0:00
Dear audience, it is a
pleasure for me to give you
the presentation on "Ethics
and Drug Development".
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 in Germany.
0:19
You see here the
contents of my talk.
Firstly, I will say
something regarding
the ethical framework for
clinical research and medicine.
Then I will explain something
about the research
ethics committees,
which are also named in
the United States as the
Institutional Review Board.
In the third part, I will then
go on to ethical questions
and the research
design with elements
of the research design like,
for example, randomisation,
placebo control and blinding.
The fourth part
will be shortly on
vulnerable patient groups
and I will say then also
something on the challenges in
the COVID-19 pandemic
regarding ethics and research.
Finally, I will draw some
conclusions for practice.
1:10
The Ethical Framework
for Clinical Research.
This framework here
was developed by
some colleagues from
the United States,
Emanuel, Wendler and Grady
in a publication from 2000.
Well, as they showed in
their publication first,
the medical research
should also have
some social and scientific value
over and above the mere
progress of medicine.
So the researchers should also
reflect on this kind value.
Often research projects are only
acceptable for the
broader society
one can show but there's
also social and scientific value
in the aims of these
research experiments.
The second point is the
scientific validity.
The methods and the experiments
in the clinical trial must
be according to the
standards of research.
Then there should be a
fair subject selection,
for example,
in special population groups
who could profit from
this treatment should
also then be part of the trial
and should be recruited
in such a trial.
The fourth point would be
the favorable
risk-benefit ratio.
At the start of the trial,
but also during the trial,
the benefits for the patients
and participants should
overlay the existing
risks in this trial.
Then there should be in
the fifth point an
independent review and
control of such an experiment.
And very important on the sixth,
every participant
must be freely,
and give a well informed consent
to participate in the study.
Finally, on the seventh,
we have also the respect of
the researchers and organizers
for potential and
enrolled subjects
and study participants.
