Best Practices Spotlight
Site develops incidental findings report model
Protect confidentiality in process
The first step was a mandate by the institution. The Mind Research Network (MRN) requires researchers to report incidental findings to subjects in a systematic way that protects confidentiality and is sensitive to the emotional impact of receiving the news.
The mandate evolved over a year’s period and was fully implemented several years ago, says John P. Phillips, MD, medical director of the Mind Research Network in Albuquerque, NM.
"I just became the medical director in 2006 when we were developing a system about how to look at and classify incidental findings," he recalls.
At first, people focused on reporting significant findings, but then changed the focus to incidental because the same brain scan results could be either significant or not, depending on the patient’s history and background, he explains.
"How do we know if something won’t become significant in the future?" he says. "I thought to be consistent and fair to subjects, the subjects should have an opportunity to decide what they feel about the findings themselves."
The process provides all research participants with results. According to the Mind Research Network’s evaluation of the program, it has resulted in about 8,500 scans with incidental findings from the radiological review process in 34% of these. Of the reviews with incidental findings, nearly one-third needed no referral, and only 0.9% required an urgent or immediate referral.
"Results go to every single person unless they say they don’t want to receive their report," says Jody M. Shoemaker, MS, CIP, CCRP, director of research at the Mind Research Network.
"Participants usually are eager and appreciative to receive their radiology review," she adds. "The report will say any of these: no abnormal findings, no referral necessary, routine referral, urgent referral, or immediate referral."
Each letter sent to participants includes a comments section that explains details about the nature of the finding. And they can request a copy of their brain scan to take to their community providers. The research site’s IRB approved the language in the letters, making certain subjects wouldn’t be confused, thinking this was a full clinical scan instead of a research scan, Phillips notes.
"MRN drafted the consent language in conjunction with the IRB," Shoemaker says. "We have standardized informed consent language for anyone using our facility as we want consistency across the studies."
The Mind Research Network has built HIPAA-compliant database that generates a random number to assign to each scan before they’re reviewed by a radiologist, she adds.
"Then an email is sent with the coded number to the investigator and coordinator on the study, and a hard copy is generated and mailed to the participant," she explains.
The reviews are sealed with a sticker that says "radiology review." If the review has no abnormal findings, it’s mailed to the participant as is. If there is an abnormal finding, then it’s forwarded to Phillips who contacts the subject by phone before the letter is mailed, Shoemaker says.
The research site tested the process for quality, and has addressed concerns from investigators and other research staff.
Phillips met with principal investigators to hear their suggestions and to answer their concerns.
"Some were uncomfortable with this and needed a little time to feel like this was an okay thing to proceed with," he says. "They worried that we were causing too much anxiety in subjects."
The system is being tested for use at the University of Colorado in Boulder, Shoemaker notes.
"The systems we put in place could be adopted anywhere," she says. "We’ve created a template, and John will serve that role in contacting participants and investigators."
One logistic that had to be overcome involved the imaging scans. How could these be analyzed and communicated in a way that might be useful for research subjects, but not prohibitively expensive? MRN decided upon a process that costs only $20-$25 per scan.
"We contracted with a licensed radiologist to read our scans," Phillips says. "It started off as a mandate from our external IRB, so if someone had a study where the scans wouldn’t be read, it wouldn’t be approved."
The radiologist’s cost is built into the scan cost and has a set rate that includes paying for Phillips’ time.
Every subject who has neuroimaging results has a radiological review through customized software. It sends an electronic report to the principal investigator and generates a copy for research subjects. If a neuroradiologist determines there’s a need for an urgent or immediate referral, the scan results are brought to Phillips’ attention, and he contacts the subject to explain the results and to arrange follow-up clinical care.
"I offer to take the burden off the principal investigator for all subject contact," Phillips says.
"They don’t have to worry about it, and just have to pay a little more up front," he adds. "It’s a painless system for everyone involved, and it can be easily adopted by other centers."
Phillips calls research participants when the findings appear to be urgent.
"As I follow up on the phone people can be nervous; it’s an anxiety-provoking experience," he says. "People are appreciative to hear the findings even though there might be a time of anxiety."