In coming months, all patients in the University of Washington health system and Seattle Cancer Care Alliance will be asked for their permission to have medical records and leftover blood or tissue made available for future research.
If they say yes, their records and samples would be forwarded to a new, University of Washington-led consortium called NWBio Trust.
It’s a simple premise: researchers with the Fred Hutchinson Cancer Research Center, Seattle Children’s and UW pay fees and in return get access to a vault of information without having to track down individual patients to get their consent. The patient records could include sensitive information on mental health, drug and alcohol treatment, and whether the person has sexually transmitted diseases like HIV.
Some of the potential uses raise ethical questions. To stay financially afloat, the trust says it would also sell anonymous tissue specimens and related records to pharmaceutical and biotech companies for research.
That concerns several members of a University of Washington ethics board.
“The line between research versus selling became blurry to us,” one member said. Members spoke on the condition of anonymity, because they are not allowed to discuss these proceedings publicly.
Another concern is that patients’ medical information could inadvertently be made public, which could affect an individual’s health insurance or employment. That's because researchers within the consortium could have complete access to patient files, which includes names.
Before approaching patients for their consent, NWBio Trust had to receive approval from an Institutional Review Board, an ethics board run by the UW. This kind of board was created in the 1970s to consider the ethics of medical research and to protect human subjects.
The UW has six boards to oversee all its research proposals.
Karen Moe is the head of the university’s Human Subjects Division, which coordinates all the boards. She said that even when patients aren’t undergoing an experimental treatment, there are still ethical concerns for the board to explore regarding NWBio Trust.
“Are subjects and participants being asked for consent?” she said. “What is provided to them in the way of information as part of the consent process – and then the issue of identifiability is a major issue.”
Patients give permission at the check-in desk for a doctor’s appointment, with forms appearing on one of those little screens.
In a pilot project, 80 percent of patients gave permission, according to NWBio Trust founder John Slattery, a vice dean at the UW School of Medicine. Slattery said that if patients want to opt out, that’s fine.
“We felt that most people would be comfortable actually saying yes for general use; it’s supporting medical research with real patient experience and with specimens from real patients,” he said.
Doctors won’t see whether patients give consent, so it would not affect their treatment. If patients aren’t interested, Slattery said, “We don’t ask why.”
The form currently includes two questions. But Slattery said he is hoping the board will approve a third question: Would patients donate additional slivers of tissue for the purpose of research?
“If your tumor is to be included in the research we’re doing, we need an extra little bit of that,” Slattery said. “Under federal regulations, we need to separately ask you for permission to take this extra pinch.”
The tissue would be taken as part of a regular biopsy.
Industry Pays More
In a UW lecture from 2013, the Bio Trust’s director, Dr. Stephen Schmechel, said bio-banks around the country have had trouble sustaining themselves financially.
Before coming to the UW, Schmechel started a similar project at the University of Minnesota and said outside companies were an important source of revenue.
“We liked to work with for-profit industry because we could increase our rates anywhere between 50 to 110 percent, doing those sorts of contracts with industry primarily as a means of generating cash to float the boat," he said.
But those fees aren’t always apparent to patients. The project’s website states that NWBio Trust “will not make any money from your tissue or blood samples.”
It does say another institution could profit from a discovery involving Bio Trust samples. A brochure for patients says researchers will pay a “small service fee.”
The informed consent form that patients sign does not mention fees. But it does say that records and specimens could be used by “pharmaceutical or biotech companies.”
Slattery said the fees offset the costs of the program.
“NWBio Trust does collect fees both internally from investigators and outside as it distributes these specimens. But those fees – nobody makes any profit off of those things. They simply keep a rather expensive apparatus running," he said.
The Arizona State Example
Michelle Mello is a professor at Stanford Law School and the Stanford School of Medicine. She said bio-banks are growing around the country and seem to hold great promise.
“The appeal of bio-banking is the appeal of so-called ‘big data’ generally: that by pooling information we can explore all kinds of questions that are not possible to explore with smaller samples from a narrower population,” she said.
Most patients don’t seem to have concerns about how their specimens or data could be used, but some do. In a 2010 article in the New England Journal of Medicine, Mello profiled a legal settlement paid by Arizona State University to the Havasupai tribe for improper use of their blood samples.
Tribal members were told the samples would be used to study diabetes, but later they were passed along for research on schizophrenia, inbreeding and genetics, which tribal members opposed. Mello said that while it’s common to ask patients for wide-open consent, it could be useful to give patients more control over their information.
“I was once asked to sign a general consent and I thought to myself, ‘I’m quite happy for my sample to be used by other academic researchers,’” she said, “but I don’t want it sold to a private company and used to develop commercial products.”
Mello said she didn’t have a way to give consent for academic research only, so she opted out.
In the past, patients typically gave informed consent for just one specific research project.
At Schmechel’s 2013 lecture, an audience member seemed surprised that the UW will ask patients for “blanket consent” to all future uses of their records and tissue.
“The question is, does the blanket consent allow the patient to participate in any study under the sun?” Schmechel replied. “Yes.”
And patients won’t know which studies their information is involved in. But he added that each separate study must also receive IRB approval.
IRB Members Protest
Some members of the IRB overseeing NWBio Trust say university officials have aggressively pushed the project and the review process was “contentious.”
Now, committee members are protesting the university’s decision to take NWBio Trust out of their hands and assign it to a different committee.
Karen Moe says these kinds of transfers are routine and occur frequently. In this case, the change was made to accommodate a conflict of John Slattery’s – he is being appointed as a member of this IRB and oversight of NWBio Trust is being swapped to avoid any conflict of interest.
The IRB has pushed back. Members say switching oversight at this point creates “an appearance of impropriety.”
A letter dated Jan. 1 and signed by the entire committee said that removing the Bio Trust could be seen as “interference with the committee’s judgment” and “conveys a lack of respect for the good-faith work of this committee.”
They are asking that Slattery recuse himself from NWBio Trust matters or join a different committee instead.