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THEO 353L4 - Research involving Human Subjects.

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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 [Show More]

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