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0:00
My name is Christian Lenk from
the Institute for the History,
Theory & Ethics of Medicine
at Ulm University in Germany.
And I'm also the Chair
of the Research Ethics Committee
at my university.
And today I will talk to you
about the theme,
The Ethical and Legal Framework
for International
Tissue Transfer.
0:22
On table of contents,
you see that
I will first give you
a short introduction
into the theme,
and then I will go into
some more theoretical issues
for the introduction,
namely the no-property rule,
then the bundle theory
of property,
and the problem
of commodification
of body material.
And then I will go
more to practical
issues of transfer
of human tissue for research,
and then the last points
come to some conclusions
for the practice of
research that are surely
also interesting for you.
1:01
I will then come to
my introduction and first,
it is important to describe
the area of relevance
for my talk and
the handling of tissue
for research has to be
distinguished from other fields.
For example,
tissue and body material
from transplantation purposes
because there you will find
other ethical
and legal regulations.
Many of the notions
which are used in ethics and law
do also have a meaning
in common language,
like for example,
the notion of donation,
or also of commercialization.
In the case of donation,
when you make a donation,
in practice,
normally you will see
that this is implicitly
or explicitly bound
to a specific use
and this is also
the case in the area
of tissue research.
Tissue or body material
is given by the donor
for a noncommercial use
normally in medical research
and on the other side,
it is expected that it is
used for specified
and described aims,
for example,
non-commercial research
at the university hospital.
So you see, on the one hand,
the term of donation
is also used in common language,
we can say,
and on the other hand,
it is in a specified way
used in medical practice
and in research.
And then you have to see,
okay,
what issues
are there important for me
if I talk of tissue donation?
And so we can say obviously
also in medical research,
we have then
the donation as a gift
with a specified use
and the researcher
has then the right to use
the tissue in a specified way.
You can also say about the time
that we have different ethical
and legal qualities
of human tissue.
For example, first,
it is donated from the patient,
the tissue,
but then it might change
its character or its quality.
For example, if it is used
as a medicinal product,
like, for example,
a blood donation.
We can also say
that sometimes there are
different ethical
and legal qualities
of human tissue.
For example, directly
at the donation then tissue
or body material
comes from the patient
and then it is used
in the medical system
for other purposes.
Think of a blood donation,
for example,
if you do something
with this body material
and later on, you can use it,
for example,
as a medicinal product.
Then it is very important to see
that in different countries,
there are also different ethical
and legal regulations.
For example,
in the European area
or in the US area,
and I only want to
give you one example
for such a regulation
and this is the last point,
the recommendation REC
from 2006 number 4
of the Council of Europe,
from the Committee of Ministers
on research
on biological materials
of human origin
and for medical research,
such recommendations
and guidelines
are very important
to see for a larger area,
like here for the
European countries, okay.
What are common rules
for the treatment
and for dealing
with human tissue
and body material,
and this makes it quite easier,
for example,
in the international context,
to have contact with
colleagues in other countries
and to use also body material
from other countries.
And if you take this
recommendation,
for example, then you
have an overview about
the most important points there,
namely the information of patients,
how you should use
body material for research
and also what limitations
there are, for example,
in respect to possible
commercialization
of body material.
The last point
is very important.
