/or personal data
p.000021: are taken) and/or their families, but also for society as a whole53 when it sees its core values being flouted.
p.000021: To be convinced of this, one only has to consider the many tragedies that marked the 20th century in particular in this
p.000021: context.
p.000021:
p.000021: Research acquires the status of a common good when it is the subject of scientific and ethical
p.000021: evaluation according to international54 and local ethical standards. When a research protocol involves clinical
p.000021: research, i.e. when it involves people and/or human samples and/or personal data, such research can be
p.000021: implemented only under strict conditions, which must be adhered to throughout the investigation.
p.000021:
p.000021: In the view of these members, research involving people, human samples or personal data is only a good when (1) it
p.000021: satisfies the ethical and regulatory requirements of international and local ethical standards, and (2) it leads to an
p.000021: increase in scientific knowledge which (3) in the short, medium or long term produces a better understanding of disease
p.000021: and contributes to the medical care of individuals. When these conditions are met, it is reasonable and justified for
p.000021: legislators to encourage the public to participate in research, because of the benefits that it is likely to bring to
p.000021: the community.
p.000021:
p.000021: The reason why this is so is that research is the best way – if not the only way – to enable a hypothesis associated
p.000021: with an individual case to be turned into a relevant scientific fact at the level of a population or population group.
...
Health / ill
Searching for indicator ill:
(return to top)
p.000011: collection (or "conscription") of body material post mortem, whenever a clinician or researcher (1)
p.000011: regards such collection as potentially useful, (2) directly or indirectly (via a colleague or a biobank) has
p.000011: access to the body of the deceased, and (3) determines that the person concerned has not indicated any
p.000011: objection to a post mortem removal of organs for transplantation purposes.
p.000011:
p.000011:
p.000011: 24 B. Williams, “A critique of utilitarianism” in J.J.C. Smart & B. Williams (Eds). Utilitarianism, for and against.
p.000011: Cambridge: Cambridge University Press, 1990: 82-117.
p.000011: 25 S. Shapshay & K. Pringle, “Participation in biomedical research is an imperfect moral duty: A
p.000011: response to John Harris” Journal of Medical Ethics 2007; 33(7): 414-417.
p.000011: 26 I. de Melo-Martin, “Response to Rosamond Rhodes” Newsletter on Philosophy and Medicine 2008; 7(2): 13-14.
p.000011: 27 See e.g. S.H. Woolf et al., “Giving Everyone the Health of the Educated: An Examination of Whether Social Change
p.000011: Would Save More Lives than Medical Advances” American Journal of Public Health 2007; 97(4): 679:
p.000011: “[C]orrecting disparities in education-associated mortality rates would have saved more than a million lives rather
p.000011: than about 178 thousand that were averted by medical advances” . See also T. Pogge, “Responsibilities for
p.000011: poverty-related ill health” Ethics International Affairs 2002; 16: 71: “[P]overty is far and away the most important
p.000011: factor in explaining health deficits. Because they are poor, 815 million persons are malnourished, 1.1 billion
p.000011: lack access to safe water, 2.4 billion lack access to basic sanitation, more than 880 million lack access
p.000011: to health services, and approximately 1 billion have no adequate shelter”.
p.000011:
p.000012: 12
p.000012: FINAL VERSION
p.000012:
p.000012: The law stipulates (Art. 12) that the consent of the person concerned is presumed for any removal of material after
p.000012: death and is therefore authorised in all cases, unless the person has expressed an objection to post mortem removal of
p.000012: organs for transplantation. Given that the Belgian population is totally unaware that under the 2008 Law, not objecting
p.000012: to the post mortem removal of organs for transplantation is treated as equivalent to not objecting to the post mortem
p.000012: removal of organs for the purposes of scientific research and of tissue and cells for scientific research or
p.000012: therapeutic purposes, and given, therefore, that citizens who do not agree will not express an objection because they
p.000012: are not aware that they need to do so, the 2008 Law has made access to material from the body of deceased people
p.000012: extremely easy.
p.000012:
p.000012:
...
Social / Access to Social Goods
Searching for indicator access:
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p.000007: benefit from participation in cooperative social arrangements have obligations towards one other when they
p.000007: are asked to assume the risks and duties that are often associated with involvement in such cooperative
p.000007: activities.8 This duty of fairness is in turn sometimes broken down as follows:
p.000007:
p.000007: 1. A duty not to behave like a free-rider: People who refuse to participate in biomedical research
p.000007: while accepting its benefits behave like free-riders towards people who do participate in biomedical
p.000007: research. As we all (at least in industrialised countries) derive benefit from the results of biomedical
p.000007: research, non-participants have a moral debt that entails a duty to support biomedical research.9
p.000007:
p.000007: 2. A duty to help maintain public goods: Regardless of whether non-participants are free-riding, everyone has a
p.000007: duty to participate in biomedical research because the knowledge it generates must be regarded as a "public good".
p.000007: A "public good" is a good that can be used by one person without reducing its enjoyment by another person. In
p.000007: addition, everyone (potentially) derives benefit from a "public good", which is why it is impossible to exclude
p.000007: people who do not contribute to it from the enjoyment of it.10 The problem with "public goods" is that
p.000007: people do not feel called upon to contribute to them, even when the benefits to them of the "public
p.000007: good" outweigh the
p.000007:
p.000007: collection of bodily material post mortem, whenever a clinician or researcher regards such collection as potentially
p.000007: useful and has access to the body of the deceased.
p.000007: 6 A.L. Caplan, “Is there a duty to serve as a subject in biomedical research?” IRB: Ethics and Human Research 1984;
p.000007: 6(5): 1-5; S. Chan & J. Harris, “Free riders and pious sons - why science research remains obligatory” Bioethics 2009;
p.000007: 23(3): 161-171; J. Harris, “Scientific research is a moral duty” Journal of Medical Ethics 2005; 31: 242-248; R.
p.000007: Rhodes, “In defense of the duty to participate in biomedical research” American Journal of Bioethics 2008; 8(10):
p.000007: 37-44. See also e.g. C.D. Herrera, “Universal compulsory service in medical research” Theoretical Medicine 2003; 24(3):
p.000007: 215-231.
p.000007: 7 J. Harris, “Scientific research is a moral duty” Journal of Medical Ethics 2005; 31: 242-248.
p.000007: 8 J. Rawls, A theory of justice. Cambridge: Harvard University Press, 1971.
p.000007: 9 A.L. Caplan, “Is There a Duty to Serve as a Subject in Biomedical Research?” IRB: Ethics and Human Research 1984;
p.000007: 6(5): 1-5; H.M. Evans, “Should patients be allowed to veto their participation in clinical research?”
p.000007: Journal of Medical Ethics 2004; 30:198-203; D. Orentlicher, “Making research a requirement of treatment: why we should
p.000007: sometimes let doctors pressure patients to participate in research” Hastings Center Report 2005; 35(5): 20-28.
p.000007: 10 D. Woodward & R.D. Smith, “Global Public Goods and Health: Concepts and Issues” in R. Smith et al. (Eds). Global
...
p.000008: their bodies are concerned, the effect of which persists after death.
p.000008:
p.000008: 2) Criticism of the argument concerning the maintaining of public goods
p.000008:
p.000008: A "public good" is a good that can be used by one person without reducing its enjoyment by another. In addition,
p.000008: everyone (potentially) derives benefit from a "public good", which is why it is impossible to exclude people who do not
p.000008: contribute to it from the enjoyment of it. As biomedical research leads to very important medical knowledge which
p.000008: benefits us all, some argue that we have a duty to support the production of such knowledge by participating in
p.000008:
p.000008:
p.000008: 11 I. Brassington, “John Harris’ argument for a duty to research” Bioethics 2007; 21(3): 160-168; I.
p.000008: Brassington, “Defending the duty to research?” Bioethics 2011; 25(1): 21-26; I. de Melo-Martin, “Response
p.000008: to Rosamond Rhodes” Newsletter on Philosophy and Medicine 2008; 7(2): 13-14.
p.000008:
p.000009: 9
p.000009: FINAL VERSION
p.000009:
p.000009: biomedical research ourselves.
p.000009:
p.000009: The main problem with this argument is that the claim that biomedical research is a "public good" must itself be
p.000009: qualified. One may legitimately ask to what extent biomedical research does actually give rise to research
p.000009: results which are available to the public, to affordable treatments and to discoveries that are relevant (and
p.000009: at the very least harmless).
p.000009:
p.000009: The argument that there is a general obligation to participate in biomedical research because we all derive benefit
p.000009: from its results in the industrialised world takes no account of the social context of access to healthcare. In
p.000009: fact, access to the results of biomedical research also depends, in the industrialised world, on factors
p.000009: such as financial opportunity (health insurance), the availability of preventive care and the ability to
p.000009: process the influx of information about medical solutions and developments. This means that any such obligation does
p.000009: not exist or only exists to a much lesser extent on the part of disadvantaged groups.12
p.000009:
p.000009: Many biomedical research projects do not aim – or not primarily – to improve the general welfare, but are (at least
p.000009: in part) driven by greed. Often, the results are not shared with colleagues13 or even have a
p.000009: counter-productive effect, because part of the research and (especially) of the development of diagnostic and
p.000009: therapeutic methods is restricted for many years by patents that are granted.14
p.000009:
p.000009: In addition, there is no denying that many biomedical research projects, including many studies with
p.000009: human experimental subjects, provide little or no relevant information and therefore cannot contribute to an
p.000009: improvement to the general welfare.15
p.000009:
p.000009: Moreover, the point should not be overlooked that biomedical research projects can also be harmful to the people
p.000009: involved. Those in charge of research can simply exploit the participants, treating them as a mere means to
p.000009: gain prestige and/or wealth (one only has to think, for example, of the late Henrietta Lacks and her family16, the
p.000009: late John Moore17 and members of the Havasupai tribe in the United States18). We may also add that the results of
p.000009: research, for example in the case of genetic research, can also have discriminatory effects or a stigmatising impact
p.000009: (not just for the participant, but also for the group to which he or she belongs).19
p.000009:
p.000009: In short, even if it were possible to demonstrate that biomedical research as a social concept should be regarded as a
p.000009: "public good", one might ask how we can infer from this a duty to
p.000009:
p.000009: 12 I. de Melo-Martin, “Response to Rosamond Rhodes” Newsletter on Philosophy and Medicine 2008; 7(2): 13-14.
p.000009: 13 See Advisory Committee Opinion no. 51 of 12 March 2012 on the publication of the results of
p.000009: experiments conducted on humans.
p.000009: 14 See for example Sterckx, Sigrid (2009), “Patenting and licensing of university research: Promoting innovation or
p.000009: undermining academic values?”, Science & Engineering Ethics, published online on 19 September 2009 (doi
p.000009: 10.1007/s11948-009-9168-8), printed version 2011, vol. 17(1), pp. 45-64. Cockbain, Julian & Sterckx, Sigrid
p.000009: (2011), “Something more is necessary – Are genes and genetic diagnostic tests statutory subject matter for US
p.000009: patents?”, Expert Review of Molecular Diagnostics 11(2), pp. 149-158. Sterckx, Sigrid (2007), “Patents and Access to
p.000009: Drugs in Developing Countries: An Ethical Analysis”, in Chadwick, Ruth; Kuhse, Helga; Schüklenk, Udo & Singer,
p.000009: Peter (Eds). The Bioethics Reader – Editors’ Choice. Oxford: Blackwell, pp. 145-161.
p.000009: 15 S. Holm, B. Hofmann & J.H. Solbakk, “Conscription to Biobank Research?” in H. Solbakk, S. Holm & B. Hofmann (Eds).
p.000009: The Ethics of Research Biobanking. New York: Springer, 2009: 255-262.
p.000009: 16 Skloot, R. The Immortal Life of Henrietta Lacks. New York: Crown, 2010.
p.000009: 17 Moore v. Regents of University of California (51 Cal.3d 120, Supreme Court of California), 9 July 1990.
p.000009: 18 Van Assche, Kristof & Sterckx, Sigrid (2012), “The protection of human dignity in research involving human body
p.000009: material” in van Beers, B.; Corrias, L. & Werner, W. (Eds). Probing the Boundaries of Humanity (submitted, undergoing
p.000009: revision by Cambridge University Press).
p.000009: 19 Ibid.
p.000009:
p.000010: 10
p.000010: FINAL VERSION
p.000010:
p.000010: participate in biomedical research projects. Such research projects must at the very least meet a number of
p.000010: minimum requirements in terms of relevance, social benefits and minimal risk of harm (not just physical harm and
p.000010: infringements of privacy, but also emotional and moral harm – see below). It would therefore be difficult to establish
p.000010: that there is a general duty to participate in biomedical research.20
p.000010:
...
p.000011: donating organs for a transplant), by definition makes biomedical research less attractive than other possible ways of
p.000011: helping others.
p.000011:
p.000011:
p.000011: 2. The harm resulting from removing body material after death overrides the potential benefits
p.000011:
p.000011:
p.000011: A second line of argument that might be adopted by the defenders of a system of presumed consent for post mortem
p.000011: removal of body material is based on the utilitarian argument that the post mortem collection and use of biological
p.000011: material are permissible or even obligatory in ethical terms, because they can provide significant benefits to society
p.000011: and do scarcely any harm (the possibility of slight harm to the relatives of the person from whom the material is
p.000011: removed is recognised by the proponents of this view, but they believe that, ultimately, they do not outweigh the
p.000011: potential benefits – see below). Such a view implies that the removal of human body material post mortem could become a
p.000011: routine practice.
p.000011:
p.000011: The system of presumed consent as provided for in the Law of 19 December 2008 amounts in practice to the automatic
p.000011: collection (or "conscription") of body material post mortem, whenever a clinician or researcher (1)
p.000011: regards such collection as potentially useful, (2) directly or indirectly (via a colleague or a biobank) has
p.000011: access to the body of the deceased, and (3) determines that the person concerned has not indicated any
p.000011: objection to a post mortem removal of organs for transplantation purposes.
p.000011:
p.000011:
p.000011: 24 B. Williams, “A critique of utilitarianism” in J.J.C. Smart & B. Williams (Eds). Utilitarianism, for and against.
p.000011: Cambridge: Cambridge University Press, 1990: 82-117.
p.000011: 25 S. Shapshay & K. Pringle, “Participation in biomedical research is an imperfect moral duty: A
p.000011: response to John Harris” Journal of Medical Ethics 2007; 33(7): 414-417.
p.000011: 26 I. de Melo-Martin, “Response to Rosamond Rhodes” Newsletter on Philosophy and Medicine 2008; 7(2): 13-14.
p.000011: 27 See e.g. S.H. Woolf et al., “Giving Everyone the Health of the Educated: An Examination of Whether Social Change
p.000011: Would Save More Lives than Medical Advances” American Journal of Public Health 2007; 97(4): 679:
p.000011: “[C]orrecting disparities in education-associated mortality rates would have saved more than a million lives rather
p.000011: than about 178 thousand that were averted by medical advances” . See also T. Pogge, “Responsibilities for
p.000011: poverty-related ill health” Ethics International Affairs 2002; 16: 71: “[P]overty is far and away the most important
p.000011: factor in explaining health deficits. Because they are poor, 815 million persons are malnourished, 1.1 billion
p.000011: lack access to safe water, 2.4 billion lack access to basic sanitation, more than 880 million lack access
p.000011: to health services, and approximately 1 billion have no adequate shelter”.
p.000011:
p.000012: 12
p.000012: FINAL VERSION
p.000012:
p.000012: The law stipulates (Art. 12) that the consent of the person concerned is presumed for any removal of material after
p.000012: death and is therefore authorised in all cases, unless the person has expressed an objection to post mortem removal of
p.000012: organs for transplantation. Given that the Belgian population is totally unaware that under the 2008 Law, not objecting
p.000012: to the post mortem removal of organs for transplantation is treated as equivalent to not objecting to the post mortem
p.000012: removal of organs for the purposes of scientific research and of tissue and cells for scientific research or
p.000012: therapeutic purposes, and given, therefore, that citizens who do not agree will not express an objection because they
p.000012: are not aware that they need to do so, the 2008 Law has made access to material from the body of deceased people
p.000012: extremely easy.
p.000012:
p.000012:
p.000012: a) Similarities with the debate on presumed consent versus informed consent for
p.000012: post mortem organ transplantation, but a different ethical conclusion
p.000012:
p.000012: Pleas for as permissive a regime as possible for the post mortem removal of body material for therapeutic and
p.000012: research purposes are often based on ethical arguments that we also encounter in the context of
p.000012: discussions on the post mortem removal of organs for transplantation, e.g. the arguments cited by various
p.000012: prominent bioethicists to advocate a system of presumed consent for organ transplantation after death.
p.000012:
p.000012: These specific arguments are discussed briefly below, since the distinction between the post mortem removal of body
p.000012: material for a therapeutic purpose that will directly benefit a patient and removal for research purposes is seen as a
p.000012: fundamental distinction by those Committee members who oppose the presumed consent regime provided for in the law of 19
p.000012: December 2008. The view of these members does not mean they reject the presumed consent regime in force in Belgium for
p.000012: post mortem removal of organs for transplantation. They contend that the problems lie in the extension of this regime.
p.000012: They reason that the benefits on the basis of which one may opt deliberately for a system of presumed consent
...
p.000023: a mere tool. In their view it cannot be seen as desecrating or disregarding the sacredness of the body, even though its
p.000023: physical integrity is affected. At the symbolic level, moreover, some advocates of keeping the opt-out system point
p.000023: out that removing human body material for research has the effect of delaying the body's natural decay
p.000023: after death, and giving it a potential symbolic "utility". Of course there are differing sensitivities, beliefs and
p.000023: attitudes vis-à-vis the body and the respect due to the mortal remains of the deceased, as well as to family members
p.000023: and to the social groups to which the deceased belonged. The Committee members in favour of retaining the opt-out
p.000023: system believe that, if accompanied by certain guarantees, it is a safe and transparent means of preventing corpses
p.000023: from being tampered with for the sake of research in an unjustified and potentially profane way.
p.000023:
p.000023: Some of these members also point out that all research, especially that involving human body material, is
p.000023: already regulated by safety, health and ethical rules. Thus any research on human body material must have received
p.000023: approval from a medical ethics committee and must be carried out in approved laboratories on material obtained,
p.000023: stored and transported according to specific rules.
p.000023:
p.000023: Some opponents of the opt-out system under certain conditions argue that it is not a moral duty for everyone to
p.000023: contribute to research, since not everyone has equal access to healthcare and hence to the benefits of
p.000023: scientific research. While it is unfortunately true that access to healthcare is not equal for all, the solution is to
p.000023: act to dispel this disparity. Non- participation on this ground will do nothing to solve this problem of unfairness. In
p.000023: addition,
p.000023:
p.000023: 56 However, the French expert who was heard by the select committee was highly critical of French law and the opt-out
p.000023: system.
p.000023:
p.000024: 24
p.000024: FINAL VERSION
p.000024:
p.000024: the knowledge gained through the development of research may help to reduce the cost of certain forms of care and thus
p.000024: make them accessible to a larger number of people.
p.000024:
p.000024: 2. Ethical points concerning the treatment of people’s final wishes and critical interests in the
p.000024: context of an opt-out system for post mortem removal of material for scientific purposes
p.000024:
p.000024: Members who wish to keep the opt-out regime would like to stress the following point: at no time does this scheme,
p.000024: in their view, have the effect of completely negating individuals’ autonomy regarding their final wishes
p.000024: for funeral arrangements. When the removal of material is for scientific purposes, we must remember that the
p.000024: entire body is not regarded as having been donated to science (which would require an explicit wish on the
p.000024: part of the deceased, expressed during his or her lifetime, to "donate his or her body to
p.000024: science/medicine/the Faculty"). Only partial removals of material, made in compliance with the rules governing the care
...
p.000029: assessment should therefore be performed by the researchers in the research protocol of the risk
p.000029: of identification and stigmatisation of relatives, depending on the type of genetic investigation planned and the
p.000029: susceptibility to stigmatisation of the disease or physiological characteristic under investigation. The Ethics
p.000029: Committee which evaluates the protocol will need to check that adequate measures have been planned to 1) regulate the
p.000029: use and disclosure of identity-
p.000029:
p.000030: 30
p.000030: FINAL VERSION
p.000030:
p.000030: sensitive data/results in a research context, e.g. by stipulating that the results of these investigations
p.000030: will only be disclosed in databases that are subject to data-sharing policies58, and 2) prevent any disclosure or use
p.000030: of these results outside the context of the research.
p.000030:
p.000030: ***
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030: 58 OECD principles and guidelines for access to research data from public funding: document available
p.000030: at the address:
p.000030: http://www.oecd.org/sti/sci- tech/oecdprinciplesandguidelinesforaccesstoresearchdatafrompublicfunding.htm
p.000030:
p.000030:
p.000031: 31
p.000031: FINAL VERSION
p.000031:
p.000031: The opinion was prepared in the select commission 2010/3bis, consisting of:
p.000031:
p.000031:
p.000031:
p.000031: Joint chairpersons
p.000031: S. Sterckx
p.000031: G. Genicot
p.000031: Joint reporters
p.000031: S. Sterckx
p.000031: G. Genicot
p.000031: E. Heinen
p.000031: V. Pirard
p.000031: Members
p.000031: A. Herchuelz
p.000031: T. Locoge
p.000031: R. Rubens
p.000031: Member of the Bureau
p.000031: M. Dupuis
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Member of the Secretariat
p.000031: L. Dejager
p.000031:
p.000031:
p.000031:
p.000031: Experts interviewd
p.000031: Mme Hélène Antoine-Poirel, professeur en Génétique humaine / Human Molecular Genetics (GEHU) aux Cliniques
p.000031: universitaires Saint-Luc / de Duve Institute / UCL
p.000031: Mme Florence Bellivier, professeur de droit à l’Université Paris Ouest Nanterre La Défense Mme Bianka Dörr, professeur
p.000031: de droit aux universités de Zürich et de Bâle
p.000031: M. Nick van Gelder, chercheur doctorant en droit médical à l’Universiteit Antwerpen
p.000031:
p.000031:
p.000031: Experts consulted
p.000031: M. Patrick Niaudet, président du Conseil d’Orientation de l’Agence de la Bio médecine (France)
p.000031: M. Kristof Van Assche, Dr., chercheur à la Vrije Universiteit Brussel, Faculté de Droit et de Criminologie,
p.000031: Département Metajuridica, Research Group on Law, Science, Technology & Society
p.000031:
p.000031:
p.000031:
...
