Wiesing-DoH-Helsinki-20141111

 
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The Declaration of Helsinki – its history and its future
Urban Wiesing
Helsinki, 11.11.2014
Fifty years ago, in June 1964, the delegates of the national medical associations
came from all over the world to Helsinki to attend the 18th
General Assembly of the
World Medical Association. The Finnish president of the WMA, Dr. Urpo Siirala,
invited the delegates. The Finnish medical association was responsible for organizing
the assembly. The delegates might have thought to attend one of numerous
meetings, as many others before. They might have thought to be involved in
business as usual. Those who thought this were wrong. But the delegates could have
hardly imagined the historical significance that would later be gained by this general
assembly and by their decision to adopt a certain document. The document they
adopted without a dissentient vote would serve for generations of researchers as a
point of reference. The document on “Recommendations guiding doctors in clinical
research” came to be known as the “Declaration of Helsinki”. It was the first
international set of ethical principles for research involving human subjects. In the
following years this guideline became the most influential one and still is. One tiny
step had been taken by the delegates that would later turn out to be a giant leap. As I
said: This happened 50 years ago.
“But the road to the Helsinki declaration was neither straight nor smooth.”1
The work
took more than a decade. The discussion started shortly after the founding of the
World Medical Association in 1947, two years after the war, and still in the wake of
the crimes committed by German doctors in the concentration camps. In the same
year, the Nuremberg Code as a guideline for medical research on human subjects
resulted from the “Doctors’ Trial” at the Nuremberg Trials.
What was the Nuremberg Code? And what was its role in history? The Nuremberg
code was meant to prevent crimes like those committed by Nazi doctors in the
concentration camps. Therefore it demanded to obtain participants’ voluntary consent
without any exception. In addition, the code set a limit on reasonable risks and
demanded that subjects have the right to leave the experiment at any time. However,
the code attracted little interest at first. How could it? It served to justify the judgment
of an American military court. It was a secret document in some countries. What
authority could such a Code claim to have? This was a difficult question to answer.
The Nuremberg Code was an important document, but it did not serve as an
influential answer to the demanding situation in medical research. Another answer
was needed.
In 1953 a first proposal for a position paper was submitted to the Medical Ethics
Committee of the WMA. It was published a year later as the “Resolution on Human
Experimentation”. In contrast to the Nuremberg Code, participants’ informed consent
was not an absolute condition. It gives researchers a little leeway when it comes to

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1

 Susanne Lederer (2007): Research without Borders: The Origin of the Declaration
of Helsinki. In: Schmidt/Frewer: A History and Theory of Human Experimentation.
Stuttgart, Franz Steiner Verlag, p. 145-167, p. 145.
 

 
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research on those incapable of giving informed consent. These patients could be
included in experiments if their legally authorized representatives provided consent
on their behalf. Even though this first document was vague, very short and somewhat
poorly phrased, it shows important characteristics of the subsequent declaration: first
of all the resolution stresses the respect for the individual. Furthermore, it
differentiates between research on healthy volunteers and research performed on
patients for whom medical treatments are considered. This is not mentioned in the
Nuremberg Code. And the declaration makes research possible on those incapable
of giving informed consent under strict regulations.
Seven years later, in 1961, the Medical Ethics Committee presented the first draft of
the declaration. Three additional years of intense and controversial debates had to
pass until it was adopted. Many suggestions have been made and discussed –
among them the suggestion to implement an article on astronauts, which has not
been done. Highly controversial were the questions on research with prisoners and
with children. The discussion continued up to the General assembly in Helsinki, and
corrections were made until the day before. Finally the declaration was adopted in a
version that represents the character of the further versions: A compromise,
balanced, far away from unrealistic demands, but clear in central norms for the
protection of participants. Research with children was not totally prohibited, but
regulated, and the same goes for prisoners. Realism is one of the characteristics that
makes and has made the declaration acceptable for 50 years.
Medicine and human subject research: a dilemma
The declaration is the most imported document of ethical principles for the regulation
of research involving human subjects. But why did it gain such an importance? The
declaration is what it is because it gives an answer: an answer to a question that is
desperately needed to be answered in modern medicine; an answer to the
fundamental ethical question of research involving human subjects, an answer to a
dilemma.
What is the dilemma modern medicine is confronted with? On the one hand, modern
medicine knows that precise knowledge concerning the efficacy and safety of
interventions can only be gained from research involving human subjects. Animal or
laboratory experimentation is necessary and a prerequisite to clinical research. But
they cannot provide the knowledge relevant for medical practice. On the other hand,
research involving human subjects is fraught with ethical conflicts that cannot be
completely prevented. If one conducts research on human subjects, there will always
be the risk of harming them. Exposing the patients to such risks is inconsistent with
the medical professional’s obligations, especially with the old Hippocratic principle
primum nil nocere, do no harm. However, harmful effects are inevitable in research. If
the researcher knows beforehand that the patient will not be exposed to any risks
because the intervention is effective and does not inflict any harm, then no further
research is needed.
Research involving human subjects is controversial because of the risks. Therefore
one might think that it is morally preferable to abstain from research involving human
subjects. But this idea is fundamentally wrong. Abstaining from conducting this
research to avoid ethical conflicts would mean treating future patients with previously
untested drugs. This would significantly lessen the quality of medical practice. And
now we are arriving at one of the central dilemmas of modern medicine: The

