Elements of an incidental findings management plan
Questions IRBs should ask
When the answer to the question of "Could there be incidental findings from this study?" is "Yes," experts agree that the protocol should include an incidental findings management plan.
What's in that plan could vary, depending on the type of study involved, and the nature of the findings, says Judy Illes, PhD, an imaging neuroscientist and Canada Research Chair in Neuro-ethics for the National Core for Neuroethics at the University of British Columbia in Vancouver.
"The management plan may rightfully take different courses depending on the nature of the study, the institution, and the access to medical personnel," she says. "There's not just one path, there are multiple morally acceptable trajectories for responding. But those need to be properly articulated both to the institution and to the human subjects."
Michael Hadskis, LLM, assistant professor of law at Dalhousie University, Halifax, Nova Scotia, has studied both the ethical and legal ramifications of incidental findings in MRI research.
He says an appropriate incidental findings management plan should start with the type of abnormalities likely to be uncovered during the study and which would prompt researchers to make a referral to a specialist.
"Some might be very minor, say non-acute sinusitis," he says. "Others might include an aneurysm ready to burst. The IRB needs to be very clear about what kinds of abnormalities will trigger a referral and when to refer."
A Stanford Working Group on Reporting Results of Genetic Research recognizes three categories of findings and makes recommendations for dealing with them. The highest, Category I, would include results that have "high clinical validity and utility," as well as "a high probability and magnitude of harm resulting from not offering the information," and for which "effective preventive measures exist."
The group recommended that those findings should be offered to participants, while findings that fall slightly below that level may or may not, depending upon the circumstances.
Hadskis says an IRB might take issue with the researcher's criteria for referrals.
"If the researcher says, 'We're not going to refer it unless it's an aneurysm that's just about to rupture,' the IRB might say there are less severe conditions that are still important and still might require a referral," he says.
Timing issues: In imaging research, the timing of a referral may be important, since a condition such as an aneurysm would require immediate action. In some cases, Hadskis says, a condition might be immediately apparent even during a screening, but in others, a problem may only show up with closer review days or weeks later.
"The researcher has to be clear as to when they are going to be looking for these issues," Hadskis says. "And when they spot it, how quickly are they going to get it to a radiologist, how quickly is the radiologist going to review it and have the situation addressed, or provide an opinion as to whether it needs more investigation.
"If there's going to be some time lag, let's hear about it."
The introduction of a specialist from outside the research team reviewing a subject's scan requires the express consent of the participant, Hadskis says. He says the researcher should ask for that permission in the initial informed consent, even though identifying information would be removed from a suspicious scan before it is shown to a specialist.
If the specialist who reviews the scan discovers that is it indeed a valid medical finding, or that follow-up steps need to be taken to determine if it is, then the researchers need to have a plan in place for how to communicate that to a participant.
There are various means of doing so, all of which have advantages and disadvantages.
Because the finding is incidental to the study, the researcher is unlikely to be an expert in the subject's condition and may not be able to answer important questions about it. The researcher also may not have a long-standing relationship with the patient.
Hadskis says the specialist who confirmed the finding would be the most knowledgeable, but he says in his experience, some are not as good at communicating face-to-face with patients.
A family physician would have an existing relationship with the subject, but perhaps not the expertise to answer questions. In the case of either the specialist or family physician, the subject would have to give permission beforehand for research results to be shared.
"The IRB has to consider who's going to give this information, when and how, and in what context," he says. "It's very fact-specific. It will all depend on the circumstances."
On the other hand, Susan M. Wolf, JD, a professor of law, medicine and public policy at the Center for Bioethics, University of Minnesota, Minneapolis, recommends that results always be given directly to the subject by a member of the research team. She argues that the research participant alone should decide whom to tell about his or her findings.
When a finding suggests that there need to be further tests or scans, who should pay for them?
While it's not the responsibility of researchers to pay for extra testing, they should be ready to advise subjects who lack health insurance as to where they might go for help, Wolf says.
Informed consent: Hadskis says the entire pathway for handling incidental findings should be outlined in the informed consent document, so a participant knows exactly what would happen and who would be consulted if a finding turned up.
The consent should include the possible risks of an incidental finding (the physical risks of follow-up procedures, the psychological risks of learning about a potential problem, and the financial risks of learning about a serious ailment) as well as asking permission for any outside review of the subject's data. Doing this beforehand minimizes the stress a subject could encounter having to give permission at every step, Hadskis says.
"If you waited until there was something suspicious and then contacted the participant asking, do you consent to the [specialist] referral — now you're going to stress them out," he says.
Hadskis says outlining this process will inevitably add length to the consent document.
"My position is you don't need to scare them away — I'm happy for the language to be clear that it's a very remote possibility," Hadskis says. "But we have to inform them.
"Unfortunately, now your informed consent form is longer and, if not drafted properly, more complex. But it doesn't have to be particularly complex."
Wolf says that in the case of genetic or genomic research, the management plan also should include a process by which the researcher can talk to participants to see what kind of information they would want to be alerted about, and what they would rather not be told.
"In addition to educating research subjects about the possibility that incidental findings would be found, you should ask them for permission to seek a clinical consult because of HIPAA issues and also to get a sense of what kinds of information they want or don't want."
When the answer to the question of "Could there be incidental findings from this study?" is "Yes," experts agree that the protocol should include an incidental findings management plan.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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