Social / Age
Searching for indicator age:
(return to top)
p.000019: have the right to know the arrangements that the legislators have made in this area, which may have a direct
p.000019: impact on their bodies after their
p.000019:
p.000019: 50 J. Savulescu, “For and Against: No Consent Should Be Needed for Using Leftover Body Material for Scientific
p.000019: Purposes – Against” British Medical Journal 2000; 325: 648, 649. A comparable view is found in, for example, R. Rhodes,
p.000019: “Rethinking Research Ethics” American Journal of Bioethics 2005; 7: 16-17.
p.000019: 51 Moreover, various studies have shown that even such protection cannot be guaranteed. See e.g. McGuire,
p.000019: A.L. & Gibbs, R.A. (2006), “Genetics. No longer de-identified”, Science 312, pp. 370–371. See also Schmidt, H. &
p.000019: Callier, S. (2012), “How anonymous is 'anonymous'? Some suggestions towards a coherent universal coding system
p.000019: for genetic samples”, Journal of Medical Ethics 38(5), pp. 304-309. See also Lowrance, W.W. & Collins, F.S. (2007),
p.000019: “Identifiability in genomic research”, Science 317, pp. 600–602.
p.000019: 52 As examples of the interesting literature on moral complicity, see John Gardner, “Complicity and Causality”
p.000019: Criminal Law and Philosophy 2007; 1: 127-141; Ronald M. Green, “Benefiting from ‘Evil’: An Incipient Moral Problem in
p.000019: Human Stem Cell Research” Bioethics 2002; 16: 544-556; Christopher Kutz, Complicity: Ethics and Law for a Collective
p.000019: Age. Cambridge: Cambridge University Press, 2000; and Helen Watt, ed., Cooperation, Complicity & Conscience – Problems
p.000019: in Healthcare, Science, Law and Public Policy. London: The Linacre Centre, 2006.
p.000019:
p.000020: 20
p.000020: FINAL VERSION
p.000020:
p.000020: death, and to be told the reasons for these measures and the ways of registering an objection to them.
p.000020: They argue that it is under these conditions of clarity, publicity and education that the profoundly
p.000020: ethical significance of this system can be preserved.
p.000020:
p.000020: These members stress that the opt-out system must involve transparency and honesty with the general public – and hence
p.000020: the repeated provision of comprehensive explanations of its principle, its purpose and how it works. This is required
p.000020: firstly because of the sensitive area to which it relates – the use of body material after death – but
p.000020: also because it reflects a certain climate of trust: in return for the limitation of individual autonomy that the
p.000020: scheme involves, for reasons relating to the public interest and the public good, as will be explained below, the legal
p.000020: regime in this area must be perfectly transparent.
p.000020:
p.000020: It is true that, in principle, there is nothing exceptional about some limitation of individual autonomy in the
p.000020: field of governance, which has been postulated in theory many times in philosophies of the social
p.000020: contract. But it remains important ethically for members of the public to have the significance of the opt-out
...
Social / Child
Searching for indicator children:
(return to top)
p.000014: mortem collection and use of body material, the risk of a strong reaction is probably very slight, but the Alder Hey
p.000014: scandal in the United Kingdom,33 which still arouses emotion many years after the events concerned, demonstrates the
p.000014: scale of the trauma that can result from a "leak" in a single case.
p.000014:
p.000014: 2) Potential disadvantages for close relatives of the deceased
p.000014:
p.000014: If we examine the question from the perspective of the close relatives, it is fair to say that the disadvantages of
p.000014: biomedical research on body material from a deceased person may be more severe and are likely to affect a larger number
p.000014: of people than the removal of organs from a deceased person for transplantation. Alongside the comparable potential
p.000014: drawbacks – associated with the potential psychological disturbance that some family members may experience
p.000014: from the idea of the body being cut open, material removed, and the dead person’s body being exploited –
p.000014: there may also be disadvantages which are specific to the context of biomedical research on body material removed post
p.000014: mortem.
p.000014:
p.000014:
p.000014: 32 See e.g. Nys, H. (2009) “Bloed, zweet en tranen. Kritische ontleding van de wet van 19 december 2008 inzake
p.000014: het verkrijgen en het gebruik van menselijk lichaamsmateriaal”, Rechtskundig Weekblad, 2009-2010, p.
p.000014: 184, n° 26.
p.000014: 33 Royal Liverpool Children’s Inquiry Report (2001), available
p.000014: at
p.000014: http://www.ricinquiry.org.uk/download/index.htm [consulted on 23 August 2012].
p.000014:
p.000015: 15
p.000015: FINAL VERSION
p.000015:
p.000015: 3) Potential disadvantages from the point of view of the deceased: harm to posthumous "interests"?
p.000015:
p.000015: In the literature, it is sometimes assumed rather casually, without many supporting arguments being
p.000015: offered, that what happens to the body of someone who has died has no implications as far as that person is concerned.
p.000015: However, conclusions on this subject ought to be based on an analysis of the possible arguments, rather than
p.000015: on mere suppositions. One of the reasons why such an analysis is far from simple is that terms are sometimes used in
p.000015: this context that cannot be applicable (e.g. the "rights" of the deceased), or that may intuitively seem
p.000015: to be applicable, but require clarification and argumentation (e.g. the "interests" of the deceased), or that
p.000015: clearly can be applicable but have less normative force as a concept and, like any term on which we wish to develop an
p.000015: ethical argument, require explanation (e.g. the "wishes" of the deceased).
p.000015:
p.000015: The question of whether there are what may be called posthumous "interests" is much discussed and gives
p.000015: rise to differing views. Three positions can be distinguished in this debate.
p.000015:
p.000015: A first group claims that deceased individuals may incur harm from posthumous events. This group is found in the
...
Social / Fetus/Neonate
Searching for indicator foetuses:
(return to top)
p.000003: transplantation of organs, inserted by the Law of 25 February 2007, together with the deletion of Article 10, § 4, 3,
p.000003: of the said law by the same Law of 25 February 2007; and secondly, the scope of Article 12 of the Law of 19 December
p.000003: 2008 on the acquisition and use of human body material for human medical applications or for scientific
p.000003: research purposes.
p.000003:
p.000003: The Committee considered that these two aspects are clearly distinct from one another and that each requires
p.000003: specific ethical reflection. It has therefore deemed it appropriate to separate them, and to respond to the
p.000003: Minister’s request in two Opinions. The first Opinion (Opinion no. 50 of 9 May 2011) focuses on the Law of 13 June
p.000003: 1986 on the removal and transplantation of organs. The present Opinion deals with the Law of 19 December 2008 on the
p.000003: acquisition and use of human body material for human medical applications or for scientific research
p.000003: purposes.
p.000003:
p.000003:
p.000003: A. Scope of the Law of 19 December 2008
p.000003: This law applies "to the donation, removal, acquisition, testing, handling, preservation, storage,
p.000003: distribution and use of body material intended for human applications or for scientific research purposes"
p.000003: (Article 3, § 1, Paragraph 1). Its scope is therefore very broad and awkward to define. To do so, reference must be
p.000003: made to the definitions contained in Article 2 of the law:
p.000003: - human body material: "any human biological material, including human tissue and cells, gametes, embryos,
p.000003: foetuses and substances extracted from them, regardless of their degree of transformation";
p.000003: - cells: "isolated cells of human origin cells or a group of cells of human origin not linked
p.000003: together by connective tissue"
p.000003: - tissue: "any constituent part of the human body consisting of cells";
p.000003: - removal: "act by which the human body material is extracted from the human body";
p.000003: - human medical application: "use of human body material on or in a human recipient, including extracorporeal
p.000003: application";
p.000003: - scientific research: "any use of human body material for the development of knowledge for the exercise
p.000003: of the health care professions."
p.000003:
p.000003: The law therefore applies to any removal of human body material intended for human medical applications
p.000003: or for scientific research purposes, in the sense which has just been recapitulated but which is not
p.000003: further specified in the text. Its scope encompasses the removal of and all operations carried out using
p.000003: stem cells, regardless of their origin,
p.000003:
p.000003:
p.000004: 4
p.000004: FINAL VERSION
p.000004:
p.000004: including from cord blood, peripheral blood or bone marrow or of mesenchymal origin (Art. 3, § 2). The Law of 19
p.000004: December 2008 does not apply, however, to:
p.000004: - what happens after death to the body itself: on this point, reference should be made to the Law of 20 July 1971 on
p.000004: funerals and burials and to the regional decrees on the same subject. These latter do not mention the "donation of the
p.000004: body to science" for educational (and research) purposes, which of course is done on a voluntary basis, as the use of
...
Social / Incarcerated
Searching for indicator restricted:
(return to top)
p.000008:
p.000009: 9
p.000009: FINAL VERSION
p.000009:
p.000009: biomedical research ourselves.
p.000009:
p.000009: The main problem with this argument is that the claim that biomedical research is a "public good" must itself be
p.000009: qualified. One may legitimately ask to what extent biomedical research does actually give rise to research
p.000009: results which are available to the public, to affordable treatments and to discoveries that are relevant (and
p.000009: at the very least harmless).
p.000009:
p.000009: The argument that there is a general obligation to participate in biomedical research because we all derive benefit
p.000009: from its results in the industrialised world takes no account of the social context of access to healthcare. In
p.000009: fact, access to the results of biomedical research also depends, in the industrialised world, on factors
p.000009: such as financial opportunity (health insurance), the availability of preventive care and the ability to
p.000009: process the influx of information about medical solutions and developments. This means that any such obligation does
p.000009: not exist or only exists to a much lesser extent on the part of disadvantaged groups.12
p.000009:
p.000009: Many biomedical research projects do not aim – or not primarily – to improve the general welfare, but are (at least
p.000009: in part) driven by greed. Often, the results are not shared with colleagues13 or even have a
p.000009: counter-productive effect, because part of the research and (especially) of the development of diagnostic and
p.000009: therapeutic methods is restricted for many years by patents that are granted.14
p.000009:
p.000009: In addition, there is no denying that many biomedical research projects, including many studies with
p.000009: human experimental subjects, provide little or no relevant information and therefore cannot contribute to an
p.000009: improvement to the general welfare.15
p.000009:
p.000009: Moreover, the point should not be overlooked that biomedical research projects can also be harmful to the people
p.000009: involved. Those in charge of research can simply exploit the participants, treating them as a mere means to
p.000009: gain prestige and/or wealth (one only has to think, for example, of the late Henrietta Lacks and her family16, the
p.000009: late John Moore17 and members of the Havasupai tribe in the United States18). We may also add that the results of
p.000009: research, for example in the case of genetic research, can also have discriminatory effects or a stigmatising impact
p.000009: (not just for the participant, but also for the group to which he or she belongs).19
p.000009:
p.000009: In short, even if it were possible to demonstrate that biomedical research as a social concept should be regarded as a
p.000009: "public good", one might ask how we can infer from this a duty to
p.000009:
p.000009: 12 I. de Melo-Martin, “Response to Rosamond Rhodes” Newsletter on Philosophy and Medicine 2008; 7(2): 13-14.
p.000009: 13 See Advisory Committee Opinion no. 51 of 12 March 2012 on the publication of the results of
p.000009: experiments conducted on humans.
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.000003: application";
p.000003: - scientific research: "any use of human body material for the development of knowledge for the exercise
p.000003: of the health care professions."
p.000003:
p.000003: The law therefore applies to any removal of human body material intended for human medical applications
p.000003: or for scientific research purposes, in the sense which has just been recapitulated but which is not
p.000003: further specified in the text. Its scope encompasses the removal of and all operations carried out using
p.000003: stem cells, regardless of their origin,
p.000003:
p.000003:
p.000004: 4
p.000004: FINAL VERSION
p.000004:
p.000004: including from cord blood, peripheral blood or bone marrow or of mesenchymal origin (Art. 3, § 2). The Law of 19
p.000004: December 2008 does not apply, however, to:
p.000004: - what happens after death to the body itself: on this point, reference should be made to the Law of 20 July 1971 on
p.000004: funerals and burials and to the regional decrees on the same subject. These latter do not mention the "donation of the
p.000004: body to science" for educational (and research) purposes, which of course is done on a voluntary basis, as the use of
p.000004: the body in this way can be stipulated by the deceased in his or her will;
p.000004: - the removal of organs for transplantation, which is the subject of the Law of 13 June 1986 on the removal and
p.000004: transplantation of organs;
p.000004: - procedures using blood, blood components and blood products of human origin, which are covered by the
p.000004: Law of 5 July 1994 on blood and blood products of human origin;
p.000004: - the removal of and procedures with human body material for autologous use within a single procedure;
p.000004: - the removal and procedures performed with body material exclusively for diagnostic purposes for the benefit of
p.000004: the person from whom the material was removed, provided it is not used for any other purpose;
p.000004: - hair (with the exception of follicles), nails, urine, breast milk, faeces, sweat and tears (Art. 3, § 3).
p.000004:
p.000004: As the Committee stressed in its Opinion no. 50, it is thus appropriate to make a clear distinction
p.000004: between organs removed for therapeutic purposes, referred to by the Law of 13 June 1986 and tissues and cells removed
p.000004: for any purpose whatsoever, or organs removed for scientific research purposes, referred to by the Law of 19
p.000004: December 2008. However, this distinction between the scope of the Laws of 13 June 1986 and 19 December
p.000004: 2008 respectively does not always seem to be properly observed in practice.
p.000004:
p.000004: [ …see the French, Dutch or German version of the opinion on
p.000004: www.health.belgium.be/bioeth under the headings avis or adviezen or Gutachten].
p.000004:
p.000004: [B. ….]
p.000004:
p.000004: C. Subject of this Opinion
p.000004: This Opinion does not directly address the use of human body material, but considers the conditions under which it is
p.000004: obtained after death. It aims to provide an ethical assessment of Article 12 of the Law of 19 December 2008, which
p.000004: states that Articles 10, 11, 12, 13 and 14 of the Act of 13 June 1986 on the removal and transplantation of
...
p.000014: disadvantages? In other words, for what specific reasons do the members of the Committee consider the system provided
p.000014: for by the law to be ethically indefensible?
p.000014:
p.000014: c) Posthumous removal of body material: the nature and ethical relevance of the possible disadvantages
p.000014:
p.000014: 1) Potential disadvantages for society
p.000014:
p.000014: When people learn about the system used to obtain body material post mortem for research purposes, this could have a
p.000014: direct impact on the number of organs removed post mortem, as there is currently no possibility of adopting
p.000014: differing positions in terms of objecting or consenting to the removal of body material and the removal
p.000014: of organs. In other words, a system which is ethically problematic (or perceived as such) for the posthumous removal
p.000014: of body material for research could undermine the system of presumed consent for posthumous organ
p.000014: donation with which we are familiar in Belgium.32
p.000014:
p.000014: More generally, it could even lead to a collapse in the confidence that many citizens have towards the government and
p.000014: biomedical research. While the population remains unaware of what is permitted by the 2008 law in terms of the post
p.000014: mortem collection and use of body material, the risk of a strong reaction is probably very slight, but the Alder Hey
p.000014: scandal in the United Kingdom,33 which still arouses emotion many years after the events concerned, demonstrates the
p.000014: scale of the trauma that can result from a "leak" in a single case.
p.000014:
p.000014: 2) Potential disadvantages for close relatives of the deceased
p.000014:
p.000014: If we examine the question from the perspective of the close relatives, it is fair to say that the disadvantages of
p.000014: biomedical research on body material from a deceased person may be more severe and are likely to affect a larger number
p.000014: of people than the removal of organs from a deceased person for transplantation. Alongside the comparable potential
p.000014: drawbacks – associated with the potential psychological disturbance that some family members may experience
p.000014: from the idea of the body being cut open, material removed, and the dead person’s body being exploited –
p.000014: there may also be disadvantages which are specific to the context of biomedical research on body material removed post
p.000014: mortem.
p.000014:
p.000014:
p.000014: 32 See e.g. Nys, H. (2009) “Bloed, zweet en tranen. Kritische ontleding van de wet van 19 december 2008 inzake
p.000014: het verkrijgen en het gebruik van menselijk lichaamsmateriaal”, Rechtskundig Weekblad, 2009-2010, p.
p.000014: 184, n° 26.
p.000014: 33 Royal Liverpool Children’s Inquiry Report (2001), available
p.000014: at
p.000014: http://www.ricinquiry.org.uk/download/index.htm [consulted on 23 August 2012].
p.000014:
p.000015: 15
p.000015: FINAL VERSION
p.000015:
p.000015: 3) Potential disadvantages from the point of view of the deceased: harm to posthumous "interests"?
p.000015:
p.000015: In the literature, it is sometimes assumed rather casually, without many supporting arguments being
...
p.000022: conditions for the collection of sufficient (though not unlimited: on this point see the recommendations
p.000022: of the members supporting this position) amounts of material, legislators can ensure, among other things, the ethical
p.000022: regulation of the demand for and use of human body material by researchers. When the needs for human body
p.000022: material are met through official channels in a country, there is less risk of "unofficial" circuits
p.000022: controlled by criminal gangs developing to meet those needs. This indirectly protects socially vulnerable
p.000022: categories of people (such as prisoners) who are the regular victims of these networks in some countries.
p.000022:
p.000022: A simplifying and clarifying effect on rules and structures
p.000022:
p.000022: The rules for the regulation and control of human body material in an enormous variety of contexts (transplantation,
p.000022: fertilisation, development of treatments, removal, analysis, research, storage, transportation, etc.)
p.000022: are becoming increasingly complex and require multiple regulatory or inspection bodies. This causes delays,
p.000022: increases costs and leads to confusion of responsibilities and categorisation. The current system, which
p.000022: encompasses the post mortem donation of organs, tissues and cells for transplantation and/or scientific
p.000022: research in a single model (the opt-out regime), concentrates responsibilities for the issue of human body material
p.000022: within human biomaterial institutions and biobanks and reduces the quantity of records and the number of stages in the
p.000022: process. This constitutes a guarantee of
p.000022:
p.000022:
p.000022: 55 See the report published in Le Monde on 22 July 2012.
p.000022:
p.000023: 23
p.000023: FINAL VERSION
p.000023:
p.000023: safety and practicality.
p.000023:
p.000023: The clarity of the system is one of the factors that have led to a consensus in France, where the opt-out system for
p.000023: the removal of tissue or organs has existed since 2003, apparently without having caused any particular problems
p.000023: so far. The creation of the National Committee for Biovigilance, whose work is coordinated by the National Agency
p.000023: for Medicines and Health Products Safety (MSNA), has enabled collection and other activities relating to
p.000023: human body material to be controlled, in particular through inspections on the ground. The application of the right to
p.000023: object (the opt-out) was not a subject for further debate during the revision of the bioethics law in 201156.
p.000023:
p.000023: Moreover, it should also be noted that it too is regarded as a solidarity-based system, and one which is not forbidden
p.000023: either by EU directives or the Oviedo Convention.
p.000023:
p.000023: 5) Some important points
p.000023:
p.000023: It should be recalled that the opt-out system cannot be regarded, under these conditions, as "conscription".
p.000023: Encouraging the donation of a sufficient volume of material does not mean that everyone participates (as we can always
p.000023: rebut the presumption), but it does require that we are all socially encouraged to participate. To those who cite
...
Social / Racial Minority
Searching for indicator racial:
(return to top)
p.000021: increase in scientific knowledge which (3) in the short, medium or long term produces a better understanding of disease
p.000021: and contributes to the medical care of individuals. When these conditions are met, it is reasonable and justified for
p.000021: legislators to encourage the public to participate in research, because of the benefits that it is likely to bring to
p.000021: the community.
p.000021:
p.000021: The reason why this is so is that research is the best way – if not the only way – to enable a hypothesis associated
p.000021: with an individual case to be turned into a relevant scientific fact at the level of a population or population group.
p.000021: In other words, the scientific approach makes possible a process of objectivisation and generalisation with
p.000021: which an empirical approach cannot compete. And this twofold transformation of a hypothesis (or an observed fact)
p.000021: into scientific fact (or demonstrated fact) and from an individual level to a collective level has a major impact in
p.000021: the field of public health. In fact, this latter is only possible as an intellectual category and as a form of
p.000021: intervention in the public sphere because we have the intellectual and statistical means of moving from the individual
p.000021: case (which is of course observable in a care provision context, independently of any research) to the cohort, and from
p.000021: the cohort to the population. There is thus a consistency of scale, but also in principle of goals, between the field
p.000021: of research and that of public health. It is for this reason that the Committee
p.000021:
p.000021: 53 Thus the Tuskegee scandal can be seen as representing the continuation and reproduction of racial and class
p.000021: violence against Afro-Americans in the United States, despite the development of social structures between the 30s and
p.000021: the 70s.
p.000021: 54 Derived, it will be recalled, from the Helsinki Declaration (Seoul 2008)
p.000021: (http://www.wma.net/en/30publications/10policies/b3/), the Guidelines of CIOMS, the Council for International
p.000021: Organisations of Medical Sciences. (http://www.cioms.ch/images/stories/CIOMS/guidelines/guidelines_nov_2002_blurb.htm),
p.000021: and the Unesco Universal Declaration on Bioethics and Human Rights (http://portal.unesco.org/en).
p.000021:
p.000022: 22
p.000022: FINAL VERSION
p.000022:
p.000022: members who hold this position believe that it is fundamentally justified to encourage individuals to
p.000022: participate in research, and that scientific research is a “common good under certain conditions” which should of
p.000022: course be strictly regulated, but which should also be promoted, in particular through an opt-out system for post
p.000022: mortem removal of human body material.
p.000022:
p.000022: 3) The social significance of the opt-out scheme
p.000022:
p.000022: The opt-out regime serves as a social signal. The reason why the legislators wish to encourage research
p.000022: is that it is regarded as a good for society. It is therefore not treated as a neutral activity that it would be
p.000022: inappropriate to promote at the level of society or even, simply, as an activity without any interest
p.000022: to the community. The purpose of the opt-out scheme is not to override the freedom of individuals, but
p.000022: to adjust it in order to communicate the fact that research is a social and collective “good”, particularly
p.000022: because of its links with public health.
p.000022:
...