 
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unsolvable problem lies in the fact that physicians are not permitted to use
empirically untested interventions but are simultaneously not supposed to empirically
test them. The ethical principle “do no harm” cannot be realized in therapy without
clinical research. But clinical research is ethically critical because it violates the
principle “do no harm”.
This ethical dilemma is much older than the Declaration of Helsinki. The ethical
dilemma arose when medicine wanted to become a science based discipline. And
the declaration is by no means the first regulatory response to this conflict. Some
national institutions had been aware of this problem since the end of the 19th
century.
They adopted regulations and continued to do so in 20th
century. These national
regulations emphasized, among other things, the patient’s informed consent as a
requirement for research. But they had little influence. They failed to prevent the
unspeakably cruel experiments performed on inmates of the Nazi concentration
camps. That means: The fundamental problems of research involving human
subjects were known, but the response thereto was insufficient.
These ethical problems grew larger with the increase in complexity and power of
medicine. It grew larger with scientific progress. In addition the problem grew larger
with the altered self-conception of the people. They did not want put themselves at
the disposal of medical science without being asked. They simply did not want to
become guinea pigs. An increased awareness of the ethical issues called for new
solutions. Moreover, the Nazi crimes and other scandals in medical research
threatened to undermine the public’s faith in the entire medical community. The
Nuremberg Code was one answer but more or less unknown. The Declaration of
Helsinki gave the most important answer to the dilemma associated with research
involving human subjects.
This is the historical achievement of the declaration. It gives an answer to an
unavoidable dilemma of modern medicine, to an unavoidable conflict between the
role of a physician and the role of a researcher. The declaration regulates an
unavoidable tension between exposing current patients to risks for the benefit of
future patients. Therefore the declaration stresses the protection of the participants
on the one hand and medicine’s need for research on the other.
Final part
After the adoption of the declaration the inevitable happened: the declaration was
debated. It was classified from the very beginning as too permissive by some
commentators and as too restrictive by others. The debate on whether the
Declaration of Helsinki is too “research-friendly” or too restrictive persists up to the
present day. But if a document is criticized to be too liberal and also criticized to be
too restrictive it may very well be a balanced compromise.
In an open society, in the modern world the Declaration of Helsinki is the object of
controversial discussions. This is unavoidable; it is a sign of an open society. It has to
be welcomed; it is nothing but necessary. It can only serve to improve the document.
There is no doubt: The international literature on the declaration was extremely
helpful for the last revision process and I am sure for the others as well. And – I
assure you by my own experience – the WMA is willing to lead such a discussion.
The WMA – the proud owner of the declaration, as they call themselves – does not

