research ethics 2 - PHL116 Bioethics Research Ethics 2 I....

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PHL116 Bioethics Research Ethics 2 I. Background One criticism of clinical trials in the US is that they do not include an adequate representation of the population for whom the therapies/drugs under study are being developed. This is clearly problematic because the drugs may pose different kinds of risks for the underrepresented population and information about that should be gained before the drug is distributed to these persons to prevent harm. However, the problem is that underrepresented populations are typically oppressed populations, or populations of persons who have been the target of discrimination, and so including members of these populations while upholding the three conditions of autonomy (non-coercion, effective deliberation and liberty of action) via adequate standards of informed consent, and ensuring that harm does not come to these populations because of past discrimination is a difficult matter. Each of the authors in this section has a different response to these issues. II. Abbreviated History of Codes and Federal Regulations on Research Involving Human Subjects from Munson Book (1) Nuremberg Code (1949) – in Munson book—specifies ethical standards of informed consent for experimentation with human subjects. (2) Belmont Report (1979) – again, specifies ethical standards of informed consent and for equitable research with human subjects. (3) NIH and the Alcohol, Drug Abuse and Mental Health Administration (1990) directed that minorities and women be included in study populations. (4) Clinton (1997) - In 1997, Clinton endorsed a stringent set of policies governing all federally funded human research, which required that: 1.) an explicit informed consent be given 2.) the sponsor of experiment be identified to the subject 3.) the subject be told whether experiment is classified 4.) permanent records of the experiment and subjects must be kept 5.) an external review be conducted before the experiment can proceed III. Tuskegee Syphillis Experiment: Macon County, Alabama (1930- 399 Black men diagnosed with syphilis 201 Black men free of the disease Subjects were given a diagnosis of “bad blood” and were treated with placebos. Term could have meant anything from sickle cell disease to an iron deficiency to syphilis. They were never given anything more than placebos. This was seen as important because blacks were shown to be no better at tolerating syphilis. Results were published in peer reviewed medical journals like JAMA. Because they were experiemental subjects, they were not subject to laws that required them to be treated. In the 1940’s, when penicillin became available, they withheld it from study participants. Experimenters conducting the Tuskeegee study failed to see relevance of Nuremberg code 1947 to their research.
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Stages of Syphilis Primary Stage The primary stage of syphilis is usually marked by the appearance of a single sore (called a chancre), but there may be multiple sores. The time between infection with syphilis and the start of the first symptom can
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research ethics 2 - PHL116 Bioethics Research Ethics 2 I....

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