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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
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

objectives
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

slide4

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

data deposition in dbgap
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

what is in dbgap
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

types of data in dbgap
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

data sharing
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

data de identification
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

d ata a ccess c ommittee dac
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

data access who can access the data and how
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

why do we need to share gwas and other data
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

data security
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

what s next after gwas new but similar nih policy for
What’s next after GWAS? New but similar NIH Policy for….
  • Sequencing: Exome, Deep, Whole Genome Sequencing……
  • ‘OMICS’ Era
  • Genomics
  • Transcriptomics
  • Proteomics ………..

NIAID/DAIDS

fully compliant
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

basic elements of informed consent
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

basic elements of informed consent1
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

basic elements of informed consent2
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

basic elements of informed consent3
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

basic elements of informed consent4
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

basic elements of informed consent5
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

basic elements of informed consent6
Basic Elements of Informed Consent

Element 7: List contact for research related questions

Element 8: States voluntariness and no loss of benefits

NIAID/DAIDS

thank you
Thank You!

For questions contact ProPEP at NIAIDOPCROPOLICYGROUP@mail.nih.gov

NIAID/DAIDS