The question of whether to return incidental findings to research subjects is tricky. If a study team notices, say, an anomaly on a CT scan, or a blood test result indicative of a potential problem, should the participant be told of the finding? The participant’s wishes, and whether anything could be done in response to the finding, are two concepts to consider before deciding whether, and how, to let subjects know about issues that might affect their health.
The decision becomes even murkier when it comes to returning results of genetic analysis. Studies looking at genetic information may find anomalies that put an individual at increased risk for a particular condition. But some patients don’t want to be told of such findings, as described in a recent New York Times piece. The article notes that while some researchers feel obligated to tell participants of such findings, some study subjects feel they have a right not to find out these results.
One anecdote in the article that caught our human-research-protection loving eye is that, in one example given, the consent form described attempts to contact individual subjects in the event something of “high medical importance” was found. However, the study subject quoted reports not having noticed that language in the consent form. This lapse reinforces longstanding concerns about the consent process that subjects may not closely read consent forms or, if they do, they may not retain what the form said.
The article addresses concepts that we in human subject research encounter frequently, such as the difference between treatment and research and respect for persons. You’re encouraged to click the link above and read the whole article.