Health, privacy: A tricky balance

Researchers are grappling with the ethical consequences of increasingly expansive genomic sequencing.

by Parker Lemke

Researchers are deciphering increasingly large sections of human genetic code. But along the way, they sometimes discover genes in their subjects that reveal higher risks for illnesses such as cancer.

It has been almost a decade since the debate emerged over whether and how scientists should inform research participants of the results of genomic sequencing, said Susan Wolf, a University of Minnesota law, medicine and public policy professor.

A public summit aimed at exploring the balance between individual privacy and family health risks will bring that conversation to the Humphrey School of Public Affairs on Thursday.

To address the emerging topics of bioethics, experts at the conference will work to develop guidelines for how genomic researchers should impart vital health information to family members of study participants.

As geneticists expand their examination of their subjects’ genetic makeup, they inevitably stumble upon individual traits that are potential health risks, Wolf said, raising questions about whether researchers are obligated to relay those findings to participants and their families.

“If somebody is about to step off a curb in front of a bus, do I have an obligation to pull them back?” said Brian Van Ness, a genetics, cell biology and development professor. “Most people would say, ‘Yeah, you kind of should.’”

But privacy concerns and research confidentiality can muddle those ethical lines, Wolf said.

Family matters

There is a difference between research labs and health care providers, said Bonnie LeRoy, a genetics, cell biology and development professor who directs the University’s genetic counseling graduate program.

“Clinical work and research are not the same things,” she said.

In a clinical setting, she said, an individual patient’s health takes priority, while a researcher’s main obligation is to his or her study and obtaining data to improve medicine’s overall practice. But sometimes research participants go into studies without that distinction in mind and expect to be taken care of, she said.

Thursday’s summit will focus on the question of family access to information about genetic risk factors discovered in genomic research, said Wolf. She chairs the event’s organizer, the University’s Consortium on Law and Values in Health, Environment & the Life Sciences.

“Researchers have had no idea what to do, because they take their privacy [and] confidentiality responsibilities very seriously,” she said, adding that they rarely ask subjects at the onset of a project whether they want their families informed of any incidental findings.

Both researchers and health care providers, LeRoy said, should advise participants and patients how to broach the subject of undesirable and unexpected results with family members, even distant ones.

“‘You haven’t seen me in two years. Guess what, we’re all at risk for cancer,’” she said.

“That usually doesn’t go very well.”

Barriers for biobanks

Premature results or samples gathered years before a study ends can impede the disclosure of information to participants and their families, LeRoy said.

“Are the results good enough for me to scare somebody and tell them, ‘You have this gene change — I think it could cause cancer — but I’m not sure,’” she said. “Who would want to know that?”

Genetics, cell biology and development professor Van Ness said it can also be difficult to identify and locate individuals when working with genetic materials stored in biobanks.

“The bank may be accessed for a study 10 years after they donated the sample,” he said.

Many consent forms for those who provide biobank samples indicate information won’t circle back to them, Van Ness said.

Biobanks are looking at a collection of data and their ability to potentially predict diseases or responses to therapies, Van Ness said, and not advising individuals on health care issues.

Creating guidelines

On Thursday, a group of experts will discuss findings on how and whether to provide family access to research at the public conference on campus. The presentation will house an audience of researchers, physicians, federal policymakers, bioethicists, study participants and their relatives, she said.

“We are going to be advocating legal change, policy change, ethics change,” Wolf said.

Next year, the group will finalize its recommendations using feedback from Thursday’s conference and start testing them out.

Van Ness, who studies genetic predictors for bone marrow cancer progression and therapeutic responses, said he hasn’t run into any issues with releasing information to patients’ families in his work, since it focuses mostly on drug-response genes.

But he said as technology advances, there need to be standardized guidelines.

“It’s getting much easier to look at the entire genome, and so we are soon to be launching projects that will have entire genome databases,” Van Ness said. “The ethical issue will now become front and center for us.”