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Legal and ethical issues associated with NIPT
Transcript of Legal and ethical issues associated with NIPT
What we know about NIPT
Simpler, earlier test compared to current standard of care
Legal governance of prenatal testing techniques
Testing for medical purposes is governed by professional guidelines / standards of care
Practice and policy recommendations
No special rules needed, but policies must address unique issues posed by NIPT (simplicity and timing of test)
Largely risk free
Second tier or contingent screening tool
"No irrevocable obstetrical decision should be made in pregnancies with a positive non-invasive prenatal testing result without confirmatory invasive diagnostic testing" - SOGC
Only available as a private option
Robust informed consent and disclosure/access to information are legally and ethically required
Facilitating and supporting autonomous decision-making is key
Respect the boundaries of the technology
Timothy Caulfield, Vardit Ravitsky, Jo-Ann Johnson, Maeghan Toews, Robyn Hyde-Lay, Marianne Clark, Kalina Kamenova, Nicki Baron, Tania Bubela, Christen Rachul, Zubin Master, Erin Nelson, Christopher McCabe, HLI team
Assistant Professor, Faculties of Law and Pharmacy, University of Alberta
Subject to legal rules governing consent, privacy, access to information, etc.
Boundaries: Testing for certain medical and non-medical purposes are prohibited by law and/or socially controversial
Sex Selection Banned
Procedures that select sex of embryo or identify sex of
embryo other than for clinical purposes
But NIPT may heighten social tensions surrounding sex- selective abortions
NIPT not implicated as procedure identifies sex of embryo
Germline genetic alteration
Transmittable alterations of embryonic or adult cell genome
NIPT not implicated
Legal and ethical considerations
Disclosure and access to information
What is the scope of the legal obligation to inform the patient about NIPT?
Legal and ethical duties
Duty to inform patient of availability of NIPT
Legal and ethical duties
Duty to respect patient autonomy, especially when test becomes standard of care
NIPT and disability
Duty to act on positive result by ordering confirmatory test
Duty to refer
Duty to reveal all material information revealed by test
Can a physician withhold clinically irrelevant information revealed by NIPT from the patient?
Duty to provide counselling
Duty to facilitate free and informed consent
Duty to avoid coercion, undue pressure to make decision, etc.
Is NIPT a threat to the existence and future of persons living with developmental and intellectual disabilities?
Wrongful birth and wrongful life claims
Claim by parents of disabled child
Claim by disabled child for "unwanted life"
That negligence denied them opportunity to make informed choice regarding continuation of pregnancy
Successful claims yield damages for pain and suffering & costs of raising child
Negligence denied parents termination option
Rarely successful - claim consistently rejected by Canadian courts
Sex selective abortions