Banking Biological Samples for Pediatric Research Botkin儿科的研究生物样品组成的银行.pptVIP

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Banking Biological Samples for Pediatric Research Botkin儿科的研究生物样品组成的银行.ppt

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Banking Biological Samples for Pediatric Research Botkin儿科的研究生物样品组成的银行

* * Treuman Katz Center for Pediatric Bioethics - 2008 Conference Treuman Katz Center for Pediatric Bioethics - 2008 Conference Banking Biological Samples for Pediatric Research Jeffrey R. Botkin, M.D., M.P.H. Professor of Pediatrics and Medical Ethics Associate Vice President for Research University of Utah * Stored Human Tissues “The most serious and intractable issues in health law and ethics today are raised by the collection, storage, and future use of tissue samples. Imagine the vast amount of personal information contained in stored tissue samples …” Professor Lawrence O. Gostin, Georgetown University Tissue Banking Increasingly common element of clinical research protocols Genotype – phenotype correlations Environmental – phenotype correlations Pharmacogenomic research Toxicogenomic research Tissue Banking Storage of tissue permits easy access to “human subjects” Tissues acquired for clinical or research purposes Research can be conducted that is remote in time and place Tissue Banking Linkage of results of biological assays with informational databases Medical records Family history records Cancer registries Public health records Research with Human Subjects 45CFR46: Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or?(2) Identifiable private information. Research with Human Tissues Use in research is human subjects research if tissue source can be identified What constitutes “de-identification?” 45CFR46 the identity of the subject may readily be ascertained by investigator HIPAA: removal of 18 identifiers or expert opinion What are the ethical issues raised by research with human tissues? Ethical and Regulatory Issues Who “owns” tissue samples? Defining the risks to individuals from research with tissue samples Defining the risks to racial or ethnic groups from research with tissues Ethical and Regul