The SRA Symposium - College of Medicine

Papers
The pastor of the Bergen hospital complained to the authorities who eventually held a criminal
hearing and found Hansen “guilty of trespass against a patient, ordering him to forfeit his hospital
post and to pay costs,” (Lock 1995). Of course, there is a bit more to this story than outlined here,
but this is nevertheless an example of what is possibly the first expression of true public (rather
than professional practitioner’s) concern for humans who are research subjects—a concern that
would ultimately lead to the federal regulations we follow today.
The issue of patient consent received attention from the Prussian government at the turn of the
nineteenth century. In 1891, prisoners could not be treated with tuberculin for tuberculosis
without their consent. A few years later (1898), Dr. Albert Neisser, a professor of dermatology and
venereology at the University of Breslau, failed to obtain consent from prostitutes admitted to the
hospital for other ailments for experiments with a syphilis vaccination.. The Royal Disciplinary
Court fined Neisser for failing to obtain consent from the women. (Vollmann and Winau, 1996)
This incident contributed directly to the Minister for Religious, Educational and Medical Affairs’
1900 directive that patients in clinics and hospitals receive “proper explanation of the possible
negative consequences” and give “unambiguous consent” for any medical intervention that was
not specifically for diagnosis, treatment or immunization (Evans and Beck 2002). This was the first
regulation to deal with nontherapeutic research on living humans (Vollmann and Winau, 1996).
In Russia at the same time, Dr. D. V. Dmitriev created a comprehensive informed consent document
for a volunteer donating a portion of his thyroid for transplantation. This document has all
the elements required today: explanation, risks, benefit, voluntariness, cost, procedures. It was evidently
commonplace for individuals to sell body parts and tissue for transplantation and experimentation.
Kubar comments that Dmitriev’s statement indicates that the issue of clear explanation
of procedures and their consequences had been raised in Russia and also that medical experiments
were considered in the context of criminal and civil law. Other issues of human experimentation
were considered under public morality.
First in the U.S. and then in England in 1907, William Osler advocated what we now call informed
consent and was of the opinion that any experiments with possible “ill-result” was “always immoral
without a definite specific statement from the individual himself, with a full knowledge of
the circumstance,.” (Evans and Beck, 2002).
Russia required patient consent for surgery by a law passed in December 1924. Taking its lead
from this statute, in 1936 the Scientific Medical Council of the People’s Commissariat of Health
Care of the RSFSR adopted regulations governing the development of new drugs and procedures
with human research subjects. This was the first law regulating biomedical research in Russia.
Although it did consider several concerns present in modern regulations (risk, harm, consent and
assent, prior animal studies), it did not encompass the idea of independent ethics boards (Kubar,
2001).
The Health Department of the German Reich, in 1931, passed a regulation prohibiting experiments
with humans unless thorough animal tests had been completed and unless the human
subjects had given “clear and undebatable” consent. Vollman and Winau note particularly that this
regulation was based on the principles of beneficence, nonmaleficence, patient autonomy, and a legal
doctrine of informed consent. Moreover, it made specific distinction between therapeutic and
nontherapeutic research. This regulation remained in effect throughout World War II, although
the German definition of “human” underwent a change. Ironically, almost concurrently, a 1933
Reich law prohibited the use of animals for medical experimentation.
200 2005 Symposium Proceedings Book