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NCI officials explain recommendations
The National Cancer Institute (NCI) 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 for IRBs with regard to handling research in which biospecimens are collected and studied. 1
"The ethical and legal issues addresses 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 IRBs 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.
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