Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

The Declaration of Helsinki and its Revisions – A Mirror of the History of Ethical and Social Debates in Clinical Research

Annette Kiesewetter (Abschlußjahr: 2010)

"I swear (...) that I will fulfil according to my ability and judgement this oath and this covenant:(...) Whatever houses I may visit, I will come for the benefit of the sick, remaining free of all intentional injustice (...)". (Hippocratic Oath, classical version)

For more than 2000 years medical students take the Hippocratic Oath after finishing their medical education, just before starting their professional medical career, committing themselves to practice medical art according to ethical principles. The idealistic image of a trustworthy and competent doctor, respectful to the patients, dedicated to cure the sick nether minding their social status nor ethnical background, promote a very special doctor-patient-relationship of trust, which is the basis for a successful therapy. Against this background considerations concerning ethical principles for doctors are debated since the ancient world when medicine developed as a science.

Visions on ethics depend on a variety of factors like the idea of man, cultural influences, education, social system or religious values, etc. and therefore go under changes. The development of sciences goes along with the development of new methods, establishes new disciplines and opens up new dimensions of research with all its promising possibilities and challenges. Challenges also for every set of ethical principles which therefore has to be reviewed regularly.

Today's ethical codices for medical practice and medical research have their roots in a century-old tradition of ethical and societal discussions on ethical behaviour in medicine. Thus the first part of this paper pictures the evolution of ethical principles in medicine over the last centuries. Using the example of the Declaration of Helsinki of 1964, the second part of this paper will show the necessity of regular revisions of ethical principles according to changing ethical values and altering challenges caused by scientific progress and depicts the difficulties of integrating different ethical visions in one code with worldwide extend of validity.

Pages: 32
Annexes: 2