History of Research Ethics

The history of research ethics can be divided into a number of periods of time:

1. Pre-1800 

Prior to 1800, when conducting experimentation or research with human

participants (probably better described as "subjects" at the time), there was little
consideration of research ethics, but as the nineteenth century progressed, researchers
began to devote more time to considering the ethical implications of their work.

2. 1800–1939

Dr. Albert Neisser's research in Prussia provided an early illustration of the cycle
of damage. Dr. Neisser injected little quantities of syphilis-infected blood into healthy
people in order to find a syphilis vaccine. They all got syphilis, suffered horribly, and
died. Following public protest, the Prussian government issued the Prussian Directive in
1900, which was the first ethical guideline for researchers, emphasizing the need of
obtaining informed permission. Regrettably, this response to detrimental research had
little effect on the elimination of unethical research.

3. 1939–1947

The events of the third era (1939–1947) were all the more remarkable given the
rising awareness of the relevance of scientific ethics in Central Europe. There are several
well-documented cases of unethical and destructive research that took place in various
places of the world prior to and throughout this time period. The Nuremberg Code,
developed by the attorneys during the Nuremberg Trials and published in 1947, was the
reaction this time, emphasizing the need of seeking "voluntary permission" and avoiding
potential suffering. Unfortunately, the Nuremberg Code was not widely embraced and, as
a result, had little influence on future research ethics.

4. 1947–1964
The World Medical Association was the next to respond, publishing the
Declaration of Helsinki at their meeting in Finland in 1964. The Declaration, which has
since been amended multiple times, is still extensively used today and is routinely
included in clinical trial procedures for new drugs. The Declaration should make it clear
to researchers what is expected of them when recruiting volunteers for their studies.
While the Declaration has had a significant impact, it has not put an end to unethical or
destructive research.

5. 1964–present
The incident at Alder Hey Children's Hospital is one of the most visible cases of
unethical research activity leading in injury in recent years. Many toddlers and newborns
who died and had postmortems had their organs harvested for scientific reasons without
first obtaining informed consent from their parents or guardians between 1988 and 1995.
When this was revealed, often many years after the loss of these children, it caused
parents a great deal of additional anguish and upset.

The events at Alder Hey drew two reactions. First, the Department of Health
released the "Research Governance Framework for Health and Social Care," which
outlined who was responsible for what inside and outside of the research team
(Department of Health, 2001). The Human Tissue Act of 2004, which established a clear
legal framework for the collection, storage, and use of human tissue, was far more
essential. The ethical and legal constraints for utilizing human tissue in research are now
clear to researchers.