Article Appraisal: Assignment
Answer 1: The ethical principles described in the Belmont Report which were violated in the study included lack of respect for people (since individuals with diminished autonomy like the slaves were not entitled to protection), lack of Beneficence (the individuals portrayed in the studies were not protected against harm rather they were harmed) and lack of justice (treatments were often extended to Whites and African-American population or Blacks were denied appropriate treatment for the purpose of experimentation).
Answer 2: The violation of ethical principles could have been prevented by seeking informed consent from the patients or their families for being included in a clinical trial, the patients and their families should be transparently and comprehensively briefed about the pros or cons in participating in such experimentation or trial, the benefits and risks of including a patient should be evaluated before including an individual in a clinical trial and finally, every patient should be fairly treated for the intervention protocol. This means individuals belonging to low socio-economic status or racially deprived must get equal opportunity for being selected in an experimental study.
Answer 3: The subjects who were included in the experimental trials were certainly vulnerable. For instance, in Dr. James Sim’s experimentation, her slave Anarcha was repeatedly used for experimentation in spite of her health conditions. She was suffering from the vaginal infection and still she was used for experimentation.
Answer4: The Tuskegee study clearly portrayed the racial bias and atrocity in defining the epidemiology of a particular disease. This study was carried out on predominantly African-American population and hence, syphilis was designated as a disease with greater prevalence in such population (since most of the experimentation was carried out African-American population). This finding created social and racial differentiation.
Answer 5: an ethical dilemma, which I have witnessed in my practice settings, is regarding the clinical trials on Cancer patients who are admitted in our health-care setup. I have noticed that patients who provide informed consent for being included in the trial are extended differential treatment. What I mean, that whenever a new cancer drug is tested for its efficacy profile, certain individuals are provided placebo (the cancer medication is not provided), while some cancer patients are treated with the drug. The former group represents the control group while the later group represented the experimental group. I feel that such type of studies should be a cross-over trial and individuals must get a chance to receive the treatment as well as placebo, if at all there is a need for a control group.
Answer 6: Informed consent is an important attribute for any research study. This is because the patient and their family members are made aware regarding the pros and cons of being included in the study. Hence, informed consent is a documentation that the patient or their family members have consciously decided to be included in the study and there no injustice has been done.
Answer 7: Vulnerable populations are such populations who are always at the risk of getting harmed, for being included in a clinical study. For example, cancer patients are often immune-compromised, and if some of them are assigned to the control group, they will not receive any medications. Such research design will lead to chances of increased infection and mortality.
Answer 8: Institutional Review Board is a research and clinical trial sanctioning body for a specific health-care setup or a group of health-care set ups. This board comprises of Physicians, Administrators, Ethical Committee and Patient’s representative for granting the permission for a clinical trial in that health-care setup.
Answer 9: As a registered nurse, I should voice my concern to the nurse manager or the hospital administration whenever the interests of a patient would seem to get compromised for being used as an experimental subject. I would ensure appropriate supportive care, even if the patient has to form a part of the control arm of a clinical trial.
Answer 10: The clinical trial manager is ultimately responsible for maintaining the ethical principles while conducting a research study. This is because such individuals are aware of the study protocol and are apprised of the intermittent data. Hence, they are best suitable to understand the treatment jeopardy that takes place in the certain group of patients under the context of the clinical trial.
Washington, H. (2009).Medical Apartheid: The Dark History of Medical Experimentation
on Black Americans from Colonial Times to the Present. Int. J. Appl. Psychoanal. Studies 6(4), 356–360