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Should patient records be used for research?
Ethical debate is about patient privacy
Ethical concerns and privacy regulations make for a more complicated situation when health care researchers desire to view patient records to find potential research subjects.
"The regulations governing access to private information are fairly vague in some ways, especially with respect to research," says Joseph S. Brown, PhD, a professor of psychology and vice chair of the University of Nebraska Medical Center IRB in Omaha, NE. Brown also is the Schumacher Chair of Ethics at the University of Nebraska – Omaha.
"The regulations talk about adequate protection for privacy, but they don't specify what adequate protection would mean," Brown says. "The common practice is to have fairly wide access, respected under HIPAA, but it's not clearly defined."
This results in the ethical perspective that ethics boards should have more oversight over privacy and require greater restrictions on access to medical information, he adds.
For example, a physician who is a partner in a practice that sees diabetic patients might decide to engage in research involving diabetics. The physician investigator needs to know who to approach to ask to be in the study, so how does he or she find out?
An obvious solution is to look through the medical practice's patient files.
"Typically, the IRB would grant access to files of every patient at the practice, but we would find that to be an overexpansion of access because damage could be done to patients when more people know about their condition," Brown says.
This ethical perspective is that no harm is done if the person looking through the patient files is the patients' physician. The patients' own physician would already have access to these files and could use these to recall particulars of patients' medical histories. Then he or she could contact patients to see if they would be interested in participating in a research study or at least allowing an investigator to review their files to see if they might meet the study's criteria, he explains.
"I think most hospitals and IRBs would extend access to files to a physician's partner because this second doctor has the potential of caring for the patient," Brown says. "But we argue the potential to look in files is not the same as looking in files."
Once the partner looks in the files there is no expansion of privacy rights that would make it ethically palatable for the physician partner to approach these patients to ask if they would like to be in a research study, he explains.
"It's different if the doctor who is taking care of them looks at the file," he says. "There are confidentiality issues, but no privacy issues here, and we draw distinction between those two cases."
But if the patients' physician's partner is the one who is looking at the files without their knowledge, then there are potential harms, Brown says.
"The physician might see the file of his or her next-door neighbor or child's teacher," he says. "In general, we believe it's best if patients believe their data are held privately and only viewed when they are sick."
If patients believed their private medical records could be viewed without their permission by researchers or other individuals, then they might be less willing to divulge some types of information, and this could negatively impact their health care, he adds.
"This is a controversial proposal, and plenty of people would disagree with our analysis," Brown says.
There are other ways to conduct research involving screening medical files without infringing on patients' privacy rights, he notes.
One strategy would be for investigators to ask physicians to approach their own patients and ask if it's all right if the investigator looks at their medical files to see if they're eligible for a study, he suggests.
Or, hospitals and physician practices could create a blanket permission form that asks if patients would allow their records to be accessed by other health care or research professionals solely for screening purposes.
"You could ask patients in the hospital if it's okay if they're screened, and the hospital intake could include asking them explicitly for permission," Brown says.
Researchers do have the option of reviewing medical data that contains no identifiers, which eliminates the privacy concerns.
"One alternative of last resort is to consider an institutional review board or privacy board offering a waiver of consent," Brown says. "This is done under narrow circumstances if risk is minimal and if according to another portion of regulations subjects' rights won't be seriously compromised."
Another option would be to sift through electronic medical files in which patient identifiers are encrypted and the key is available only to patients' providers. In this scenario, the investigator might find out that a particular hospital or physician's practice has X number of patients diagnosed with diabetes. Then it would be up to the investigator to ask the provider to contact these patients and inquire if they would be open to sharing their medical files with a researcher for the purpose of seeing if they would be eligible for a particular study.
If this electronic screening method were used to send out generic letters to people, there are ethical concerns that go beyond privacy issues, Brown says.
"There might be concerns on the part of the hospital or practice ethics board if patients were receiving solicitations to be in research based on private health information," he says. "Their perception might be: 'Who are you? Why are you contacting me, and how do you know this about me?"
Many hospitals might require that before a patient can be asked to participate in a study that his or her primary physician is consulted.
Sometimes researchers use the strategy of sending a study recruiter to a hospital emergency department to sit and wait for patients meeting a specific disease criteria to come through the ED doors. The recruiter would have asked intake staff to see if these patients would be all right with having a researcher approach them to talk about the study.
In this scenario, the patients have the right to say, "No," and so their privacy rights are protected, Brown says.