Social / Religion
Searching for indicator religious:
(return to top)
p.000014: at
p.000014: http://www.ricinquiry.org.uk/download/index.htm [consulted on 23 August 2012].
p.000014:
p.000015: 15
p.000015: FINAL VERSION
p.000015:
p.000015: 3) Potential disadvantages from the point of view of the deceased: harm to posthumous "interests"?
p.000015:
p.000015: In the literature, it is sometimes assumed rather casually, without many supporting arguments being
p.000015: offered, that what happens to the body of someone who has died has no implications as far as that person is concerned.
p.000015: However, conclusions on this subject ought to be based on an analysis of the possible arguments, rather than
p.000015: on mere suppositions. One of the reasons why such an analysis is far from simple is that terms are sometimes used in
p.000015: this context that cannot be applicable (e.g. the "rights" of the deceased), or that may intuitively seem
p.000015: to be applicable, but require clarification and argumentation (e.g. the "interests" of the deceased), or that
p.000015: clearly can be applicable but have less normative force as a concept and, like any term on which we wish to develop an
p.000015: ethical argument, require explanation (e.g. the "wishes" of the deceased).
p.000015:
p.000015: The question of whether there are what may be called posthumous "interests" is much discussed and gives
p.000015: rise to differing views. Three positions can be distinguished in this debate.
p.000015:
p.000015: A first group claims that deceased individuals may incur harm from posthumous events. This group is found in the
p.000015: religious community, and associates the corpse's physical intactness with the deceased’s interests in the
p.000015: (presumed) afterlife. From this point of view, posthumous interests are significant because the deceased
p.000015: begins a second life after death, of a spiritual nature, and the physical intactness of the body may be a crucial
p.000015: precondition for this. We will not consider this point of view any further in the rest of this Opinion.
p.000015:
p.000015: A second group believes that the dead cannot incur any harm from posthumous events and that it therefore makes no sense
p.000015: to speak of harm to the ante mortem person from events occurring post mortem. They argue that the dead can no
p.000015: longer have any interests, and hence no interests that can be affected by the posthumous use of their body
p.000015: material.34
p.000015:
p.000015: For example this reasoning is found in a very pronounced form in Jonsen: “Consent is ethically important
p.000015: because it manifests and protects the moral autonomy of persons … [and] it is a barrier to exploitation and
p.000015: harm. These purposes are no longer relevant to the cadaver, which has no autonomy and cannot be harmed.”35 Some
p.000015: people who have similar views on the issue stress that posthumous interests, if they exist, are in any
p.000015: case easily ousted by the interests of the living, who need the body material of the deceased for their health.36
p.000015:
...
Social / Threat of Violence
Searching for indicator violence:
(return to top)
p.000021: increase in scientific knowledge which (3) in the short, medium or long term produces a better understanding of disease
p.000021: and contributes to the medical care of individuals. When these conditions are met, it is reasonable and justified for
p.000021: legislators to encourage the public to participate in research, because of the benefits that it is likely to bring to
p.000021: the community.
p.000021:
p.000021: The reason why this is so is that research is the best way – if not the only way – to enable a hypothesis associated
p.000021: with an individual case to be turned into a relevant scientific fact at the level of a population or population group.
p.000021: In other words, the scientific approach makes possible a process of objectivisation and generalisation with
p.000021: which an empirical approach cannot compete. And this twofold transformation of a hypothesis (or an observed fact)
p.000021: into scientific fact (or demonstrated fact) and from an individual level to a collective level has a major impact in
p.000021: the field of public health. In fact, this latter is only possible as an intellectual category and as a form of
p.000021: intervention in the public sphere because we have the intellectual and statistical means of moving from the individual
p.000021: case (which is of course observable in a care provision context, independently of any research) to the cohort, and from
p.000021: the cohort to the population. There is thus a consistency of scale, but also in principle of goals, between the field
p.000021: of research and that of public health. It is for this reason that the Committee
p.000021:
p.000021: 53 Thus the Tuskegee scandal can be seen as representing the continuation and reproduction of racial and class
p.000021: violence against Afro-Americans in the United States, despite the development of social structures between the 30s and
p.000021: the 70s.
p.000021: 54 Derived, it will be recalled, from the Helsinki Declaration (Seoul 2008)
p.000021: (http://www.wma.net/en/30publications/10policies/b3/), the Guidelines of CIOMS, the Council for International
p.000021: Organisations of Medical Sciences. (http://www.cioms.ch/images/stories/CIOMS/guidelines/guidelines_nov_2002_blurb.htm),
p.000021: and the Unesco Universal Declaration on Bioethics and Human Rights (http://portal.unesco.org/en).
p.000021:
p.000022: 22
p.000022: FINAL VERSION
p.000022:
p.000022: members who hold this position believe that it is fundamentally justified to encourage individuals to
p.000022: participate in research, and that scientific research is a “common good under certain conditions” which should of
p.000022: course be strictly regulated, but which should also be promoted, in particular through an opt-out system for post
p.000022: mortem removal of human body material.
p.000022:
p.000022: 3) The social significance of the opt-out scheme
p.000022:
p.000022: The opt-out regime serves as a social signal. The reason why the legislators wish to encourage research
p.000022: is that it is regarded as a good for society. It is therefore not treated as a neutral activity that it would be
p.000022: inappropriate to promote at the level of society or even, simply, as an activity without any interest
p.000022: to the community. The purpose of the opt-out scheme is not to override the freedom of individuals, but
p.000022: to adjust it in order to communicate the fact that research is a social and collective “good”, particularly
p.000022: because of its links with public health.
p.000022:
...
Social / Victim of Abuse
Searching for indicator trauma:
(return to top)
p.000014: little more time and resources, poses far fewer ethical problems than the system set up by law. What about the
p.000014: disadvantages? In other words, for what specific reasons do the members of the Committee consider the system provided
p.000014: for by the law to be ethically indefensible?
p.000014:
p.000014: c) Posthumous removal of body material: the nature and ethical relevance of the possible disadvantages
p.000014:
p.000014: 1) Potential disadvantages for society
p.000014:
p.000014: When people learn about the system used to obtain body material post mortem for research purposes, this could have a
p.000014: direct impact on the number of organs removed post mortem, as there is currently no possibility of adopting
p.000014: differing positions in terms of objecting or consenting to the removal of body material and the removal
p.000014: of organs. In other words, a system which is ethically problematic (or perceived as such) for the posthumous removal
p.000014: of body material for research could undermine the system of presumed consent for posthumous organ
p.000014: donation with which we are familiar in Belgium.32
p.000014:
p.000014: More generally, it could even lead to a collapse in the confidence that many citizens have towards the government and
p.000014: biomedical research. While the population remains unaware of what is permitted by the 2008 law in terms of the post
p.000014: mortem collection and use of body material, the risk of a strong reaction is probably very slight, but the Alder Hey
p.000014: scandal in the United Kingdom,33 which still arouses emotion many years after the events concerned, demonstrates the
p.000014: scale of the trauma that can result from a "leak" in a single case.
p.000014:
p.000014: 2) Potential disadvantages for close relatives of the deceased
p.000014:
p.000014: If we examine the question from the perspective of the close relatives, it is fair to say that the disadvantages of
p.000014: biomedical research on body material from a deceased person may be more severe and are likely to affect a larger number
p.000014: of people than the removal of organs from a deceased person for transplantation. Alongside the comparable potential
p.000014: drawbacks – associated with the potential psychological disturbance that some family members may experience
p.000014: from the idea of the body being cut open, material removed, and the dead person’s body being exploited –
p.000014: there may also be disadvantages which are specific to the context of biomedical research on body material removed post
p.000014: mortem.
p.000014:
p.000014:
p.000014: 32 See e.g. Nys, H. (2009) “Bloed, zweet en tranen. Kritische ontleding van de wet van 19 december 2008 inzake
p.000014: het verkrijgen en het gebruik van menselijk lichaamsmateriaal”, Rechtskundig Weekblad, 2009-2010, p.
p.000014: 184, n° 26.
p.000014: 33 Royal Liverpool Children’s Inquiry Report (2001), available
p.000014: at
p.000014: http://www.ricinquiry.org.uk/download/index.htm [consulted on 23 August 2012].
p.000014:
p.000015: 15
p.000015: FINAL VERSION
p.000015:
p.000015: 3) Potential disadvantages from the point of view of the deceased: harm to posthumous "interests"?
p.000015:
...
Searching for indicator victim:
(return to top)
p.000016: 40 M. Wicclair, “Ethics and research with deceased patients” Cambridge Quarterly of Healthcare Ethics
p.000016: 2008; 17(1): 87-97.
p.000016: 41 Law Reform Commission of Canada. Procurement and transfer of human tissues and organs, working paper
p.000016: 66, 1992: 45.
p.000016: 42 For an analysis of these principles, see e.g. D. Price. Human Tissue in Transplantation and
p.000016: Research: A Model Legal and Ethical Donation Framework. Cambridge: Cambridge University Press, 2010. The summary of the
p.000016: arguments that we present here is largely drawn from this impressive work.
p.000016: 43 R. Dworkin. Life’s Dominion. London: Harper Collins, 1993: 199-217.
p.000016:
p.000017: 17
p.000017: FINAL VERSION
p.000017:
p.000017: character and moral values most closely. Unlike experiential interests, critical interests may be harmed after death.44
p.000017:
p.000017: A remark frequently heard regarding the determination of what happens to one’s own body material after death is
p.000017: that it may be a matter of critical interest while the person is still alive, but not subsequently,
p.000017: because (as stated earlier), there is no longer a subject and hence no longer the possibility of regressive
p.000017: causality of the negation of this critical interest.
p.000017:
p.000017: It may be objected to the point on the lack of a subject that it is generally recognised in other contexts that
p.000017: individuals’ interests may be harmed without their being aware of it at the time or in the future. For example, one may
p.000017: be the victim of theft or defamation without being aware of it, or fall into a coma, meaning that others have to make
p.000017: crucial decisions that fundamentally affect one’s welfare. It is therefore wrong to believe that we can only have an
p.000017: interest in things of which we are conscious. In short, the "mental state account of harm,"
p.000017: i.e. the idea that one must be aware of harm for there to be any harm at all, is inadequate.
p.000017:
p.000017: Wishes can be fulfilled by events after the death of the person concerned just as they can by events during his or her
p.000017: lifetime. Fulfilment of wishes in the former case is just as positive as in the latter. It is true that the dead may
p.000017: never know whether their wishes have actually been fulfilled or have been ignored, but it is not clear why a simple
p.000017: lack of knowledge of what has happened would imply that they have not been harmed by their wishes being ignored.45
p.000017:
p.000017: In short, regardless of whether a person is aware of the fulfilment or non-fulfilment of his or her wishes, harm can be
p.000017: caused simply by non-fulfilment of those wishes. Such a concept of harm that is unrelated to one’s experience of it
p.000017: adequately captures the very essence of the problem that arises when prior manifestations of wishes (advance
p.000017: directives) are not respected. For example, if the wishes of persons in a persistent vegetative state that have been
...
Social / access to healthcare
Searching for indicator access to healthcare:
(return to top)
p.000023: physical integrity is affected. At the symbolic level, moreover, some advocates of keeping the opt-out system point
p.000023: out that removing human body material for research has the effect of delaying the body's natural decay
p.000023: after death, and giving it a potential symbolic "utility". Of course there are differing sensitivities, beliefs and
p.000023: attitudes vis-à-vis the body and the respect due to the mortal remains of the deceased, as well as to family members
p.000023: and to the social groups to which the deceased belonged. The Committee members in favour of retaining the opt-out
p.000023: system believe that, if accompanied by certain guarantees, it is a safe and transparent means of preventing corpses
p.000023: from being tampered with for the sake of research in an unjustified and potentially profane way.
p.000023:
p.000023: Some of these members also point out that all research, especially that involving human body material, is
p.000023: already regulated by safety, health and ethical rules. Thus any research on human body material must have received
p.000023: approval from a medical ethics committee and must be carried out in approved laboratories on material obtained,
p.000023: stored and transported according to specific rules.
p.000023:
p.000023: Some opponents of the opt-out system under certain conditions argue that it is not a moral duty for everyone to
p.000023: contribute to research, since not everyone has equal access to healthcare and hence to the benefits of
p.000023: scientific research. While it is unfortunately true that access to healthcare is not equal for all, the solution is to
p.000023: act to dispel this disparity. Non- participation on this ground will do nothing to solve this problem of unfairness. In
p.000023: addition,
p.000023:
p.000023: 56 However, the French expert who was heard by the select committee was highly critical of French law and the opt-out
p.000023: system.
p.000023:
p.000024: 24
p.000024: FINAL VERSION
p.000024:
p.000024: the knowledge gained through the development of research may help to reduce the cost of certain forms of care and thus
p.000024: make them accessible to a larger number of people.
p.000024:
p.000024: 2. Ethical points concerning the treatment of people’s final wishes and critical interests in the
p.000024: context of an opt-out system for post mortem removal of material for scientific purposes
p.000024:
p.000024: Members who wish to keep the opt-out regime would like to stress the following point: at no time does this scheme,
p.000024: in their view, have the effect of completely negating individuals’ autonomy regarding their final wishes
p.000024: for funeral arrangements. When the removal of material is for scientific purposes, we must remember that the
p.000024: entire body is not regarded as having been donated to science (which would require an explicit wish on the
p.000024: part of the deceased, expressed during his or her lifetime, to "donate his or her body to
p.000024: science/medicine/the Faculty"). Only partial removals of material, made in compliance with the rules governing the care
p.000024: for and handling of dead bodies, are allowed. Once these have been performed, the last wishes of the deceased can be
p.000024: fully respected and his or her wishes regarding funeral arrangements complied with.
p.000024:
...
Social / education
Searching for indicator education:
(return to top)
p.000011: potential benefits – see below). Such a view implies that the removal of human body material post mortem could become a
p.000011: routine practice.
p.000011:
p.000011: The system of presumed consent as provided for in the Law of 19 December 2008 amounts in practice to the automatic
p.000011: collection (or "conscription") of body material post mortem, whenever a clinician or researcher (1)
p.000011: regards such collection as potentially useful, (2) directly or indirectly (via a colleague or a biobank) has
p.000011: access to the body of the deceased, and (3) determines that the person concerned has not indicated any
p.000011: objection to a post mortem removal of organs for transplantation purposes.
p.000011:
p.000011:
p.000011: 24 B. Williams, “A critique of utilitarianism” in J.J.C. Smart & B. Williams (Eds). Utilitarianism, for and against.
p.000011: Cambridge: Cambridge University Press, 1990: 82-117.
p.000011: 25 S. Shapshay & K. Pringle, “Participation in biomedical research is an imperfect moral duty: A
p.000011: response to John Harris” Journal of Medical Ethics 2007; 33(7): 414-417.
p.000011: 26 I. de Melo-Martin, “Response to Rosamond Rhodes” Newsletter on Philosophy and Medicine 2008; 7(2): 13-14.
p.000011: 27 See e.g. S.H. Woolf et al., “Giving Everyone the Health of the Educated: An Examination of Whether Social Change
p.000011: Would Save More Lives than Medical Advances” American Journal of Public Health 2007; 97(4): 679:
p.000011: “[C]orrecting disparities in education-associated mortality rates would have saved more than a million lives rather
p.000011: than about 178 thousand that were averted by medical advances” . See also T. Pogge, “Responsibilities for
p.000011: poverty-related ill health” Ethics International Affairs 2002; 16: 71: “[P]overty is far and away the most important
p.000011: factor in explaining health deficits. Because they are poor, 815 million persons are malnourished, 1.1 billion
p.000011: lack access to safe water, 2.4 billion lack access to basic sanitation, more than 880 million lack access
p.000011: to health services, and approximately 1 billion have no adequate shelter”.
p.000011:
p.000012: 12
p.000012: FINAL VERSION
p.000012:
p.000012: The law stipulates (Art. 12) that the consent of the person concerned is presumed for any removal of material after
p.000012: death and is therefore authorised in all cases, unless the person has expressed an objection to post mortem removal of
p.000012: organs for transplantation. Given that the Belgian population is totally unaware that under the 2008 Law, not objecting
p.000012: to the post mortem removal of organs for transplantation is treated as equivalent to not objecting to the post mortem
p.000012: removal of organs for the purposes of scientific research and of tissue and cells for scientific research or
p.000012: therapeutic purposes, and given, therefore, that citizens who do not agree will not express an objection because they
...
p.000019: 51 Moreover, various studies have shown that even such protection cannot be guaranteed. See e.g. McGuire,
p.000019: A.L. & Gibbs, R.A. (2006), “Genetics. No longer de-identified”, Science 312, pp. 370–371. See also Schmidt, H. &
p.000019: Callier, S. (2012), “How anonymous is 'anonymous'? Some suggestions towards a coherent universal coding system
p.000019: for genetic samples”, Journal of Medical Ethics 38(5), pp. 304-309. See also Lowrance, W.W. & Collins, F.S. (2007),
p.000019: “Identifiability in genomic research”, Science 317, pp. 600–602.
p.000019: 52 As examples of the interesting literature on moral complicity, see John Gardner, “Complicity and Causality”
p.000019: Criminal Law and Philosophy 2007; 1: 127-141; Ronald M. Green, “Benefiting from ‘Evil’: An Incipient Moral Problem in
p.000019: Human Stem Cell Research” Bioethics 2002; 16: 544-556; Christopher Kutz, Complicity: Ethics and Law for a Collective
p.000019: Age. Cambridge: Cambridge University Press, 2000; and Helen Watt, ed., Cooperation, Complicity & Conscience – Problems
p.000019: in Healthcare, Science, Law and Public Policy. London: The Linacre Centre, 2006.
p.000019:
p.000020: 20
p.000020: FINAL VERSION
p.000020:
p.000020: death, and to be told the reasons for these measures and the ways of registering an objection to them.
p.000020: They argue that it is under these conditions of clarity, publicity and education that the profoundly
p.000020: ethical significance of this system can be preserved.
p.000020:
p.000020: These members stress that the opt-out system must involve transparency and honesty with the general public – and hence
p.000020: the repeated provision of comprehensive explanations of its principle, its purpose and how it works. This is required
p.000020: firstly because of the sensitive area to which it relates – the use of body material after death – but
p.000020: also because it reflects a certain climate of trust: in return for the limitation of individual autonomy that the
p.000020: scheme involves, for reasons relating to the public interest and the public good, as will be explained below, the legal
p.000020: regime in this area must be perfectly transparent.
p.000020:
p.000020: It is true that, in principle, there is nothing exceptional about some limitation of individual autonomy in the
p.000020: field of governance, which has been postulated in theory many times in philosophies of the social
p.000020: contract. But it remains important ethically for members of the public to have the significance of the opt-out
p.000020: regime for the community explained to them, as well as the details of how to refute presumed consent if they wish to.
p.000020: This is the only way to counter the charge of disguised "conscription" that the scheme’s detractors sometimes
p.000020: level at it.
p.000020:
p.000020: In line again with the opponents of the system established by the 2008 Law, proponents of the opt-out system also
p.000020: hold that there is no individual moral obligation to participate in research, and that an individual would not
...
Searching for indicator educational:
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p.000003: foetuses and substances extracted from them, regardless of their degree of transformation";
p.000003: - cells: "isolated cells of human origin cells or a group of cells of human origin not linked
p.000003: together by connective tissue"
p.000003: - tissue: "any constituent part of the human body consisting of cells";
p.000003: - removal: "act by which the human body material is extracted from the human body";
p.000003: - human medical application: "use of human body material on or in a human recipient, including extracorporeal
p.000003: application";
p.000003: - scientific research: "any use of human body material for the development of knowledge for the exercise
p.000003: of the health care professions."
p.000003:
p.000003: The law therefore applies to any removal of human body material intended for human medical applications
p.000003: or for scientific research purposes, in the sense which has just been recapitulated but which is not
p.000003: further specified in the text. Its scope encompasses the removal of and all operations carried out using
p.000003: stem cells, regardless of their origin,
p.000003:
p.000003:
p.000004: 4
p.000004: FINAL VERSION
p.000004:
p.000004: including from cord blood, peripheral blood or bone marrow or of mesenchymal origin (Art. 3, § 2). The Law of 19
p.000004: December 2008 does not apply, however, to:
p.000004: - what happens after death to the body itself: on this point, reference should be made to the Law of 20 July 1971 on
p.000004: funerals and burials and to the regional decrees on the same subject. These latter do not mention the "donation of the
p.000004: body to science" for educational (and research) purposes, which of course is done on a voluntary basis, as the use of
p.000004: the body in this way can be stipulated by the deceased in his or her will;
p.000004: - the removal of organs for transplantation, which is the subject of the Law of 13 June 1986 on the removal and
p.000004: transplantation of organs;
p.000004: - procedures using blood, blood components and blood products of human origin, which are covered by the
p.000004: Law of 5 July 1994 on blood and blood products of human origin;
p.000004: - the removal of and procedures with human body material for autologous use within a single procedure;
p.000004: - the removal and procedures performed with body material exclusively for diagnostic purposes for the benefit of
p.000004: the person from whom the material was removed, provided it is not used for any other purpose;
p.000004: - hair (with the exception of follicles), nails, urine, breast milk, faeces, sweat and tears (Art. 3, § 3).
p.000004:
p.000004: As the Committee stressed in its Opinion no. 50, it is thus appropriate to make a clear distinction
p.000004: between organs removed for therapeutic purposes, referred to by the Law of 13 June 1986 and tissues and cells removed
p.000004: for any purpose whatsoever, or organs removed for scientific research purposes, referred to by the Law of 19
p.000004: December 2008. However, this distinction between the scope of the Laws of 13 June 1986 and 19 December
p.000004: 2008 respectively does not always seem to be properly observed in practice.
p.000004:
p.000004: [ …see the French, Dutch or German version of the opinion on
...
