IRBs and discussions over commercial tissue banking
IRBs expertise makes them the go-to board for approval
Commercial tissue repositories looking for sources of human tissue, and hospitals that discard tissue from surgeries daily, could appear to be a match made in heaven.
But a hospital's decision to enter into a relationship with a commercial repository is a complicated one — one that often draws in the IRB, with its existing experience with privacy and consent issues.
"There really wasn't any other ethical board within the hospital that we felt had the expertise to review it ethically," says Jan Trott, director of the Office of Research Affairs at Maine Medical Center, in Scarborough, ME, which began a collaboration with a commercial repository four years ago. "So the IRB took this on, even though it really didn't fit the usual guidelines."
Maine Medical Center's experience not only resulted in a successful tissue banking program there, it led to an online guide to working with commercial tissue repositories, created by Julien Murphy, PhD, a professor of philosophy at the University of Southern Maine, in Portland, ME.
Murphy, who heads up the university's Bioethics Project, also served on the medical center's clinical ethics committee and is currently on the center's tissue banking steering committee.
"As we worked on it, it occurred to a couple of us that if we were confronting this matter, then other hospitals were probably confronting it as well," Murphy says. Her hope is that other IRBs will use the online guide as a resource when discussing similar collaborations at their own institutions.
"We wanted to do this so that every site that was approached wouldn't be starting from scratch in trying to think about these issues," she says.
A new kind of arrangement
Murphy says that in the early 2000s, when the medical center was approached, commercial companies were just beginning to try to enlist public and private hospitals to provide tissue samples for research.
"After the genome was mapped, genomic research was developing, and it appeared that there was a great need to make available to researchers large amounts of human tissue from a variety of different patients, primarily to determine different gene functions," she says.
The companies thought that hospitals' surgical departments, who were disposing of these types of tissue remnants every day, might be a useful source of tissue for researchers.
"This was a really new idea in 2001 or 2002," Murphy says. "Many hospitals, when they were confronted with this proposal, knew that they needed to take it to some sort of ethics committee."
IRBs, which often already handle privacy issues for hospitals, were an obvious choice, she says, although many IRBs declined to take the issue up, saying it was outside their purview. At other hospitals, particularly smaller ones where the IRB serves as a sort of "one-stop shop," IRBs did review the proposals.
A proposal for providing tissue to a repository is different from the type of research protocol an IRB is used to reviewing, Murphy says. It's impossible to identify at the outset who eventually will be using the tissue, and for what purpose. Researchers from all over the world could potentially end up with tissue donated from a hospital in one corner of the United States.
"The question was, could you conduct informed consent appropriately, when you could basically tell the tissue donor next to nothing about who would use the tissue, or where or what would be done with it?" she says.
She also notes the regulatory environment for collaborations is murky. Regulations are inconsistent and many basic questions, such as ownership of human tissue, remain unanswered.
Trott says her board also was concerned with the impact on the public if the hospital entered into a commercial tissue banking arrangement.
"We were worried about how people would react if it ended up on the front page of the newspaper that the medical center was selling tissue," she says.
And she notes that there weren't many institutions to consult about their own experiences, since the practice was so new. Murphy says there is a dearth of published information about commercial collaborations for tissue.
The Maine Medical Center set up a steering committee to oversee the project, and asked Murphy and others to look at the ethical issues involved.
Those issues included the privacy of genetic information derived from the tissue and whether tissue would be linked with medical records. Clinical data about a tissue sample — everything from the patient's medical history to the eventual outcome — can greatly increase its usefulness to researchers.
Murphy says her group also looked at issues of institutional integrity — how a commercial proposal would fit with the hospital's mission, the ethics of investing in commercial repositories and potential conflicts of interest.
"The big difference between an IRB looking at a commercial collaboration from any other banking protocol is just thinking clearly about that commercial piece," she says. "How to protect the integrity of the collecting institution, if the collaboration has any commercial aspects to it."
Consent, confidentiality key
In her discussions with IRBs, Murphy says their biggest issues tend to center around informed consent and confidentiality, and maintaining a link between tissue samples and patient medical information.
Consent was an important concern at Maine Medical Center, Trott says, leading to a long process in writing the consent form, and a plan to hire two nurses, at the repository's expense, to administer the consent to patients. The nurses work through the clinical trials office to allow for greater oversight of the process.
