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¶ … Consent Process
Following a number of high-profile abuses of patients in experiments during the early 20th century, the need for an informed consent process became apparent. To determine the current state of affairs with this process, this paper reviews the relevant literature to explain the key issues and concerns for obtaining informed consent from study subjects and how this process reflects the code of conduct set forth in Section 4.8 of the International Congress of Harmonization (ICH) "Guideline for Good Clinical Practice E6(R1)." Finally, a summary of the research and important findings concerning these key issues and concerns are presented in the conclusion.
The straightforward definition provided by Black's Law Dictionary states that informed consent is "a person's agreement to allow something to happen that is based on a full disclosure of facts needed to make the decision intelligently" (1990, p. 779). In 1964, the initial guideline for conducting clinical trials and for the provision of protections of human subjects was published in the Declaration of Helsinki that stipulated the fundamental requirement for patient protection and the centrality of human subjects' welfare over all other considerations in the conduct of clinical trials (Bloswick & Skowron, 2015). In addition, the Declaration of Helsinki...
Moreover, informed consent provisions must be rigorously updated to ensure that all human subjects are provided with the most up-to-date guidance concerning the implications of their participation in a clinical trial (Guideline for good clinical practice, 1996). This requirement is congruent with the guidance provided by Saks and Golshan (2013) who advise, "By speaking of 'an' informed consent, we do not mean to imply that this is something done only at the beginning of the process. In a 'process view' of an informed consent, an informed consent unfolds over time" (p. 2).
In addition, it is also important to assure that human subjects are not subjected to undue pressure or coercion to obtain their informed consent for participation in clinical trials and that they understand they can terminate their…
References
Black's law dictionary. (1990). St. Paul, MN: West Publishing Co.
Bloswick, A. & Skowron, H. A. (2015, Spring). Informed consent documentation in pharmaceutical industry-sponsored clinical trials. Ethics & Medicine, 31(1), 51-55.
Guideline for good clinical practice E6(R1). (1996, June 10). International Congress of Harmonization (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. Retrieved from http://www.ich.org/fileadmin/Public_Web_Site / ICH_Products/Guidelines/Efficacy/E6/E6_R1_Guideline.pdf.
Jhanwar, V. & Bishnoi, R. (2010, January-June). Comprehensibility of translated informed consent documents used in clinical research in psychiatry. Indian Journal of Psychological Medicine, 32(11), 7.
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