Social / philosophical differences/differences of opinion
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p.000002: Opinion no. 54 of 10 December 2012 on consent for the post mortem removal of human body material for human medical
p.000002: applications or for scientific research purposes
p.000002:
p.000002: CONTENTS
p.000002:
p.000002: 1. Definition of the subject of the Opinion
p.000002:
p.000002: A. Scope of the Law of 19 December 2008
p.000002: B. General guarantees contained in the Law of 19 December 2008
p.000002: C. Subject of this Opinion
p.000002:
p.000002: 2. Legal framework
p.000002:
p.000002: A. The fundamental right to informed consent in (bio)medical contexts
p.000002:
p.000002: B. Informed consent in Belgian (bio)medical legal texts
p.000002:
p.000002: 1. General rules
p.000002: 2. Specific texts on the removal of body material
p.000002: a) Removal in vivo
p.000002: b) Removal post mortem
p.000002: 3. Analysis of the preparatory documents for the Law of 19 December 2008
p.000002:
p.000002: C. Supranational rules and survey of comparative law
p.000002:
p.000002: 1. European Directive of 31 March 2004 on setting standards of quality and safety relating to human tissues
p.000002: and cells
p.000002:
p.000002: 2. Convention on human rights and biomedicine and additional protocol concerning transplantation of
p.000002: organs and tissues of human origin
p.000002:
p.000002: 3. Additional protocol to the Convention on human rights and biomedicine concerning biomedical research
p.000002: 4. French law
p.000002:
p.000002: D. Conclusions on the legal framework
p.000002:
p.000002: 3. Ethical considerations
p.000002:
p.000002: A. Introductory considerations
p.000002:
p.000002: B. Position opposing the opt-out system for post mortem removal of human body material
p.000002:
p.000002: 1. There is no general duty to participate in biomedical research
p.000002:
p.000002: a) Criticisms of the idea of a duty to participate in biomedical research due to a moral duty of fairness
p.000002: 1) Criticism of the argument about free-riding behaviour
p.000002: 2) Criticism of the argument concerning the maintaining of public goods
p.000002:
...
p.000002: 1. The ethical foundation of the opt-out system
p.000002:
p.000002: a) Preliminary points
p.000002:
p.000002: b) Elements of the ethical foundation of the opt-out regime for post mortem
p.000002: removal of material for scientific purposes
p.000002:
p.000002: 1) Society as a moral community
p.000002: 2) Scientific research as a “common good under certain conditions”
p.000002: 3) The social significance of the opt-out scheme
p.000002: 4) Practical effects of the opt-out regime
p.000002: 5) Some important points
p.000002:
p.000002: 2. Ethical points concerning the treatment of people’s final wishes and critical interests in the context
p.000002: of an opt-out system for post mortem removal of material for scientific purposes
p.000002:
p.000002: 3. Summary of the position in favour of keeping the opt-out with the addition of further conditions
p.000002:
p.000002: 4. Recommendations and conclusions
p.000002:
p.000002: A. Recommendations made jointly by all Committee members
p.000002:
p.000002: B. Recommendations and conclusions of members opposed to the opt-out system for post mortem removal of human
p.000002: body material
p.000002:
p.000002: C. Recommendations and conclusions of members in favour of the opt-out system for post mortem removal of human body
p.000002: material
p.000002:
p.000002: 1. Improving public information
p.000002: 2. Evaluating the ethical and scientific appropriateness of collecting human body material
p.000002: 3. Increased protection for individuals’ genetic material
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
p.000002:
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p.000002:
p.000003: 3
p.000003: FINAL VERSION
p.000003:
p.000003: The point 1 of the opinion has been partially translated; the points 2 hasn’t been been translated. These points are
p.000003: available only in French, Dutch or German on the website of the Committee: www.health.belgium.be/bioeth
p.000003: under the headings ‘avis’ or ‘adviezen’ or ‘Gutachten’.
p.000003:
p.000003:
p.000003: Request for an opinion of 12 February 2010 from Mrs L. Onkelinx, Minister of Social Affairs and Public Health,
p.000003: concerning the scope of Article 12 of the Law of 19 December 2008 on the acquisition and use of human body material for
p.000003: human medical applications or for scientific research purposes.
p.000003:
p.000003: 1. Definition of the subject of the Opinion
p.000003: In a letter dated 12 February 2010, the Minister of Social Affairs and Public Health sought the Committee’s opinion on
p.000003: two aspects of organ removal: firstly, Articles 6, § 2, and 7, § 2 , 3 °, of the Law of 13 June 1986 on the removal and
p.000003: transplantation of organs, inserted by the Law of 25 February 2007, together with the deletion of Article 10, § 4, 3,
p.000003: of the said law by the same Law of 25 February 2007; and secondly, the scope of Article 12 of the Law of 19 December
p.000003: 2008 on the acquisition and use of human body material for human medical applications or for scientific
p.000003: research purposes.
p.000003:
p.000003: The Committee considered that these two aspects are clearly distinct from one another and that each requires
p.000003: specific ethical reflection. It has therefore deemed it appropriate to separate them, and to respond to the
p.000003: Minister’s request in two Opinions. The first Opinion (Opinion no. 50 of 9 May 2011) focuses on the Law of 13 June
p.000003: 1986 on the removal and transplantation of organs. The present Opinion deals with the Law of 19 December 2008 on the
p.000003: acquisition and use of human body material for human medical applications or for scientific research
p.000003: purposes.
p.000003:
p.000003:
p.000003: A. Scope of the Law of 19 December 2008
p.000003: This law applies "to the donation, removal, acquisition, testing, handling, preservation, storage,
p.000003: distribution and use of body material intended for human applications or for scientific research purposes"
p.000003: (Article 3, § 1, Paragraph 1). Its scope is therefore very broad and awkward to define. To do so, reference must be
p.000003: made to the definitions contained in Article 2 of the law:
p.000003: - human body material: "any human biological material, including human tissue and cells, gametes, embryos,
p.000003: foetuses and substances extracted from them, regardless of their degree of transformation";
p.000003: - cells: "isolated cells of human origin cells or a group of cells of human origin not linked
p.000003: together by connective tissue"
p.000003: - tissue: "any constituent part of the human body consisting of cells";
p.000003: - removal: "act by which the human body material is extracted from the human body";
p.000003: - human medical application: "use of human body material on or in a human recipient, including extracorporeal
p.000003: application";
p.000003: - scientific research: "any use of human body material for the development of knowledge for the exercise
p.000003: of the health care professions."
p.000003:
p.000003: The law therefore applies to any removal of human body material intended for human medical applications
p.000003: or for scientific research purposes, in the sense which has just been recapitulated but which is not
p.000003: further specified in the text. Its scope encompasses the removal of and all operations carried out using
p.000003: stem cells, regardless of their origin,
p.000003:
p.000003:
p.000004: 4
p.000004: FINAL VERSION
p.000004:
p.000004: including from cord blood, peripheral blood or bone marrow or of mesenchymal origin (Art. 3, § 2). The Law of 19
p.000004: December 2008 does not apply, however, to:
p.000004: - what happens after death to the body itself: on this point, reference should be made to the Law of 20 July 1971 on
p.000004: funerals and burials and to the regional decrees on the same subject. These latter do not mention the "donation of the
p.000004: body to science" for educational (and research) purposes, which of course is done on a voluntary basis, as the use of
p.000004: the body in this way can be stipulated by the deceased in his or her will;
p.000004: - the removal of organs for transplantation, which is the subject of the Law of 13 June 1986 on the removal and
p.000004: transplantation of organs;
p.000004: - procedures using blood, blood components and blood products of human origin, which are covered by the
p.000004: Law of 5 July 1994 on blood and blood products of human origin;
p.000004: - the removal of and procedures with human body material for autologous use within a single procedure;
p.000004: - the removal and procedures performed with body material exclusively for diagnostic purposes for the benefit of
p.000004: the person from whom the material was removed, provided it is not used for any other purpose;
p.000004: - hair (with the exception of follicles), nails, urine, breast milk, faeces, sweat and tears (Art. 3, § 3).
p.000004:
p.000004: As the Committee stressed in its Opinion no. 50, it is thus appropriate to make a clear distinction
p.000004: between organs removed for therapeutic purposes, referred to by the Law of 13 June 1986 and tissues and cells removed
p.000004: for any purpose whatsoever, or organs removed for scientific research purposes, referred to by the Law of 19
p.000004: December 2008. However, this distinction between the scope of the Laws of 13 June 1986 and 19 December
p.000004: 2008 respectively does not always seem to be properly observed in practice.
p.000004:
p.000004: [ …see the French, Dutch or German version of the opinion on
p.000004: www.health.belgium.be/bioeth under the headings avis or adviezen or Gutachten].
p.000004:
p.000004: [B. ….]
p.000004:
p.000004: C. Subject of this Opinion
p.000004: This Opinion does not directly address the use of human body material, but considers the conditions under which it is
p.000004: obtained after death. It aims to provide an ethical assessment of Article 12 of the Law of 19 December 2008, which
p.000004: states that Articles 10, 11, 12, 13 and 14 of the Act of 13 June 1986 on the removal and transplantation of
p.000004: organs apply to any removal of human body material after death. […].
p.000004:
p.000004:
p.000004: [2. Legal framework]
p.000004:
p.000004: 3. Ethical considerations
p.000004:
p.000004: A. Introductory considerations
p.000004: Various types of human body material are used in an increasing number of contexts with an ever wider spectrum of
p.000004: possible purposes. As Bronwyn Parry vividly puts it:
p.000004:
p.000004: The act of excising and collecting bodily parts and tissues for anatomical analysis or pedagogical use has a
p.000004: long tradition. However, the practice of intentionally harvesting them for re-utilisation … is
p.000004: relatively new. [The perfection of
p.000004:
p.000004:
p.000005: 5
p.000005: FINAL VERSION
p.000005:
p.000005: transplantation technologies and] advances in molecular biology are together creating an
p.000005: unprecedented demand for human corporeal material ... Whole organs such as kidneys, along with corneas, mitral
p.000005: heart valves, … ligaments, … ova, sperm, and embryonic stem cells are now routinely transferred … for
p.000005: reincorporation in recipient individuals or use in … research programmes. The exponential increase in demand for
p.000005: biomaterials … is now culminating in new forms of bio-commerce...1
p.000005:
p.000005: In addition to use for directly therapeutic purposes (such as transplantation), human body material is also
...
p.000009: therapeutic methods is restricted for many years by patents that are granted.14
p.000009:
p.000009: In addition, there is no denying that many biomedical research projects, including many studies with
p.000009: human experimental subjects, provide little or no relevant information and therefore cannot contribute to an
p.000009: improvement to the general welfare.15
p.000009:
p.000009: Moreover, the point should not be overlooked that biomedical research projects can also be harmful to the people
p.000009: involved. Those in charge of research can simply exploit the participants, treating them as a mere means to
p.000009: gain prestige and/or wealth (one only has to think, for example, of the late Henrietta Lacks and her family16, the
p.000009: late John Moore17 and members of the Havasupai tribe in the United States18). We may also add that the results of
p.000009: research, for example in the case of genetic research, can also have discriminatory effects or a stigmatising impact
p.000009: (not just for the participant, but also for the group to which he or she belongs).19
p.000009:
p.000009: In short, even if it were possible to demonstrate that biomedical research as a social concept should be regarded as a
p.000009: "public good", one might ask how we can infer from this a duty to
p.000009:
p.000009: 12 I. de Melo-Martin, “Response to Rosamond Rhodes” Newsletter on Philosophy and Medicine 2008; 7(2): 13-14.
p.000009: 13 See Advisory Committee Opinion no. 51 of 12 March 2012 on the publication of the results of
p.000009: experiments conducted on humans.
p.000009: 14 See for example Sterckx, Sigrid (2009), “Patenting and licensing of university research: Promoting innovation or
p.000009: undermining academic values?”, Science & Engineering Ethics, published online on 19 September 2009 (doi
p.000009: 10.1007/s11948-009-9168-8), printed version 2011, vol. 17(1), pp. 45-64. Cockbain, Julian & Sterckx, Sigrid
p.000009: (2011), “Something more is necessary – Are genes and genetic diagnostic tests statutory subject matter for US
p.000009: patents?”, Expert Review of Molecular Diagnostics 11(2), pp. 149-158. Sterckx, Sigrid (2007), “Patents and Access to
p.000009: Drugs in Developing Countries: An Ethical Analysis”, in Chadwick, Ruth; Kuhse, Helga; Schüklenk, Udo & Singer,
p.000009: Peter (Eds). The Bioethics Reader – Editors’ Choice. Oxford: Blackwell, pp. 145-161.
p.000009: 15 S. Holm, B. Hofmann & J.H. Solbakk, “Conscription to Biobank Research?” in H. Solbakk, S. Holm & B. Hofmann (Eds).
p.000009: The Ethics of Research Biobanking. New York: Springer, 2009: 255-262.
p.000009: 16 Skloot, R. The Immortal Life of Henrietta Lacks. New York: Crown, 2010.
p.000009: 17 Moore v. Regents of University of California (51 Cal.3d 120, Supreme Court of California), 9 July 1990.
p.000009: 18 Van Assche, Kristof & Sterckx, Sigrid (2012), “The protection of human dignity in research involving human body
p.000009: material” in van Beers, B.; Corrias, L. & Werner, W. (Eds). Probing the Boundaries of Humanity (submitted, undergoing
...
p.000013: removed for transplantation proves unsuitable, it should be available for use in scientific research
p.000013: related to transplantation. Except in exceptional circumstances, the family must be informed.
p.000013:
p.000013: As we shall see, the relative value of the benefits and drawbacks of a system of presumed consent for posthumous
p.000013: removal of body material for research purposes is totally different from the relative value of the benefits and
p.000013: drawbacks of a system of presumed consent for posthumous removal of organs for transplantation. The balance tips in the
p.000013: latter case on the negative side.
p.000013:
p.000013:
p.000013: b) Posthumous removal of body material: the benefits are less certain and, although they exist, often
p.000013: less important
p.000013:
p.000013: The aim of the law – to ensure enough body material can be obtained so that biomedical research can be performed
p.000013: – is less important and urgent than the aim of organ transplantation. The posthumous removal of human body
p.000013: material from a specific deceased person cannot directly save a life.
p.000013:
p.000013:
p.000013: 31 Naturally, these members are aware that some people have objections to a system of presumed consent
p.000013: for posthumous organ donation. However, they believe that these objections are not decisive. We cannot go
p.000013: into this debate in detail, since it is not essential to the question which this opinion is supposed to answer;
p.000013: however, we will make some brief remarks. Opponents of a system of presumed consent for posthumous organ donation
p.000013: often remark that such a system leads to organs sometimes being removed from people who did not wish to be
p.000013: donors, because a certain percentage of people who do not wish to donate organs fail to register their wish not to do
p.000013: so. If organ removal is performed anyway, this constitutes a fundamental breach of their wishes regarding
p.000013: the disposal of their body after death. They hold that in an opt-in regime or informed consent regime, organ
p.000013: removal is far less likely to be performed on someone who did not want it. On this type of argument, see e.g. R.M.
p.000013: Veatch & J.B. Pitt, "The myth of presumed consent: Ethical problems in organ procurement strategies"
p.000013: Transplantation Proceedings 1995; 27: 188-192. However, one could equally well say that in an opt-in system, the
p.000013: organs of people who do wish to donate organs, but have failed to register this wish, will not be removed. It is not
p.000013: clear why this would be regarded as less serious from a moral point of view than the removal of organs
p.000013: from people who did not wish to donate, but had not registered their opposition. Moreover, as numerous opinion polls
p.000013: show that those who are willing to donate their organs easily outnumber those who are not, it seems appropriate,
p.000013: on the basis of a 'fewer mistakes claim', to opt for a system of presumed consent. See e.g. MB Gill,
p.000013: "Presumed Consent, Autonomy, and Organ Donation" Journal of Medicine and Philosophy 2004, 29 (1): 37-59. Again, though,
p.000013: the main reason why these members of the Committee are in favour of a system of presumed consent in the specific
p.000013: context of the post mortem removal of organs for transplantation is related to its particularly important
p.000013: and direct therapeutic benefits (given that they normally help save lives). Of course, it goes without saying that any
p.000013: authority introducing a system of presumed consent must make constant efforts to give its citizens clear
p.000013: and detailed information. In this area, the Belgian authorities still have a lot of work to do, as already noted by the
p.000013: Advisory Committee in its Opinion no. 50 of 9 May 2011 (especially in point 4.E.2.d.). In a system of presumed consent
p.000013: for post mortem organ transplantation, there will certainly be occasional cases in which organs are taken from people
p.000013: who did not wish to donate, but had not registered their opposition and had not told their relatives either. In such
p.000013: cases, the wishes of the deceased will not have been respected. However, the principle that a person's wishes about
p.000013: what will happen to his or her body after death must be respected as far as possible is not an absolute one. In other
p.000013: words, this principle may, in exceptional cases, be overridden by other moral principles, such as when another person's
p.000013: life is at stake and we can reasonably assume that the transplant will save his or her life.
p.000013:
p.000014: 14
p.000014: FINAL VERSION
p.000014:
p.000014: Moreover, the aim of obtaining enough body material to be able to carry out biomedical research, which
p.000014: Committee members opposed to extending the opt-out certainly do not deny is highly laudable in many
p.000014: cases (see below), can be achieved in another way, one which is ethically justifiable. A sufficient stock of
p.000014: body material for research can, with some effort, be obtained using a regime of informed consent or, more
p.000014: correctly formulated, explicit authorisation (see on this point the specific recommendations in Opinion no. 45 of 19
p.000014: January 2009 concerning human biological material banks, point VI.1.2.C.; we will return to the details of such a
p.000014: regime later on, in the chapter "Recommendations and conclusions").
p.000014:
p.000014: However, the system provided for in the 2008 Law is easier for those wishing to obtain post mortem body material, and
p.000014: is also cheaper, as it takes less time than the system proposed by these members. In these members’ view, however,
p.000014: this is not sufficient reason to prefer the system established in the 2008 Law.
p.000014:
p.000014: So much for the point that the benefits of the posthumous removal of body material for research purposes
p.000014: are relatively limited and that there is an alternative way to obtain these benefits, which, although it requires a
p.000014: little more time and resources, poses far fewer ethical problems than the system set up by law. What about the
p.000014: disadvantages? In other words, for what specific reasons do the members of the Committee consider the system provided
p.000014: for by the law to be ethically indefensible?
p.000014:
p.000014: c) Posthumous removal of body material: the nature and ethical relevance of the possible disadvantages
p.000014:
p.000014: 1) Potential disadvantages for society
p.000014:
p.000014: When people learn about the system used to obtain body material post mortem for research purposes, this could have a
p.000014: direct impact on the number of organs removed post mortem, as there is currently no possibility of adopting
p.000014: differing positions in terms of objecting or consenting to the removal of body material and the removal
p.000014: of organs. In other words, a system which is ethically problematic (or perceived as such) for the posthumous removal
...
p.000015: offered, that what happens to the body of someone who has died has no implications as far as that person is concerned.
p.000015: However, conclusions on this subject ought to be based on an analysis of the possible arguments, rather than
p.000015: on mere suppositions. One of the reasons why such an analysis is far from simple is that terms are sometimes used in
p.000015: this context that cannot be applicable (e.g. the "rights" of the deceased), or that may intuitively seem
p.000015: to be applicable, but require clarification and argumentation (e.g. the "interests" of the deceased), or that
p.000015: clearly can be applicable but have less normative force as a concept and, like any term on which we wish to develop an
p.000015: ethical argument, require explanation (e.g. the "wishes" of the deceased).
p.000015:
p.000015: The question of whether there are what may be called posthumous "interests" is much discussed and gives
p.000015: rise to differing views. Three positions can be distinguished in this debate.
p.000015:
p.000015: A first group claims that deceased individuals may incur harm from posthumous events. This group is found in the
p.000015: religious community, and associates the corpse's physical intactness with the deceased’s interests in the
p.000015: (presumed) afterlife. From this point of view, posthumous interests are significant because the deceased
p.000015: begins a second life after death, of a spiritual nature, and the physical intactness of the body may be a crucial
p.000015: precondition for this. We will not consider this point of view any further in the rest of this Opinion.
