Dr. M is the Principal Investigator of a prospective longitudinal study elucidating the transition of minimal cognitive impairment to dementia. The study involves patients aged 60 years and above who are recruited from the hospital’s memory clinic of which Dr. M is the Director.
According to the research protocol, which has been approved by the local institutional ethics review board, prospective participants are referred by clinicians to a research nurse, who provides them with information and takes their consent. Patients are informed that their participation will last for over three years and will involve blood tests and magnetic resonance imaging (MRI) scans: at baseline and annually. The participants are told that these assessments will not be shared with them as the purpose of the research is to generate new knowledge and is not part of their treatment. Consent is retaken before each follow up and may be withdrawn at any time without consequence to the patient’s ongoing clinical treatment. Only patients who are mentally competent are included in the study.
The MRI scans are assessed by a neurologist who is a co-investigator on the project. At a 12-month follow up with one participant, the neurologist notices a small space-occupying lesion. However, he cannot determine its clinical significance without further clinical information and investigations. The research team had not anticipated finding evidence of other serious medical indications and had not asked participants in the consent process if they should be informed of such incidental findings. They debate whether they should break protocol and inform the patient of the lesion. The patient involved is 72 years old.