By Ryan Pferdehirt, D.Bioethics, HEC-C and Tarris Rosell, DMin, PhD

August 2020

Clinical Research Trial Bioethics Case Study

The patient is a 44-year-old male, suffering from complications from an aggressive form of cancer. The patient’s condition has continued to worsen, with treatments not as effective as expected, and now expectations are low. The patient is non-responsive but does have a completed advance directive, which states that aggressive measures should cease if there is not a high expectation of meaningful recovery. It also lists his wife as surrogate decision maker, which she is doing. The patient is currently on GIP (general in-patient hospice).

It was recently brought to the surrogate decision maker’s attention that there is a new clinical research trial available that the patient would likely qualify for. The research is new, so the short-term and long-term risks and benefits are not fully known. While there is a possibility of improvement for the patient, there is expected to be discomfort and quality of life impacts. It is agreed that the likelihood of full recovery is low. The patient’s attending physician and oncologist agree that the research may be beneficial.

Initially, the patient’s wife agreed but after reflection is now stating that she is not sure if that is the right decision. The advance directive does not outline anything related to research. Since the patient has not expressed anything relating to research either, the patient’s wife is worried whether it is in his best interest and would he have agreed to participate.

The patient’s wife and attending physician are both requesting an ethics review.