ELSI Flashcards
1
Q
Roe v Wade
A
- abortion decision based on viability (24w) and right is based on right to privacy/autonomy
- states can’t make laws forbidding abortion prior to viability
2
Q
Planned Parenthood v Casey
A
- allowed states to institute several restriction under “undue burden” test
- permissible restrictions: waiting periods, parental notification, restrictions of public funding
- undue burdens: life of mother, spousal consent
3
Q
TRAP Laws
A
- Targeted Restrictions of Abortion Providers
- doctors that practice must have admitting privileges in hospitals within 30 miles, and others
4
Q
“Script Laws”
A
mandatory counseling required when someone elects to have an abortion that may spread inaccurate information
5
Q
Dickey-Wicker Case
A
no federal funding for work in which embryos created, destroyed, or put at risk
6
Q
Moral Behaviors
A
influenced by personal values or belief system
7
Q
Ethical Behaviors
A
influenced by deliberate consideration and may utilize professional standards
8
Q
Professional Codes/Standards
A
provide guidance but are not binding
9
Q
2 Ethical Theories of Genetic Counseling
A
- Ethic of care: based on value of interpersonal relationships
- Principle-based ethics: moral reasoning and analysis; core principles of autonomy, beneficence, nonmaleficence, and justice
10
Q
Ethical Issues in Research
A
- privacy, data sharing, and interest of family
- return of results
- commercialization issues
- multiple uses of samples
- withdrawal from research
11
Q
Nuremburg Code
A
- list of ethical precepts for research
- attempted to define how one does research ethically with human subjects
12
Q
Components of Ethical Research
A
- voluntariness (informed consent)
- experiment should yield results for the good of society and should not be unnecessary
- animal experimentation should have already been done (if applicable)
- reduce risk, pain, suffering
- death or disabling injury should not occur
- degree of risk taken should not exceed benefits
- appropriate facilities and resources that protect experimental subjects
- person conducting research should be qualified to do so
- subjects can always withdraw
- must be willing to suspend research if in best interest
13
Q
Tuskegee Syphilis Study
A
- study of African American sharecroppers, 2/3 had syphilis
- attempt to see natural history of disease but subjects were poor, isolated, and uninformed about what was going on; were not treated
- study created outrage and distrust of medical community
14
Q
Willowbrook
A
- institution for children with DD/ID
- children purposely exposed to hepatitis to see course of disease and how inoculation worked
- caused harm to a vulnerable population
15
Q
U.S. Experiments in Guatemala
A
- deliberately exposed subjects with STIs
- subjects included prisoners, soldiers, prostitutes, mental patients
- attempted to study ability of penicillin to prevent/treat infection but no useful information obtained
16
Q
Common Rule
A
- federal policy for human research subjects protection
- sets up IRB and its format/function
- provides additional protections for vulnerable populations (children, prisoners, pregnant women and fetuses, individuals with impaired decision making)
17
Q
Clinical Equipoise
A
- question in equipoise generally in doubt
- equally likely that one outcome is true or other true
- in absence of equipoise, other, less preferable approaches may be used to compare alternatives
18
Q
Therapeutic Misconception
A
- patients may assume that participating in research is in their best interests
- patients may feel that agreeing to participate is a quid pro quo for receiving treatment
19
Q
Autonomy
A
- respect for this based on recognition of intrinsic value of each individuals
- confidentiality (except for mandatory reporting for NBS, communicable disease, birth defects, child abuse)
- truth telling
- voluntariness
- informed consent (full disclosure, establishing capacity)
20
Q
Decision-Making Capacity for Minors
A
- cannot give consent but must give assent
- exception is emancipated minor (pregnant, financially independent, married)
21
Q
Decision-Making Capacity for Mentally Ill
A
- not permanently incapacitated
- may temporarily lose capacity due to mental illness but can regain it
22
Q
Beneficence
A
- professional acts in best interests of patient
- required to do good
- balanced against paternalism
23
Q
Nonmaleficence
A
- restrictions on behavior as opposed to actions that promote behavior
- protects individuals, do no harm
24
Q
Justice
A
- societal interests, access, opportunity
