(2006年8月30日)食品和藥物管理局正尋求產業界的投入以制定利用及保護基因研究數據的新政策.
FDA斟酌基因藥物研究數據政策
(2006年8月30日)食品和藥物管理局正尋求產業界的投入以制定利用及保護基因研究數據的新政策.
該機構在1930年8月對發表各界對國家衛生研究所資助或進行全基因相關研究(Genome-Wide Association Studies)所制定的新政策的看法。被稱為GWAS,他們是相關研究關於人類遺傳變異基因, 觀察疾病或條件的存在與否,以確定基因與明顯特徵的相關性。
GWAS稱"所提出的政策發表各階段GWAS各階段研究中數據公開程序、數據查閱原則、智慧財產權保護問題的研究,以及保護研究參與者的相關議題。根據尋求資訊(RFI),刊登在聯邦公報gpoaccess.gov/fr/index.html..
例如,美國FDA提議建立一個GWAS資料庫中心美國衛生研究所. "資料庫將提供一個單一入口式以獲得美國衛生研究所贊助的GWAS的基本資料及基因-表現型資料集。雖然NIH希望這個途徑可以成為獲得全部NIH贊助的GWAS資料集,該資料庫不會成為這些資料的唯一消息來源. 資料庫也會從其他來源接受GWAS數據.
http://www.healthdatamanagement.com/html/news/NewsStory.cfm?articleId=13918
FDA Mulls Gene Study Data Policy
(August 30, 2006) The Food and Drug Administration is seeking industry input as it develops new policies for the use and protection of data in genetic research.
The agency on Aug. 30 published a request for information to get comments on a proposed new policy for National Institutes of Health-supported or conducted Genome-Wide Association Studies. Known as GWAS, they are studies of genetic variation across the entire human genome that are designed to identify genetic associations with observable traits, or the presence or absence of a disease or condition.
"The proposed policy addresses data sharing procedures, data access principles, intellectual property and issues regarding the protection of research participants through all phases of GWAS," according to the RFI, published in the Federal Register at gpoaccess.gov/fr/index.html.
For instance, FDA is proposing development of a central GWAS data repository at the National Institutes of Health. "The repository will provide a single point of access to basic information about NIH-supported GWAS and to available genotype-phenotype datasets for GWAS," according to the request for information. "Although the NIH envisions that access to all NIH-supported GWAS datasets will be possible through this repository, it does not intend this repository to become the exclusive source of these data. The repository will also accept GWAS datasets contributed from other sources."