Walterboro South Carolina
Jaime E. Davis-Nash (J.D.)
The article, a review of “Ethical and legal issues in research involving human subjects: do you want a piece of me” (2006), is about the legal aspects, and ethical concerns, in regards to clinical trial participants’ dignity and privacy. The author’s abstract raises the question of how “These ethical concerns have been translated into a complex regulatory apparatus in the USA, containing specific legal provisions concerning such matters as participant safety, informed consent, and confidentiality.” Since future research may affect participants in a negative way, clearly defined parameter need to be set in place prior to such studies. Morally and ethically, researchers should feel obliged to attend to whatever needs arise from the study. Biomedical researchers gather data to analyze and come to a generalisable conclusion. These conclusions aid, hopefully, in the improvement of medical advances for future generations. Participants are needed to obtain this data. However, because biomedical research is not for the immediate benefit of the participant, other factors come into play. Participant and investigator trust, privacy issues, beneficence, personal dignity, among other ethical issues that may arise from the study. Human study, addressed by an extensive regulatory structure, developed "by the federal Department of Health and Human Services (DHHS)," to govern biomedical research conduct. Institutional Review Boards (IRB) must review and approve the initial research. Additionally, continued oversight and annual research activity reapproval are also part of the process. Each study must ensure minimization of all physical and psychological risks. Things like reasonable benefit, risks equitable subject selection, informed consent, purpose, compensation, duration, and nature of research, and experiments. Tissue study helps researchers gain insight on...