Consent and Confidentiality in Genetics
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Transcript Consent and Confidentiality in Genetics
Sonia M. Suter, M.S., J.D.
Assoc. Prof. of Law
George Washington University
Consent
Informed
Consent
Wrongful
Birth/Life
Privacy
and Confidentiality
Confidentiality
Exceptions
Medical
“Every adult human of adult years and sound
mind has a right to determine what shall be done
with his own body.” (Cardozo, 1914)
Ethical
Underpinnings
Bodily Integrity:
treatment requires patient’s consent
Right to control access to one’s physical space
Autonomy/Self-Determination
Right to make decisions for and about oneself
Response to paternalism
Battery
A claim for touching without consent or legal
justification
Long common law tradition
Medical
corollary
Medical treatment requires consent
Right to refuse medical treatment
“Inferred/assumed” constitutional liberty
interest
Limited
physical invasiveness
Collecting genetic sample or medical exams
Invasiveness
is largely informational
Collecting information
Disseminating information
Common
law requires consent for invasive
procedures: testing, exams, etc.
State
statutes require consent for
Collection of DNA samples
Genetic analysis
Retention of genetic information/samples
Uses of genetic information
Disclosure of genetic information to 3d parties
Not
only is consent required for medical
intervention/treatment
Consent
must be informed
Autonomy
Fosters
and self-determination
Rational Decision Making
Encourages
physicians to think carefully
about medical recommendations
Moves
from paternalism to shared decision
making
Duty
to inform patients about procedure
Duty to “satisfy the vital informational needs of the
patient” (Canterbury v. Spence, 1972)
Origins
in Battery
Requires limited disclosure: proposed treatments
No physical injury necessary
Few defenses if no consent
Movement
to Negligence (vast majority)
Broader range of disclosure requirements
Causation more difficult to prove
Usually must show physical injury
Information
Professional Standard
What a reasonable practitioner would disclose
Patient-based standard:
Information material to reasonable patient
Typical
to disclose (2 approaches)
information to disclose:
Diagnosis
Nature and purpose of treatment
Risks of treatment
Treatment alternatives
Consequences of refusal to test/treat
Physician
liable if
Fail to disclose required information
(Reasonable) patient would’ve decided
differently -- causation
AND patient suffered physical harm -- damages
Emphasis
Few
on physical risks/physical harms
cases regarding non-physical risks/harm
Not
traditional risks of invasive treatment
Exceptions: reproductive testing
Invasiveness, physical risks
Risks
are largely psychosocial
Anxiety, altered self-image
Altered family relationships
Social/group stigmatization
Discrimination
Impact on privacy and confidentiality
Several state statutes require informed consent
for genetic testing
Handful describe information to disclose for
(presymptomatic/predictive) testing
Nature and purpose of test
Effectiveness and limitations of test
Implications of taking test
Meaning of test results
Procedure of providing test results
(no information reasonable doc wouldn’t know) -- MI
Some statutes for disclosure and retention
Clear
ethical/legal duty to obtain consent for
any genetic test, physical examination
Legal
duty to disclose range of information
Diagnosis/Genetic Risk
Testing options
Nature and purpose of genetic tests
Physical risks
Consequences of not testing
What
about psychosocial risks?
Uncertainty
Limited data on psychological stress, effect on
family dynamics, risks of discrimination
Risks
depend on numerous variables
Penetrance/expressivity/severity/nature of
disease
Unclear
about degree of risk
reach of legal obligations
Statutes that mandate disclosure of “implications
of genetic testing” are vague
Common law focuses on physical risks
Duty
would be based on standard of care or
materiality of information
Causation
may be hard to show
Studies suggest concerns about discrimination
don’t influence decisions
Exceptions: some of the psychological risks
Damages
Law is highly reluctant to allow recovery for pure
emotional distress without physical harm
Goals
Enable “clients to make informed independent
decisions, free of coercion, by providing or
illuminating the necessary facts and clarifying
the alternatives and anticipated consequences.”
of Genetic Counseling
(NSGC Code of Ethics)
Decisions based on personal values and life plans
Emphasizes
informed decision making
Emphasizes independent decision making
Nondirectiveness: goes beyond IC
Nondirectiveness
avoids prescriptiveness
At
the extreme, may not answer question
“what would you do?”