- fair and equal, especially as it related to access to care and allocation of resources
25
Q
HIPAA
A
- restricts transfer of personal medical information without permission and transparency to ensure privacy and security of health data
- PHI = name, address, phone numbers, SSN, date of birth/death
26
Q
Duty to Warn
A
- potential breach of confidentiality
- must be serious, forseeable, imminent, actionable (not many cases in genetics reach this high bar)
- duty to warn relatives fulfilled by informing patient
27
Q
Duty to Recontact
A
- important to establish terms/limitations with patient in advance
- if variant reclassified that does not change medical management, less of burden to recontact
- if benign>path or path>anything else, high burden of recontact
28
Q
How Long to Keep Records
A
7-10 years
29
Q
How Many Days to Complete Chart Documentation
A
15 days
30
Q
Presymptomatic Testing
A
- reasons to test: intervention, long-range planning, alleviation of uncertainty, research
- reasons not to test: predictive uncertainty, psychological harm, discrimination in employment/insurance
- right not to know
31
Q
Genetic Testing in Minors
A
- criteria for childhood testing: diagnostic purposes, effective treatment, medical/educational interventions
- ethical concerns arise when results cannot impact medical management, onset of condition in adulthood, severity of disease
- reasons to test: autonomy (parents rights, promote adolescence), beneficence (reduce anxiety, positive effect on family, life planning)
- reasons not to test: nonmaleficence (poor body image, feelings of unworthiness, shame/fear, change in family relationships), autonomy (future decision-making, confidentiality), nonmaleficence (tenet of do no harm, no immediate medical benefit)
- where possible, testing should be deferred to allow for informed consent rather than surrogate decision-making
32
Q
Prenatal Testing
A
- subset of testing minors and may include tests not medically relevant to birth
- termination is an option
- testing controversial when parents disagree, test reveals parental gene status, parents test for less serious/later onset conditions
33
Q
Code of Ethics
A
- nonbinding code that may be superseded by state/federal laws
- presents the moral obligations deduced from the kinds of activity in which the members of the profession are engaged
- rational and systematic ordering of principles, duties, rules, and virtues characteristic of profession and intrinsic achievement of ends to which profession dedicated
- expresses duties and goals through rules as well as ideals toward which to strive
34
Q
NSGC Code of Ethics - Genetic Counselors and Themselves
A
- genetic counselors value professionalism, competence, integrity, objectivity, veracity, dignity, accountability and self-respect in themselves as well as in each other
- goal for GC is being best resource possible within relationships
- need to be prepared, standard of practice, truth-telling, taking care of oneself/having self-awareness
35
Q
NSGC Code of Ethics - Genetic Counselors and Their Clients
A
- the counselor-client relationship is based on values of care and respect for the client’s autonomy, individuality, welfare, and freedom in clinical and research interactions
- goal is to provide best qualitative and quantitative care and services for clients
- appropriate/efficient/prompt services, referring clients when unable to support them, confidentiality, placing client’s best interests first
36
Q
NSGC Code of Ethics - Genetic Counselors and Their Colleagues
A
- the genetic counselors’ professional relationships with other genetic counselors, trainees, employees, employers and other professionals are based on mutual respect, caring, collaboration, fidelity, veracityandsupport
- goal is to maintain/improve quality of genetic services and professional development through relationship with colleagues
- peer support, encouraging ethical behavior, respect for other professionals, supervision, professional and personal boundaries
37
Q
NSGC Code of Ethics - Genetic Counselors and Society
A
- the relationships of genetic counselors with society include interest and participation in activities that have the purpose of promoting the well-being of society and access to genetic services and health care; these relationships are based on the principles of veracity, objectivityandintegrity
- participation as concerned citizen and as a professional, keeping up to date with genetics, principle of justice, laws and regulations
38
Q
Genetic Discrimination
A
- insurance: denial of coverage including health, life, disability, long-term care
