Ethics

Question 1

What did Belmont report (1978) identified as central ethical themes in human subject research?

Answer 1

Autonomy
Beneficence
Nonmaleficence
Justice

A: ejaze dast khod
B: kindness
N: do not harm
J:treated fair

ABNJ

Question 2

What does each criteria in Belmont report mean?

Answer 2

Autonomy: patient right to self-governance
Allows patients to make informed, independent decisions that are free of coercion
Provider illuminates necessary facts and clarifies alternatives, as well as consequences

Beneficence: help others further their important and legitimate interests

Nonmaleficence: do no harm
Consider permitting harm ONLY when harm is unavoidable and ensures there is a corresponding benefit

Justice: equitable distribution of burden and benefit
Prevents discrimination with respect to access and service

Question 3

What are the principles of ethics?

Answer 3

Question 4

An adult patient finds out she has a pathogenic variant in BRCA and pushes her sister to also have genetic testing. You see the sister in clinic, and she decides she does not want to pursue testing, this is an example of…….

Answer 4

Autonomy

Question 5

Taking a patient outside for fresh air is an example of …..

Answer 5

Beneficence

Question 6

Sending testing for all patients to the same laboratory regardless of their insurance coverage (i.e. private vs. Medicaid) is an example of……

Answer 6

Justice

Question 7

Multiple checks to avoid a laboratory reporting error is an example of…..

Answer 7

Nonmaleficence

Question 8

What is HIPPA?

Answer 8

Health Insurance Portability and Accountability Act of 1996

Question 9

What does HIPPA cover?

Answer 9

Prohibits the use of health-related information by group health insurance plans to: deny coverage, determine eligibility, or to increase premiums

• Some cases, preexisting conditions can be excluded for up to 12 months
• Genetic information: if symptoms are absent, is not considered a preexisting condition

Question 10

What are the limitations of HIPPA?

Answer 10

• Cannot prevent higher premiums for an entire group
• Does not apply to those purchasing insurance on the open market
• Cannot stop employers from refusing to offer coverage

Question 11

What is GINA?

Answer 11

Genetic Information Nondiscrimination Act

Question 12

When does GINA signed?

Answer 12

Law signed into action on May 21, 2008

Question 13

What does GINA protects?

Answer 13

Protects individuals against discrimination based on their genetic information in health coverage and in employment.

Question 14

What GINA does not apply to?

Answer 14

• Information regarding current health status
• Information about disease if previously diagnosed and manifested
• Certain insurances: life, disability, and/or long-term care
• Individuals employed by:
  US Military, VA, Indian Health Service, Federal Employees Health Benefits
  Companies with <15 employees

Question 15

What is Rosa’s law?

Answer 15

Law states that reference to “mental retardation” must be changed to “intellectual disability” or “intellectual disabilities”

Question 16

Why gene editing is OK to use?

Answer 16

Most research is limited to somatic cells (not germline) therefore will not impact future generations

Question 17

What are the criteria for minor testing?

Answer 17

• Diagnostic needs
• Effective treatments
• Medical and/or educational intervention

Question 18

What are the ethical consideration of minor testing?

Answer 18

• Results cannot impact medical management
• Adult-onset conditions
• Disease severity

Question 20

What does minor testing arguments for and against in autonomy?

Answer 20

Autonomy

Arguments for
* Parental rights to make medical decisions for their children
Assumption: parents will make the right decision
* Parental coping with medical and psychological impacts of knowing
* Children under the age of 18 consent/assent to testing on their own? Does not allowing them to have testing remove their right to know?
* Child empowerment to take a larger role in their health, increasing adherence

Arguments against
* One of the strongest arguments against genetic testing in minors is that it disregards their future decision-making capacity and confidentiality
Not testing a minor (through consent of their parent) allows the child to decide for themselves if they want testing
Child should be able to choose if they want their parents to know results of their testing
* Discrimination for disability or life insurance?

Question 21

What does minor testing arguments for and against in beneficence?

Answer 21

Beneficence

Arguments for
* Knowledge of at-risk status positively affects body image and self-esteem.
* Decrease anxiety and risk for depression by early/healthy coping skills
* Reduce parental anxiety
* Earlier testing allows more adjustment time
* Begin future life planning

Arguments against
* There is no benefit to testing children for adult-onset conditions if no medical intervention is available

Question 22

What does minor testing arguments for and against in nonmaleficence?

Answer 22

Nonmaleficence

Argument against
* Avoid psychosocial harm of the minor
* Avoid changes to relationships
Is the parent-child bond at risk?
How would survivors guilt impact siblings’ relationships during this formative period?

Question 23

What is incidental findings?

Answer 23

Any genetic result that is NOT related to the primary reason for genetic testing but has:

• Medical significance
• Legal significance
• Reproductive implications
• Social/emotional implications

Question 24

What are the points to consider with incidental findings based on ACMG policy statement?

Answer 24

ACMG Policy Statement (2013)

• Clinical laboratories to analyze/report variants in any of the 57 listed genes thought to be clinically actionable
  ACMG secondary findings v3.1 list: 90 genes
• Recommendations are not all evidence-based
• Follow-up to review the controversy surrounding recommendations
  Patient autonomy, incidental findings in children, clinical laboratory considerations, result communication, and prediction of disease likelihood
  Need for pre-test counseling and ability to opt-out