Extreme
nondirectiveness may conflict with
self-determination and informed consent
Prevents coercion regarding actual decision
But prescribes manner of decision making and
Prevents access to information patient believes
would help with the decision
“Cousins” of Informed Consent
Wrongful birth:
parents sue for lost chance to avoid birth of child
Wrongful life:
Claim for failure to disclose reproductive risks, which
limits reproductive options
child sues for lost chance to have birth prevented
Liability if
Breach of standard of care by not providing
information about reproductive risks and
Lack of information prevents patients from avoiding
conception or terminating pregnancy
Wrongful
Fewer than 10 states prohibit these claims
Usual damages:
Extraordinary costs/costs of delivery
Less typical damages
Emotional distress, ordinary costs of raising the child
Wrongful
birth claims widely recognized
life claims rarely recognized
Only 4 states: NJ, CA, WA, ME
Damages limited to extraordinary costs
Claim
for termination based on inaccurate
diagnosis of abnormality
Subject
Far
of only a handful of judicial opinions
less likely basis of lawsuit than wrongful
birth claim
Failing to identify prenatal conditions can lead
to wrongful birth claims
Incorrectly diagnosing a condition that leads to a
termination is not likely to result in a wrongful
termination claim
Best defense against wrongful birth claim is not
only to offer a test, but TO test
.:. Strong incentive to PUSH prenatal testing
But inconsistent with goals of genetic counseling
Different
from (informed) consent
But
based on overlapping concerns and
interests of autonomy and self-determination
Privacy
and confidentiality are not precisely
the same, overlapping rights
Control
Right
over personal information
to be let alone
Control
over one’s physical person
Protection
of disclosed information
(confidentiality)
“Cousin”
of Privacy
It’s relational
Protects information disclosed in confidence
Physician
must not reveal sensitive
information without patient’s consent
Fiduciary obligation – relationship of trust
Longstanding
medical ethical obligation
Hippocratic Oath -> Code of Medical Ethics AMA
Privacy
is infringed by unauthorized access to
information
Confidentiality
infringed when person in a
confidential relationship fails to protect the
information
Good
in its own right
Protects autonomy
Space to develop and maintain self/identity
Prevents us from being misunderstood
Limits shame/stigmatization/discrimination
Necessary for intimacy
Builds trust in medical care
Encourages participation in research
Every
Tend
state safeguards medical records
to protect privacy by entity
Protections depend largely on who possesses info
Few state laws are intended to be comprehensive
Lots
of Variation
Protects individually identifiable health
information, in any form, electronic or nonelectronic, held or transmitted by covered entity
Individually identifiable information
relates to physical/mental health or condition
Provision of or payment of health care
Includes genetic information
Covered entities
Health plans
Health care clearinghouses
And health care providers
Ensures
Allows review and requested amendments
Covered
patient access to medical records
entities must
Provide patients with information about privacy
rights
Adopt written privacy provisions
Safeguard patient records
Sets
national “floor” of privacy standards
Most courts recognize legal duty to preserve
patient confidentiality
Some base on invasion of privacy (tort)
Others distinguish where obligation of secrecy, a
fiduciary duty
Additional bases for duty:
Testimonial privilege
licensing statutes
implied K
Etc.
Genetic
information is personal/intimate
Influences physical, psychological traits
Reveals information about family members
Much of it is hidden
Potentially
sensitive information
May predict susceptibility to disease
Can be misunderstood/ history of abuse
Can be basis of discrimination or stigmatization
Fear of discrimination can undermine health care
and research
Over
30 states address the issue
Great variation
Tend
to focus on information, as opposed to
specific entity or use
Protect
information at different stages:
From information gathering to dissemination
Some
require personal access to one’s info
Require
To obtain genetic information
To retain genetic sample or information
(written and/or informed) consent
Description of information retained
Potential uses and limitations
For disclosure of genetic info to 3d party
Purpose for which information being requested
Information to be disclosed
Individuals/entities making disclosure
To whom disclosure made
Broad
definition of genetic information (GI):
Genetic information about individual and family
Genetic information shall be treated as health
information as described in HIPPA
Focus
is primarily on nondiscrimination
Confidentiality
provision
GI must be treated as confidential
Must be kept separate from employment records
as required by American with Disabilities Act
Confidentiality is not absolute principle
Exceptions where “necessary to protect the welfare
of the individual or of the community.”
(AMA Code of Ethics)
Legal duty is not absolute
May breach without liability (discretion to warn)
To protect public health/ family members
Contagious diseases
Sometimes duty to breach confidentiality
Duty to report communicable diseases, gunshot wounds,
evidence child neglect/abuse, etc.
Duty to warn identifiable 3d party of risk of psychopath
Legislative
exceptions to privacy protections:
Diagnosis, treatment
Newborn screening
Law enforcement
Court order
Paternity testing
Anonymized research
Etc.
Exceptions
to confidentiality within doctorpatient relationship?
Patient won’t disclose genetic risk to relative
Client has gene for late-onset condition
E.g., Huntington disease gene, inherited thyroid
carcinoma
50% risk children will inherit condition
Existing condition, hidden genetic component
E.g., testicular feminization syndrome
25% risk to patient’s female cousins
Risks of prenatal abnormalities
E.g., inherited balanced translocation
50% risk sibs will have translocation
Different
kinds of risks from usual exceptions
to confidentiality
Risk to others is not created by patient
Not contagious disease, psychopath
Patient’s
refusal to share information doesn’t
create risk
Genetic risk already exists
Patient actions make it difficult to warn relative
BUT
relative might benefit from information
Strong
bias in favor of confidentiality
Right and responsibility of patient to determine
who shall access his/her information (NSGC)
Privilege
but no duty to warn relatives when
Attempts to encourage patient disclosure fail
Harm is serious, imminent, and foreseeable
The at-risk relative is identifiable
Disease is preventable
Harm of not disclosing > harm of disclosing
Very
(ASHG)
hard to meet all of these conditions
Pate v. Threlkel (1995- Florida)
Duty to daughter of patient – AD thyroid cancer
Foreseeable risk and benefit of knowledge
BUT duty fulfilled by informing patient of risk
NO duty to seek out and warn relatives
Safer v. Pack (1996 – NJ App.)
Duty to daughter of patient with colon cancer
Immediate family, avertable risk
Refused to decide limits of duty
Requires reasonable steps to insure info reaches those
at risk
Tension: duty to warn and confidentiality
Many
norms of genetic counseling consistent
with legal obligations
Consent, Informed consent
Privacy and Confidentiality generally
Unresolved
area: confidentiality concerns v.
risks to uninformed relatives
Professional guidelines might conflict with legal
obligations (discretion v. duty to warn)
Education, discussion with patient goes long way
toward dissolving dilemma