Lesson 4 – Research involving Human Subjects
Introduction
3 objectives of research involving human subjects:
1- Socially beneficial
Meeting scholarly standards
Benefits outweighing the harm
2- Interests and rig
...
Lesson 4 – Research involving Human Subjects
Introduction
3 objectives of research involving human subjects:
1- Socially beneficial
Meeting scholarly standards
Benefits outweighing the harm
2- Interests and rights of research subjects
Be promoted
Be protected
3- Establishment of trust between the research community and the public
Research involving human subjects:
Often presents minimal risk
Abuses and tragedies are brought to the worlds awareness
o WWII to May 2001
o A healthy volunteer died after inhaling a drug in a United States federally
financed asthma study at Johns Hopkins University
Research involving human subjects must involve more than the researchers
Research Involving Human Subjects
Need to judge:
Which research programs that involve humans should be allowed to proceed/halted
Dignity of human subject must be respected above all values including the potential
benefit of the research to humanity
“subject- centered perspective”
“perspective of the participant” always kept in mind
singularity of the present concrete human person takes precedence over the
plurality of future “humanity” who might benefit from the research
many substantive issues are identified as needing consideration in the ethical deliberation of
research involving human subjects
Key Issues:
consent is informed and voluntary
confidentiality is protected
conflict of interest be guarded against
the scientific method & design is sound
the potential risk does NOT outweigh probably benefit
the goal is suitably worthwhile
research subjects are selected equitably
“vulnerable” subjects are adequately protected
no discrimination involved in choosing subjects
Historical Context
abuse of human research subjects in these cases paved the way to the development
of codes and statements designed to protect human subjects of research
Nuremberg Trials: The Doctors Trial
1946-attrocities committed by German physicians in the name of research were
investigated at War Crimes Tribunal at Nuremberg (“The Doctors Trial”)
Tried for:
participating in the Nazi program to euthanize persons not considered “worthy” to
live
conducting painful & often deadly experiments on thousands of prisoners in
concentration camps without their consent
Experiments divided into 3 categories:
-sixteen doctors were found guilty of “willing participation in the systematic torture, mutilation
& killing of prisoners in experiments
-7 were executed
High altitude:
test when crews of damaged aircrafts could safely parachute
freezing experiments to find an effective treatment for hypothermia
Drug treatments:
developing drugs & treatment for injuries & illnesses
tested immunization compounds & serums for prevention & treatment
o malaria, typhus, tuberculosis, typhoid fever, yellow fever, & infectious
hepatitis
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