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Feedback to subjects can be tricky but important
Internet has changed how we see personal data
As Americans become increasingly accustomed to learning more about their own health, it's becoming more common for research participants to expect to learn about their personal results during a study.
"In the genetics domain, we're seeing people getting more interested in getting information about themselves in direct-to-consumer testing," says Stephanie Malia Fullerton, DPhil, an assistant professor in the department of bioethics and humanities at the University of Washington School of Medicine in Seattle, WA.
"I think this is changing people's perceptions about access to their information," Fullerton says. "And with the rise in technology and the Internet, people are far more used to knowing and controlling their personal information."
Online social networking sites also have changed the public's perception of privacy.
"People in their 20s and 30s, who are very involved in social networking, have a very different sense of what they wish to make public or keep private about themselves," Fullerton says. "And they have a better sense about how to control their information."
There are parallels to this in patient care where people now can access their medical records and sometimes even correct them, Fullerton says.
"There is a greater expectation because of the changes in technology that people should be able to correct, access, and edit their medical information," she adds.
Against this backdrop are research and the tradition of keeping individual subject information from the individual subjects.
Some researchers and IRBs take the position that no personal information collected during a research study should be communicated to research subjects. Others say subjects are entitled to this information because it's about them.
"I think there's a middle way, and it's connected to benefits," Fullerton says.
"We have an obligation in the research domain to give people information that is so overwhelmingly important to them that it would be unfair to not communicate that information back," she says. "This is if the information would make a tangible difference in their health care."
However, this does not mean researchers are obligated to return genetic test results to patients or to communicate health issues that would not make a tangible difference in their health care.
"There are certain cases where you have an ethical duty to communicate information back, and you don't want to close that door completely," Fullerton says.
Making common sense of the issue
The key is for IRBs and researchers to use common sense: "If research information potentially could save someone's life, then not communicating it back to them would be untenable," Fullerton says.
For example, if a person is seen at a research visit and the person's blood pressure is dangerously high, then the clinic should refer the person immediately to a doctor or emergency room, she explains.
With genetics research, IRBs will need to consider a different situation. So far, nearly all of the genetic variance associated with disease risk is very common in populations and most only increase a person's lifetime risk of a disease by a very small amount, Fullerton says.
These two features make it difficult for IRBs and investigators to consider giving information back to participants, she adds.
"That information ultimately is not going to make a difference in someone's clinical care, and it's not supplemental to family history information, which is far more relevant than a genotype," she says. "So it's very unclear what to do with that information."
Occasionally there is the rare genetic finding that poses a true ethical dilemma. These are findings that would appear to be important for clinical care, although they are not in the category of life-threatening risk.
For example, a genetic researcher might accidentally discover a person who has a chromosomal abnormality that had not been detected, such as an extra X chromosome, Fullerton suggests.
"They've gone through their whole life believing they're one gender, although the extra X chromosome has various implications," she says. "This is clinically well-defined, and when people are diagnosed with this condition and found during routine clinical care they might be given testosterone supplements."
But this isn't a life-threatening condition, and someone could live a long life undiagnosed.
IRBs might consider making an exception for these types of circumstances and permitting investigators to give participants the results. But there are other ethical issues to consider.
One is that finding out this type of information could be disruptive to a person's identity and emotionally painful to the participant.
"Is this information that we researchers should be communicating back to the person who was identified or not?" Fullerton asks. "I don't know the answer, and so far, no one knows because it's a very difficult question."
Further research should be done to consider this ethical dilemma. Meanwhile, IRBs and investigators should make decisions on a case-by-case basis. If they decide to share sensitive information with participants, they should have a process that will ensure this communication is done appropriately.
"I believe it is inappropriate for IRBs to basically insist that researchers never return anything," Fullerton says. "I think what IRBs should be looking for in protocol applications is some plan from investigators for how they intend to manage clinically actionable, usually incidental research findings."
These plans might include a risk and benefits calculation, anticipation of unusual results, and steps that will be taken if results are to be communicated to research participants. Among these steps are processes for confirming results by a certified lab and referring participants to specialists, she adds.