May 17, 2019
Breakthroughs in genetics have often raised complex ethical and legal questions, which loom ever larger as genetic testing is becoming more commonplace, affordable, and comprehensive and genetic editing becomes poised to be a consumer technology. As genetic technologies become more accessible to individuals, the ethical and legal questions around the consumer use of these technologies become more pressing.
As these questions become more pressing, now is the time to re-consider what ethical and regulatory safeguards should be implemented and discuss the many questions raised by advancements in consumer genetics.
Presentation: Vardit Ravitsky, Associate Professor, Bioethics Programs, Department of Social and Preventive Medicine, School of Public Health, University of Montreal; Director, Ethics and Health Branch, Center for Research on Ethics - Prenatal Genome Sequencing: Ethical and Regulatory Implications for Post-Birth Access to Information
Learn more: https://petrieflom.law.harvard.edu/events/details/2019-petrie-flom-center-annual-conference
💚😋Kolkata Escort Service Call Girls, ₹5000 To 25K With AC💚😋
Vardit Ravitsky, "Prenatal Genome Sequencing: Ethical and Regulatory Implications for Post-Birth Access to Information"
1. Prenatal genome sequencing:
Ethical & regulatory implications
for post-birth access to information
Vardit Ravitsky, PhD
Bioethics Program, University of Montreal
@VarditRavitsky
May 17th, 2019
3. What is Non-Invasive Prenatal Testing (NIPT)?
Tests cell-free fetal DNA floating in maternal plasma
At 9-10 weeks gestation, ~10-15% of cffDNA comes from placenta
cffDNA clears from woman’s blood within 2 hours after
birth, ensuring tested DNA is from current pregnancy
4. What makes NIPT unique?
Easy – just a blood test
Safe – no associated risk of pregnancy loss (miscarriage)
Early – week 9-10 (amnio starts at 15)
Reliable – screening test, but for certain conditions
(e.g. trisomy 21) ‘quasi-diagnostic’
Commercial offer – introduced by private companies
Expansion – used for a growing number of conditions
5. What can NIPT currently test for?
Fetal sex (for x-linked conditions)
Blood type
Trisomy 21, 13, 18
Other (more rare) trisomies
Sex chromosome abnormalities
Autosomal single-gene disorders
Micro-deletion syndromes
Technically: whole genome sequencing (NIPW)
7. What makes NIPT unique?
Invasive testing - only carried out for conditions ‘severe
enough’ to justify the risk of miscarriage
Safety & timing of NIPT may lower the threshold for
‘appropriate testing’
Individuals may wish to test for -
less severe / treatable conditions
late-onset conditions
non-medical information such as sex and paternity
physical or even cognitive / behavioral traits
8. What does the future hold?
Ultrasound made the uterus transparent
and revolutionized our perception of
the fetus
Whole genome NIPT could make
the fetus itself ‘transparent’
9. Ethical and social issues surrounding NIPT
Focused on testing as a ‘search and destroy mission’
the assumption of termination
Concerns regarding routinization
On individual level:
erosion of counseling an consent
increased pressure to test and terminate
On societal level:
Eugenics, threat to diversity, to disability rights
increased stigma and discrimination
10. Ethical and social issues surrounding NIPT
However, if prenatal testing is based on the notion of
informed choice
not of ‘search and destroy’
then preparation for birth is a good reason to test
Yet, issues related to post-birth challenges have been
only marginally addressed in bioethics
11. What happens post-birth if parents use NIPW?
Issues arise regarding:
Privacy
Right to an open future
Right not to know
Consent
Potential harms:
Family level (dynamics, psychological issues)
Societal level (discrimination)
13. NIPW: Post-birth challenges
Existing analysis that may assist:
Genetic testing of children / minors
received ample attention
ethical analysis
professional guidelines
14. NIPW: Post-birth challenges
Existing analysis that may assist:
Genetic testing of children / minors
received ample attention
ethical analysis
professional guidelines
Newborn screening as gov-run programs
Much ethical & legal scrutiny
Now considering sequencing newborns:
the BabySeq project
15. NIPW: Post-birth challenges
Existing analysis to explore:
Genetic testing of children / minors has received ample
attention
Ethical analysis, professional guidelines
Whole-Genome Sequencing of newborns: the BabySeq
project
16. Testing a fetus, not a child
dangerous links to debate on moral status of fetus & abortion
Why NIPW is different?
17. Testing a fetus, not a child
dangerous links to debate on moral status of fetus & abortion
Reasons for testing may be unclear even to parents
possibility of using info for a termination-decision makes it difficult
to justify limiting the offer of NIPW
Why NIPW is different?
18. Testing a fetus, not a child
dangerous links to debate on moral status of fetus & abortion
Reasons for testing may be unclear even to parents
possibility of using info for a termination-decision makes it difficult
to justify limiting the offer of NIPW
Commercial context
Private offer harder to limit than gov-run programs
For-profit drive of companies to offer expanded pricier packages
Reproductive prenatal tourism
Why NIPW is different?
22. prioritizing
privacy/open-future
banning NIPW
prioritizing parental autonomy
allowing unrestricted
NIPW & post-birth use of info
normative arguments
against open future /
right not to know
unrestricted NIPW
Spectrum of possible conceptual approaches
23. prioritizing
privacy/open-future
banning NIPW
unrestricted NIPW
but limited parental
post-birth use of info
prioritizing parental autonomy
allowing unrestricted
NIPW & post-birth use of info
normative arguments
against open future /
right not to know
unrestricted NIPW
Spectrum of possible conceptual approaches
24. prioritizing
privacy/open-future
banning NIPW
nuanced approaches
based on type of
information
unrestricted NIPW
but limited parental
post-birth use of info
prioritizing parental autonomy
allowing unrestricted
NIPW & post-birth use of info
normative arguments
against open future /
right not to know
unrestricted NIPW
Spectrum of possible conceptual approaches
25. NIPW: Post-birth challenges
If we move into a future where many babies are born already
sequenced prenatally…
much genetic info will be available on individuals who never
consented to testing
legal protections against any type of genetic discrimination
would have to be strengthened
cultural change will be needed
26. “Whether we view NIPD gladly as a way
to reduce human suffering, warily as a
step towards a eugenic dystopia, or as a
mix of both,
we should agree that the better we prepare,
the more likely we are to avoid the worst
misuses of this potentially transformative
technology.”
Hank Greely, Nature 2010