brain injury, consent, surrogate decision-making, autonomy, respect for persons, justice, rehabilitation, clinical trial, inclusion
A 28-year-old man has a traumatic brain injury from a motor vehicle accident that occurred 2 years ago when he was on his way to work. He was treated conservatively, without any neurosurgical interventions, and underwent an inpatient medical rehabilitation program. The man has no other physical impairments and is mostly independent but has residual effects. These include attention deficits, memory impairment, and behavioral changes, such as increased impulsivity, a lack of insight, and poor judgment. Because of these complications, he is unable to return to work as an accountant.
Prior to the accident, the man and his friends lived in a rented apartment in the city. After he lost his job and could not afford to pay rent, he moved back to the suburbs to live with his parents. He does not have a close relationship with his parents because he was raised primarily by his now-late grandparents. Nonetheless, his parents support his participation in a hospital outpatient rehabilitation program.
A team of researchers in the outpatient hospital is conducting a clinical trial on Donepezil, an oral medication that can improve memory impairment in people with neurological conditions, including brain injury. This research will also include the use of functional magnetic resonance imaging (fMRI) and cognitive intervention measures. Under the research protocol, Donepezil is taken daily for 4 weeks. The research participants must be admitted to the hospital on the first day of medication and then subsequently monitored for adverse reactions and undergo fMRI scans. Thereafter, the participants will be required to come to the hospital on a weekly basis for cognitive evaluation.
One of the researchers plans to recruit the man into the study, but because of his memory impairment, the researcher approaches his parents instead. The researcher provides a comprehensive explanation about the study to the man’s parents, including details about participation during the study period and risk and benefits of joining the study. The researcher also informs the man’s parents that the hospital admission and fees for all tests will be covered by the study’s sponsors and that participants who complete the study will be reimbursed for travel expenses. After one of the parents signs the informed consent form, the researchers proceed with the study.
Questions
Ideally, how should the researchers approach the informed consent process, given the man’s cognitive deficits?
Discuss whether it is appropriate to allow the man’s parents to have a major role in deciding on his research involvement. What are some of the challenges associated with this, in relation to the ethical goals of informed consent, and how might they be addressed, if at all?
Aside from respect for autonomy or respect for persons, what other ethics principles are implicated in this case and in what way?
