Epidemiology Project prizes confidentiality
By Jeff Hansel
Post-Bulletin, Rochester MN
The Rochester Epidemiology Project doesn’t study you. Instead, REP researchers study illnesses in all of Olmsted County.
Nobody scurries down the hall to grab your personal medical records to review every nuance of your private medical history.
Instead, segments of the county’s population are studied as a whole, based on research hypotheses. Researchers look for, say, broken hips that occur during a specific time frame, from 2001 to 2005 perhaps — or 1960 to 1990.
Records of almost all county residents have been preserved by almost all local providers, going back for decades.
"Much of what is known about the epidemiology of neurologic diseases in particular can be traced to the Rochester Epidemiology Project, inasmuch as many of the initial studies were performed in Rochester," says a 1996 article in Mayo Clinic Proceedings.
Protecting the privacy of patients is paramount. The records get stored within locked rooms with video surveillance, REP officials say. Every time access to stored records occurs, the researcher must sign in and out to document the researcher’s presence.
To gain approval for a study, a researcher first asks permission of the institutional review boards of Olmsted Medical Center and Mayo Clinic. Approved studies have rigid inclusion and exclusion criteria so that only data pertinent to the study gets included. That means researchers are only allowed to look at records that fit the study. Data outside the age range or date of diagnosis does not become part of the study.
"If you give permission for your information to be used for research, your data automatically becomes part of the REP, and you allow medical scientists to use your medical information to conduct research without any additional demand on your time," says a REP pamphlet.
More than 95 percent of Olmsted County resident have given signed authorization for data from their medical record to be used in research studies.
"We love it when they give people their right of consent, which we think is a basic right," said Twila Brase, president of the Citizens’ Council on Health Care, a Minnesota organization that supports "patient and doctor freedom, medical innovation and the right to a confidential doctor-patient relationship."
But Brase said potential study participants always should ask what risks are brought by participation.
"I think what people have to realize is that research in and of itself can be considered good — or not good — depending on the project, and the person’s perspective of the project," she said.
Confidentiality can be promised today, Brase said. But can it be promised tomorrow?
For its part, the REP cites its 42-year history of patient confidentiality.
The REP researchers include social workers and physicians, in addition to nurses, said Dr. Barbara Yawn, co-director of the REP. Each is legally barred by federal law from sharing private patient information.
The vast majority of medical events in the county for the past 42 years has become part of the database, and the project’s electronic "records-linkage system" has been key for researchers. It collects, archives, codes and retrieves "all medical diagnoses and other medical information for a given person over his or her life."
A company like Merck might put out a request for research proposals, or REP researchers might initiate a study.
"There isn’t anyplace else in the United States that can give them medical records on a community basis," said Yawn.
A research team, for example, might hypothetically want to compare 200 people who had a stroke caused by a blood clot between ages 65 and 85 with the general population of the county.
Did the 200, hypothetically, see a foot specialist as a child more often than people in the general population? If so, could that mean that childhood foot problems might predict a higher risk of stroke later in life?
To confirm the recorded stroke, as defined in the study, Epidemiology Project nurses review medical records, searching through thousands of records for specific bits of information. The number of records looked at creates an arduous yet important task for researchers.