p.000015:
p.000015: A second group believes that the dead cannot incur any harm from posthumous events and that it therefore makes no sense
p.000015: to speak of harm to the ante mortem person from events occurring post mortem. They argue that the dead can no
p.000015: longer have any interests, and hence no interests that can be affected by the posthumous use of their body
p.000015: material.34
p.000015:
p.000015: For example this reasoning is found in a very pronounced form in Jonsen: “Consent is ethically important
p.000015: because it manifests and protects the moral autonomy of persons … [and] it is a barrier to exploitation and
p.000015: harm. These purposes are no longer relevant to the cadaver, which has no autonomy and cannot be harmed.”35 Some
p.000015: people who have similar views on the issue stress that posthumous interests, if they exist, are in any
p.000015: case easily ousted by the interests of the living, who need the body material of the deceased for their health.36
p.000015:
p.000015: The claim that posthumous interests do not exist and that we can do whatever we like with the body of the deceased – at
p.000015: least if we are solely taking the position of the previously living person as our basis and we disregard the possible
p.000015: impact on the relatives and on society – is based on two combined assumptions:
p.000015:
p.000015: 1) Lack of subject: After death, there is no longer a subject who has interests and there is therefore no one to be
...
p.000029: susceptibility to stigmatisation of the disease or physiological characteristic under investigation. The Ethics
p.000029: Committee which evaluates the protocol will need to check that adequate measures have been planned to 1) regulate the
p.000029: use and disclosure of identity-
p.000029:
p.000030: 30
p.000030: FINAL VERSION
p.000030:
p.000030: sensitive data/results in a research context, e.g. by stipulating that the results of these investigations
p.000030: will only be disclosed in databases that are subject to data-sharing policies58, and 2) prevent any disclosure or use
p.000030: of these results outside the context of the research.
p.000030:
p.000030: ***
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
p.000030:
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p.000030: 58 OECD principles and guidelines for access to research data from public funding: document available
p.000030: at the address:
p.000030: http://www.oecd.org/sti/sci- tech/oecdprinciplesandguidelinesforaccesstoresearchdatafrompublicfunding.htm
p.000030:
p.000030:
p.000031: 31
p.000031: FINAL VERSION
p.000031:
p.000031: The opinion was prepared in the select commission 2010/3bis, consisting of:
p.000031:
p.000031:
p.000031:
p.000031: Joint chairpersons
p.000031: S. Sterckx
p.000031: G. Genicot
p.000031: Joint reporters
p.000031: S. Sterckx
p.000031: G. Genicot
p.000031: E. Heinen
p.000031: V. Pirard
p.000031: Members
p.000031: A. Herchuelz
p.000031: T. Locoge
p.000031: R. Rubens
p.000031: Member of the Bureau
p.000031: M. Dupuis
p.000031:
p.000031:
p.000031:
p.000031:
p.000031: Member of the Secretariat
p.000031: L. Dejager
p.000031:
p.000031:
p.000031:
p.000031: Experts interviewd
p.000031: Mme Hélène Antoine-Poirel, professeur en Génétique humaine / Human Molecular Genetics (GEHU) aux Cliniques
p.000031: universitaires Saint-Luc / de Duve Institute / UCL
p.000031: Mme Florence Bellivier, professeur de droit à l’Université Paris Ouest Nanterre La Défense Mme Bianka Dörr, professeur
p.000031: de droit aux universités de Zürich et de Bâle
p.000031: M. Nick van Gelder, chercheur doctorant en droit médical à l’Universiteit Antwerpen
p.000031:
p.000031:
p.000031: Experts consulted
p.000031: M. Patrick Niaudet, président du Conseil d’Orientation de l’Agence de la Bio médecine (France)
p.000031: M. Kristof Van Assche, Dr., chercheur à la Vrije Universiteit Brussel, Faculté de Droit et de Criminologie,
p.000031: Département Metajuridica, Research Group on Law, Science, Technology & Society
p.000031:
p.000031:
p.000031:
p.000031: The working documents of the select commission 2010/3bis – request for opinion, personal contributions of
p.000031: the members, minutes of the meetings, documents consulted – are stored as Annexes 2010/3bis at the Committee’s
p.000031: documentation center, where there may be consulted and copied.
p.000031:
p.000031: ***
p.000031:
p.000031: This opinion is available on the website www.health.belgium.be
p.000031:
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p.000032: 32
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Searching for indicator philosophy:
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p.000008: others’ past contributions will neither increase or decrease the moral value or the costs associated with those
p.000008: contributions.
p.000008:
p.000008: To make the argument that non-participants are free-riders convincing, it would also be necessary to
p.000008: demonstrate that non-participants actually hinder biomedical research significantly by their refusal to
p.000008: participate; yet the right of objection is always maintained, even in the most radical opt-out systems. Although the
p.000008: presumption of consent is justifiable under certain conditions and in some cases, removing the possibility of
p.000008: refuting that presumption would not be, because of the freedom that individuals should always have where
p.000008: their bodies are concerned, the effect of which persists after death.
p.000008:
p.000008: 2) Criticism of the argument concerning the maintaining of public goods
p.000008:
p.000008: A "public good" is a good that can be used by one person without reducing its enjoyment by another. In addition,
p.000008: everyone (potentially) derives benefit from a "public good", which is why it is impossible to exclude people who do not
p.000008: contribute to it from the enjoyment of it. As biomedical research leads to very important medical knowledge which
p.000008: benefits us all, some argue that we have a duty to support the production of such knowledge by participating in
p.000008:
p.000008:
p.000008: 11 I. Brassington, “John Harris’ argument for a duty to research” Bioethics 2007; 21(3): 160-168; I.
p.000008: Brassington, “Defending the duty to research?” Bioethics 2011; 25(1): 21-26; I. de Melo-Martin, “Response
p.000008: to Rosamond Rhodes” Newsletter on Philosophy and Medicine 2008; 7(2): 13-14.
p.000008:
p.000009: 9
p.000009: FINAL VERSION
p.000009:
p.000009: biomedical research ourselves.
p.000009:
p.000009: The main problem with this argument is that the claim that biomedical research is a "public good" must itself be
p.000009: qualified. One may legitimately ask to what extent biomedical research does actually give rise to research
p.000009: results which are available to the public, to affordable treatments and to discoveries that are relevant (and
p.000009: at the very least harmless).
p.000009:
p.000009: The argument that there is a general obligation to participate in biomedical research because we all derive benefit
p.000009: from its results in the industrialised world takes no account of the social context of access to healthcare. In
p.000009: fact, access to the results of biomedical research also depends, in the industrialised world, on factors
p.000009: such as financial opportunity (health insurance), the availability of preventive care and the ability to
p.000009: process the influx of information about medical solutions and developments. This means that any such obligation does
p.000009: not exist or only exists to a much lesser extent on the part of disadvantaged groups.12
p.000009:
p.000009: Many biomedical research projects do not aim – or not primarily – to improve the general welfare, but are (at least
p.000009: in part) driven by greed. Often, the results are not shared with colleagues13 or even have a
p.000009: counter-productive effect, because part of the research and (especially) of the development of diagnostic and
p.000009: therapeutic methods is restricted for many years by patents that are granted.14
p.000009:
p.000009: In addition, there is no denying that many biomedical research projects, including many studies with
p.000009: human experimental subjects, provide little or no relevant information and therefore cannot contribute to an
p.000009: improvement to the general welfare.15
p.000009:
p.000009: Moreover, the point should not be overlooked that biomedical research projects can also be harmful to the people
p.000009: involved. Those in charge of research can simply exploit the participants, treating them as a mere means to
p.000009: gain prestige and/or wealth (one only has to think, for example, of the late Henrietta Lacks and her family16, the
p.000009: late John Moore17 and members of the Havasupai tribe in the United States18). We may also add that the results of
p.000009: research, for example in the case of genetic research, can also have discriminatory effects or a stigmatising impact
p.000009: (not just for the participant, but also for the group to which he or she belongs).19
p.000009:
p.000009: In short, even if it were possible to demonstrate that biomedical research as a social concept should be regarded as a
p.000009: "public good", one might ask how we can infer from this a duty to
p.000009:
p.000009: 12 I. de Melo-Martin, “Response to Rosamond Rhodes” Newsletter on Philosophy and Medicine 2008; 7(2): 13-14.
p.000009: 13 See Advisory Committee Opinion no. 51 of 12 March 2012 on the publication of the results of
p.000009: experiments conducted on humans.
p.000009: 14 See for example Sterckx, Sigrid (2009), “Patenting and licensing of university research: Promoting innovation or
p.000009: undermining academic values?”, Science & Engineering Ethics, published online on 19 September 2009 (doi
p.000009: 10.1007/s11948-009-9168-8), printed version 2011, vol. 17(1), pp. 45-64. Cockbain, Julian & Sterckx, Sigrid
p.000009: (2011), “Something more is necessary – Are genes and genetic diagnostic tests statutory subject matter for US
p.000009: patents?”, Expert Review of Molecular Diagnostics 11(2), pp. 149-158. Sterckx, Sigrid (2007), “Patents and Access to
p.000009: Drugs in Developing Countries: An Ethical Analysis”, in Chadwick, Ruth; Kuhse, Helga; Schüklenk, Udo & Singer,
p.000009: Peter (Eds). The Bioethics Reader – Editors’ Choice. Oxford: Blackwell, pp. 145-161.
p.000009: 15 S. Holm, B. Hofmann & J.H. Solbakk, “Conscription to Biobank Research?” in H. Solbakk, S. Holm & B. Hofmann (Eds).
p.000009: The Ethics of Research Biobanking. New York: Springer, 2009: 255-262.
p.000009: 16 Skloot, R. The Immortal Life of Henrietta Lacks. New York: Crown, 2010.
p.000009: 17 Moore v. Regents of University of California (51 Cal.3d 120, Supreme Court of California), 9 July 1990.
...
p.000011: and do scarcely any harm (the possibility of slight harm to the relatives of the person from whom the material is
p.000011: removed is recognised by the proponents of this view, but they believe that, ultimately, they do not outweigh the
p.000011: potential benefits – see below). Such a view implies that the removal of human body material post mortem could become a
p.000011: routine practice.
p.000011:
p.000011: The system of presumed consent as provided for in the Law of 19 December 2008 amounts in practice to the automatic
p.000011: collection (or "conscription") of body material post mortem, whenever a clinician or researcher (1)
p.000011: regards such collection as potentially useful, (2) directly or indirectly (via a colleague or a biobank) has
p.000011: access to the body of the deceased, and (3) determines that the person concerned has not indicated any
p.000011: objection to a post mortem removal of organs for transplantation purposes.
p.000011:
p.000011:
p.000011: 24 B. Williams, “A critique of utilitarianism” in J.J.C. Smart & B. Williams (Eds). Utilitarianism, for and against.
p.000011: Cambridge: Cambridge University Press, 1990: 82-117.
p.000011: 25 S. Shapshay & K. Pringle, “Participation in biomedical research is an imperfect moral duty: A
p.000011: response to John Harris” Journal of Medical Ethics 2007; 33(7): 414-417.
p.000011: 26 I. de Melo-Martin, “Response to Rosamond Rhodes” Newsletter on Philosophy and Medicine 2008; 7(2): 13-14.
p.000011: 27 See e.g. S.H. Woolf et al., “Giving Everyone the Health of the Educated: An Examination of Whether Social Change
p.000011: Would Save More Lives than Medical Advances” American Journal of Public Health 2007; 97(4): 679:
p.000011: “[C]orrecting disparities in education-associated mortality rates would have saved more than a million lives rather
p.000011: than about 178 thousand that were averted by medical advances” . See also T. Pogge, “Responsibilities for
p.000011: poverty-related ill health” Ethics International Affairs 2002; 16: 71: “[P]overty is far and away the most important
p.000011: factor in explaining health deficits. Because they are poor, 815 million persons are malnourished, 1.1 billion
p.000011: lack access to safe water, 2.4 billion lack access to basic sanitation, more than 880 million lack access
p.000011: to health services, and approximately 1 billion have no adequate shelter”.
p.000011:
p.000012: 12
p.000012: FINAL VERSION
p.000012:
p.000012: The law stipulates (Art. 12) that the consent of the person concerned is presumed for any removal of material after
p.000012: death and is therefore authorised in all cases, unless the person has expressed an objection to post mortem removal of
p.000012: organs for transplantation. Given that the Belgian population is totally unaware that under the 2008 Law, not objecting
...
p.000013: donors, because a certain percentage of people who do not wish to donate organs fail to register their wish not to do
p.000013: so. If organ removal is performed anyway, this constitutes a fundamental breach of their wishes regarding
p.000013: the disposal of their body after death. They hold that in an opt-in regime or informed consent regime, organ
p.000013: removal is far less likely to be performed on someone who did not want it. On this type of argument, see e.g. R.M.
p.000013: Veatch & J.B. Pitt, "The myth of presumed consent: Ethical problems in organ procurement strategies"
p.000013: Transplantation Proceedings 1995; 27: 188-192. However, one could equally well say that in an opt-in system, the
p.000013: organs of people who do wish to donate organs, but have failed to register this wish, will not be removed. It is not
p.000013: clear why this would be regarded as less serious from a moral point of view than the removal of organs
p.000013: from people who did not wish to donate, but had not registered their opposition. Moreover, as numerous opinion polls
p.000013: show that those who are willing to donate their organs easily outnumber those who are not, it seems appropriate,
p.000013: on the basis of a 'fewer mistakes claim', to opt for a system of presumed consent. See e.g. MB Gill,
p.000013: "Presumed Consent, Autonomy, and Organ Donation" Journal of Medicine and Philosophy 2004, 29 (1): 37-59. Again, though,
p.000013: the main reason why these members of the Committee are in favour of a system of presumed consent in the specific
p.000013: context of the post mortem removal of organs for transplantation is related to its particularly important
p.000013: and direct therapeutic benefits (given that they normally help save lives). Of course, it goes without saying that any
p.000013: authority introducing a system of presumed consent must make constant efforts to give its citizens clear
p.000013: and detailed information. In this area, the Belgian authorities still have a lot of work to do, as already noted by the
p.000013: Advisory Committee in its Opinion no. 50 of 9 May 2011 (especially in point 4.E.2.d.). In a system of presumed consent
p.000013: for post mortem organ transplantation, there will certainly be occasional cases in which organs are taken from people
p.000013: who did not wish to donate, but had not registered their opposition and had not told their relatives either. In such
p.000013: cases, the wishes of the deceased will not have been respected. However, the principle that a person's wishes about
p.000013: what will happen to his or her body after death must be respected as far as possible is not an absolute one. In other
p.000013: words, this principle may, in exceptional cases, be overridden by other moral principles, such as when another person's
p.000013: life is at stake and we can reasonably assume that the transplant will save his or her life.
p.000013:
p.000014: 14
p.000014: FINAL VERSION
p.000014:
...
p.000016: According to many bioethicists, this feeling is much more than an intuition, and is in fact based on clear ethical
p.000016: principles.42 They believe that the right to respect post mortem for the wishes of the person expressed ante
p.000016: mortem derives from the autonomy with which the person took decisions while alive about what should happen after
p.000016: his or her death. It can be argued that the decision about how our mortal remains will be disposed of after death is
p.000016: the expression of our final wishes, and hence perhaps our most fundamental wishes.
p.000016:
p.000016: In the terminology used by Ronald Dworkin in his analysis, this is a "critical" interest rather than an "experiential"
p.000016: interest. Things are of experiential interest to a person on account of the enjoyment they bring him or her (e.g.
p.000016: playing sport, going out for a meal, gardening). The value of such things is solely related to the personal
p.000016: experience that the person in question has of them, and it does not really matter whether other people also
p.000016: consider them important. Conversely, things are of critical interest to a person when they have a critical
p.000016: impact on his or her life goals.43
p.000016:
p.000016: By contrast with when he or she is merely engaged in the pursuit of pleasurable experiences, it is essential for a
p.000016: person setting significant life goals that his or her wishes should be respected and taken into account by
p.000016: others. From this point of view, people have the right to choose independently the fate for their body material after
p.000016: their death that reflects their life,
p.000016:
p.000016:
p.000016: 38 W. Glannon, “Persons, lives, and posthumous harms” Journal of Social Philosophy 2001; 32(2): 128.
p.000016: 39 See e.g. W. Waluchow, “Feinberg’s theory of preposthumous harm” Dialogue 1986; 25: 731.
p.000016: 40 M. Wicclair, “Ethics and research with deceased patients” Cambridge Quarterly of Healthcare Ethics
p.000016: 2008; 17(1): 87-97.
p.000016: 41 Law Reform Commission of Canada. Procurement and transfer of human tissues and organs, working paper
p.000016: 66, 1992: 45.
p.000016: 42 For an analysis of these principles, see e.g. D. Price. Human Tissue in Transplantation and
p.000016: Research: A Model Legal and Ethical Donation Framework. Cambridge: Cambridge University Press, 2010. The summary of the
p.000016: arguments that we present here is largely drawn from this impressive work.
p.000016: 43 R. Dworkin. Life’s Dominion. London: Harper Collins, 1993: 199-217.
p.000016:
p.000017: 17
p.000017: FINAL VERSION
p.000017:
p.000017: character and moral values most closely. Unlike experiential interests, critical interests may be harmed after death.44
p.000017:
p.000017: A remark frequently heard regarding the determination of what happens to one’s own body material after death is
p.000017: that it may be a matter of critical interest while the person is still alive, but not subsequently,
p.000017: because (as stated earlier), there is no longer a subject and hence no longer the possibility of regressive
p.000017: causality of the negation of this critical interest.
p.000017:
p.000017: It may be objected to the point on the lack of a subject that it is generally recognised in other contexts that
p.000017: individuals’ interests may be harmed without their being aware of it at the time or in the future. For example, one may
...
p.000017: undergone a crucial (though less drastic) change to his or her personal identity, which leads us to conclude that
p.000017: even in the case of a persistent vegetative state, the person who was previously capable is regarded as
p.000017: the person who incurs the harm, rather than the subsequently incapable person.46
p.000017:
p.000017: Joel Feinberg, well known for his analysis of the concept of harm, stresses that:
p.000017:
p.000017: All interests are the interests of some person or other and a person’s surviving interests are simply
p.000017: the ones that we identify by naming him, the person whose interests they were. He is of course at that moment
p.000017: dead but that does not prevent us from referring now, in the present tense, to his interests, if they are still capable
p.000017: of being blocked or fulfilled, just as we refer to his outstanding debts or claims, as if they are still capable of
p.000017: being paid.47
p.000017:
p.000017:
p.000017: 44 See e.g. R.A. Belliotti. Posthumous Harm: Why the Dead Are Still Vulnerable. Lanham, Md.: Lexington
p.000017: Books, 2012.
p.000017: 45 J. Feinberg. The Moral Limits of the Criminal Law, Vol. I, Harm to Others. Oxford University Press, 1984.
p.000017: 46 See for example A. Buchanan, “Advance directives and the personal identity problem” Philosophy and Public
p.000017: Affairs 1988; 17(4): 277-302; H. Kuhse, “Some reflections on the problem of advance directives, personhood and personal
p.000017: identity” Kennedy Institute of Ethics Journal 1999; 9(4): 347- 364.
p.000017: 47 J. Feinberg. The Moral Limits of the Criminal Law, Vol. I, Harm to Others. Oxford University Press, 1984, 83.
p.000017:
p.000018: 18
p.000018: FINAL VERSION
p.000018:
p.000018: He argues that it is absurd to think that as soon as the person to whom we have promised something dies, an
p.000018: unfulfilled promise which was made while that person was still alive ceases to be a serious injustice to him
p.000018: or her.48 Such an outlook seems far from counter- intuitive or controversial.
p.000018:
p.000018: It might be objected that even if the existence of "surviving interests" and "posthumous harm" is
p.000018: conceded, the deceased is in any case no longer able to assert any rights, and that surviving interests are thus
p.000018: completely devoid of substance. However, this argument can be countered with the point that the obligation to uphold
p.000018: such interests is based on the rights that the person was able to exercise ante mortem and that while the rights
p.000018: themselves may have lapsed, some of the duties associated with them survive post mortem. In this light,
p.000018: surviving duties may very well exist without there being any surviving rights.
p.000018:
p.000018: Wellmann stresses, for example, that although rights cannot survive the death of their holder, certain
...
p.000019: the presumption. However, they consider it regrettable that the population is not more aware of this possibility, and
p.000019: think that this lack of information should be remedied by all appropriate means (see recommendations): citizens
p.000019: have the right to know the arrangements that the legislators have made in this area, which may have a direct
p.000019: impact on their bodies after their
p.000019:
p.000019: 50 J. Savulescu, “For and Against: No Consent Should Be Needed for Using Leftover Body Material for Scientific
p.000019: Purposes – Against” British Medical Journal 2000; 325: 648, 649. A comparable view is found in, for example, R. Rhodes,
p.000019: “Rethinking Research Ethics” American Journal of Bioethics 2005; 7: 16-17.
p.000019: 51 Moreover, various studies have shown that even such protection cannot be guaranteed. See e.g. McGuire,
p.000019: A.L. & Gibbs, R.A. (2006), “Genetics. No longer de-identified”, Science 312, pp. 370–371. See also Schmidt, H. &
p.000019: Callier, S. (2012), “How anonymous is 'anonymous'? Some suggestions towards a coherent universal coding system
p.000019: for genetic samples”, Journal of Medical Ethics 38(5), pp. 304-309. See also Lowrance, W.W. & Collins, F.S. (2007),
p.000019: “Identifiability in genomic research”, Science 317, pp. 600–602.
p.000019: 52 As examples of the interesting literature on moral complicity, see John Gardner, “Complicity and Causality”
p.000019: Criminal Law and Philosophy 2007; 1: 127-141; Ronald M. Green, “Benefiting from ‘Evil’: An Incipient Moral Problem in
p.000019: Human Stem Cell Research” Bioethics 2002; 16: 544-556; Christopher Kutz, Complicity: Ethics and Law for a Collective
p.000019: Age. Cambridge: Cambridge University Press, 2000; and Helen Watt, ed., Cooperation, Complicity & Conscience – Problems
p.000019: in Healthcare, Science, Law and Public Policy. London: The Linacre Centre, 2006.
p.000019:
p.000020: 20
p.000020: FINAL VERSION
p.000020:
p.000020: death, and to be told the reasons for these measures and the ways of registering an objection to them.
p.000020: They argue that it is under these conditions of clarity, publicity and education that the profoundly
p.000020: ethical significance of this system can be preserved.
p.000020:
p.000020: These members stress that the opt-out system must involve transparency and honesty with the general public – and hence
p.000020: the repeated provision of comprehensive explanations of its principle, its purpose and how it works. This is required
p.000020: firstly because of the sensitive area to which it relates – the use of body material after death – but
p.000020: also because it reflects a certain climate of trust: in return for the limitation of individual autonomy that the
p.000020: scheme involves, for reasons relating to the public interest and the public good, as will be explained below, the legal
p.000020: regime in this area must be perfectly transparent.
p.000020:
...
