1. Experiments with human beings in clinical trials has a large effect on ethics.
a) Placebo effect: if have disease with a reasonably acceptable treatment, but someone says they have a better treatment. One study would give new treatment to one group and a placebo to the other group to determine the quantitative value of the new treatment. Ethicists say that is improper b/c one group isn’t getting treatment. Instead, they say you should give new treatment to one group and old treatment to second group and see if new treatment works better.
b) The purpose of the study is to find out risks, so it may be difficult to evaluate the risks and benefits when you don’t know what they are.
c) National Research Act of 1974 required HEW to write rules and regulations governing clinical research in US. The legislation created the institutional review board, made NIH funding contingent on request of IRB, quickly resulting in requirement of journals by author’s stipulation in manuscripts that IRB reviewed the research as it unfolded.
d) Informed Consent: there is more need to counsel the patient as to the risks, etc and what is known in the standard practice. FDA has taken this aspect of research (informed consent) to task.
e) Federal government has sanctioned and removed federal funding in some cases.
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