MultiIC Symposium II Application of Genomic Technologies to PopulationBased Studies

1
Multi-IC Symposium IIApplication of Genomic
Technologies to Population-Based Studies

• Panel 5
• Informed consent and institutional approvals

Department of Health and Human Services National
Institutes of Health
2
Panelists Group 5 Consent

• Richard Fabsitz NHLBI
• Kat Gwinn NINDS
• Bob Hoover, NCI
• Dan Levy, NHLBI
• Marcelle Morrison-Bogorad NIA
• Tony Phelps, NIA (in absentia)
• Laura Rodriguez, NHLBI (in absentia)
• Steve Sherry NCBI

Department of Health and Human Services National
Institutes of Health
3
Suggestions from Last Year

• Centralized IRBs? Or standardized language?
• FAQs for genetics/genetic epidemiology
  specifically?
• Sample consent language elements

Department of Health and Human Services National
Institutes of Health
4
What We Are (and arent) Talking About

• Discussing Today
• Consent and Approval Process in Context of
  Sharing Phenotypic and Genotypic Data
• in the trenches
• practical approaches
• Experiences
• Goal sample elements for WGAS
• (Not today GWAS or DHHS policy and guidelines
  being developed in other forums)

Department of Health and Human Services National
Institutes of Health
5
DbGaP Experiences

• Multiple levels of Permissions
• Given disease only
• Any disease of that broad category/in same organ
• Any disease
• Future Studies
• Allowed in some, not in others
• Collapsed to two groups
• That disease category only
• Broadly (any disease)

6
GAIN Experience

• The TAG noted five areas that were of major
  importance re whether project could be included
  in GAIN
• Disease restrictions
• Any other restrictions (need to re-consent to
  share, inform if findings)
• Adequacy (genetics mentioned, future use,
  sharing)
• Withdrawal promises
• Commercial use

7
Other IC Experience

• Layered consent requires heavy documentation,
  tracking, and inefficiencies
• Do subjects really prefer them?
• Model Consent Forms very useful within a
  consortium (such as ADRC)
• Centralized Repositories for data and
  biologicals, facilitate sharing, uniform policy
• Moving Target
• As we learn what doesnt work, changes are made

8
Questions

• How do we manage older consents, on archived
  materials or data?
• How do we avoid silo-ing collections as occurs
  with multiple projects/variable consents?
• What should be the triggers for re-consent vs.
  consulting IRB vs. finding acceptable?
• How do we inform PIs of changes in needed consent
  form language (Type 5?)?
• What else do PIs need to help guide them forward
  in this process?

9
Model Consent or Sample Language?

• Sample consent
• useful to IRBs to allow standardization
• Decreases the broad variability in IRB review of
  documents (Multi IC mtg I)
• BUT decreased local flexibility, may not always
  be appropriate for certain study
• Sample language
• More adaptable to a variety of studies
• ? International studies?

10
Straw PersonSample Consent Elements

• Not disease or organ specific
• this sample and associated data will be used to
  study many medical conditions (and normal
  variations)
• Shared broadly
• This sample and associated data may be shared
  with a number of investigators after all
  identifying information is removed
• Discuss genetics
• Genetics studies will be done to try to
  determine what genes might increase the risk of
  some diseases in some people
• Discuss future use, sharing
• this data (these samples) may be shared with
  researchers, without any information that will
  identify you individually
• this data will be housed in a public database
• Do not promise that data will be discarded
• Comment on commercial use
• investigators from both academic (university)
  and commercial (company) organizations will have
  access to this data