PMC:3897848 / 13194-16893
Annnotations
{"target":"https://pubannotation.org/docs/sourcedb/PMC/sourceid/3897848","sourcedb":"PMC","sourceid":"3897848","source_url":"https://www.ncbi.nlm.nih.gov/pmc/3897848","text":"Distribution Policy for Biospecimens and Data\nMany biobanks have policies for the distribution of biospecimens and data. For example, there is a guideline to distribute biospecimens in the National Health and Nutrition Examination Survey (NHANES), which is a program of studies designed to assess the health and nutritional status of adults and children in the United States. NHANES's biospecimens are representative samples of Americans and should not be used for the independent case-control study, and 1individual vial must be stored permanently. All proposals for the use of NHANES samples are evaluated by a technical panel for scientific merit and by the NHANES Ethics Review Board (ERB). To determine if this limited resource should be used in the proposed projects, a technical panel will evaluate the public health significance and scientific merit of the proposed research. Distribution of a 0.5-mL sample is available once, and after finishing the research, the remaining samples are abandoned, or remnants more than 0.3 mL should be returned to NHANES; third-party biospecimen transfer is not permitted. Researchers who received specimens must submit the result of the analysis, such as quality control and analytical methods with documents, to the National Center for Health Statistics (NCHS). Surplus data without DNA analysis results would be opened in the website and given a period of 3 months for analysis. A researcher's intellectual property rights are not permitted because of research for public health (http://www/cdc/gov/nchs/nhanes.htm).\nThe Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial (PLCO) biorepository in the United States has 2.9 million biological samples, including blood, and researchers can use samples and data through the process of peer review. Researchers can submit summarized proposals to the PLCO, and the chosen research is recommended for full research proposals and submissions are available twice in June/July or December/January annually. The review process takes 4 or 6 months. Researchers with approved proposals should submit IRB approval documents and contract the Material Transfer Agreement (MTA) mutually, and biospecimens are distributed to researchers when approved; researchers should report experimental results to Information Management Systems (IMS) (http://www.plcostars.com).\nAt present, distribution of biospecimens is available to Korean researchers irrespective of research funds, and the distribution for data is accessible to Korean researchers without financial sponsors in Korean biobanks. All proposals for distribution of data and biospecimens should be reviewed and be approved by the IRB belonging to an institute prior to submission. Opened data and biospecimens for distribution in the NBK are shown in Tables 2 and 3. First of all, researchers who want to receive the data and biospecimens have to submit the application document to the NBK. The submitted documents will be reviewed, and a board meeting for distribution is held monthly; distribution of work for the approved application will be performed approximately within one or two months from submission of the application documents for distribution. NBK is planning a website for the distribution process.\nMost of the distributed biospecimens are DNA samples in the NBK, and a few body fluid samples, including sera and plasma, were distributed. According to the advancement of the technology, the minimum quantity for clinical examination and for the analysis of metabolites is diminishing. However, sera and plasma are very limited resources, and political decisions and long-term planning for the use of body fluid samples will be needed [12].","divisions":[{"label":"Title","span":{"begin":0,"end":45}}],"tracks":[]}