Protection of Human Rights in Research

Christodoulou Thekla and Hising Joakim

Bioethics

24/10/2016

Overview

What do we mean by ”protection” and what do we protect?

Historical background

Ethical conflicts within known cases

Discussion points

Protection?

Protection?

•Health

•Scientific design

•Integrity

•Law

•Research

•Susceptibility

Chart flow for History of events:

1939-1945

• Nazi Medical War Crimes: During the Nazi era, experiments were performedon non-consenting subjects.

1946

• Nuremberg Doctors’ Trial: The individuals who conducted Nazi experimentsduring WWII were tried separately from other war criminals because of theirprofessional status as physicians and the horrendous and unique nature oftheir crimes. They were found guilty of “crimes against humanity”.

1947

• Nuremberg code: Nazis physicians are tried at Nuremberg, Germany, forresearch atrocities performed on Prisoners of war. This resulted in theNuremberg Code, the first internationally recognized code of research ethics,issued by the Nazi War Crimes Tribunal.

Nazi Medical War Crimes (1939-1945)

German physicians adopting a “Euthanasia” program: victims deemed of “unworthy of life”

“Medical experiments” performed on thousands of concentration camp prisoners without informant consent

Included deadly studies and tortures, e.g. injecting people with gasoline and live viruses, immersing people in ice water,

forcing people to ingest poisons

As a result, many dead or permanently crippled victims

A victim of a Nazi medical experiment is

immersed in icy water at the Dachau

concentration camp. SS doctor Sigmund

Rascher oversees the experiment.

Germany, 1942.

Nazi physician Carl Clauberg (at left),

who performed medical experiments on

prisoners in Block 10 of the Auschwitz

camp. Poland, between 1941 and 1944.

Unethical and gruesome experiments

Survival of Axis alliance military personnel:

-high altitude experiments

-freezing experiments

Development and testing of

pharmaceuticals for German military/soldiers

in the field:

-immunization experiments

-bone-grafting experiments

-gas experiments

Advance racial and ideological beliefs of the

Nazi worldview:

-serological experiments-sterilization experiments

Nuremberg code (1947): First modern ethical code

Set of research ethics principles for human experimentation

Ethical standard of medical behavior accepted worldwide and established at the Nuremberg trials

Consequence of Nazi crimes of violating human rights during World War II

Free power of choice and sufficient knowledge of the research objectives

Voluntary informed consent

Likelihood of some good resultingScientific Studies

Animal model experimentationBased on prior research

Unnecessary injury and sufferingAvoidance of physical or

psychological harm

Humanitarian importance above anything elseBenefits should outweigh risks

Proper experience of researcherQualified investigators

Freedom of libertyRight to withdraw consent

Research must stop if harm is resultingTermination of studies

Newspaper of The New York Times, October 19,

1945, indicating the beginning of Nuremberg trials

Did things get better after the Nuremberg Trials?

Chart flow for History of events:

1932-1972

• Syphilis Study at Tuskegee: Long-term study of the effects of untreated Syphilis.

1944-1974

• Cold War Human Radiation Experiments, US: More than 400 experiments todetermine the effects of exposure to ionizing radiation on human health or tocalibrate instruments designed to detect radiation.

1946-1956

• Fernald state school, Massachusetts: 19 boys who thought they wereparticipating in a science club were fed radioactive milk by researchers whowanted to learn about the digestive system.

1963

• Jewish Chronic Disease Hospital Study: Studies to develop information about thehuman immune system’s response to cancer.

Jewish Chronic Disease Hospital study (1963)

Studies to develop information on the nature of the human transplant rejection

process

Involved injection of live cancer cells into patients who were hospitalized with

various chronic diseases

Researchers stated that consent was given orally, but not documented:

- Documentation was not necessary

- More dangerous medical procedures are undertaken without the use of consent

forms

- Would scare the patients unreasonably

- Good cause of action

True nature of study: Deceiving and unprofessional conduct from the researchers

Chart flow for History of events:

1964

• Declaration of Helsinki: The WorldMedical Association drafted thefirst international agreementrecommending ethical standardsfor clinical research.

The Belmont report (1979)

Ethical principles and guidelines for the protection of human subjects in research

Consequence of previous human subject violations

• Practice:Outcome: Reasonable expectation of success

• Research:Outcome: Permits a conclusion to be drawn

(A) Defined boundaries between research and

practice

• Respect for Persons: -Having the right to self-govern (autonomy)

-Informed consent

• Beneficence:-Benefits outweigh the risks

• Justice:-Equitable selection of participants-Fairness in distributing benefits

(B) Consists of 3 basic principles

• Serve to preserve the public trust in research

• Protection of human exploitation

• Special protection for most vulnerable (e.g. children, pregnant women, prisoners)

(C) Overall emphasis of the principles

Puffenberger et al 2004

Puffenberger et al 2004

Cases for discussion

A) Case poly-pharmaca:

A medical doctor has observed good treatment effect in two different drugs and wants to try

giving both drugs simultaneously to a group of his patients. However, there is a problem; the

two drugs have never been combined before. Do you think the doctor should be allowed to give

the drug combination to his patients?

B) Modern case: Berlin patient

Timothy Ray Brown, long known only as the "Berlin Patient" had HIV for 12 years before he

became the first person in the world to be cured of the infection following a stem cell transplant

in 2007.