- Clinical Commentary
Regarding the question of whether to disclose the incidental finding or not to the 72-year-old subject, one needs to consider several issues pertaining to the elderly subject, investigator team, informed consent process, illness under examination and wider societal and cultural context. First, in terms of the subject, would keeping the incidental finding secret in the context of the informed consent be respectful of the wishes of the subject? One needs to bear in mind that consent was taken with the understanding that assessments will not be further shared with the subject as the assessments were done in the research study to generate new data and were not part of clinical evaluation or treatment. In one sense, autonomy of the subject in agreeing and consenting to the study investigations must be respected and the subject is comfortable that no results of the extensive assessments (blood tests and brain scans which are performed at baseline and annually for three years prospectively) will be proffered in the course of the project. At a more personal level, it may also be that the subject prefers not to know of any incidental findings even if present, which in some cases may be related to cultural notions of abnormal findings and ill health.
Second, from the standpoint of the research team, would awareness of the space-occupying lesion but not informing the subject constitute a breach of ethical principles of beneficence and non maleficence? When the subject is enrolled in a research study, it is understood that the balance between research risks and benefits should have been evaluated in favour of the latter. Although more needs to be clarified to determine the clinical significance of the lesion, there is a possibility that the lesion may be malignant which would pose [End Page 289] further challenges. If the lesion is detected early, there may be a likelihood of early intervention, including surgical or non-surgical options. If the lesion of undetermined stage at present is not treated expediently and expeditiously, is there a possibility of it progressing to a stage when delayed treatment may be less effective? In this aspect, the welfare of the subject needs to be kept in mind. Even if nondisclosure is opted, is it just to allow the subject to continue in the longitudinal study if the small intracerebral lesion turns out to be malignant or that treatment may be rendered less effective over time?
Third, with regard to the informed consent procedure, does the patient fully appreciate the details and implications of the study including not sharing laboratory or neuroimaging evaluations? For the process of informed consent to be meaningful, there are three elements that need to be present, namely adequate and appropriate disclosure of details about the study, demonstration of understanding of the information presented, as well as voluntariness in participation. Pertaining to adequate disclosure, was there appropriate disclosure and discussion of some of the key aspects of the study, including prospective nature lasting three years, repeated measurements and no sharing of details of assessments? The subject needs to have an appreciation of the impact of the information beyond intellectual comprehension. Was he or she cognisant of the number of visits over the entire course of the study as well as the amount of time involved for each visit? What was the response of the subject when it was made known that additional information obtained from the study evaluations will not be revealed or disclosed?
Factors that may influence the understanding in this case include older age with possible easier fatigability and shorter attention span, severity of illness with related level of cognitive impairment, educational level, and familiarity with research procedures, all of which are unclear in this case at this point. With respect to voluntariness, was there any undue coercion or influence that may compromise the respect for autonomy of the research subject? It is noteworthy that the team has painstakingly committed to retake the consent before each follow up (thrice over three years) and that the subject can withdraw from the participation in the study at any point in time. Were there factors that may affect the willingness of the subject...