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Future Use of Stored Samples & Data and the NIH Policy on GWAS and dbGaP

Future Use of Stored Samples & Data and the NIH Policy on GWAS and dbGaP. Dione Washington, M.S. -- ProPEP Sudha Srinivasan, Ph.D.-- TRP Tanisha Savage-- ProPEP (HJF-DAIDS). DAIDS Regional Training Event 2012 Johannesburg, South Africa. Objectives.

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Future Use of Stored Samples & Data and the NIH Policy on GWAS and dbGaP

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  1. Future Use of Stored Samples & Data and the NIH Policy on GWAS and dbGaP Dione Washington, M.S. -- ProPEP Sudha Srinivasan, Ph.D.-- TRP Tanisha Savage-- ProPEP(HJF-DAIDS) DAIDS Regional Training Event 2012 Johannesburg, South Africa NIAID/DAIDS

  2. Objectives • To inform stakeholders about the NIH Policy on GWAS and dbGaP and trends in genetic research. • To describe the implications for future use of stored samples & data. NIAID/DAIDS

  3. NIH GWAS Policy and dbGaP Guidelines NIAID/DAIDS

  4. The database of Genotypes and Phenotypes (dbGaP) was developed to archive and distribute the results of studies that have investigated the interaction of genotype and phenotype. NIAID/DAIDS

  5. Data Deposition in dbGAP • All studies funded after Jan 25, 2008 are subject to data deposition as per NIH GWAS policy guidelines • Studies funded prior to this date are not required to do so, but NIH believes in data sharing and would like the investigators to do so if possible NIAID/DAIDS

  6. What is in dbGAP? • Includes individual level phenotype /exposure such as height, weight, blood pressure, blood glucose (diabetes) and others… • Genotype and sequence data • Associations between clinical/ phenotypic data such as blood pressure, height, weight., etc. and genotype and sequence data • Can be for individuals or groups of people • DE-IDENTIFIED data at all levels NIAID/DAIDS

  7. Types of data in dbGAP [1] Study documentation, including study description, protocol documents, questionnaires [2] phenotypic data for each variable assessed-individual and summary form [3] genetic data, including individual study subjects’ genotypesand sequence data [4] statistical results including association and linkage analyses, when available NIAID/DAIDS

  8. Data Sharing • Data submitted for the GWAS repository has to be coded and de identified by the submitting investigator • Investigatorretains the key to the code that would link to specific individuals or groups. • NIH would never receive the code or any other information that would enable the identification of the individuals NIAID/DAIDS

  9. Data de-identification • DATA needs to de identified, and the 18 identifiers enumerated at section 45C.F.R. 164.514 (b) (2) –HIPAA privacy rule enacted in 1996 have to be removed • IRBs/Privacy Board officials of the submitting institutions are responsible for ensuring that data submission is in compliance of NIH policy NIAID/DAIDS

  10. Data Access Committee (DAC) • Adjudicating or oversight group for the GWAS policy • grants access to controlled data in dbGAP, • assures appropriate data use • Data Access Committee is comprised of individuals with different technical and ethical expertise • Users wishing access to controlled data must submit a Data Use Certification (DUC) which must be approved by the DAC committee NIAID/DAIDS

  11. Data access: Who can access the data and how? • Tiered data access • Public and Authorized users • Vetting process by DAC committee and approved before given access • eRA commons ID needed for access • Foreign investigators must have eRA account or collaborate with other investigator who does NIAID/DAIDS

  12. Why do we need to share GWAS and other data? • GWAS particularly powerful for the study of common complex diseases, where the individual genetic contributions to the disease are expected to be relatively weak • GWAS most informative when the study population is large- the larger the population, the greater the statistical power to find real associations and address multiple research hypotheses… NIAID/DAIDS

  13. Data Security • Very secure • Data only released in encrypted files to authorized users • Each scientist using the data is responsible for establishing a secured facility for local use of the data NIAID/DAIDS

  14. What’s next after GWAS? New but similar NIH Policy for…. • Sequencing: Exome, Deep, Whole Genome Sequencing…… • ‘OMICS’ Era • Genomics • Transcriptomics • Proteomics ……….. NIAID/DAIDS

  15. Description of the Stored Samples Consent Template NIAID/DAIDS

  16. Fully Compliant • Meets: • 45 CFR 46.116 and 117 • 21 CFR 50.25 and 27 (if applicable) • NIH Policy for GWAS and dbGaP • DAIDS Policy • Addresses: • Best practices and future trends in genetics research • Use of samples and data in future research NIAID/DAIDS

  17. Basic Elements of Informed Consent Element 1: Involves research and describes procedures. • Describe the purpose of this study • Discover genetic changes associated with HIV/AIDS • Collection of additional (e.g. blood/body fluids/tissue) for future genetic testing, sequencing, and use in research NIAID/DAIDS

  18. Basic Elements of Informed Consent Element 2: Describes foreseeable risks and discomforts • Physical Risks • Possible side effects from drawing the blood sample include mild pain, bleeding, bruising, and infection at the site of the needle insertion • Psychological or Social Risks Associated with Loss of Privacy • Loss of privacy • Risk associated to genetic research NIAID/DAIDS

  19. Basic Elements of Informed Consent Element 3: Describes reasonably expected benefits • There may be no direct benefit • New and improved medical care, treatment and prevention of this HIV/ AIDS for others based on genetic result(s) • This study may increase overall understanding about HIV/AIDS NIAID/DAIDS

  20. Basic Elements of Informed Consent Element 4: Discloses alternatives to participating in the research • An alternative option is not to participate • Elect not to grant permission for storage of samples (e.g. blood/body fluids/tissue) • An alternative option is to withdraw consent NIAID/DAIDS

  21. Basic Elements of Informed Consent Element 5: States how confidentiality is maintained • Describe how research study data would be used, stored, and/or shared • Describe the level of confidentiality (e.g., identifiable, coded, or anonymized samples) NIAID/DAIDS

  22. Basic Elements of Informed Consent Element 6: Explains compensation and available medical treatment • Indicate what participants will receive for their participation in this study • Clearly state there will be no financial compensation for products from study related samples • If injury occurs, describe whether medical treatments are available and where further information may be obtained NIAID/DAIDS

  23. Basic Elements of Informed Consent Element 7: List contact for research related questions Element 8: States voluntariness and no loss of benefits NIAID/DAIDS

  24. Thank You! For questions contact ProPEP at NIAIDOPCROPOLICYGROUP@mail.nih.gov NIAID/DAIDS

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