Economic / Economic/Poverty
Searching for indicator poor:
(return to top)
p.000010:
p.000010: The attempt to justify the obligation to participate in biomedical research on the grounds of a duty to help others
p.000010: is based on a confusion between what are known as "perfect" and "imperfect" duties in the vocabulary of
p.000010: ethics. Whereas the duty not to harm others can be regarded as a perfect duty, the duty to help others is
p.000010: merely an imperfect duty.21 As was convincingly argued by the influential 18th century philosopher Immanuel Kant,
p.000010: it is more serious to harm people that it is not to help them, and the duty of non-maleficence should be regarded as
p.000010: more important than the duty of beneficence.
p.000010:
p.000010: The imperfect duty to help others implies that we must consider the happiness of others as an end in itself, but that
p.000010: we have considerable leeway as to how we go about doing this, and can balance it against other objectives
p.000010: (including private ones). This even means that the pursuit of other people’s happiness does not always have to
p.000010: be preferred.22
p.000010:
p.000010: To postulate a perfect moral duty to help others is untenable for at least the following two reasons.
p.000010:
p.000010: Firstly, because it imposes too great a demand.23 Such an obligation would imply that people have a duty not only to
p.000010: participate in research, but also to perform all kinds of other actions that promote the life of the community, but
p.000010: that we normally regard as purely voluntary (e.g. giving surplus food to the hungry or alms to the poor). In addition,
p.000010: the moral duty to help others also implies from a utilitarian viewpoint that participation in biomedical research is
p.000010: obligatory even if a significant risk exists, as long as the expected benefits to society are significant enough.
p.000010:
p.000010: A second reason why postulating a perfect moral duty to help others is indefensible is that such a requirement would
p.000010: undermine our moral integrity and have a profoundly alienating effect. Given that there are very many ways to limit
p.000010: harm to others, we would be required to spend most of our time and energy fighting against poverty, hunger, war and so
p.000010: on, rather than on other projects that reduce the harm to others to a lesser extent. As pointed out
p.000010:
p.000010:
p.000010: 20 In the view of other members, research is a "public good" provided it is circumscribed by
p.000010: international ethical standards (such as the Helsinki Declaration or the CIOMS Guidelines) which define
p.000010: what the fundamental objectives of research should be in order for it to be ethically justified. In this context, the
p.000010: minimum standards for the protection of people participating in research or contributing to it by means of
p.000010: samples or personal data should be applied. Assessments by ethics committees, which are required by law, aim to check
...
p.000011: access to the body of the deceased, and (3) determines that the person concerned has not indicated any
p.000011: objection to a post mortem removal of organs for transplantation purposes.
p.000011:
p.000011:
p.000011: 24 B. Williams, “A critique of utilitarianism” in J.J.C. Smart & B. Williams (Eds). Utilitarianism, for and against.
p.000011: Cambridge: Cambridge University Press, 1990: 82-117.
p.000011: 25 S. Shapshay & K. Pringle, “Participation in biomedical research is an imperfect moral duty: A
p.000011: response to John Harris” Journal of Medical Ethics 2007; 33(7): 414-417.
p.000011: 26 I. de Melo-Martin, “Response to Rosamond Rhodes” Newsletter on Philosophy and Medicine 2008; 7(2): 13-14.
p.000011: 27 See e.g. S.H. Woolf et al., “Giving Everyone the Health of the Educated: An Examination of Whether Social Change
p.000011: Would Save More Lives than Medical Advances” American Journal of Public Health 2007; 97(4): 679:
p.000011: “[C]orrecting disparities in education-associated mortality rates would have saved more than a million lives rather
p.000011: than about 178 thousand that were averted by medical advances” . See also T. Pogge, “Responsibilities for
p.000011: poverty-related ill health” Ethics International Affairs 2002; 16: 71: “[P]overty is far and away the most important
p.000011: factor in explaining health deficits. Because they are poor, 815 million persons are malnourished, 1.1 billion
p.000011: lack access to safe water, 2.4 billion lack access to basic sanitation, more than 880 million lack access
p.000011: to health services, and approximately 1 billion have no adequate shelter”.
p.000011:
p.000012: 12
p.000012: FINAL VERSION
p.000012:
p.000012: The law stipulates (Art. 12) that the consent of the person concerned is presumed for any removal of material after
p.000012: death and is therefore authorised in all cases, unless the person has expressed an objection to post mortem removal of
p.000012: organs for transplantation. Given that the Belgian population is totally unaware that under the 2008 Law, not objecting
p.000012: to the post mortem removal of organs for transplantation is treated as equivalent to not objecting to the post mortem
p.000012: removal of organs for the purposes of scientific research and of tissue and cells for scientific research or
p.000012: therapeutic purposes, and given, therefore, that citizens who do not agree will not express an objection because they
p.000012: are not aware that they need to do so, the 2008 Law has made access to material from the body of deceased people
p.000012: extremely easy.
p.000012:
p.000012:
p.000012: a) Similarities with the debate on presumed consent versus informed consent for
p.000012: post mortem organ transplantation, but a different ethical conclusion
p.000012:
...
Searching for indicator poverty:
(return to top)
p.000010: more important than the duty of beneficence.
p.000010:
p.000010: The imperfect duty to help others implies that we must consider the happiness of others as an end in itself, but that
p.000010: we have considerable leeway as to how we go about doing this, and can balance it against other objectives
p.000010: (including private ones). This even means that the pursuit of other people’s happiness does not always have to
p.000010: be preferred.22
p.000010:
p.000010: To postulate a perfect moral duty to help others is untenable for at least the following two reasons.
p.000010:
p.000010: Firstly, because it imposes too great a demand.23 Such an obligation would imply that people have a duty not only to
p.000010: participate in research, but also to perform all kinds of other actions that promote the life of the community, but
p.000010: that we normally regard as purely voluntary (e.g. giving surplus food to the hungry or alms to the poor). In addition,
p.000010: the moral duty to help others also implies from a utilitarian viewpoint that participation in biomedical research is
p.000010: obligatory even if a significant risk exists, as long as the expected benefits to society are significant enough.
p.000010:
p.000010: A second reason why postulating a perfect moral duty to help others is indefensible is that such a requirement would
p.000010: undermine our moral integrity and have a profoundly alienating effect. Given that there are very many ways to limit
p.000010: harm to others, we would be required to spend most of our time and energy fighting against poverty, hunger, war and so
p.000010: on, rather than on other projects that reduce the harm to others to a lesser extent. As pointed out
p.000010:
p.000010:
p.000010: 20 In the view of other members, research is a "public good" provided it is circumscribed by
p.000010: international ethical standards (such as the Helsinki Declaration or the CIOMS Guidelines) which define
p.000010: what the fundamental objectives of research should be in order for it to be ethically justified. In this context, the
p.000010: minimum standards for the protection of people participating in research or contributing to it by means of
p.000010: samples or personal data should be applied. Assessments by ethics committees, which are required by law, aim to check
p.000010: that ethical and regulatory considerations have been properly taken into account. These members argue that the fact
p.000010: that the outcome of research is unpredictable does not invalidate its justification or discredit its status as a public
p.000010: good. At the same time, they do not hold that the notion of public good per se implies an obligation
p.000010: for all individuals to participate in research (see below on how this notion of 'public good' is interpreted, in light
p.000010: of the concept of a 'moral community' which these members apply to society).
p.000010: 21 S. Shapshay & K. Pringle, “Participation in biomedical research is an imperfect moral duty: A
p.000010: response to John Harris” Journal of Medical Ethics 2007; 33(7): 414-417.
p.000010: 22 T.E. Hill. Dignity and practical reason in Kant’s moral theory. Ithaca: Cornell University Press, 1992.
p.000010: 23 L. Murphy, Moral Demands in Nonideal Theory. Oxford: Oxford University Press, 2000.
p.000010:
p.000011: 11
p.000011: FINAL VERSION
p.000011:
p.000011: convincingly by Bernard Williams, a person who had such a duty would degenerate into a harm-minimising
p.000011: instrument without personal integrity, because the actions he or she performed would not reflect his or her
p.000011: deepest convictions and life projects.24
p.000011:
p.000011: We could certainly accept, like Kant, that there is an imperfect moral duty to help others, but here again we might
p.000011: ask why this duty should result in mandatory participation in biomedical research.25 The duty of beneficence
p.000011: requires us to benefit our fellow-humans, but there are many ways to do so, some of which are much more relevant than
p.000011: participation in biomedical research.26 Even if contributing to the fight against disease were regarded as our main
p.000011: task, it is not clear why participating in research would be the only or best way to do this. It may well be that
p.000011: biomedical research (especially as practised today ) is not the best way to reduce the global burden of disease.
p.000011: Given the close link between poverty and disease, poverty reduction is probably a far more effective
p.000011: way to combat disease than furthering biomedical research.27
p.000011:
p.000011: We may also add that the fact that biomedical research can only contribute indirectly to the welfare and health of
p.000011: human beings after the lapse of a (sometimes lengthy) period of time and without any guarantee of success, whereas
p.000011: other options are direct, much faster if not instantaneous and far more certain (e.g. contributing to food aid or
p.000011: donating organs for a transplant), by definition makes biomedical research less attractive than other possible ways of
p.000011: helping others.
p.000011:
p.000011:
p.000011: 2. The harm resulting from removing body material after death overrides the potential benefits
p.000011:
p.000011:
p.000011: A second line of argument that might be adopted by the defenders of a system of presumed consent for post mortem
p.000011: removal of body material is based on the utilitarian argument that the post mortem collection and use of biological
p.000011: material are permissible or even obligatory in ethical terms, because they can provide significant benefits to society
p.000011: and do scarcely any harm (the possibility of slight harm to the relatives of the person from whom the material is
p.000011: removed is recognised by the proponents of this view, but they believe that, ultimately, they do not outweigh the
p.000011: potential benefits – see below). Such a view implies that the removal of human body material post mortem could become a
p.000011: routine practice.
p.000011:
p.000011: The system of presumed consent as provided for in the Law of 19 December 2008 amounts in practice to the automatic
p.000011: collection (or "conscription") of body material post mortem, whenever a clinician or researcher (1)
p.000011: regards such collection as potentially useful, (2) directly or indirectly (via a colleague or a biobank) has
p.000011: access to the body of the deceased, and (3) determines that the person concerned has not indicated any
p.000011: objection to a post mortem removal of organs for transplantation purposes.
p.000011:
p.000011:
p.000011: 24 B. Williams, “A critique of utilitarianism” in J.J.C. Smart & B. Williams (Eds). Utilitarianism, for and against.
p.000011: Cambridge: Cambridge University Press, 1990: 82-117.
p.000011: 25 S. Shapshay & K. Pringle, “Participation in biomedical research is an imperfect moral duty: A
p.000011: response to John Harris” Journal of Medical Ethics 2007; 33(7): 414-417.
p.000011: 26 I. de Melo-Martin, “Response to Rosamond Rhodes” Newsletter on Philosophy and Medicine 2008; 7(2): 13-14.
p.000011: 27 See e.g. S.H. Woolf et al., “Giving Everyone the Health of the Educated: An Examination of Whether Social Change
p.000011: Would Save More Lives than Medical Advances” American Journal of Public Health 2007; 97(4): 679:
p.000011: “[C]orrecting disparities in education-associated mortality rates would have saved more than a million lives rather
p.000011: than about 178 thousand that were averted by medical advances” . See also T. Pogge, “Responsibilities for
p.000011: poverty-related ill health” Ethics International Affairs 2002; 16: 71: “[P]overty is far and away the most important
p.000011: factor in explaining health deficits. Because they are poor, 815 million persons are malnourished, 1.1 billion
p.000011: lack access to safe water, 2.4 billion lack access to basic sanitation, more than 880 million lack access
p.000011: to health services, and approximately 1 billion have no adequate shelter”.
p.000011:
p.000012: 12
p.000012: FINAL VERSION
p.000012:
p.000012: The law stipulates (Art. 12) that the consent of the person concerned is presumed for any removal of material after
p.000012: death and is therefore authorised in all cases, unless the person has expressed an objection to post mortem removal of
p.000012: organs for transplantation. Given that the Belgian population is totally unaware that under the 2008 Law, not objecting
p.000012: to the post mortem removal of organs for transplantation is treated as equivalent to not objecting to the post mortem
p.000012: removal of organs for the purposes of scientific research and of tissue and cells for scientific research or
p.000012: therapeutic purposes, and given, therefore, that citizens who do not agree will not express an objection because they
p.000012: are not aware that they need to do so, the 2008 Law has made access to material from the body of deceased people
p.000012: extremely easy.
p.000012:
p.000012:
...
Economic / Food Insecurity
Searching for indicator hunger:
(return to top)
p.000010:
p.000010: The imperfect duty to help others implies that we must consider the happiness of others as an end in itself, but that
p.000010: we have considerable leeway as to how we go about doing this, and can balance it against other objectives
p.000010: (including private ones). This even means that the pursuit of other people’s happiness does not always have to
p.000010: be preferred.22
p.000010:
p.000010: To postulate a perfect moral duty to help others is untenable for at least the following two reasons.
p.000010:
p.000010: Firstly, because it imposes too great a demand.23 Such an obligation would imply that people have a duty not only to
p.000010: participate in research, but also to perform all kinds of other actions that promote the life of the community, but
p.000010: that we normally regard as purely voluntary (e.g. giving surplus food to the hungry or alms to the poor). In addition,
p.000010: the moral duty to help others also implies from a utilitarian viewpoint that participation in biomedical research is
p.000010: obligatory even if a significant risk exists, as long as the expected benefits to society are significant enough.
p.000010:
p.000010: A second reason why postulating a perfect moral duty to help others is indefensible is that such a requirement would
p.000010: undermine our moral integrity and have a profoundly alienating effect. Given that there are very many ways to limit
p.000010: harm to others, we would be required to spend most of our time and energy fighting against poverty, hunger, war and so
p.000010: on, rather than on other projects that reduce the harm to others to a lesser extent. As pointed out
p.000010:
p.000010:
p.000010: 20 In the view of other members, research is a "public good" provided it is circumscribed by
p.000010: international ethical standards (such as the Helsinki Declaration or the CIOMS Guidelines) which define
p.000010: what the fundamental objectives of research should be in order for it to be ethically justified. In this context, the
p.000010: minimum standards for the protection of people participating in research or contributing to it by means of
p.000010: samples or personal data should be applied. Assessments by ethics committees, which are required by law, aim to check
p.000010: that ethical and regulatory considerations have been properly taken into account. These members argue that the fact
p.000010: that the outcome of research is unpredictable does not invalidate its justification or discredit its status as a public
p.000010: good. At the same time, they do not hold that the notion of public good per se implies an obligation
p.000010: for all individuals to participate in research (see below on how this notion of 'public good' is interpreted, in light
p.000010: of the concept of a 'moral community' which these members apply to society).
p.000010: 21 S. Shapshay & K. Pringle, “Participation in biomedical research is an imperfect moral duty: A
p.000010: response to John Harris” Journal of Medical Ethics 2007; 33(7): 414-417.
p.000010: 22 T.E. Hill. Dignity and practical reason in Kant’s moral theory. Ithaca: Cornell University Press, 1992.
...
Searching for indicator hungry:
(return to top)
p.000010: remedying medical needs, the promotion of biomedical research is a moral duty.
p.000010:
p.000010: The attempt to justify the obligation to participate in biomedical research on the grounds of a duty to help others
p.000010: is based on a confusion between what are known as "perfect" and "imperfect" duties in the vocabulary of
p.000010: ethics. Whereas the duty not to harm others can be regarded as a perfect duty, the duty to help others is
p.000010: merely an imperfect duty.21 As was convincingly argued by the influential 18th century philosopher Immanuel Kant,
p.000010: it is more serious to harm people that it is not to help them, and the duty of non-maleficence should be regarded as
p.000010: more important than the duty of beneficence.
p.000010:
p.000010: The imperfect duty to help others implies that we must consider the happiness of others as an end in itself, but that
p.000010: we have considerable leeway as to how we go about doing this, and can balance it against other objectives
p.000010: (including private ones). This even means that the pursuit of other people’s happiness does not always have to
p.000010: be preferred.22
p.000010:
p.000010: To postulate a perfect moral duty to help others is untenable for at least the following two reasons.
p.000010:
p.000010: Firstly, because it imposes too great a demand.23 Such an obligation would imply that people have a duty not only to
p.000010: participate in research, but also to perform all kinds of other actions that promote the life of the community, but
p.000010: that we normally regard as purely voluntary (e.g. giving surplus food to the hungry or alms to the poor). In addition,
p.000010: the moral duty to help others also implies from a utilitarian viewpoint that participation in biomedical research is
p.000010: obligatory even if a significant risk exists, as long as the expected benefits to society are significant enough.
p.000010:
p.000010: A second reason why postulating a perfect moral duty to help others is indefensible is that such a requirement would
p.000010: undermine our moral integrity and have a profoundly alienating effect. Given that there are very many ways to limit
p.000010: harm to others, we would be required to spend most of our time and energy fighting against poverty, hunger, war and so
p.000010: on, rather than on other projects that reduce the harm to others to a lesser extent. As pointed out
p.000010:
p.000010:
p.000010: 20 In the view of other members, research is a "public good" provided it is circumscribed by
p.000010: international ethical standards (such as the Helsinki Declaration or the CIOMS Guidelines) which define
p.000010: what the fundamental objectives of research should be in order for it to be ethically justified. In this context, the
p.000010: minimum standards for the protection of people participating in research or contributing to it by means of
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.000013: often remark that such a system leads to organs sometimes being removed from people who did not wish to be
p.000013: donors, because a certain percentage of people who do not wish to donate organs fail to register their wish not to do
p.000013: so. If organ removal is performed anyway, this constitutes a fundamental breach of their wishes regarding
p.000013: the disposal of their body after death. They hold that in an opt-in regime or informed consent regime, organ
p.000013: removal is far less likely to be performed on someone who did not want it. On this type of argument, see e.g. R.M.
p.000013: Veatch & J.B. Pitt, "The myth of presumed consent: Ethical problems in organ procurement strategies"
p.000013: Transplantation Proceedings 1995; 27: 188-192. However, one could equally well say that in an opt-in system, the
p.000013: organs of people who do wish to donate organs, but have failed to register this wish, will not be removed. It is not
p.000013: clear why this would be regarded as less serious from a moral point of view than the removal of organs
p.000013: from people who did not wish to donate, but had not registered their opposition. Moreover, as numerous opinion polls
p.000013: show that those who are willing to donate their organs easily outnumber those who are not, it seems appropriate,
p.000013: on the basis of a 'fewer mistakes claim', to opt for a system of presumed consent. See e.g. MB Gill,
p.000013: "Presumed Consent, Autonomy, and Organ Donation" Journal of Medicine and Philosophy 2004, 29 (1): 37-59. Again, though,
p.000013: the main reason why these members of the Committee are in favour of a system of presumed consent in the specific
p.000013: context of the post mortem removal of organs for transplantation is related to its particularly important
p.000013: and direct therapeutic benefits (given that they normally help save lives). Of course, it goes without saying that any
p.000013: authority introducing a system of presumed consent must make constant efforts to give its citizens clear
p.000013: and detailed information. In this area, the Belgian authorities still have a lot of work to do, as already noted by the
p.000013: Advisory Committee in its Opinion no. 50 of 9 May 2011 (especially in point 4.E.2.d.). In a system of presumed consent
p.000013: for post mortem organ transplantation, there will certainly be occasional cases in which organs are taken from people
p.000013: who did not wish to donate, but had not registered their opposition and had not told their relatives either. In such
p.000013: cases, the wishes of the deceased will not have been respected. However, the principle that a person's wishes about
p.000013: what will happen to his or her body after death must be respected as far as possible is not an absolute one. In other
p.000013: words, this principle may, in exceptional cases, be overridden by other moral principles, such as when another person's
p.000013: life is at stake and we can reasonably assume that the transplant will save his or her life.
p.000013:
...
p.000015:
p.000015: The question of whether there are what may be called posthumous "interests" is much discussed and gives
p.000015: rise to differing views. Three positions can be distinguished in this debate.
p.000015:
p.000015: A first group claims that deceased individuals may incur harm from posthumous events. This group is found in the
p.000015: religious community, and associates the corpse's physical intactness with the deceased’s interests in the
p.000015: (presumed) afterlife. From this point of view, posthumous interests are significant because the deceased
p.000015: begins a second life after death, of a spiritual nature, and the physical intactness of the body may be a crucial
p.000015: precondition for this. We will not consider this point of view any further in the rest of this Opinion.
p.000015:
p.000015: A second group believes that the dead cannot incur any harm from posthumous events and that it therefore makes no sense
p.000015: to speak of harm to the ante mortem person from events occurring post mortem. They argue that the dead can no
p.000015: longer have any interests, and hence no interests that can be affected by the posthumous use of their body
p.000015: material.34
p.000015:
p.000015: For example this reasoning is found in a very pronounced form in Jonsen: “Consent is ethically important
p.000015: because it manifests and protects the moral autonomy of persons … [and] it is a barrier to exploitation and
p.000015: harm. These purposes are no longer relevant to the cadaver, which has no autonomy and cannot be harmed.”35 Some
p.000015: people who have similar views on the issue stress that posthumous interests, if they exist, are in any
p.000015: case easily ousted by the interests of the living, who need the body material of the deceased for their health.36
p.000015:
p.000015: The claim that posthumous interests do not exist and that we can do whatever we like with the body of the deceased – at
p.000015: least if we are solely taking the position of the previously living person as our basis and we disregard the possible
p.000015: impact on the relatives and on society – is based on two combined assumptions:
p.000015:
p.000015: 1) Lack of subject: After death, there is no longer a subject who has interests and there is therefore no one to be
p.000015: harmed. Partridge, for example, argues that the concept of interests that survive death is totally
p.000015: incoherent, “as there is no … one who can be harmed at the point that any wrongful setback of interest
p.000015: occurs”.37 Glannon takes the view that the concept of "harm" involves a comparison between anterior and posterior
p.000015: bodily or mental states, and that an action occurring after death cannot cause a real change because it no
p.000015: longer has any influence on the person’s intrinsic
p.000015:
p.000015: 34 See e.g. A. Spital & C. Erin, “Conscription of cadaveric organs for transplantation: Let’s at least talk about it”
p.000015: American Journal of Kidney Diseases 2002; 39(3): 611-615; and J.S. Taylor, “The Myth of Posthumous Harm” American
p.000015: Philosophical Quarterly 2005; 42(4): 311-322.