- employment
39
Q
Genetic Information
A
- genetic tests
- genetic tests of family members
40
Q
Non-Genetic Information
A
- sex/age
- routine tests (i.e cholesterol tests)
- analysis of infectious agents
41
Q
Regulators of Genetic Testing
A
- CLIA: quality standards for laboratory testing, analytical validity only
- FTC: false or misleading advertising
- FDA: regulation of test kits, lab-developed tests (“medical devices”), approval of algorithms
- states
42
Q
Genetic Discrimination
A
- using genetic information to treat individuals differently or unfairly
- insurance: denial of coverage including health, life, disability, long-term care
- employment
43
Q
Genetic Information
A
- genetic tests
- occurrence of disease in family members (4th degree relatives)
- genetic tests of family members
- participation in research involving genetic testing
- participation in education and genetic counseling
- genetic profiles of tumors
44
Q
Non-Genetic Information
A
- sex/age
- routine tests (i.e cholesterol tests, blood counts, LFTs)
- analysis of infectious agents
- tests of metabolites or proteins directly related to a disease
45
Q
Principles
A
sources/guides for values, rules, duties, and rights
46
Q
Values
A
priorities that are thought to be important and desirable
47
Q
Rules
A
specific guidelines of what should/should not be done
48
Q
Ideals
A
goals to which we aspire
49
Q
Duties
A
behaviors that are defined by our professional or social role
50
Q
Virtues
A
morally and socially desirable characteristics
51
Q
Rights
A
justified claims
52
Q
Protections from Laws Before GINA
A
- Civil Rights Act: protections in workplace if employer discriminated based on genetic trait strongly related to particular ethnic group
- Americans with Disabilities Act: prohibits discrimination against individuals with disabilities (including those with genetic disorder) but no protections in unexpressed genetic conditions
- HIPAA: prohibits use of health-related information by group health insurance plans to deny coverage/determine eligibility/raise premiums for individual (whole group may be charged higher premium)
- Executive Order 13145: prohibited workplace genetic discrimination in federal departments and agencies
- State Laws: various levels of protection
53
Q
GINA - Title I
A
- Health Insurance: insurer cannot require an individual to provide genetic information or information on family member for eligibility/coverage/premium-setting, insurer cannot us genetic info to make enrollment/coverage decisions, cannot require individual to have genetic test, cannot request/purchase genetic information
- Research Exception:
- Exemptions
54
Q
GINA - Title II
A
- Employment:
- Exemptions:
55
Q
GINA - Title I
A
- enforced by US dept of labor, treasury, and health + human services
- Health Insurance: insurer cannot require an individual to provide genetic information or information on family member for eligibility/coverage/premium-setting, insurer cannot use genetic info to make enrollment/coverage decisions, cannot require individual to have genetic test, cannot request/purchase genetic information
- Research Exception: group health plan engaged in research may request (but not require) a genetic test for specific research activities without affecting eligibility/premiums
- Exemptions: military personnel, federal employees health benefits plan, individuals receiving care from VA, individuals receiving care from Indian Health Service, current health status (GINA does not affect health insurance based on manifested disease), discrimination in life/disability/long-term care insurances, coverage determinations (insurer can require genetic information necessary for decision-making)
56
Q
GINA - Title II
A
- enforced by equal employment opportunity commission
- applies to local and state governments and private employers with 15+ employees, labor unions, employment agencies, labor-management programs
- Employment: genetic information cannot be used for decisions regarding hiring/firing/job assignments/promotions, employers cannot request/require/purchase genetic info about family member/fetus/embryo
- Exemptions: genetic information may be collected for toxic-monitoring programs/wellness programs, unintended acquistion of information not prohibited
57
Q
T/F: GINA does not preempt more protective state laws
A
True
58
Q
Consequences of Violating GINA
A
- civil fines of $100 per violation incidence
- criminal fines up to $250,000 with 10 y in prison for violations of commercial and malicious
- individuals may pursue private litigation
