The Ethically Required Level of Mental Capacity Needed for Consent to Participate in Clinical Research on the Terminally Ill
Manduca-Barone, Alessandro Angelo
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While medical informed consent documents have received much attention in literature and throughout varying North American legal jurisdictions, the competence needed to be able to provide informed consent is often overlooked. This is especially apparent in the medical research field where clinical trials are done with terminally ill human subjects. However, analyzing competence is crucial for the protection of subjects’ autonomy. If informed consent is to be truly considered an expression of autonomous action, then it is necessary that the decision-maker be sufficiently competent to provide that informed consent. Given the vital role that competence plays in proper autonomous decision-making, the following will first engage in an examination of the concept of competence and second the requisite competence needed for terminally ill subjects to be able to provide informed consent to research participation. Since there is still some disagreement regarding the components of competence, first a proper description of competence will be provided. This will involve depicting competence as being comprised of four sub-abilities, specifically understanding, appreciation, reasoning, and voluntariness. With the proper depiction of competence, the remainder of this work will contend that current approaches to determine competency requirements are flawed, that the medical research context ought to require more stringent competency requirements than the medical practice context for the terminally ill, and that a Subject Rights Advocate (SRA), unaffiliated with the research study, should be employed to bolster/enhance and evaluate the competence of terminally ill potential subjects, as well as solicit the final informed consent. It will additionally be argued that the method the SRA ought to use in achieving such aims should be based on a conversational approach.