Privacy rules, advancing technology raise tissue procurement questions
IRBs have responsibility over use, study
Investigators have a variety of options available with regard to using human tissue in research, and each new possibility raises additional questions and ethical concerns that should be considered by IRBs. IRBs will need to establish policies that address whether patient consent is necessary and specify how long tissue samples can be stored and by whom. Also, IRBs should consider how to handle situations in which research using a patient’s tissue inadvertently uncovers health problems, such as HIV disease, and how disclosure to the patient will be handled. The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP) offer little guidance, but for the most part, IRBs are on their own in developing policies regarding the handling of human tissues.
Always or occasionally necessary
Many IRB coordinators would argue that informed consent is necessary whenever tissue is procured during a trial. "It is important to inform the subject of all the risks and benefits involved in tissue procurement and the methods employed to ensure privacy and confidentiality of data," says Mary Barnhart, CIM, IRB coordinator of Oakwood Healthcare System in Dearborn, MI.
The OHRP offers guidelines stating that human subjects would not be involved and tissue procurement would not be considered human research if the following conditions apply:
- The material in its entirety was collected simply for unrelated clinical purposes.
- The material was collected for legitimate but unrelated research purposes, and the material was submitted without identifiable private data or information.
Only in these cases would informed consent not be required, Barnhart says. "The present guidance from the regulatory bodies is that consent should be obtained for all specimens that are prospectively collected," Barnhart adds. "However, we must remember that guidance is not a regulation; it’s the FDA’s or OHRP’s current thinking on how to meet the requirements of the regulation."
Federal guidance often changes and is modified as new issues arise, including the relatively new practice of genetic testing. "For many types of research with tissue, such as genetic testing, it should be mentioned in the consent form that blood will be drawn and the test done on it," says David Forster, JD, MA, CIP, director of regulatory and legal affairs for the Western Institutional Review Board in Olympia, WA. "If it’s low-risk testing, then generally a statement in the regular consent form is sufficient," Forster says. "If they plan to do genetic testing with the sample, then we usually require a separate consent form or a consent form addendum."
Forster recommends that consent forms incorporate all of the elements required by regulations, including a discussion of why the sponsor wants to do genetic testing, what will be done, and what the confidentiality risks are, including the possible effect on insurance and employment. "Then you go on to list steps of how the genetic information will be identified and whether a link will be maintained with the subject’s identity, or whether a link is permanently broken so they are truly anonymous," Forster explains. "It’s a case-by-case situation, and generally if the link is maintained, then the standards are higher, and the board expects more in terms of confidentiality and information given to subjects."
Also, there are controversial issues raised by each new technology or medical/scientific trend. For example, should an IRB be concerned about whether institutions collecting cord blood are exploiting parental fears about very low-risk disease dangers to their children? "One of the concerns I had about cord blood was that I was fearful people out there were trying to sell its storage to mothers and parents to buy as additional insurance for their kids," says Frank L. Gold, MD, CIP, associate dean for organizational ethics and co-chair of the Peoria Community IRB at the University of Illinois College of Medicine in Peoria. "The benefits of storing a child’s cord blood are unforeseeable," Gold adds.
Officials with a cord storage bank company recently met with the Peoria Community IRB to discuss establishing a contractual relationship. Company officials had alleviated Gold’s concern by saying that the company’s primary goal was to establish a public cord bank, rather than a private one. "The public bank would be able to provide stem cells, cord blood samples, or collections as transplant material in a large registry," Gold says. "So, someone in Idaho could call with typing data and see if there was one on the shelf that would match." Still, these concerns will arise as private companies become involved in the business of storing and selling human tissue.
Who owns the tissue?
Storage and ownership are another hot issue involving specimen collection and study. "We have taken the stance that subjects cannot be made to waive property rights in tissues, and this derives from federal regulations," Forster says. "However, in California, there is a case that concluded people don’t have property rights in products developed from tissues."
Colorado gives people property rights over their own DNA information, but most states have no laws. Since tissue samples can be stored indefinitely and often requires the use of a tissue repository, the custom is for the repository to become the owner of the tissue, provided an informed consent has been signed by the subject, Barnhart says. "Where a repository is not used, then the tissue samples are the property of the primary investigator of the protocol or study," Barnhart adds. "Again, informed consent should be obtained, and all possible methods should be employed to ensure the privacy and confidentiality of the subject."
At hospitals and university medical centers that collect tissues for universal tissue banks, the collection process, study, and/or use of the specimens is seen as a public service. Just as blood and skin grafts can be stored for lifesaving purposes, so might umbilical cord stem cells. For instance, if the medical center affiliated with the University of Illinois College of Medicine in Peoria agrees to collect umbilical cords for the public good, it could provide a boon for people in need of stem cell-related medical services of various ethnic backgrounds, Gold says. "We’d see it as a public service locally, [because] we have 5,600 baby deliveries a year here in our community and we have a large minority population in Peoria," he reports. "It’s an area where there’s a dearth of donations, and it’s very crucial when you think about some of the treatable diseases like sickle cell anemia."
Plan for the future
Maintaining some link to the tissue donor might benefit the donor in the event some undiagnosed medical problem arises. "For obvious reasons, there are some confidential links still there; so if there is something discovered about the mother or child that’s relevant to health care, it’s possible that this could be tracked back," Gold says.
At least one umbilical cord bank company plans to handle such situations by using a code to link donors to the tissue, and only key people would be able to track the code to the donors’ names, he explains. The same cord bank would separate stem cells that are available for transplantation from those that are unsuitable, and the unsuitable tissue would be available for research, Gold says. "So the primary issues the IRB would have would be confidentiality and boilerplate concerns that are the same concerns as when tissues are banked for other purposes, such as cancer tissue that is banked for unforeseeable research," Gold says. "The other issue that’s important is that these samples are screened for HIV and hepatitis, and those are public health issues that require a mechanism for notifying the patient if these are discovered, and that’s built into the consent as well," he adds.
Would the IRB be involved in the event that some disease or infection is discovered in the stored tissue sample? Gold says that the IRB’s involvement primarily would be to make certain the storage bank has a mechanism in place to handle that sort of situation. "We can say, Do you have a mechanism in place if the patient tests positive to HIV, so that there is counseling to the patient and the appropriate referral for that problem?’" he explains. "If the answer is Yes,’ then we don’t need to see all the paperwork because the investigator will have that mechanism as standard operating procedure."
Typically, it would work like this: The bank would obtain the specimen and do infectious disease testing. If the sample is HIV-positive, then a whole procedural system would begin, and the bank would call the investigator to discuss the findings. The investigator would notify the subject’s doctor, who would be listed on the research documents, Gold says.
Forster says that disclosing health problems to subjects should not be the IRB’s responsibility. "Someone with a clinical relationship to the subject should provide that data when possible," Forster says.
Barnhart agrees. "However, if there is a good chance that research will yield results that could affect the subject’s medical care, it may be appropriate for the investigator to ask them if they wish to be contacted and informed," she says. "The decision about whether to provide results to subjects depends upon the ethical implications of each protocol," Barnhart adds. "There are cases in which it would be ethical to provide results to subjects, such as when the research is in the early stages and the clinical significance has not been determined."
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