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National Statement on Ethical Conduct in Human Research 2007 Human biospecimens submission

ID: 
21
This submission reflects the views of
Organisation Name: 
Caroline Chisholm Centre for Health Ethics
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Please identify the best term to describe the Organisation: 
Ethics / Bioethics organisation
Specific Comments
Comments: 
Ethical review before human biospecimens are used in research – paragraphs 3.4.6 – 3.4.11

Submission

 To: Public Consultation on National Statement on Ethical Conduct in Human Research 2007 – Chapter 3.4: Human Biospecimens

 From: Revd Kevin McGovern, on behalf of Caroline Chisholm Centre for Health Ethics, 47/141 Grey St, East Melbourne VIC 3002

 Date: 16 October 2012

 Thank you for the opportunity to comment on the proposed revision of Chapter 3.4 of the National Statement on Ethical Conduct in Human Research 2007.

 I have studied the consultation draft carefully. It is immediately obvious that a great deal of thought has been put into the revision of this chapter. I am impressed by the range of issues considered, and by the thoroughness and attention to detail in each area. In all that has been written, I cannot find anything which I disagree with or which causes me concern. I am pleased to endorse all that has been written.

 However, I recommend that one more paragraph should be added to this chapter.

 In the current Chapter 3.6 of the National Statement, Paragraph 3.6.7 concerns Conscientious Objection. It states:

 Those who conscientiously object to being involved in conducting research with embryos, foetuses or embryonic or foetal tissue should not be obliged to participate, nor should they be put at a disadvantage because of their objection.

 It has generally been the practice at the National Health and Medical Research Council to make an explicit statement about conscientious objection in statements and guidelines which concern matters which may be ethically contentious for some people within the Australian community. Explicit statements about conscientious objection are found in the Ethical Guidelines on the Use of Assisted Reproductive Technology in Clinical Practice and Research (2007), #5.9; Organ and Tissue Donation by Living Donors: Guidelines for Ethical Practice for Health Professionals (2007), 2.5b; Organ and Tissue Donation After Death: Guidelines for Ethical Practice for Health Professionals (2007), 2.5c-f; and in the National Statement both at 3.6.7 and at 4.1.14.

 There are some people within the Australian community who will have conscientious objections to the use of some human biospecimens because of the origin of these biospecimens.

 I am aware that the NHMRC Working Group on the Commercialisation of Human Tissue has put forward the concept of attenuation to explain why there may be trade in human tissue products while trade in human tissue is forbidden. [See, for example, Nicholas Tonti-Filippini and Nikolajs Zeps, “Trade in human tissue products,” MJA 194, no. 5 (7 March 2011): 263-265] Because of considerations such as the concept of attenuation, many people conclude that they do not have serious ethical concerns about the use of most if not all human biospecimens regardless of their origins.  However, it would be unreasonable to argue that considerations like these will address the ethical concerns of everyone. Within the broad range of the Australian community, almost certainly some people will have ethical concerns related to the origins of some human biospecimens.

 The Catholic Church has written about this matter in its most recent major international statement on bioethics. Dignitas Personae, the Instruction on Certain Bioethical Questions, was issued by the Congregation for the Doctrine of the Faith on 8 September 2008. Sections 34 and 35 of this statement concern “The use of human ‘biological material’ of illicit origin.” I have included these sections as an attachment to this submission. It states that “there is a duty to refuse to use ‘biological material’ [of illicit origin] even when there is no close connection between the researcher and the actions” through which this human biospecimen was obtained. It then notes a number of valid exceptions to this general rule. For example, Catholic teaching gives no support to those parents who refuse to vaccinate their children because some vaccines are produced using cell lines originally obtained from an aborted foetus.

 Not every Catholic will be convinced by the arguments put forward by the Congregation for the Doctrine of the Faith, and many Catholics will have no ethical concerns about the use of human biospecimens regardless of their origins. However, some Catholics – and some people of other faiths or of no faith at all – are indeed ethically troubled by the use of human biospecimens obtained, for example, from an aborted foetus. They would also be ethically troubled by the use of cell lines of human embryonic stem cells, if these are ever developed.

 As the NHMRC has done with other ethically contentious areas, it is appropriate to include an explicit statement about conscientious objection in the new Chapter 3.4.

 Basing my text on Paragraph 3.6.7 of the current Chapter 3.6, I suggest the following statement:

 Those who conscientiously object to the use of certain human biospecimens because of their origins should not be obliged to participate in their use, nor should they be put at a disadvantage because of their objection.

 Once again, I thank you for the opportunity to comment on the proposed revision of Chapter 3.4 of the National Statement on Ethical Conduct in Human Research 2007. I hope that you do decide to include a statement about conscientious objection in the final version of the new chapter. To do so would be a respectful acknowledgment of the diversity of ethical opinion within the Australian community.

