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Research a historical experiment that impacted or helped shape the development of ethical codes and regulations.

Discussion #1

Patients in the intensive care unit (ICU) often are unable to give informed consent because of cognitive or physical impairments due to illness, trauma, or sedation.1,2 In such circumstances, a patient’s family member or proxy is asked to serve as a surrogate and provide informed consent on behalf of the patient.3,4 With increasing frequency, surrogates of ICU patients are being asked to provide consent for crucial genomics research (Shelton, 2015). This article addressed computer based teachings on informed consent by these family members. I understand that in the time we live in, it is important to include computer based training based on technological dependence by much of the population. I do see a few issues with this type of teaching, however. First of all, during a very stressful time such as a family member being in the ICU someone like me is not going to have the patience to read through 30 plus slides on a computer that is explaining the consent process. On top of that, if the surrogate is in a very emotional state, which is highly likely in the ICU, patients could read all the slides and either not understand or even remember what they read because they are concerned about their family member. Lastly, if the surrogate is an older family member, they might not want to do anything on a computer. I do believe that the computer based teaching is an important tool to have, but there should always be a trained informed consent specialist that would be able to sit and talk to the patient and answer any questions they may have. I can’t speak for everyone, but being in the medical field I feel research is very important. I would not mind at all if someone studying my medical records could help someone else further down the road as long as confidentiality/ anonymity was maintained.

Discussion #2

Research a historical experiment that impacted or helped shape the development of ethical codes and regulations. Discuss the experiment and discuss the rights violated within the study (if any). Discuss any outcomes or legislature associated with the study. What type of consent would have been needed to make the study ethical and valid?

The Tuskegee Study, an observational study of over 400 sharecroppers withuntreated syphilis, was conducted by the U.S. Public Health Service to documentthe course of the disease in African American males and racial differences in theclinical manifestations of syphilis (Jones, 1981). The study began in 1932 inMacon county, Alabama and its purpose was to document the course of thedisease. Despite the availability of treatment, (initially arsenic and bismuth, thenpenicillin in 1947), the men were not told they had the disease, not givencounseling on the spread of the disease, and not given treatment during the 40 year course of the study (Heller, 1987). At the end of the trial more than 100 menhad passed away to syphillis or related complications. The study ended in 1972, when a front page newspaper article detailed ethical concerns promptingnumerous investigations to review existing federal regulations aimed at theprotection of research subjects. As a result of this unethical study the NationalCommission for the Protection of Human Subjects of Biomedical and BehavioralResearch and the National Research Act were created in 1974 (93rd Congress, 1973). This Act requires the establishment of Institutional Review Boards todetermine if the proposed selection of patients is equitable and to protect therights and welfare of human subjects.

The Tuskegee syphillis study raises a host of moral issues emanating from itsviolation of the ethical principles guiding research involving human subjects. Thisstudy violated major ethical issues including informed consent (the researchesknew that these men were not educated, poorly cared for, with no access tohealthcare and in dire economical conditions), withholding of treatment as well as maleficence and racism (Heintzelman, 1996).


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