Reporting responsibilities of incidental findings
Pros outweigh the cons
The manner in which investigators, research institutions, and review boards handle incidental findings has evolved in recent years, with a consensus now forming around the belief that research sites have an ethical responsibility when it comes to reporting certain incidental findings to research subjects.
"Things are changing in clinical medicine as well as in research," says John P. Phillips, MD, medical director of the Mind Research Network in Albuquerque, NM. Researchers sometimes encounter incidental findings during neuroimaging research for which it would be unethical to not give the information to research subjects, he notes.
The problem involves the logistics and equity of these reports: How do you report these in a systematic, feasible, and equitable way?
The Mind Research Network (MRN) has developed and recently implemented a process that so far has worked well for investigators and research participants. It involves a template for reporting the incidental findings. It also includes having Phillips handle cases in which findings are abnormal and require a telephone call to a subject before the letter is mailed.
One ethical consideration is deciding what to do if there is an incidental finding that has unclear implications, Phillips says. For example, a scan finding might indicate that a person has white matter disease, but the implication is nebulous, he notes. "We don't know if it harbors multiple sclerosis or if it won't go anywhere," Phillips says. "The research subject who hears these findings has his own understanding, and it's always different from what the researcher understands." Investigators might not know whether to downplay such findings or push for an evaluation, he adds.
As MRN developed this reporting process, ethical implications involving referrals proved to be a hurdle that needed to be overcome, says Jody M. Shoemaker, MS, CIP, CCRP, director of research at the Mind Research Network.
If a participant's letter said that a referral was recommended, although it didn't indicate the referral was urgent, then this situation could fall into a gray area. The participant might experience additional stress or face financial implications if he or she visited a community provider or had another neurological scan as part of a clinical examination. Then it could be the findings indicated nothing more serious than a sinus infection, she explains. "So we put extensive language in the consent form to address this issue," Shoemaker says.
Another risk is that an incidental finding might indicate a serious problem, but the research participant lacks medical insurance that would cover a referral or treatment, Phillips says. "We do everything we can to help them out," he adds. "I have subjects with some follow-up and no financial resources at all, and there are physicians who will treat them for free or they have to negotiate with the university system for a sliding fee scale."
Even with these types of risks from the reporting of incidental findings, there is support in the literature for making these routine, Phillips says. "Secondly, even if an informed consent form says the person won't get the results, the subject expects to be told if there's anything found at all," he adds.
Sometimes an incidental finding that appears to be a great example of why these need to be reported to subjects can prove to be problematic. For instance, Phillips recalls a case in which an incidental finding noted a potential brain tumor. It was clear to Phillips that the research participant needed to see a neurosurgeon and have another brain scan.
However, when he spoke with the participant to relay this news, the person's reaction was unpredictable. "The person said, 'Thank you very much, but I'm going to go on with my life,'" Phillips says. "I felt the person could die from this."
The research participant's sister got involved in the case and had Phillips meet with her and the research participant to discuss it and make certain there was some follow-up. This extra step seemed ethically warranted because the participant's family member provided information that put doubt on the participant's ability to make a fully informed medical decision. But the entire situation highlights how even seemingly black-and-white cases of reporting incidental findings can pose an ethical dilemma.
The MRN reached the decision that the benefits of providing incidental finding reports outweighed the risks, and that consensus in the research world is starting to form around the idea that incidental findings in neuroimaging research must be addressed in some fashion, Phillips says. "My feeling is we owe something to our research subjects," he explains. "They give a lot of themselves to be a part of the study." From an ethical point of view, compassion should be a part of the equation, he adds.
"Researchers have an obligation, just like in clinical medicine, to recognize the power differential between themselves and subjects," Phillips says.