 Yours faithfully

 Revd Kevin McGovern

on behalf of

Caroline Chisholm Centre for Health Ethics

47/141 Grey Street

East Melbourne VIC 3002

Attachment A: From the Congregation of the Doctrine of the Faith’s Dignitas Personae (Instruction on Certain Bioethical Questions), #34-35:

 The use of human “biological material” of illicit origin

 34. For scientific research and for the production of vaccines or other products, cell lines are at times used which are the result of an illicit intervention against the life or physical integrity of a human being. The connection to the unjust act may be either mediate or immediate, since it is generally a question of cells which reproduce easily and abundantly. This “material” is sometimes made available commercially or distributed freely to research centers by governmental agencies having this function under the law. All of this gives rise to various ethical problems with regard to cooperation in evil and with regard to scandal. It is fitting therefore to formulate general principles on the basis of which people of good conscience can evaluate and resolve situations in which they may possibly be involved on account of their professional activity.

 It needs to be remembered above all that the category of abortion “is to be applied also to the recent forms of intervention on human embryos which, although carried out for purposes legitimate in themselves, inevitably involve the killing of those embryos. This is the case with experimentation on embryos, which is becoming increasingly widespread in the field of biomedical research and is legally permitted in some countries…  [T]he use of human embryos or fetuses as an object of experimentation constitutes a crime against their dignity as human beings who have a right to the same respect owed to a child once born, just as to every person”.[54]  These forms of experimentation always constitute a grave moral disorder.[55]

 35. A different situation is created when researchers use “biological material” of illicit origin which has been produced apart from their research center or which has been obtained commercially. The Instruction Donum vitae formulated the general principle which must be observed in these cases: “The corpses of human embryos and fetuses, whether they have been deliberately aborted or not, must be respected just as the remains of other human beings. In particular, they cannot be subjected to mutilation or to autopsies if their death has not yet been verified and without the consent of the parents or of the mother. Furthermore, the moral requirements must be safeguarded that there be no complicity in deliberate abortion and that the risk of scandal be avoided”.[56]

 In this regard, the criterion of independence as it has been formulated by some ethics committees is not sufficient. According to this criterion, the use of “biological material” of illicit origin would be ethically permissible provided there is a clear separation between those who, on the one hand, produce, freeze and cause the death of embryos and, on the other, the researchers involved in scientific experimentation. The criterion of independence is not sufficient to avoid a contradiction in the attitude of the person who says that he does not approve of the injustice perpetrated by others, but at the same time accepts for his own work the “biological material” which the others have obtained by means of that injustice. When the illicit action is endorsed by the laws which regulate healthcare and scientific research, it is necessary to distance oneself from the evil aspects of that system in order not to give the impression of a certain toleration or tacit acceptance of actions which are gravely unjust.[57]  Any appearance of acceptance would in fact contribute to the growing indifference to, if not the approval of, such actions in certain medical and political circles.

At times, the objection is raised that the above-mentioned considerations would mean that people of good conscience involved in research would have the duty to oppose actively all the illicit actions that take place in the field of medicine, thus excessively broadening their ethical responsibility. In reality, the duty to avoid cooperation in evil and scandal relates to their ordinary professional activities, which they must pursue in a just manner and by means of which they must give witness to the value of life by their opposition to gravely unjust laws. Therefore, it needs to be stated that there is a duty to refuse to use such “biological material” even when there is no close connection between the researcher and the actions of those who performed the artificial fertilization or the abortion, or when there was no prior agreement with the centers in which the artificial fertilization took place. This duty springs from the necessity to remove oneself, within the area of one’s own research, from a gravely unjust legal situation and to affirm with clarity the value of human life. Therefore, the above-mentioned criterion of independence is necessary, but may be ethically insufficient.

Of course, within this general picture there exist differing degrees of responsibility. Grave reasons may be morally proportionate to justify the use of such “biological material”. Thus, for example, danger to the health of children could permit parents to use a vaccine which was developed using cell lines of illicit origin, while keeping in mind that everyone has the duty to make known their disagreement and to ask that their healthcare system make other types of vaccines available. Moreover, in organizations where cell lines of illicit origin are being utilized, the responsibility of those who make the decision to use them is not the same as that of those who have no voice in such a decision.

 In the context of the urgent need to mobilize consciences in favour of life, people in the field of healthcare need to be reminded that “their responsibility today is greatly increased. Its deepest inspiration and strongest support lie in the intrinsic and undeniable ethical dimension of the health-care profession, something already recognized by the ancient and still relevant Hippocratic Oath, which requires every doctor to commit himself to absolute respect for human life and its sacredness”.[58]

 [55] Cf. John Paul II, Encyclical Letter Evangelium vitae, 62: AAS 87 (1995), 472.

[56] Congregation for the Doctrine of the Faith, Instruction Donum vitae, I, 4: AAS 80 (1988), 83.

[57] Cf. John Paul II, Encyclical Letter Evangelium vitae, 73: AAS 87 (1995), 486: “Abortion and euthanasia are thus crimes which no human law can claim to legitimize. There is no obligation in conscience to obey such laws; instead there is a grave and clear obligation to oppose them by conscientious objection”. The right of conscientious objection, as an expression of the right to freedom of conscience, should be protected by law.

[58] John Paul II, Encyclical Letter Evangelium vitae, 63: AAS 89 (1995), 502.

 

Page reviewed: 3 June, 2013