 
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shy away from any debate. The declaration is a living document that is adapted to a
changing environment and improved.
However, regardless of the debate on certain revisions and paragraphs, the
declaration as a historical document is uncontroversial. For with the adoption, much
more has been accomplished in terms of implicit judgments than visible at first
glance. What does this mean? Allow me to explain.
First of all the Declaration of Helsinki embodies the acceptance that research
involving human subjects not only has scientific and technical but also ethical
dimensions. It underlines that the ethical aspects can by no means be answered by
science alone. More than science is needed, what is needed is ethics. In this respect,
the declaration is also based on the acknowledgment of the limits of science. It is a
document of scientific prudence. Science can say how the world is, yes, and better
than ever before. But science cannot say how the world should be. Science can say
how one is supposed to go about researching something, but not whether it should
be researched at all. The declaration is based on the acceptance of these
fundamental theoretical distinctions and argumentative integrity. Therefore it is a
document of argumentative transparency. In this sense the declaration is simply
modern.
The declaration also secures trust. Thanks to the declaration and others this
research no longer has an exclusively negative image. The declaration not only limits
research on human beings, but it also legitimizes it. The declaration not only protects
the participants but the researchers as well. This not only stabilizes the medical
profession but gives the system of research hope that the people will accept it. The
acceptance and trust in research is essential in modern, open societies.
The declaration expresses a profession’s will and capability of self-control. I have to
remind you that other institutions, organizations etc. could have adopted a
comparable regulation. But that is not what happened. The declaration was created
and adopted by an organization of physicians for physicians, thus creating a close
relationship to the profession and the professionals. The declaration remains an
expression of professional self-reflection. It is living proof that a profession can
regulate not only scientific but also ethical aspects responsibly.
The adoption and the successful efforts of the World Medical Association for self-
imposed regulations confirm the fundamental willingness and ability to learn as a
professional self-organization. Thus, the declaration is an expression of
responsibility: The medical profession and its world organization are aware of the
ethical challenges in conducting research on human subjects. They feel responsible
for responding appropriately. The profession has not been forced to do so. The
Declaration is an expression of a voluntary assumption of responsibility. It is an
expression of the free will of the profession and of practical reason.
If the declaration didn’t exist it would have to be invented. There is no substitute for
the declaration. And there is no declaration 2.0. No, there is only one. And today we
are celebrating its 50th
birthday.
What will happen in the future with declaration? Some things are for sure: The
scientific and technological development of modern medicine will go on. They will
confront us with new challenges. I only have to remind you of some of the latest

 
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medical projects like individualized medicine, system medicine, new developments in
genetics or biobanks. And I am sure there are more to come and are already coming.
I am speaking in particular of the Ebola crisis.
In the case of Ebola, we can see how adequate the ethical principles of the
Declaration are. We do not need a new ethics in the case of Ebola. However, we do
need to make new decisions in the face of such a global crisis, but these decisions
must be made on the basis of existing ethical principles. The ethical principles laid
down in the declaration remain valid. They are applicable to the current situation and
indeed helpful.
The Declaration stresses the importance of protecting participants on the one hand
and medicine’s need for research on the other. Both must be balanced. This holds
true when it comes to Ebola as well. A balance between exposing current patients to
potential risks for their own benefit as well as the benefit of future patients is
absolutely crucial in order to prevent a pandemic. This is precisely what needs to be
done in the case of Ebola.
Furthermore, the declaration allows the “treatment of an individual patient, where
proven interventions do not exist” under certain conditions and demands that these
cases “should subsequently be made the object of research, designed to evaluate its
safety and efficacy”. This is exactly what needs to be done now. All of these norms
are valid and applicable to the global crisis of Ebola. Allow me to reiterate: The case
of Ebola illustrates just how appropriate the ethical principles of the Declaration are.
We do not need a new ethics but ethically well founded and courageous decisions.
Ebola won’t be the last crisis the medical world is confronted with. It would not be
realistic to assume that research ethics will not be demanding in the future. But there
are good reasons as well that the declaration will meet the challenge. In the past 50
years it was well maintained, and the proud owner – the WMA – is willing to continue
to maintain the document. It has always been a document that is up to date – and I
am optimistic it will be in the future.
The frequency of the revisions has been questioned. And of course; this is a
discussable topic. However, the main question is not how often the declaration
should be revised. This is a second order question. The primary question to be
answered is: How does it keep providing the ethical principles for research involving
human subjects in the face of rapid developments in science and society? And after
answering this question the frequency of revisions can be determined. On the one
hand the frequency should be low; on the other hand it must be an appropriate
frequency to keep up with scientific and ethical progress.
As long as the declaration remains the most important answer to one of the
fundamental challenges of modern medicine I have no doubt that there will be good
reasons to meet again in 10, 25, in 50 years for the next anniversaries. And where
should a meeting take place? There is no doubt: In the city, where it started, where
the original version was adopted. James Bond, the famous British secret agent would
answer the question very briefly: “In Helsinki, where else?”