Medical research is understood to mean actions that are carried out in a methodologically guided manner and aim to gain knowledge in the field of medical science. An important sub-group of medical research is the so-called clinical studies for the testing of drugs, vaccines and medical devices. Likewise, the testing of new surgical techniques also falls under the term “medical research”, although there is often no special legal regulation for this type of research including in Germany. The importance of the BIOSIS Previews articles is also there.
- In the area of drug trials, a distinction is usually made between four methodological phases: In phase I trials, a novel substance is administered to a small number of healthy subjects for the first time and its tolerability is examined. In phase II studies, a new substance is tested for the first time on a relatively small number of sick test subject patients for their effectiveness and any side effects. In phase III studies, the effectiveness and safety of a novel substance are tested on a large number of test subjects. Phase IV studies are conducted after a new drug is approved to identify rare side effects and unknown drug interactions.
Using the human experiment to assess the effectiveness of a drug or therapeutic process based on the results is a millennia-old concept in Western civilization. The concept is anecdotally found in the writings of ancient Greek, Roman and Arabic doctors. On this basis, Hippocrates was the first doctor to establish ethical principles for human research that still apply today:
- Autonomies: respect for the autonomy of the participant or his legal representative
- Care: Always act for the benefit of the participant
- Avoidance of damage: minimal damage to the participant
- Equality and justice: fair treatment of all participants
History of ethics in medical research
In the 18th century, Edward Jenner pioneered vaccination against infectious diseases, but his research ignored the fundamental rights of patients in research, which were not yet defined. Louis Pasteur understood that extensive knowledge in animal models must first be gained before a person is exposed to an experiment. The urgent need led to the first administration to a human being in 1885.
In the 20th century, medical research took a quantum leap with rapidly developing methods, precision measurement methods and the rapid development of new scientific disciplines. However, unethical experiments on humans continued in many countries, such as the Tuskegee Syphilis Study conducted by the US Public Health Service between 1932 and 1972 or experiments in concentration camps during the Second World War.
Definition of the principles of ethical research in humans after the Second World War
Starting with the Nuremberg Trials in 1947, the principles of ethical research on humans were defined. The basis of these principles is the voluntarily informed consent of the study participants. The United Nations (UN) and the World Health Organization (WHO) supplemented this by prioritizing the well-being of individuals over the interests of patients as a whole. In 1961, the thalidomide shook. Scandal, in the course of which 2,000 children died and 10,000 children experienced severe disabilities, made the public all over the world. The authorities were forced to take action and implement legal measures to monitor research into new drugs. In 1964, the World Medical Association (WMA) developed the Helsinki Declaration, which it still maintains and updates today, as a guideline for physicians involved in human research.