Human Subject Research
According to Date (2020), “human research, protection is critical…it is of central importance because we are ethical people, and society has set up regulations to ensure minimum ethical standards in protecting subjects” (pg14). There are various ethical issues surrounding human subject research include beneficence, trust, non- maleficence as well as fidelity, among others; this is because human research is conducted by people, about people, as well as using their data. Ethical issues are an essential element for any research related to a researcher and a subject. Further, it is essential to note that ethical conduct consists of an individual acting in the right spirit. Additionally, human research subjects entail plans and practices with the sole intention of doing good; however, it may be accompanied by various risks; thus, things may go wrong; this may be a result of ethical insensitivity as well as technical errors. In any biomedical research involving human subjects, it is the role of IRB to review as well as monitor the research. It also plays an essential role in protecting the rights as well as the welfare of the human research subject. Further, according to De Winter & Dodou (2017), IRB, it has the authority to approve, require modifications (to secure approval), or disapproval research” (pg7). Helsinki Declaration is one of the most recognized principles in the world’s medical association and can be used to guide research involving human subjects through its discrete policies. The principles include, “The health of my patient will be the first consideration, the physician must promote and safeguard the health and well being and rights of the patients and medical progress is based on research that ultimately must include studies involving human subjects” (Sataloff, 2020). Finally, it is also essential to note that informed consent is a vital part of a clinical trial as it avails the potential participants with the information to enable them to understand the reasons for volunteering.
References
Date, A. S. (2020). HUMAN SUBJECT RESEARCH REVIEW FORM (Doctoral dissertation, NEW JERSEY INSTITUTE OF TECHNOLOGY).
De Winter, J. C., & Dodou, D. (2017). Human Subject Research for Engineers: A Practical Guide. Springer International Publishing.
Sataloff, R. T. (2020). Human Subject Research or Quality Improvement Project?.