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Biobanking and genomic research: Some special needs


29e Confrence internationale des commissaires la protection de la vie prive. 29e CONF RENCE INTERNATIONALE DES ... Need to rethink the construal of. consent ... – PowerPoint PPT presentation

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Title: Biobanking and genomic research: Some special needs

(No Transcript)
Biobanking andgenomic researchSome special
  • William W. Lowrance, PhD
  • (
  • September 27, 2007

Need to make clearer distinctions among the
kinds of data
  • Biobanks, major platforms of data
  • and biospecimens curated as broad resources -
    banks - for research
  • Genetic/genomic project data and biospecimen
    collections, cordoned-off
  • by research protections
  • Clinical genetic test data, held under
  • medical confidentiality

Distinctions, cont.
  • Genetic-related public-health data,
  • protected by public-health laws
  • Other sets of biological materials and derived
    data, such as forensic collections, held under
    various regimes.
  • Failure to make firm distinctions is causing
    serious confusion in dialogue and regulation!

Genetic/ genomic/ biobank exceptualism? My
view is that
  • Clinical genetic-test and related data should be
    treated like other sensitive medical data
  • But until a number of issues get sorted-out and
    reliable protections are in place, most genomic
    and research biobank data deserve special

Need to refine aspects of the whole suite of
research protections
  • - Informed consent
  • - De-identification
  • - Research-ethics oversight
  • - Safeguards
  • - Data-release policies and practices
  • - Barriers against access for
  • non-research purposes
  • - Sanctions against misuse.

Need to rethink the construal of consent
  • Traditionally, consent has been meant to be
    "fully informed"
  • But biobanking and genomic data,
  • and their risks, are very difficult for most
    people to comprehend
  • So, in consenting informed of what?

In my view, consent negotiations should inform
  • - the purposes
  • - the overall plan and any data- or
  • specimen-collecting that may involve
  • them directly
  • - the disclosure risks generally
  • - the auspices and protections that
  • make "the deal" trust-worthy
  • - anything else asked about.

Need to cope with identifiability
  • The challenge is that genomic data
  • - are extensive
  • - are very fine-grained
  • - influence many personal attributes
  • - hold implications about family
  • - are intrinsic to the body
  • - don't change during the lifetime
  • - are unique to the individual.

Identifiability, cont.
  • Whether and how to de-identify depends on the
    character of the data, the intended uses,
    consent, disclosure risks, and safeguards.
  • As an alternative or complement to
  • de-identification, controlled data-release
    should be seriously considered.

Need to improve data-release
  • For open release, must become clearer as to "how
    much" genome can be exposed without undue
    disclosure risk
  • For controlled release, must attend to the terms
    of release agreements, stewardship, security, and
  • Ref Lowrance and Collins,
  • "Identifiability in genomic research,"
  • Science 317, 600-602 (August 3, 2007).

In all of this
  • We must facilitate health research for the
    collective public good and at the same time
    protect the individuals with whom the data and
    biospecimens were, or are, associated!