The Importance of Informed Consent

¶ … 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 established the first provisions for obtaining formal informed consent from human subjects prior to their participation in clinical trials (Bloswick & Skowron, 2015).

According to Section 4.8 of the International Congress of Harmonization's "Guideline for Good Clinical Practice," the autonomy, dignity, and the right to self-determination of human subjects participating in clinical trials is of paramount importance, and all relevant protocols and controlling legislation for obtaining informed consent must be followed. 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 participation at any time without any repercussions (Bloswick & Skowron, 2015). This point is also made in Section 4.8.3 wherein it is stated: "Neither the investigator, nor the trial staff, should coerce or unduly influence a subject to participate or to continue to participate in a trial." Finally, it is vitally important to ensure that all human subjects recruited for participation in clinical trial are provided with information about the clinical trial in their native language (Jhanwar & Bishnoi, 2010) and that they are provided with sufficient time to weigh the implications of their participation prior to obtaining their informed consent (Guideline for good clinical practice, 1996).