Research studies involving humans are done routinely. Most participants have to meet certain criteria, such as age, gender or health history requirements, or the use of certain products or drugs, in order to qualify. In a Mayo Clinic study from 2004, as reported in the Archives of Internal Medicine, radiologists found that 40 percent of the 1,426 participants had some anomaly in their results that was unrelated to the purpose of the study, but which could be characterized as potentially serious.
Normally, whenever there is an abnormal result from a scan or other examination, the patient is instructed to consult with a specialist or urged to get a follow-up examination. In the Mayo Clinic study, only 35 of the over 567 participants who were found to have an abnormality followed up with any clinical action.
The issue of what researchers should do in such circumstances is unclear. It is also unclear if the 40 percent of study subjects were advised of the results and urged to contact their own physicians or even advised of the potential seriousness of these findings.
The participants may have signed waivers regarding any risks involved while in the study, but questions of duty still exist.
Do researchers have a legal duty to advise the participants of the results, especially if they found something that could be life threatening?
Even though the participants are not patients and the researchers have no duty to provide care to them?
Another concern is whether the researcher who reported the findings was even qualified to read something that was unrelated to the purpose of the study, and whether he read its significance accurately. Another fact to consider is that in many of these cases, false-positive findings are common and can lead to costly and unnecessary testing that could, in turn, lead to more risk and potential harm to the individual.
The ethical duty of the researchers should, however, at least lead them to develop a series of guidelines to use whenever medical research is conducted, as recommended by Dr. Bernard Lo of the University of California, San Francisco. There should be established protocol for reading incidental results, responding to them, and deciding whether and which information should be disclosed to the participant. Under such circumstances, ethical dilemmas like this can be minimized.
