It’s the responsibility of the IRB to analyze and approve the clinical trials proposed by the research companies through carrying out investigations on the study sites to check whether they comply with the regulations of human safety and welfare of the research subjects. In any human research, application to the FDA has to be made first so that reviews and investigations are done to validate the research and ensure that regulations are followed to the latter.
Human subjects or rather participants vary greatly ranging from those are health either first timers or who have participated before and who are volunteering as self-sacrifice to promote medical discoveries, those who are ill patients and are desperately in need of cure, and those who are motivated to participate due to the financial incentives offered. The sponsor has to inform the volunteers about the study, the expected outcomes and if there is a possibility of side effects he/she has to tell them. Thus in the event that the sponsor has neglected to tell the volunteers about the medications side effects, they are liable to punishment by the low since that is exposing human beings to risks without informing them first. Most of them argue out that it is impossible to detect or determine the expected outcome of the trial but they are supposed to do deeper research about the drug before subjecting it to human trials (McCullough & Chervenak (2011)).
For instance in the recent years there has been a drug-testing scandal that involved the department of veteran affairs as they were accused of administering drugs on war veterans who served the Iraq and Afghanistan warfare. There was a national outcry by even the media condemning the VA of using war veterans as guinea pigs in their post-traumatic stress studies. The VA had prior knowledge that the drug known as chantix had harsh probable side effects and they still continued administering it to the military veterans. The FDA linked several suicidal cases to the uptake of the drug and the most serious issue is that even the VA did not even inform the test subjects the risks or rather the side effects of the drug (no 'disposable heroes' n.d.).
There are many discussions against the use of health volunteers in medical tests as there are many risks involved they are exposed to. I tend to argue out that they shouldn’t be limited in participating since they do this out of their own will and we still need new discoveries and innovations to be made concerning the medical world therefore in fact am for that many people are supposed to be encouraged to participate in these studies so that we continue making legitimate medical discoveries (kolman et al n.d.).
Work cited
(n.d.).No 'disposable heroes'. Washington Times, The (DC). Retrieved may 4, 2012 from
Ellis P.M (n.d.). attitudes towards and participation in randomized clinical trials in oncology: a review of the literature. Kluwer academic publishers, Netherlands. From
Tishler Carl L. and Bartholomae, 2003. Repeat participation among normal health research volunteers: professional guinea pigs in clinical trials?. The johns Hopkins university press, from
(N.d.). Roles and responsibilities of institutions in human subject research. from
Kolman, J. M., Wray, N. P., Ashton, C. M., Wenner, D. M., Jarman, A. F., & Brody, B. A. (2012). Conflicts among Multinational Ethical and Scientific Standards for Clinical Trials of Therapeutic Interventions. Journal Of Law, Medicine & Ethics, 40(1), 99-121. doi:10.1111/j.1748-720X.2012.00649.x
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