...
p.000016:
p.000016: A third group in the debate on whether posthumous interests exist claims that the dead cannot incur any
p.000016: harm from posthumous events, but that people do have interests that survive death and thus can be harmed
p.000016: when these interests are violated. The existence of such surviving interests seems consistent with strong intuitions
p.000016: shared by many people on this subject, and therefore deserves further analysis.
p.000016:
p.000016: The fact that in our society we show respect for people's wishes about what should happen to their estate after their
p.000016: death and to their body (e.g. funeral preferences; donation of body to science; opt-out from organ donation) shows that
p.000016: there is a widely shared intuition (which is often upheld by the law) that certain personal wishes must be respected
p.000016: after death. Death cannot be regarded as completely destroying all moral traces of the person as he or she was when
p.000016: alive.40 As we noted earlier, some commentators speak in this regard of "interests". The Law Reform Commission in
p.000016: Canada, for example, held that:
p.000016:
p.000016: The utter disregard of one’s burial wishes, or the failure to honour one’s express wishes on the
p.000016: post-mortem uses of one’s body, lend credence to the claim that people have interests that survive their deaths
p.000016: and that they may be harmed when the interests are violated.41
p.000016:
p.000016: According to many bioethicists, this feeling is much more than an intuition, and is in fact based on clear ethical
p.000016: principles.42 They believe that the right to respect post mortem for the wishes of the person expressed ante
p.000016: mortem derives from the autonomy with which the person took decisions while alive about what should happen after
p.000016: his or her death. It can be argued that the decision about how our mortal remains will be disposed of after death is
p.000016: the expression of our final wishes, and hence perhaps our most fundamental wishes.
p.000016:
p.000016: In the terminology used by Ronald Dworkin in his analysis, this is a "critical" interest rather than an "experiential"
p.000016: interest. Things are of experiential interest to a person on account of the enjoyment they bring him or her (e.g.
p.000016: playing sport, going out for a meal, gardening). The value of such things is solely related to the personal
p.000016: experience that the person in question has of them, and it does not really matter whether other people also
p.000016: consider them important. Conversely, things are of critical interest to a person when they have a critical
p.000016: impact on his or her life goals.43
p.000016:
p.000016: By contrast with when he or she is merely engaged in the pursuit of pleasurable experiences, it is essential for a
p.000016: person setting significant life goals that his or her wishes should be respected and taken into account by
p.000016: others. From this point of view, people have the right to choose independently the fate for their body material after
p.000016: their death that reflects their life,
p.000016:
p.000016:
p.000016: 38 W. Glannon, “Persons, lives, and posthumous harms” Journal of Social Philosophy 2001; 32(2): 128.
p.000016: 39 See e.g. W. Waluchow, “Feinberg’s theory of preposthumous harm” Dialogue 1986; 25: 731.
...
p.000019: 52 As examples of the interesting literature on moral complicity, see John Gardner, “Complicity and Causality”
p.000019: Criminal Law and Philosophy 2007; 1: 127-141; Ronald M. Green, “Benefiting from ‘Evil’: An Incipient Moral Problem in
p.000019: Human Stem Cell Research” Bioethics 2002; 16: 544-556; Christopher Kutz, Complicity: Ethics and Law for a Collective
p.000019: Age. Cambridge: Cambridge University Press, 2000; and Helen Watt, ed., Cooperation, Complicity & Conscience – Problems
p.000019: in Healthcare, Science, Law and Public Policy. London: The Linacre Centre, 2006.
p.000019:
p.000020: 20
p.000020: FINAL VERSION
p.000020:
p.000020: death, and to be told the reasons for these measures and the ways of registering an objection to them.
p.000020: They argue that it is under these conditions of clarity, publicity and education that the profoundly
p.000020: ethical significance of this system can be preserved.
p.000020:
p.000020: These members stress that the opt-out system must involve transparency and honesty with the general public – and hence
p.000020: the repeated provision of comprehensive explanations of its principle, its purpose and how it works. This is required
p.000020: firstly because of the sensitive area to which it relates – the use of body material after death – but
p.000020: also because it reflects a certain climate of trust: in return for the limitation of individual autonomy that the
p.000020: scheme involves, for reasons relating to the public interest and the public good, as will be explained below, the legal
p.000020: regime in this area must be perfectly transparent.
p.000020:
p.000020: It is true that, in principle, there is nothing exceptional about some limitation of individual autonomy in the
p.000020: field of governance, which has been postulated in theory many times in philosophies of the social
p.000020: contract. But it remains important ethically for members of the public to have the significance of the opt-out
p.000020: regime for the community explained to them, as well as the details of how to refute presumed consent if they wish to.
p.000020: This is the only way to counter the charge of disguised "conscription" that the scheme’s detractors sometimes
p.000020: level at it.
p.000020:
p.000020: In line again with the opponents of the system established by the 2008 Law, proponents of the opt-out system also
p.000020: hold that there is no individual moral obligation to participate in research, and that an individual would not
p.000020: be acting immorally if he or she refused to allow the removal of human body material for human applications or
p.000020: scientific purposes.
p.000020:
p.000020: At the same time, these members stress that for the community itself, participation in research through
p.000020: post mortem donation of material is not a neutral attitude and that it matters whether a society
p.000020: encourages participation in scientific research by an opt-out regime. Moreover, these members believe that
p.000020: legislators and holders of public authority would be behaving unethically towards society if they led us to
p.000020: believe that this issue – the question of whether or not to participate in scientific research by allowing body
p.000020: material to be removed post mortem – can be left entirely to the discretion of each of us.
p.000020:
p.000020: This ethical position is based on the following supporting elements: 1) an understanding of society as a moral
...
p.000021: and the Unesco Universal Declaration on Bioethics and Human Rights (http://portal.unesco.org/en).
p.000021:
p.000022: 22
p.000022: FINAL VERSION
p.000022:
p.000022: members who hold this position believe that it is fundamentally justified to encourage individuals to
p.000022: participate in research, and that scientific research is a “common good under certain conditions” which should of
p.000022: course be strictly regulated, but which should also be promoted, in particular through an opt-out system for post
p.000022: mortem removal of human body material.
p.000022:
p.000022: 3) The social significance of the opt-out scheme
p.000022:
p.000022: The opt-out regime serves as a social signal. The reason why the legislators wish to encourage research
p.000022: is that it is regarded as a good for society. It is therefore not treated as a neutral activity that it would be
p.000022: inappropriate to promote at the level of society or even, simply, as an activity without any interest
p.000022: to the community. The purpose of the opt-out scheme is not to override the freedom of individuals, but
p.000022: to adjust it in order to communicate the fact that research is a social and collective “good”, particularly
p.000022: because of its links with public health.
p.000022:
p.000022: In this view, the regime of “presumed consent” sends a positive signal in favour of participation in
p.000022: scientific research in order to support public health, while respecting the possibility of individual
p.000022: objection.
p.000022:
p.000022: The restriction that it potentially introduces to individual autonomy does not seem here to be disproportionate in
p.000022: light of the essential importance of public health.
p.000022:
p.000022: 4) Practical effects of the opt-out regime
p.000022:
p.000022: As well as sending a clear signal about the social significance of participation in research, the opt-out scheme is one
p.000022: of the most direct ways, though not the only one, to ensure that enough body material is removed. This seems entirely
p.000022: ethically justified as a goal on the part of legislators for the following reasons:
p.000022:
p.000022: The effect of ethical regulation on the sources of human body material
p.000022:
p.000022: Using legal provisions and social structures in a country to ensure that researchers have enough material
p.000022: available is a way of combating the trafficking and black market practices to which demand for human body material
p.000022: worldwide gives rise, although it is not enough in itself to put a stop to those practices.55 By creating the
p.000022: conditions for the collection of sufficient (though not unlimited: on this point see the recommendations
p.000022: of the members supporting this position) amounts of material, legislators can ensure, among other things, the ethical
p.000022: regulation of the demand for and use of human body material by researchers. When the needs for human body
p.000022: material are met through official channels in a country, there is less risk of "unofficial" circuits
p.000022: controlled by criminal gangs developing to meet those needs. This indirectly protects socially vulnerable
...
p.000023: approval from a medical ethics committee and must be carried out in approved laboratories on material obtained,
p.000023: stored and transported according to specific rules.
p.000023:
p.000023: Some opponents of the opt-out system under certain conditions argue that it is not a moral duty for everyone to
p.000023: contribute to research, since not everyone has equal access to healthcare and hence to the benefits of
p.000023: scientific research. While it is unfortunately true that access to healthcare is not equal for all, the solution is to
p.000023: act to dispel this disparity. Non- participation on this ground will do nothing to solve this problem of unfairness. In
p.000023: addition,
p.000023:
p.000023: 56 However, the French expert who was heard by the select committee was highly critical of French law and the opt-out
p.000023: system.
p.000023:
p.000024: 24
p.000024: FINAL VERSION
p.000024:
p.000024: the knowledge gained through the development of research may help to reduce the cost of certain forms of care and thus
p.000024: make them accessible to a larger number of people.
p.000024:
p.000024: 2. Ethical points concerning the treatment of people’s final wishes and critical interests in the
p.000024: context of an opt-out system for post mortem removal of material for scientific purposes
p.000024:
p.000024: Members who wish to keep the opt-out regime would like to stress the following point: at no time does this scheme,
p.000024: in their view, have the effect of completely negating individuals’ autonomy regarding their final wishes
p.000024: for funeral arrangements. When the removal of material is for scientific purposes, we must remember that the
p.000024: entire body is not regarded as having been donated to science (which would require an explicit wish on the
p.000024: part of the deceased, expressed during his or her lifetime, to "donate his or her body to
p.000024: science/medicine/the Faculty"). Only partial removals of material, made in compliance with the rules governing the care
p.000024: for and handling of dead bodies, are allowed. Once these have been performed, the last wishes of the deceased can be
p.000024: fully respected and his or her wishes regarding funeral arrangements complied with.
p.000024:
p.000024: Concerning the point about not wishing to be complicit with research of which one disapproves, this is
p.000024: entirely understandable, and the opt-out scheme does not completely negate this moral right that each of us has
p.000024: regarding what happens to our body, including when material is removed from it for scientific purposes. Rather than a
p.000024: loss of this moral right, it would be more correct to speak of its limitation and management by means of the opt-out
p.000024: regime. As mentioned earlier, in principle only research that meets international ethical standards should be
p.000024: authorised when that research relates to people and/or human specimens and/or personal data. Such compliance
p.000024: is verified by the medical ethics committees that evaluate research protocols using human body
p.000024: material collected post mortem with a view to its use for scientific purposes. It is therefore incorrect to consider,
...
General/Other / Public Emergency
Searching for indicator emergency:
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p.000005: through the study of body material collected from humans. Thus, a recent large-scale British-Canadian
p.000005: study of breast cancer revealed that, based on the examination of nearly 2,000 tumour specimens, ten
p.000005: different tumour types had been identified, each presenting different DNA mutations and patterns of gene
p.000005: expression favouring tumours.2 It is hoped that such knowledge can be applied in new and more specific treatments.
p.000005:
p.000005: In addition, it is increasingly common for isolated human body material to form the basis for product development.
p.000005: Various products – such as bone paste, diagnostic tests and certain pharmaceutical products – are directly or
p.000005: indirectly derived from human body material.
p.000005:
p.000005: The demand for human body material is thus intense in the field of modern medicine, whether for direct
p.000005: therapeutic applications addressing life-threatening conditions, the development and production of medical devices
p.000005: that can be implanted in the human body, or the use of certain types of materials in the context of scientific
p.000005: research, sometimes at very fundamental stages. These different types of use thus relate to a variety of
p.000005: contexts, in which the link between the use of human body material and the ultimate therapeutic goal may vary in
p.000005: intensity and immediacy.
p.000005:
p.000005: This situation was analysed in two different ways by the Committee.
p.000005:
p.000005: For some members, the post mortem use of human body material cannot be justified in an opt-out regime other than in
p.000005: response to a directly life-threatening emergency, as in the case of organ transplantation from a (deceased) donor to a
p.000005: (living) recipient. These members also point out that many of the products mentioned above are being
p.000005: developed in a private context for profit-making purposes (although the development work may be based on
p.000005: fundamental research in the public sector).
p.000005:
p.000005: In the view of other members, it is neither correct nor justified to suggest that the therapeutic
p.000005: purposes that authorise an opt-out regime for post mortem collection of material should be so limited. After all,
p.000005: medical devices contribute to care and the maintenance of quality of life for a growing number of health conditions.
p.000005: As for scientific research in the strict sense of the term, the primary objective of even the most fundamental
p.000005: research must be, once human beings are involved – as is the case where human body material is used, even after
p.000005: death – "to understand the causes, development and effects of diseases and improve preventive, diagnostic
p.000005: and therapeutic interventions (methods, procedures and treatments) (...)" as stated in the Helsinki Declaration, a
p.000005: cardinal text for research ethics.3
p.000005:
p.000005:
p.000005:
p.000005: 1 B. Parry, “Entangled exchange: Reconceptualising the characterisation and practice of bodily
p.000005: commodification” Geoforum 2008; 39: 1133-1144, 1133-1134.
p.000005: 2 C. Curtis et al., “The genomic and transcriptomic architecture of 2,000 breast tumours reveals novel subgroups”
p.000005: Nature 2012; doi:10.1038/nature10983 (published online on 18 April 2012).
p.000005:
p.000005: 3 World Medical Association, Declaration of Helsinki on Ethical Principles for Medical Research
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.000013: Veatch & J.B. Pitt, "The myth of presumed consent: Ethical problems in organ procurement strategies"
p.000013: Transplantation Proceedings 1995; 27: 188-192. However, one could equally well say that in an opt-in system, the
p.000013: organs of people who do wish to donate organs, but have failed to register this wish, will not be removed. It is not
p.000013: clear why this would be regarded as less serious from a moral point of view than the removal of organs
p.000013: from people who did not wish to donate, but had not registered their opposition. Moreover, as numerous opinion polls
p.000013: show that those who are willing to donate their organs easily outnumber those who are not, it seems appropriate,
p.000013: on the basis of a 'fewer mistakes claim', to opt for a system of presumed consent. See e.g. MB Gill,
p.000013: "Presumed Consent, Autonomy, and Organ Donation" Journal of Medicine and Philosophy 2004, 29 (1): 37-59. Again, though,
p.000013: the main reason why these members of the Committee are in favour of a system of presumed consent in the specific
p.000013: context of the post mortem removal of organs for transplantation is related to its particularly important
p.000013: and direct therapeutic benefits (given that they normally help save lives). Of course, it goes without saying that any
p.000013: authority introducing a system of presumed consent must make constant efforts to give its citizens clear
p.000013: and detailed information. In this area, the Belgian authorities still have a lot of work to do, as already noted by the
p.000013: Advisory Committee in its Opinion no. 50 of 9 May 2011 (especially in point 4.E.2.d.). In a system of presumed consent
p.000013: for post mortem organ transplantation, there will certainly be occasional cases in which organs are taken from people
p.000013: who did not wish to donate, but had not registered their opposition and had not told their relatives either. In such
p.000013: cases, the wishes of the deceased will not have been respected. However, the principle that a person's wishes about
p.000013: what will happen to his or her body after death must be respected as far as possible is not an absolute one. In other
p.000013: words, this principle may, in exceptional cases, be overridden by other moral principles, such as when another person's
p.000013: life is at stake and we can reasonably assume that the transplant will save his or her life.
p.000013:
p.000014: 14
p.000014: FINAL VERSION
p.000014:
p.000014: Moreover, the aim of obtaining enough body material to be able to carry out biomedical research, which
p.000014: Committee members opposed to extending the opt-out certainly do not deny is highly laudable in many
p.000014: cases (see below), can be achieved in another way, one which is ethically justifiable. A sufficient stock of
p.000014: body material for research can, with some effort, be obtained using a regime of informed consent or, more
...
p.000020: scheme involves, for reasons relating to the public interest and the public good, as will be explained below, the legal
p.000020: regime in this area must be perfectly transparent.
p.000020:
p.000020: It is true that, in principle, there is nothing exceptional about some limitation of individual autonomy in the
p.000020: field of governance, which has been postulated in theory many times in philosophies of the social
p.000020: contract. But it remains important ethically for members of the public to have the significance of the opt-out
p.000020: regime for the community explained to them, as well as the details of how to refute presumed consent if they wish to.
p.000020: This is the only way to counter the charge of disguised "conscription" that the scheme’s detractors sometimes
p.000020: level at it.
p.000020:
p.000020: In line again with the opponents of the system established by the 2008 Law, proponents of the opt-out system also
p.000020: hold that there is no individual moral obligation to participate in research, and that an individual would not
p.000020: be acting immorally if he or she refused to allow the removal of human body material for human applications or
p.000020: scientific purposes.
p.000020:
p.000020: At the same time, these members stress that for the community itself, participation in research through
p.000020: post mortem donation of material is not a neutral attitude and that it matters whether a society
p.000020: encourages participation in scientific research by an opt-out regime. Moreover, these members believe that
p.000020: legislators and holders of public authority would be behaving unethically towards society if they led us to
p.000020: believe that this issue – the question of whether or not to participate in scientific research by allowing body
p.000020: material to be removed post mortem – can be left entirely to the discretion of each of us.
p.000020:
p.000020: This ethical position is based on the following supporting elements: 1) an understanding of society as a moral
p.000020: community, 2) a conception of scientific research as a "common good under certain conditions", 3)
p.000020: considerations about the social significance of the opt-out regime and 4) consideration of its practical
p.000020: effects.
p.000020:
p.000020: b) Elements of the ethical foundation of the opt-out regime for post mortem removal of material for
p.000020: scientific purposes
p.000020:
p.000020: 1) Society as a moral community
p.000020:
p.000020: Members of the Committee in favour of this position emphasise that, to assess the issue of the ethical justifiability
p.000020: of opting out, individual freedom cannot be the only support; although this freedom should indeed be
p.000020: respected in any democratic system, we must also consider society as a whole as a moral community.
p.000020:
p.000020: In support of this, they note that in order to function, society lays down certain rules and recommendations which
p.000020: affect the freedom of each of us, and which uphold certain values because of their relevance to the community as such.
p.000020:
p.000020: These rules and recommendations cannot be analysed solely in terms of the deprivation, diminution or
p.000020: manipulation of individual liberties that they entail. Unless one regards society as a mere accumulation of individual
p.000020: freedoms, it must be recognised that the community of citizens has a strength and legitimacy that go beyond
...
