Beruflich Dokumente
Kultur Dokumente
• Principles
– Autonomy
– Individual vs. Collective
• NIPT
• Gene editing
2
Ethics
• Do good
• Is it allowed to…
• In research
3
Ethics
• Not only answers
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(1) Research ethics
• Medical ethical committee
• Institutional Review Board
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(3) In health care
• Ethical practice in profession-led health care.
• For physicians ethics is an element of professionalism.
• The CANMEDS competency “professionalism” encompasses
ethical practice
Source: Wikipedia 7
In health care
• I will use treatment to help the sick according to my ability and
judgment, but never with a view to injury and wrong-doing.
– Beneficence
– Non-maleficence
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Gene editing, NIPT
• Questions at the beginning of life
– gene editing
– non-invasive prenatal testing (NIPT)
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Overview
• Domains
• Principles
– Autonomy
– Individual vs. Collective
• NIPT
• Gene editing
10
Principles?
• To clarify why we argue the way we argue, we need to look
beyond the surface: what are the principles?
11
Principles?
• autonomy, • reciprocity,
• privacy, • mutuality,
• justice, • solidarity,
• quality and • citizenry and
• equity • universality
12
Genetic counseling (Am J Hum Genet 1975;27:240-2)
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Autonomy
• Patient or participant chooses
• Patient or participant can say no
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Autonomy
• Patient or participant chooses
• Patient or participant can say no
Eliminating tinder for Tay-Sachs
http://www.sajr.co.za/news-and-articles/2014/12/29/eliminating-
tinder-for-tay-sachs-18-others
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Autonomy vs. coercion
First half of previous century in many countries
• Some people isolated from "normal" society
• Segregation
• Compulsory sterilization of "feeble-minded"
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Autonomy in health care
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Autonomy in health care vs. research
NOTE:
• Individual autonomy
• In genetics the patient often is the family
• E.g. a couple decides on their pregnancy
18
Principles?
• autonomy, • reciprocity,
• privacy, • mutuality,
• justice, • solidarity,
• quality and • citizenry and
• equity • universality
collective
19
Individual vs. group
• I participate in research in the interest of “patients like me”
• Vs. there is a small chance that I profit
• My genome will provide information about people with same
ancestry
• In children:
– Reluctance to include in research: avoid harm
– But for some childhood disorders one would never be able to
further develop therapy
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Overview
• Domains
• Principles
– Autonomy
– Individual vs. Collective
• NIPT
• Gene editing
21
Non-invasive prenatal testing (NIPT)
• From DNA in maternal plasma ~10% is from foetal (placental)
origin;
• RhD+ DNA in blood of RhD- mother, must be foetal!
Man RhD+
Woman RhD+
• It has the potential of helping the practice better achieve its aim
of facilitating autonomous reproductive choices.
• To evaluate this aim, it is not sufficient to report on the number
of participants, the uptake or the prevalence of aneuploidies.
– Include measure of informed decision making
• Crucial elements for the health care system include information
and counseling, education of professionals, accountability to all
stakeholders including children born from screened
pregnancies and persons living with the conditions targeted in
prenatal screening and promotion of equity of access.
24
NIPT for all?
• Ethical principles are often connected
• Equity?
• And if, whatever their choice, they and their children will be
taken care of.
– Decline or accept test
– Terminate pregnancy or not
25
Overview
• Domains
• Principles
– Autonomy
– Individual vs. Collective
• NIPT
• Gene editing
26
Gene editing - somatic
• “beneficence” (doing good) vs.
“maleficence” (doing harm):
– how safe is it?
• If safe and effective – change gene in
stemcells and give them back to patient
lacking enzyme/function (somatic gene
editing)
• In terms of ethics – simple case?
Araki et al
Trends in Biotechnology, 2016, Vol. 34, No. 2
27
Germline gene editing?
• The Council of Europe Committee on bioethics DH-BIO
stressed the Oviedo Convention as the only international
legally binding treaty addressing human rights in the biomedical
field.
The article 13 in the convention limits the purposes of any
intervention on the human genome, including in the field of
research, to prevention, diagnosis or therapy.
In addition, it prohibits any gene modification of embryos that
would be passed on to future generations
Source: http://www.coe.int/en/web/bioethics/-/gene-editing
28
Germline gene editing?
Clinical trials regulation Art 90:
29
PPPC doc Germline Gene Editing
• The PPPC of ESHG collaborates with The European Society of
Human Reproduction and Embryology (ESHRE).
• Together developing recommendations especially for
reproductive gene editing.
• What were the arguments behind this legislation, and do these
still apply and are they still considered convincing?
• If a technique can help to avoid serious genetic disorders, in a
safe and effective way, would this be a reason to reconsider
earlier standpoints?
30
PPPC doc Germline Gene Editing
• Categorical objections
• Consequentialist objections
31
PPPC doc Germline Gene Editing
• Categorical objections to Germline Gene Editing - in terms of
being at odds with e.g. naturalness, human dignity, or the
preservation of the human gene pool as a common heritage –
are often used both in public debate and legal discourse.
32
PPPC doc Germline Gene Editing
• No convincing arguments for “never edit the germline” for
serious condition
– we need better understanding of these categorical arguments
to inform the debate
34
Conclusions
• Ethics for questions and answers
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