Confronting the Day-to-Day Ethical Challenges of Clinical Research

Mike Donahue, Research Coordinator and Manager, Data and Safety Monitoring Program, University of Washington Medicine

The patient reeked of marijuana at her early-morning clinical appointment, but was otherwise lucid and calm and appeared to be fully comprehending Mike Donahue’s informed consent process. Still, Donahue was nagged by an ethical dilemma. Was the patient in a condition to be responsible for her own actions?

“The easy thing to do would be to not consent her,” says Donahue, a research coordinator and manager for the Data and Safety Monitoring Program in the Clinical Trials Office at University of Washington Medicine. Instead, he elected to go to the patient’s physician and talk the situation through.

“He assured me he’d talked to the patient and that the patient was fully capable of [understanding] the consent” process in question, Donahue says. In fact, the doctor had already gone over the trial parameters with the patient. “He didn’t see any issues” with consenting her into the study. Satisfied, Donahue allowed her to complete the process and join the trial.

While major ethics breaches occasionally hit the national headlines, Donahue says most clinical trial practitioners are far more likely to be confronted with “smaller ethical dilemmas” in their day-to-day conduct of studies. His consent struggle with the aforementioned patient is “the kind of stuff that happens more often” than huge, complex ethical situations, he notes.

“Recruitment can be really tough,” Donahue adds, and consenting patients are to be highly valued. In such conditions, clinical trial practitioners can face a lot of pressure to allow someone into a study, but if they don’t feel right about it, they’ve got to have the ethical fortitude to take further action, he says.

Donahue is an advocate of common sense and logic when looking at challenges that may turn out to be relatively small-scale in nature rather than study-enders. “’Ethical’ is such a loaded word” that it sometimes clouds straightforward thinking, he says. It’s important for clinical trial practitioners to “get back to basics” and be prepared to address routine situations with clearheaded procedures and judgement, he explains.

Author: Michael Causey