Orphaned Trigger Words
p.000002:
p.000002: B. Informed consent in Belgian (bio)medical legal texts
p.000002:
p.000002: 1. General rules
p.000002: 2. Specific texts on the removal of body material
p.000002: a) Removal in vivo
p.000002: b) Removal post mortem
p.000002: 3. Analysis of the preparatory documents for the Law of 19 December 2008
p.000002:
p.000002: C. Supranational rules and survey of comparative law
p.000002:
p.000002: 1. European Directive of 31 March 2004 on setting standards of quality and safety relating to human tissues
p.000002: and cells
p.000002:
p.000002: 2. Convention on human rights and biomedicine and additional protocol concerning transplantation of
p.000002: organs and tissues of human origin
p.000002:
p.000002: 3. Additional protocol to the Convention on human rights and biomedicine concerning biomedical research
p.000002: 4. French law
p.000002:
p.000002: D. Conclusions on the legal framework
p.000002:
p.000002: 3. Ethical considerations
p.000002:
p.000002: A. Introductory considerations
p.000002:
p.000002: B. Position opposing the opt-out system for post mortem removal of human body material
p.000002:
p.000002: 1. There is no general duty to participate in biomedical research
p.000002:
p.000002: a) Criticisms of the idea of a duty to participate in biomedical research due to a moral duty of fairness
p.000002: 1) Criticism of the argument about free-riding behaviour
p.000002: 2) Criticism of the argument concerning the maintaining of public goods
p.000002:
p.000002: b) Criticisms of the idea of a duty to participate in biomedical research arising from a duty of
p.000002: beneficence
p.000002:
p.000002: 2. The harm resulting from removing body material after death overrides the potential benefits
p.000002:
p.000002: a) Similarities with the debate on presumed consent versus informed consent
p.000002: for post mortem organ transplantation, but a different ethical conclusion
p.000002:
p.000002:
p.000002:
p.000002: 2
p.000002: FINAL VERSION
p.000002:
p.000002: b) Posthumous removal of body material: the benefits are less certain and, although they exist, often less important
p.000002:
p.000002: c) Posthumous removal of body material: the nature and ethical relevance of the possible disadvantages
p.000002:
p.000002: 1) Potential disadvantages for society
p.000002: 2) Potential disadvantages for close relatives of the deceased
p.000002: 3) Potential disadvantages from the point of view of the deceased: harm to posthumous "interests"?
p.000002:
p.000002: 3. The need to be able to avoid moral complicity with the achievement of goals one finds morally objectionable
p.000002:
p.000002: C. Favourable position towards an opt-out system for post mortem removal of human body material, with
p.000002: certain requirements in addition to current legislation
p.000002: 1. The ethical foundation of the opt-out system
p.000002:
p.000002: a) Preliminary points
p.000002:
p.000002: b) Elements of the ethical foundation of the opt-out regime for post mortem
p.000002: removal of material for scientific purposes
p.000002:
p.000002: 1) Society as a moral community
p.000002: 2) Scientific research as a “common good under certain conditions”
p.000002: 3) The social significance of the opt-out scheme
p.000002: 4) Practical effects of the opt-out regime
p.000002: 5) Some important points
p.000002:
p.000002: 2. Ethical points concerning the treatment of people’s final wishes and critical interests in the context
p.000002: of an opt-out system for post mortem removal of material for scientific purposes
p.000002:
p.000002: 3. Summary of the position in favour of keeping the opt-out with the addition of further conditions
p.000002:
p.000002: 4. Recommendations and conclusions
p.000002:
p.000002: A. Recommendations made jointly by all Committee members
p.000002:
p.000002: B. Recommendations and conclusions of members opposed to the opt-out system for post mortem removal of human
p.000002: body material
p.000002:
p.000002: C. Recommendations and conclusions of members in favour of the opt-out system for post mortem removal of human body
p.000002: material
p.000002:
p.000002: 1. Improving public information
p.000002: 2. Evaluating the ethical and scientific appropriateness of collecting human body material
...
p.000005:
p.000006: 6
p.000006: FINAL VERSION
p.000006:
p.000006: This implies that, if research meets current fundamental ethical standards4 and is based on a properly evaluated
p.000006: objective and scientific method, it is in principle never dissociated from a therapeutic purpose (in the broad sense).
p.000006: Its outcome may be unpredictable – this is what makes it research rather than a body of existing knowledge – but its
p.000006: purpose must be part of a causal chain that, in the short, medium or long term, contributes to the understanding of
p.000006: diseases and the improvement of treatment possibilities.
p.000006:
p.000006: As for the commercialisation of certain devices and applications derived from human body material extracted post
p.000006: mortem and the research associated with such activities, this represents a response to existing
p.000006: (therapeutic) needs. It should also be remembered that this profit-making activity is supervised by
p.000006: European and national legislation and that if abuses occur, they are supposed to be punished by the courts. In
p.000006: addition, in the view of the members of this second group within the Committee, it is by no means clear
p.000006: that discontinuing the opt-out regime would reduce the abuses for the sake of financial gain: it would make the sources
p.000006: of available human material scarce, which could well have precisely the opposite effect and further increase the
p.000006: importance of the market in this area.
p.000006:
p.000006: These viewpoints on the opt-out system lead to differing ethical assessments of the system established by the Law of 19
p.000006: December 2008.
p.000006:
p.000006: As indicated in the chapter on the legal aspects of our question, Article 12 of this law implies a highly significant
p.000006: double extension of the regime of "presumed consent" that applies in Belgium to post mortem organ transplants:
p.000006:
p.000006: 1) an extension from post mortem removal of organs to post mortem removal of any human body material falling
p.000006: within the scope of the 2008 Law, and
p.000006:
p.000006: 2) an extension from post mortem extraction for transplantation purposes (i.e. directly therapeutic purposes) to
p.000006: post mortem extraction for research purposes.
p.000006:
p.000006: It is this double extension that is regarded as lacking ethical justification by some members of the Committee. To
p.000006: others, it seems ethically justified, provided the conditions stipulated by the law are reinforced.
p.000006:
p.000006: No member was in favour of an unconditional opt-out system, which would apply to any removal and any use
p.000006: of human body material. The ethically sensitive nature of this "material" is emphasised by all the Committee members,
p.000006: and is the reason why there is a need for a better legal and ethical framework for its removal and use. All Committee
p.000006: members therefore believe that the system of an opt-out– which in legal terms represents a derogation from the common
p.000006: regime of consent – must always meet certain conditions in order to be justified.
p.000006:
p.000006:
p.000006: B. Position opposing the opt-out system for post mortem removal of human body material
p.000006: Some Committee members see the extension of the regime of "presumed consent" brought about by the Law of 19 December
p.000006: 2008 as ethically unacceptable.
p.000006: They argue that: (1) there is no general duty to participate in biomedical research, and such a duty therefore does
p.000006: not apply post mortem either, and (2) the collection of body material after death may have disadvantages, possibly for
p.000006: the deceased, but above all for the living and for society as a whole.5 The arguments for this position are presented
p.000006: below, based on a
p.000006:
p.000006: 4Based on the Helsinki Declaration (Seoul 2008) (http://www.wma.net/en/30publications/10policies/b3/), the Guidelines
p.000006: of CIOMS, the Council for International Organisations of Medical Sciences
p.000006: (http://www.cioms.ch/images/stories/CIOMS/guidelines/guidelines_nov_2002_blurb.htm) and the Unesco Universal
p.000006: Declaration on Bioethics and Human Rights (http://portal.unesco.org/en).
p.000006: 5 We will explain later on why, according to these members, the system of presumed consent as set out in the 2008
p.000006: Law amounts in practice to little more than the 'conscription' or automatic
p.000006:
p.000007: 7
p.000007: FINAL VERSION
p.000007:
p.000007: rebuttal of the arguments commonly used by supporters of a regime of "presumed consent" for the post mortem collection
p.000007: of human body material.
p.000007:
p.000007: 1. There is no general duty to participate in biomedical research
p.000007:
p.000007: A supposed general duty to participate in biomedical research is defended by several prominent
p.000007: bioethicists, including Arthur Caplan, John Harris and Rosamond Rhodes.6 They base this argument on several
p.000007: underlying duties, which are not, however, stressed to the same extent by all these authors, and which we will
p.000007: scrutinise in turn.
p.000007:
p.000007: • A moral obligation to help others or duty of beneficence: When our actions are likely to save others from serious
p.000007: harm and we can reasonably be expected to perform such acts (after assessing the risk and benefit to ourselves and
p.000007: the benefit to others), we should perform such actions. We have a moral obligation to help others in need, and because
p.000007: biomedical research is a necessary means of remedying medical needs, the promotion of biomedical research is a
p.000007: moral duty.7
p.000007:
p.000007: • A moral duty of fairness: Following Rawls, some of the above authors stress that people who
p.000007: benefit from participation in cooperative social arrangements have obligations towards one other when they
p.000007: are asked to assume the risks and duties that are often associated with involvement in such cooperative
p.000007: activities.8 This duty of fairness is in turn sometimes broken down as follows:
p.000007:
p.000007: 1. A duty not to behave like a free-rider: People who refuse to participate in biomedical research
p.000007: while accepting its benefits behave like free-riders towards people who do participate in biomedical
p.000007: research. As we all (at least in industrialised countries) derive benefit from the results of biomedical
p.000007: research, non-participants have a moral debt that entails a duty to support biomedical research.9
p.000007:
p.000007: 2. A duty to help maintain public goods: Regardless of whether non-participants are free-riding, everyone has a
p.000007: duty to participate in biomedical research because the knowledge it generates must be regarded as a "public good".
p.000007: A "public good" is a good that can be used by one person without reducing its enjoyment by another person. In
p.000007: addition, everyone (potentially) derives benefit from a "public good", which is why it is impossible to exclude
p.000007: people who do not contribute to it from the enjoyment of it.10 The problem with "public goods" is that
...
p.000012: post mortem organ transplantation, but a different ethical conclusion
p.000012:
p.000012: Pleas for as permissive a regime as possible for the post mortem removal of body material for therapeutic and
p.000012: research purposes are often based on ethical arguments that we also encounter in the context of
p.000012: discussions on the post mortem removal of organs for transplantation, e.g. the arguments cited by various
p.000012: prominent bioethicists to advocate a system of presumed consent for organ transplantation after death.
p.000012:
p.000012: These specific arguments are discussed briefly below, since the distinction between the post mortem removal of body
p.000012: material for a therapeutic purpose that will directly benefit a patient and removal for research purposes is seen as a
p.000012: fundamental distinction by those Committee members who oppose the presumed consent regime provided for in the law of 19
p.000012: December 2008. The view of these members does not mean they reject the presumed consent regime in force in Belgium for
p.000012: post mortem removal of organs for transplantation. They contend that the problems lie in the extension of this regime.
p.000012: They reason that the benefits on the basis of which one may opt deliberately for a system of presumed consent
p.000012: for posthumous organ donations are not convincing in the context of posthumous removal of body material. At this
p.000012: point, the disadvantages that may exist but cannot be regarded as decisive for posthumous organ donation in a system of
p.000012: presumed consent, gain in importance in an ethical appraisal, since the advantages expected from the posthumous
p.000012: removal of body material are less certain, and although they do exist, are often less important than in the case
p.000012: of the removal of organs for transplantation purposes.
p.000012:
p.000012: According to Beauchamp and Childress, there is an obligation to rescue if five conditions are all met: (1) a person's
p.000012: life or health of is in serious danger; (2) another person's intervention is required to avert this danger; (3) the
p.000012: intervention has a high probability of success; (4) the intervention does not involve any significant risk, expense
p.000012: or burden to the other person; and (5) the potential benefit to the person in need outweighs the probable risk, expense
p.000012: or burden for the other person.28 Refusing to help in such circumstances – "the failure to undertake
p.000012: easy rescue" – makes the person a "bad Samaritan" according to Joel Feinberg.29
p.000012:
p.000012: Post mortem organ removal for transplantation purposes satisfies these five conditions and is therefore an example of
p.000012: an easy rescue according to this reasoning. This is why ethicists who defend this position hold that we can establish a
p.000012: principle that people have a duty, after their death, to provide their organs for transplantation purposes if doing so
p.000012: may save the lives or substantially improve the health of others. From this point of view, to agree to a post mortem
p.000012: organ donation can no longer be regarded as a form of generosity, but must be considered an important
p.000012: morally binding duty.30 Some authors go even further than postulating a serious moral obligation here, and
p.000012: take the view that the imposition of a legally binding obligation to donate is justified (i.e. pure conscription),
p.000012: since the benefits for people
p.000012:
p.000012: 28 T.L. Beauchamp & J.F. Childress. Principles of biomedical ethics. New York: Oxford University Press, 1994: 264.
p.000012: 29 J. Feinberg. Freedom and fulfillment. Princeton, NJ: Princeton University Press, 1992: 175.
p.000012: 30 See e.g. D.A Peters, “A unified approach to organ donor recruitment, organ procurement, and
p.000012: distribution” Journal of Law and Health 1989-90; 3: 157-187, 168.
p.000012:
p.000013: 13
p.000013: FINAL VERSION
p.000013:
p.000013: experiencing a serious medical condition are very significant (organs can usually save lives) and the disadvantages for
p.000013: the dead, the relatives and society as a whole are very slight.
p.000013:
...
p.000024: science/medicine/the Faculty"). Only partial removals of material, made in compliance with the rules governing the care
p.000024: for and handling of dead bodies, are allowed. Once these have been performed, the last wishes of the deceased can be
p.000024: fully respected and his or her wishes regarding funeral arrangements complied with.
p.000024:
p.000024: Concerning the point about not wishing to be complicit with research of which one disapproves, this is
p.000024: entirely understandable, and the opt-out scheme does not completely negate this moral right that each of us has
p.000024: regarding what happens to our body, including when material is removed from it for scientific purposes. Rather than a
p.000024: loss of this moral right, it would be more correct to speak of its limitation and management by means of the opt-out
p.000024: regime. As mentioned earlier, in principle only research that meets international ethical standards should be
p.000024: authorised when that research relates to people and/or human specimens and/or personal data. Such compliance
p.000024: is verified by the medical ethics committees that evaluate research protocols using human body
p.000024: material collected post mortem with a view to its use for scientific purposes. It is therefore incorrect to consider,
p.000024: unless there is a flaw in the system of ethical evaluation, that the deceased may end up in a situation of "moral
p.000024: complicity" with fundamentally unethical research. In principle, the current system already ensures that
p.000024: research will at least meet minimum ethical standards.
p.000024:
p.000024: It is true that in the opt-out system, the "moral" value of research is not assessed directly by the individual:
p.000024: rather, this is done by the Ethics Committee, which performs this assessment in the public interest, and therefore
p.000024: at least partially and symbolically represents the deceased. However, it is true that there is no longer any
p.000024: right to determine exactly how the material is used, by contrast with what happens in the case of living
p.000024: donations. Personal preferences will no longer be taken into account. But this reduced right to determine how the body
p.000024: material is used does not seem to those Committee members who support the opt- out regime to be out of proportion,
p.000024: given the change in the person’s status by reason of his or her death. Although the deceased's critical
p.000024: interests must be taken into consideration, this cannot be done to the same extent or by similar mechanisms as
p.000024: those in place for the living. These members therefore reject the argument that the opt-out regime leads to
p.000024: an intolerable exploitation of the person of the deceased.
p.000024:
p.000024: 3. Summary of the position in favour of keeping the opt-out with the addition of further conditions
p.000024:
p.000024: The members who support this position therefore take the view that Article 12 of the Law of 19 December 2008, which
p.000024: permits the donation under an opt-out regime of body parts of people who have died for human medical applications or
p.000024: for scientific research purposes can be kept, with the addition of further conditions and the reinforcement
p.000024: of the control systems.
p.000024:
p.000024: They wish to warn against the risks of discontinuing this provision: it is doubtful whether the same level of
p.000024: participation in research can be achieved by awareness campaigns on this issue and the formalisation of
p.000024: individual wishes by certain channels. Moreover, account should be taken of the difficulty of conveying this kind
p.000024: of message to the public, a message
p.000024:
p.000025: 25
p.000025: FINAL VERSION
p.000025:
p.000025: concerning the body, death and disease. It should also be borne in mind how many different requests and appeals
p.000025: individuals are subject to these days.
p.000025:
p.000025: For all these reasons, it seems unrealistic to believe that it would be possible to achieve the same degree of
p.000025: availability of human body material by seeking an explicit statement of position from each individual. Yet,
p.000025: as has been stated, there is a proven link between the opt-out system and effective and rigorous research which
p.000025: has the potential to contribute greatly to public health. The members who support this regime therefore
p.000025: believe that it would be ethically irresponsible to recommend that the system be discontinued.
p.000025:
p.000025: However, they consider it essential to reinforce the degree of control and security regarding the collection of body
p.000025: material, for the following reasons:
p.000025:
p.000025: 1) It is unacceptable for only the use of biological material should be subject to the appraisal of a medical ethics
p.000025: committee. The removal of the material should also undergo ethical validation in some way.
p.000025:
p.000025: Of course, the fact that the specific purpose for which human biological material will be used has often not yet
p.000025: been defined at the time of collection (by contrast with the removal of material from living donors)
p.000025: makes a "regular" assessment by medical ethics committees impossible.
p.000025:
p.000025: This is why these members recommend that an agency – possibly the current Federal Agency for Medicines and Health
p.000025: Products – should, in liaison with the medical ethics committee of the hospital where the material is removed,
p.000025: verify the scientific reasons for doing so, regardless of how the collected material will be used. This would
p.000025: enable an assessment of all research needs for human body material.
p.000025:
p.000025: 2) Arrangements should be made to allow a differing response to the opt-out for therapeutic purposes and the opt-out
p.000025: for research purposes, so that if people wish to rebut the presumption of consent to the donation of
p.000025: material for research purposes, they are not therefore obliged to do so for donations for therapeutic purposes at
p.000025: the same time.
p.000025:
p.000025: 3) These members also call for the royal decrees implementing the Law of 19 December 2008 to include
p.000025: provisions specifying the establishment of an effective traceability system ranging from the collection of body
p.000025: material to its storage, transportation and final use, and ensuring that only authorised organisations can
...
p.000026:
p.000026:
p.000026: B. Recommendations and conclusions of members opposed to the opt- out system for post mortem removal of human
p.000026: body material
p.000026: In the view of some members of the Committee, the Belgian Law of 19 December 2008 amounts, in practice,
p.000026: to making human body material automatically available post mortem. They see this as going too far.
p.000026:
p.000026: These members wish to stress that they definitely consider it important to inform the public in detail about the
p.000026: importance of scientific research and to actively encourage people to contribute in some way to its progress.
p.000026:
p.000026: Fortunately, it seems that the vast majority of citizens in various countries are not at all opposed in
p.000026: principle to the provision of body material while they are alive for the purposes of biomedical research. However,
p.000026: this does not give researchers, clinicians and the public authorities the right to assume that:
p.000026:
p.000026: - No one is opposed, or
p.000026: - Anyone who agrees with the ante mortem use of his or her body material for research purposes by definition
p.000026: agrees with its post mortem use for the same purposes, or
p.000026: - Anyone who agrees with the post mortem collection of (some of) his or her organs for transplantation purposes by
p.000026: definition also agrees with the post mortem collection of body material, for either therapeutic or research purposes.
p.000026:
p.000026: Once again, these members regard it as desirable to say the least for the public to be informed about
p.000026: the value of biomedical research and encouraged to contribute to it, by donating body material and/or by
p.000026: other means. They are also aware that it would be unfair to impose a condition of "informed consent" in
p.000026: connection with research on human body material, since it is de facto impossible to inform a potential donor of
p.000026: all possible uses of his or her body material. As the term "informed consent", which requires the information to be
p.000026:
p.000027: 27
p.000027: FINAL VERSION
p.000027:
p.000027: tailored to the individual, may be misleading in this context and give the false impression that the person concerned
p.000027: will have comprehensive and adapted information and hence an ethical safeguard, these members prefer to use another
p.000027: expression.
p.000027:
p.000027: The appropriate expression in this context is "explicit authorisation". These members therefore argue that:
p.000027:
p.000027: - The explicit authorisation of the person concerned is necessary for the post mortem removal of body material for
p.000027: human medical applications, except in the case of an organ transplant within the meaning of the Act of 13 June 1986.
p.000027: In this latter case, presumed consent, together with proper performance of the associated duty of information
p.000027: provision, is sufficient.
p.000027:
p.000027: - The explicit authorisation of the person concerned is required in all cases for the post mortem removal of body
p.000027: material for research purposes.
p.000027:
p.000027: With regard to the specific arrangements and the implementation of the explicit authorisation
p.000027: referred to above, these members believe that a document along the following lines must be given to everyone:
p.000027:
p.000027:
p.000027: WHAT DO I WANT TO HAPPEN TO MY BODY MATERIAL AFTER MY DEATH?
p.000027:
p.000027: This document concerns the collection of body material after death, such as cells, tissue, brain or bones; it
p.000027: therefore does not relate to organs such as the heart, lungs, liver or kidneys. Increasing use is made of
p.000027: such body material both for therapeutic purposes, i.e. for the benefit of other patients (e.g. skin or bone
p.000027: transplants), and for scientific purposes (research with a view to discovering possible treatments for diseases). The
p.000027: question of what you want to happen to your body material after you die therefore deserves some thought.
p.000027: We invite you to make a choice between the following options and tick one of the four boxes: I, the undersigned,
p.000027: (first name and surname:)………………………………………………………………………..…………………
p.000027: (national register number – see the back of your identity card:)…………………………………..
p.000027:
p.000027: (1) agree to the removal of body material after my death:
p.000027:
p.000027: (a) for therapeutic purposes, i.e. for the benefit of another patient (note that in this case, an independent body
p.000027: will decide which patient will receive the material);
p.000027:
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| access | Access to Social Goods |
| access to healthcare | access to healthcare |
| age | Age |
| authority | Relationship to Authority |
| autonomy | Impaired Autonomy |
| children | Child |
| coma | Comatose |
| criminal | criminal |
| education | education |
| educational | education |
| emergency | Public Emergency |
| family | Motherhood/Family |
| foetuses | Fetus/Neonate |
| hunger | Food Insecurity |
| hungry | Food Insecurity |
| ill | ill |
| incapable | Mentally Incapacitated |
| influence | Drug Usage |
| mentally | Mentally Disabled |
| opinion | philosophical differences/differences of opinion |
| party | political affiliation |
| philosophy | philosophical differences/differences of opinion |
| poor | Economic/Poverty |
| poverty | Economic/Poverty |
| prisoners | Criminal Convictions |
| racial | Racial Minority |
| religious | Religion |
| restricted | Incarcerated |
| sick | Physically Ill |
| single | Marital Status |
| substance | Drug Usage |
| trauma | Victim of Abuse |
| victim | Victim of Abuse |
| violence | Threat of Violence |
| volunteers | Healthy People |
| vulnerable | vulnerable |
Indicator Peers (Indicators in Same Vulnerability)
| Indicator | Peers |
|---|
| education | ['educational'] |
| educational | ['education'] |
| hunger | ['hungry'] |
| hungry | ['hunger'] |
| influence | ['substance'] |
| opinion | ['philosophy'] |
| philosophy | ['opinion'] |
| poor | ['poverty'] |
| poverty | ['poor'] |
| substance | ['influence'] |
| trauma | ['victim'] |
| victim | ['trauma'] |
Trigger Words
consent
developing
ethics
exploit
harm
justice
protect
protection
risk
sensitive
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input