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

Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,Treuman Katz Center for Pediatric Bioethics - 2008 Conference,Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,Treuman Katz Center for Pediatric Bioethics - 2008 Conference,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,单击此处编辑母版标题样式,单击此处编辑母版文本样式,第二级,第三级,第四级,第五级,*,*,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,Banking Biological Samples for,2,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,2Stored Human Tissues“The most,Tissue Banking,Increasingly common element of clinical research protocols,Genotype phenotype correlations,Environmental phenotype correlations,Pharmacogenomic research,Toxicogenomic research,Tissue BankingIncreasingly com,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 BankingStorage of tissu,Tissue Banking,Linkage of results of biological assays with informational databases,Medical records,Family history records,Cancer registries,Public health records,Tissue BankingLinkage of resul,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 Subjects45,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,Research with Human TissuesUse,What are the ethical issues raised by research with human tissues?,What are the ethical issues ra,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 Regulatory IssuesW,Ethical and Regulatory Issues,What sort of consent should be obtained for research with tissue samples?,Is consent for unrestricted future use acceptable?,What is the role of child assent?,Should consent be obtained when subjects become adults?,Ethical and Regulatory IssuesW,Case Discussion,Retention and research use of residual newborn screening blood spots,Case DiscussionRetention and r,Residual Newborn Screening Specimens,Virtually all newborns are screened for multiple conditions using dried blood spots,State-based public health programs,Residual dried blood spots are available for almost all infants,Residual Newborn Screening Spe,Reasons for Specimen Storage,Confirmation of test results,Quality assessment of current test modalities,Forensic uses,Post-mortem disease identification,Identification of remains,Research,Related to newborn screening,Unrelated to newborn screening,Reasons for Specimen Storage C,Reasons for Discarding Specimens,Uncertainty over stability of sample,DNA appears stable,Storage costs and space,No clearly defined justification for storage,Lack of informed consent for retention,Potential legal liabilities,Reasons for Discarding Specime,NBS Retention, 6 months 24 programs,1 year 6 programs,2 - 7 years 7 programs,21 - 23 years 6 programs,indefinitely 8 programs,37 states have policies governing use of residual samples,23 programs have written usage policy,Source: Therrell et al. Pediatrics 2019;117:S212,NBS Retention 6 months 24,Research Options,“Anonymized” specimens,Pros,Valuable for epidemiologic research,Research does not involve “human subjects” under US regulations,Minimal IRB review,IRB defines exempt research,IRB may review de-identification process,No consent usually necessary for anonymous use (consent may be appropriate for collection and storage),Research Options “Anonymized”,Research Options,“Anonymized” specimens,Cons,Unable to link with health outcome of child,Cannot detect false positives and false negatives,Unable to contact family with beneficial health information,Research Options “Anonymized”,Research Options,Linked samples (identifiable),Pros,Health tracking possible,Return of health information possible,Cons,IRB review and oversight necessary,Informed permission may be necessary,Undermines value of having a specimen already,Return of information may pose risk to child and/or family,Research Options Linked sample,Informed Permission in NBS,Permission usually not sought for NBS,Only 2 states and DC have permission process for NBS,No infrastructure for obtaining permission,Acquire permission for,retention,of sample for research purposes?,Acquire permission for research,use,?,Research specific to newborn screening conditions?,Broad authorization for other research uses?,Informed Permission in NBS Per,Waiver of Consent,Permitted under 45 CFR 46.116d if all criteria are met:,1) research involves no more than minimal risk,2) waiver would not adversely affect rights and welfare of the subject,3) research could not be practicably carried out without waiver,4) when appropriate, subjects can be provided with pertinent information after participation,Waiver of ConsentPermitted und,Policy Questions,Should state health departments be able to retain NBS specimens without parental permission?,Is biomedical research permissible with retained specimens without parental permission?,Anonymous specimens only?,Identifiable specimens?,Policy QuestionsShould state h,Banking-Biological-Samples-for-Pediatric-Research-Botkin儿科的研究生物样品组成的银行课件,谢谢你的阅读,知识就是财富,丰富你的人生,谢谢你的阅读知识就是财富,23,Banking-Biological-Samples-for-Pediatric-Research-Botkin儿科的研究生物样品组成的银行课件,24,