"We wanted to make sure that the nurses who were consenting people knew how to really consent people and they weren't just signing them to get their tissue taken," Trott says.
The IRB also carefully examined the company's encryption program, which enables some coded information to travel with the tissue samples. Although the medical center is unable to tell donors exactly where their tissue will go or what it will be used for, the IRB insisted that the company guarantee tissue would only release tissue to a researcher who could show evidence of an IRB's approval for his or her project.
The company provided infrastructure for the tissue banking process at the hospital, including the encryption software and a freezing process to preserve the tissue. The Maine Medical Center's own researchers were given first rights to the tissue if they wanted it for their own research, Trott says.
"Another policy of the steering committee was that any money that was received back from this that didn't just pay for the infrastructure would be used to fund a community project," she says. "We knew we may have some bad publicity from this and we wanted to show that every angle had been covered."
One area the Maine Medical Center chose not to pursue was banking tissue from deceased patients, Trott says.
"It seems to be something that the community just doesn't want to deal with," she says. "They're open to the (tissue banking) if you consent people well and you really explain what you're doing and what you're asking for and where this tissue may go, and you give them the opportunity to ask questions.
"Taking tissue from newly expired people just leaves a bad taste in people's mouths," she says. "And right now, we're just not willing to wrestle with that piece."
In the end, Trott says, the IRB approved the structure of the tissue banking program, including policies, the encrypting procedures, the makeup and policies of the steering committee and the consent form.
After the medical center decided to go ahead with a commercial collaboration, Murphy and her colleague, geneticist Karen Rasmussen, PhD, obtained a grant from the Greenwall Foundation to build an online guide that IRBs could use as they navigate the unfamiliar waters of commercial agreements for tissue banking.
"We thought it might be useful to apply for a grant and build a national conversation about the ethical issues involved in collaborating with commercial tissue repositories."
She says they faced some challenges in researching the subject, because the idea was so new and the commercial tissue industry was changing rapidly.
"It really felt like we were researching a moving target," Murphy says. "We interviewed a number of commercial companies, as well as hospital IRBs that were collaborating with them. Even in the very short time of the grant, companies were folding or redesigning themselves and changing their objectives.
"It surprised me how volatile the commercial research repository business is," she says. "I think many companies are struggling to find a niche and I really assumed that the market would be very stable. It's still rapidly changing."
Patient support
Trott understands that volatility very well. The company that originally worked with the Maine Medical Center pulled out of tissue banking, and the hospital has since contracted with two other companies to handle the work.
After the first company fell out, "we did have a period of reconsideration," Trott says. But the hospital's research institute decided to continue the program, even supporting the project financially until new companies could be found.
"Now the tissue bank is self-supporting again from these other companies," she says. "But we're using the same infrastructure and the same policies and they're agreeing to that."
In fact, Trott says, the medical center got the new companies to agree to use the Maine Medical Center's existing consent form, rather than using their own forms. Trott says that enabled the tissue to be potentially used by more than one company without requiring patients to sign multiple forms.
"One thing we didn't want is to have our patients consented over and over and over again just to have a patient's tissue," Trott says.
She says response from patients to the tissue banking project has been better than she expected.
"We've been very pleased that most people want to do it," she says. "We really were afraid that people would be very resentful of this.
"In most cases, these are people who have just been told they have cancer and they're being asked to give up a piece of their tumor. Most people at that point, even that early on, want to help and think this is a way of helping. We've been very pleased with that reaction."
And she believes that the collaboration will help other patients in the future, as researchers are able to do more and more studies using tissue, rather than human subjects.
"That's going to change research," Trott says. "You won't have to use animals and humans as much if you can actually use tissue from people who have this specific disease and see how well it's going to work. We really believed in that journey and we still do. We still think that that will happen."
Since writing the guide, Murphy and her colleagues have been giving presentations on the ethics of collaborating with commercial tissue repositories at medical conferences around the world. Now, she says, they are focusing on writing journal articles that will disseminate the information they gathered in creating the guide, and they'll be updating the site with new information.
To view the online guide to collaborations with commercial tissue repositories, go to http://usm.maine.edu/bioethics/biobank/
Commercial tissue repositories looking for sources of human tissue, and hospitals that discard tissue from surgeries daily, could appear to be a match made in heaven.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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