An additional ethical consideration falls under the modified informed consent plan listed in this grant. According to the grant, those consenting patients who are assigned to the intervention group “ may choose standard consultation as a real option” . This statement seems nonsensical given the proposed methodology. Once the interview has been conducted and the therapist provided with the results of the interview, the information cannot be rescinded. It would become unethical for the practitioner to ignore the preferences stated by the patient during the interview. While the patients can withdraw consent for further participation in the study and for the use of their data, the effect of the study would already have occurred and could not be removed.
Their care would be altered regardless of their final consent. Another major assumption of this grant is that a “ normal consultation” , as it is described in this study, does not allow for patient choice. The converse to the ethical guidelines of best interest described above is the responsibility of a medical practitioner to respect the treatment wishes of a patient as long as that patient is capable of making autonomous decisions (Slowther, 2010; Appelbaum & Grisso, 1988).
Any ethical consultation thus must include a discussion of the patient's choice in their treatment. This represents a major flaw in the methodology of the study, as the only true distinction between the study group and the control then becomes that the patient is directly asked to provide an opinion during the pre-consult interview. The possibility exists that a patient-directed practice will already include such direct questions as a matter of course! This issue would potentially invalidate the results of the study since in this case there would be no actual “ intervention” being performed on the intervention group.
Unless the consultation is being observed by the researchers, which carries with it its own ethical implications for patient privacy, it would become impossible to separate the situations of patient choice from the consultations where the patient simply accepts the base recommendation of the therapist.
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