A paper was submitted that attempted to evaluate a new tool for diagnosing an acute symptom. This symptom is one that could be linked with various medical conditions—some causing little harm and some life threatening. The researchers recruited (and continue to recruit) patients into the study through a website devoted to this symptom. Patients viewing the website are asked if they would like to take part in an online survey. They are then asked to describe their symptoms in detail, and the tool (a computer algorithm) tells them their likely diagnosis. There is no mention of ethics committee approval having been granted in the paper. The website does have a standard disclaimer that patients are asked to sign, which states, among other things that the information contained in the website, and its associated websites, is provided as “a service to the Internet community, and does not constitute medical diagnosis or advice.“ It also states: “You grant us a non-exclusive worldwide royalty-free license to use or exploit in any manner, sell or transfer all data and information provided by you to us so long as such data and information is not identifiable to you.” - Does such a disclaimer constitute sufficiently informed consent?
- The website seems to tap into the problematic area of symptom checkers and diagnosis over the Internet. - Such websites are often used to feed trends and details to background commercial interests. - The people using the tool are often vulnerable with high expectations of these diagnostic tools. - The disclaimer as provided is meaningless—it essentially says that the result is not diagnostic at all. - Despite the claim that no relationship was formed, there is a de facto therapeutic relationship. - The paper indicated that the website was carrying out research on “patients” and so it could be argued that ethics approval should be sought. - The editor should engage the authors in a debate about the fact that there is a de facto relationship that could potentially harm vulnerable people.