Joint Ethico-Medical Committee of
Catholic Union of Great Britain
the Guild of Catholic
Submission to the Department of Health in response to The Consultation Text of the Draft Additional Protocol to the Convention on Human Rights and Biomedicine, on Medical Research
The Joint Ethico-Medical Committee is composed of members drawn from two parent bodies; the Catholic Union of Great Britain and the Guild of Catholic Doctors. The Catholic Union is an organisation of the Catholic Laity which is not affiliated with the hierarchy but which represents the Catholic viewpoint, where relevant, in Parliamentary and legislative matters. The Guild of Catholic Doctors represents Catholic Medical Practitioners in the United Kingdom.
We welcome the opportunity to comment on this important document. We will address only certain paragraphs.
Paragraph 86 / Article 8
Ethically, a parent only has the power and authority to consent on behalf of a child to procedures which are of benefit to the child themselves. Similar limitations must apply to "representatives" on behalf of the incompetent, when the research involves invasive procedures. In other respects we agree that the other conditions stated in this paragraph are essential if any such research is to be permitted.
There is a contradiction in point 6 "the person concerned does not object....". If the person is incapable of giving consent, what judgements and criteria are used to establish that the person concerned does not object?
We are concerned that the example of �...healthy minors undergoing research...� is used. Healthy minors should not be subject to any invasive research, which by definition will be of no benefit to themselves. This would be in contravention of Article 2 of the Convention (Primacy of the human being) which states "The interests and welfare of the human being shall prevail over the sole interest of society or science."
This paragraph in essence states that the investigation of normal physiological processes are legitimate areas of research on children. We accept that observational research is permissible, but not invasive research. (See comments below). We disagree with the statement "Any restriction based on the requirement of �potential direct benefit� for the persons undergoing the test would make such studies impossible in future". Acceptance of this statement completely negates the fundamental principle of the convention; and in effect argues that the benefits to society override the concerns and dignity of the individual.
Paragraph 97 / Article 20
It is important that �minimal risk and minimal burden� are clearly defined in the protocol and not left to the explanatory report which the covering letter from Professor Sir John Pattison states has �...no legal status [but]... may act as a guide to the proper interpretation of the provisions.�
We accept that questioning, observation etc and obtaining bodily fluids without invasive procedure are acceptable. We also accept the use of blood and tissue, surplus to diagnostic / therapeutic requirements, taken at the time of invasive therapeutic or diagnostic intervention. We do, however, object to the taking of blood and tissue and other invasive procedures which are purely for research purposes and which can be of no benefit to the participant. Although this at times may limit the advancement of scientific knowledge, the principle of the convention is paramount and making exceptions introduces the concept that the ends justify the means - which to many is unacceptable.
Article 2 of the Convention by excluding research on human embryos in vitro, whilst avoiding another important debate, clearly places humans in their origins in a separate category outside the protection of the protocol. This effectively bestows a lower status on man at one of his stages which is contrary to the statement of principle in Article 1 of the Convention itself. By excluding man in his most formative stages, differing ethical environments for scientific research have already been created. The Convention does not address this issue which it should.
The draft protocol and commentary are broadly acceptable when applied to research on man beyond his embryonic life, and they contain many useful and positive measures. The sections dealing with minors or those who lack competence needs to be tightened. It is the vulnerable who require most protection, and the exceptions made to those who are unable to consent result in their not being treated with equal or the same respect accorded to other categories of persons covered by the Convention. This introduces an element of incoherence into it and the explanations in the commentary are not persuasive and on occasion even wrong.
The effect of this across the 43 possible countries affected would lead to different interpretations and different ethical climates. This in turn would tempt researchers to seek the most liberal climate in which to conduct their studies. This is contrary to the purpose of the Convention.
We thank you for inviting our comments on these vital documents, and we trust they are of assistance.
Dr Anthony Cole, JP., FRCP., KSG. Chairman of the Catholic Union Dr Michael Jarmulowicz, FRCPath., MB.BS., BSc., Master Guild of Catholic Doctors