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0:00
Dear audience,
it is a pleasure for me to
give you a presentation
on the History and Foundations of
Medical Research Ethics today.
My name is Christian Lenk,
I'm a Professor of
Medical Ethics at
the Institute for the History, Theory and
Ethics of Medicine at Ulm University, Germany.
0:21
You see here the table
of contents for my talk.
Firstly,
I will give you a short
historical introduction.
Secondly, I will go on
to the time after WW2
through the development
of the Nuremberg Code,
and also the further development of
medical research ethics after WW2.
I will then go into the
elements of consent in part 3.
Finally, in part 4 I
will go into the details
regarding ethical regulations
of medical research
according to the
Declaration of Helsinki
from the World's
Medical Association.
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Firstly, the historic
introduction.
The first regulations of
medical research arose in
the 1930s in Germany
and the United States.
It started with some cases where patients
were enlisted into medical experiments
and this posed some
problems because
it was not for the advantage
of these patients,
and so the state
authorities had to see that
the regulation of this research
was necessary and also reasonable.
Then in the follow-up
of these experiments,
they established a duty
of adequate information
and also a right of the
patients for voluntary consent.
Already at this time,
patients should receive
adequate information
and should also
give their consent.
A special problem,
before the 1930s was the
recruitment of marginalised groups
like orphans, prisoners or
prostitutes for medical research.
For example, in the case of
syphilis research in Germany,
there was the case
of Professor Neisser
who recruited healthy women
and then inoculated
syphilis into their bodies,
so that they became
syphilitic in the end.
This was seen as acceptable
by the state authorities.
These marginalised groups,
all these groups in society,
seemed to need special protection
regarding medical research.
Following this, it
emerged as a legal rule
that faulty, incomplete or
missing patient information
can result in negligence or injury
towards research participants.
The idea behind
this is as follows.
Normally, one needs the
full information about
the measures of
therapy or research.
For example, if somebody takes
blood or other
research measures,
and if the participants
are not properly informed,
they cannot consent to
such an intervention,
to the body or the mind.
Therefore, this seems
to be unacceptable
and can be interpreted
as a 'damage' or
an 'injury' towards these
research participants.
An important period for the
development of research ethics
