Ethics - Clinical and Research Practices and GINA

What types of employers are regulated under Title 2 of GINA?

- 15 or more employees - Labor unions - Employment agencies

What is NOT defined as genetic information by GINA?

- Age - Gender - Routine labs (CBC, cholesterol, etc.) - Infectious disease tests

What are the four core ethical principles?

- Autonomy - Beneficence - Nonmaleficence - Justice

Health insurers cannot use genetic information to...

- Determine eligibility, premiums, or coverage - Cannot request or require genetic testing

What numbers associated with a person are considered PHI?

- Full zip code - Dates other than year - Phone number - SSN, MRN, account numbers - Health insurance numbers - Vehicle identifiers - Device identifiers, IP address

What are the four categories of the NSGC Code of Ethics?

- GC's and Themselves - GC's and Their Clients - GC's and their Colleagues - GC's and Society

What steps may be used to resolve an ethical conflict?

- Get the facts - Identify the principles in conflict - Resolve - review guidelines, consult committees/professionals

Employers cannot use genetic information to make decisions regarding...

- Hiring - Firing - Promotions - Position

What does GINA define as genetic information?

- Individual's genetic test - Family history of a disease (up to 4th degree) - Genetic testing of family members - Research - Participation in genetic counseling - Genotypes, polymorphisms, chromosomal changes, tumor testing

What insurances are not protected under GINA?

- Life - Disability - Long term care

What groups are exempt from Title 1 of GINA?

- Military personnell under Tricare - Federal employees - VA - Indian Health Services

What personal information/features are considered PHI?

- Name (full or last and initial) - Email address - Biometric (finger print, voice) - Full face photographs

What ethical issue are related to genomic research?

- Privacy and data sharing - Return of results - Commercialization - Withdrawal of research - Multiple sample use (i.e. using for more than one study, saving for future use, etc.)

What is an exception to Title 2 of GINA?

- Toxic monitoring programs - Wellness programs

What entities are responsible for enforcing GINA?

- US Dept of Labor - Treasury - Health and Human Services - Equal Employment Opportunity Commission

Genetic discrimination violates what laws/acts?

4th Amendment, Civil Rights Act, and Americans with Disabilities Act

What is the purpose of a position statement?

Assert beliefs held/encouraged by the society Align with Code of Ethics

Confidentiality is primarily related to what ethical principle?

Autonomy

Informed consent is related to what ethical principle?

Autonomy

Define autonomy.

Based on respect of client and their self-rule Obligates confidentiality, informed consent, and truth telling

What is the ethic of care?

Concerned with the relationship between the patient and the counselor Based on natural human caring and empathy

Many ethical dilemmas arise when there are....

Conflicting values between individuals or groups

Define nonmaleficence.

Do no harm Ex. discussing possible outcomes of choices

Title 2 of GINA relates to...

Employment

Define justice.

Equal distribution of burden and benefit; fair and equal

What theory is the primary basis of genetic counseling?

Ethic of Care

T/F: Employers can be punished for accidentally receiving an employee's genetic information.

FALSE

T/F: The Americans with Disabilities Act protects people with unexpressed genetic conditions.

FALSE

T/F: GINA's protections also apply to those with manifested genetic disease.

FALSE Only presymptomatic/carriers/fhx

T/F: Professional codes are laws that are to be legally followed.

FALSE - guidance, not legally binding

Title 1 of GINA is in regards to...

Health insurance

What is an exception to Title 1 of GINA?

If a group health plan is engaged in research, they can request genetic information Must comply with protections and requires consent

Ethics vs. Laws

Laws - set a minimum standard of conduct

Morals vs. Ethics

Moral - influenced by personal values or beliefs Ethics - influenced by deliberate consideration or reason; a process

What is the purpose of a practice guideline?

Provide recommendations on optimizing patient care Based on systemic review of evidence

What is the purpose of a code of ethics?

Provides ethical framework - duties, principles, values of GC's What professionals strive to achieve

What are principal based ethics?

There is a basis of reasoning to guide conduct Emphasis on moral reasoning and analysis

When can insurers use genetic information?

To determine coverage of genetic testing (Ex. BRCA status to determine coverage of a prophylactic mastectomy)

Define beneficence.

To do good; to act in the patient's best interest

T/F: Combinations of identifiers (ex. Mr Brown from New York) are considered PHI.

True

T/F: HIPAA prevents group insurance plans (not individual insurance plans) from discriminating against individuals with disabilities by raising premiums, etc.

True

What is genetic discrimination?

Using genetic information to treat someone differently or unfairly