Conducting Biosocial Surveys Collecting, Storing, Accessing, and Protecting Biospecimens and Biodata (2010) / Chapter Skim
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2 Collecting, Storing, Using, and Distributing Biospecimens
2 Collecting, Storing, Using, and Distributing Biospecimens
Pages 19-40
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From page 19... ...
To be sure, epidemiologists have a long tradi tion of collecting biological data (often mimicking a clinical setting in the field) along with social and demographic data (that are often less rich than social surveys)
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From page 20... ...
This capability raises the prospect of having to deal with unprecedented amounts of personal information -- the entire genome sequence from large numbers of individuals. While such data may have great potential for the discovery of biomarkers and functional studies, dealing with the data and their implications for privacy and protection of human subjects will require addressing many as yet unanswered questions.
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From page 21... ...
. ISBER was formed in part to develop effective strategies for the long-term storage of biological specimens; it "fosters education and research and promotes quality and safety in all activities relating to specimen collection, storage and dissemi nation" (International Society for Biological and Environmental Repositories, 2005, p.
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From page 22... ...
Rather, they provide "salient guiding principles that define state-of-the-science biospecimen resource practices, promote biospecimen and data quality, and support adherence to ethical and legal requirements" (National Cancer Institute, 2007, p.
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A primary consideration is that the privacy of study participants should be respected and protected. Sound scientific research involving biospecimens depends on protecting the privacy of the participants who contribute them and the confidentiality of their data.
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From page 24... ...
However, the unrestricted release of both the individual survey data and the biodata poses potential risks for breaches of confidentiality. Although the public release of nominally deidentified data used to be widely accepted, the concept of deiden tification needs to be reconsidered when the data can represent an individual's entire genome sequence or the state of a million or more variant positions along the genome, possibly together with various social, economic, psychological, or physiological characteristics.
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From page 25... ...
. Many biosocial surveys will not be con ducted in HIPAA-covered entities, but following the guidelines is a good step toward protecting privacy, so the spirit of that law can perhaps serve as a useful guiding principle.
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From page 26... ...
The NCI recommendations regarding privacy and confidentiality (National Cancer Institute, 2007) include a detailed section designed to help guide bio repositories in their role as honest brokers of sensitive information.
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From page 27... ...
The NCI guidance discussed earlier includes detail on the necessary systems: "An informatics system should support all aspects of bio specimen resource operations, including (but not limited to) research partici pant enrollment and consent; biospecimen collection, processing, storage, and dissemination; QA/QC; collection of research participant data; data security; validation documentation; and management reporting functions.
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From page 28... ...
Interviewers or other survey staff who collect biological specimens from human subjects should take precautions to avoid infection from any pathogens that may be present in the specimens, especially when blood samples are being collected (Twitchell, 2003)
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From page 29... ...
Activities that need to be monitored and checked for reliability or drift include the calibration of measurement instruments, the timing of specimen collections, specimen treatment, shipping methods, transit duration, and field processing (e.g., aliquoting and reagents) , as well as practices within the labo ratories that perform the assays.
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From page 30... ...
Once the decision has been made on which specific biomarkers are of interest, a place to start in laboratory selection is to understand whether the markers are to be available for clinical purposes or are purely research measures. Clinical measures, such as conventional blood counts, clinical biochemistries, many antibodies to infectious agents, and many hormone levels, can be obtained in a number of places and are likely to be performed with standardized methods and rigorous quality control, often with procedures dictated by the Clinical Laboratory Improvement Amend ments (CLIA)
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From page 31... ...
Also, as noted above, the level of standardization and quality control may not be as high as in clinical laboratories, further impeding clinical interpretation. Decisions about reporting on biomarkers determined in research laboratories need to be made on a case-by-case basis, with medical input.
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These costs must be accounted for and should be reflected in the budget. As discussed later in this chapter, the panel agreed that the data sharing plan submitted with a research proposal should address these issues.
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From page 33... ...
or controllers for liquid nitro gen freezers, should be protected by a UPS. UPSs used in repositories should be tested on an annual basis to ensure their proper backup capabilities" (International Society for Biological and Environmental Repositories, 2008, p.
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Finally, the informed consent process should include anticipating and requesting permission for the storage of specimens, as well as their future use (see above) , and the specimen archive should include information that both links use of the specimens back to the informed consent documents and links the specimens to the data derived from them.7 Specimens need to be stored with information that will allow determination of consent approvals.
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From page 35... ...
If the proposed analyses lie beyond the competence of the original investigators, for example, projects will need to ensure that they have adequate support for the purpose. The panel agreed that the data sharing plan of a research proposal should specify policies and implementation plans for archiving and sharing both specimens and the data derived therefrom.
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From page 36... ...
. investigators with small biospecimen collections should be encouraged to establish or join an existing IRB-approved regulated biospecimen resource" (p.
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In one recent prominent case, Washington University v. Catalona, the Federal District Court for the Eastern District of Missouri ruled that the research participants (human subjects)
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From page 38... ...
The decisions of the district court and the appeals court reflect a public policy that medical research can advance only with continuing access to bio specimens. Nevertheless, it is possible that in another set of circumstances, the informed consent document could be interpreted as giving study participants the right to withdraw and physically repossess their biospecimens.
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From page 39... ...
If a discovery made using the mate rial leads to a commercial application, for example, the MTA describes how any receipts or profits from the application will be allocated. In the case of MTAs governing biospecimens from repositories and the data derived therefrom, investigators need to ensure that the agreement is specific about what can and cannot be analyzed.
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