NCI provides ethical, legal guidelines for handling biospecimen resources
NCI provides ethical, legal guidelines for handling biospecimen resources
NCI officials explain recommendations
The National Cancer Institute of Bethesda, MD, decided to address a deficit in quality of biospecimens collected for research purposes with the recent publication of improved recommendations.
"The underlying need of personalized medicine is to have particularly reliable methods to detect certain biomarkers for cancer and other diseases," says Jim Vaught, PhD, deputy director of the office of biorepository and biospecimen research at NCI.
"There are a number of initiatives within NCI and elsewhere that led the NCI to believe that or confirm that the quality of biospecimens collected for research purposes is not uniformly high," Vaught says. "And we need to address them on a more consistent basis than has been done before."
The National Cancer Institute Best Practices for Biospecimen Resources, published last summer, provides a blueprint for both clinical trial sites and IRBs with regard to handling research in which biospecimens are collected and studied.1
"The ethical and legal issues address five main areas," says Nicole Lockhart, PhD, a biospecimen technology program specialist in the office of biorepository and biospecimen research at NCI.
These are the custodianship of biospecimens, recommendations for informed consent, privacy protection, access to biospecimens and data, and intellectual property and resource sharing, Lockhart says.
"What we try to do in this document is discuss existing federal regulations and guidance," Lockhart explains. "We would like everyone to adhere to existing guidance and regulations."
While NCI doesn't mandate or recommend a specific plan, the goal is to raise awareness of the issues involved in collecting biospecimens, Lockhart says.
Here are the main areas of ethical, legal, and best policy practices that researchers might need to keep in mind:
• Responsible custodianship. "Custodianship is something we are trying to investigate further," Lockhart says. "We held workshops in 2007 dedicated to the issue of custodianship, and we're working on some publications derived from those workshops to try to answer more specific guidance to investigators."
NCI focuses on making any policies transparent so research volunteers know exactly what is happening with the biospecimens.
One of the aspects of custodianship that is difficult involves how the courts have addressed ownership of biospecimens, she notes.
"This gets into the issue of ownership and how the courts have addressed this issue," Lockhart says.
One landmark court decision was the case of Moore v. Regents of the University of California, Lockhart says.
The Supreme Court of California decided in 1990 that John Moore had no property rights to a cell line that was developed and commercialized from his hairy cell leukemia biospecimen.
Another case was Catalona v. Washington University in which a Missouri judge ruled in March, 2006, that the university, and not the researcher or patient, owned the biological samples under dispute.2
"I think what an IRB could do is maybe clarify custodianship when they're looking at a protocol," Lockhart suggests.
NCI uses the term "custodianship" rather than "ownership" because the word better describes the research institution's role in caretaking of the specimen, she adds.
"In most cases the development of a drug involves the use of thousands of specimens, so for any one participant to derive some financial benefit is a stretch," Lockhart says. "If you go down that road you'd never get any new treatments."
• Informed consent issues. NCI recommends that the informed consent document should say something about how the research participant would not derive any financial benefits from the development of a drug or treatment that results in part from use of the biospecimen, Lockhart says.
"A lot of patients are fine with that," she adds. "They've seen some of these blockbuster drugs developed for diseases like breast cancer, and they want mass treatments available to help their family and loved ones."
Another informed consent issue is whether the volunteers will receive research results.
"We're not advocating that research results be returned," Lockhart says. "It's a very complicated issue, and people are still trying to determine whether it's appropriate."
But participants should know whether they'll receive study results, she adds.
"We are again advocating transparency," Lockhart says.
"Participants should know whether their data will be shared," Lockhart says. "Researchers need a lot of samples, and research participants need to know whether their samples are shared at their own institution or shipped across the country and used in a collaboration."
The key is to make certain the informed consent document is clear on this subject.
"Some informed consents are specifically for tissue banking, and they might be written in a broader way where the patient consents to donating tissue to a tissue bank," Lockhart notes. "Sometimes the informed consent form will say something about future research use, but these vary in specificity."
Sometimes the informed consent document will say the tissue may be used for future research projects, but these projects will be approved by an IRB, Lockhart says.
"I think as long as the informed consent is well designed and whatever future research is within the bounds of the informed consent, and so long as it doesn't result in additional risk then it should be sufficient," Lockhart adds.
• Privacy protection. "Part of our recommendations describes HIPAA and how it relates to biospecimen resources," Lockhart says.
One issue of concern is whether a study can have a general authorization for use of protected health information under HIPAA, Lockhart says.
This issue is an ongoing question, so it's something that investigators and IRBs will have to think about thoroughly.
"Investigators will need to think about what type of data they need and how it will impact how they structure their informed consent," Lockhart says.
"Breaches in privacy and confidentiality are rare, but institutions are taking a very protectionist role and being cautious," she adds. "I'm fairly certain that there are public health exemptions, such as a public health emergency."
Protocols should be compliant with all HIPAA regulations, including data encryption and identifiable information, she says.
"HIPAA is not the end-all of privacy," Lock-hart says. "There are other means of protecting people."
For instance, privacy and confidentiality can be protected through the use of intelligent bioinformatics and encrypting data, and investigators might use these methods.
• Access to data and biospecimens. "We advocate having transparent policies so a researcher who would like to use biospecimens in their research can find out where they can obtain the specimens from and what access policies are in place," Lockhart says.
"Not all resources will be in a position to share samples, but everyone should have defined policies that are equitable and determined scientifically and clearly communicated," Lockhart says. "Generally, an access committee serves the role of reviewing these policies."
The access part of the recommendations was put in the NCI paper because NCI felt there were uneven policies about access across biospecimen resources, Vaught says.
"We want to encourage more open policies about access," he says.
"Not only does NCI feel like the quality of biospecimens access has been inconsistent, but that access to biospecimens has sometimes not been as open as it should be," Vaught says.
For example, some investigators and institutions might be storing specimens and not making them readily available for research for as long as they should, he says.
"We're encouraging access to be more open and specimens to be more available," Vaught says. "They should be more openly available to be used by other researchers."
In general, the NCI paper provides IRBs, research institutions, and investigators with ethical issues to consider and some guidance to best practices.
It should also help IRBs and investigators look at biospecimens in a less clinical way than their scientific backgrounds would encourage.
"Not everyone can see tissue and biospecimens in that way," Lockhart says. "Some cultures place a very high value on any part of their bodies, and in some cases they see it as part of their soul."
Also, there are ethical, religious, and cultural differences in philosophy about biospecimens, and investigators and IRBs need to be sensitive to these, she adds.
"People do feel sometimes an inherent attachment to what's attached to themselves, and there might be some misunderstanding as to the importance of biospecimens," Lockhart says.
"There is a lot of research going on, but if the general public doesn't realize those molecules come from tissues, and if people don't donate blood or let their remnant tissue be used for research, then research won't continue," Lockhart says.
"We want to raise awareness of these issues so there can be greater communication," Lockhart adds.
References
- National Cancer Institute Best Practices for Biospecimen Resources. Bethesda, MD: National Cancer Institute, National Institutes of Health; June 2007:1-48. Available at: http://biospecimens.cancer.gov.
- Vaught JB, Lockhart N, Thiel KS, et al. Ethical, legal, and policy issues: Dominating the biospecimen discussion. Can Epid Biomark 2007;16:2521-2523.
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