ELS issues in PGx Stev

•Goals of pharmacogenetics and/or pharmacogenomics to:

•Maximize efficacy of medications and/or

•Minimize toxicity of medications

• True

• False

Field of pharmacogenetics and/or pharmacogenomics rapidly developed with  intention of clinical application of individualizing therapy:

• True

• False

There are different challenges which can impact clinical implementation of pharmacogenomics  including:

• •Ethical, legal, and social issues

• These issues can highlight risk, benefit, and public and professional acceptance of clinical implementation of pharmacogenomics

• True

• False

Ethical Issues

•Pharmacogenomic and/or genetic testing may expose individuals to genetic discrimination

•Genetic discrimination: if individual with  known genetic disorder or genetic polymorphism is treated differently by employer or insurance company

• True

• False

Ethical Issues

Pharmacogenomic and/or genetic information may be used to:

• Cancel health insurance

• Limit health insurance

• Deny health insurance

• All of the above

Ethical Issues

The Genetic Information Nondiscrimination Act (GINA) of 2008 protects from discrimination based on genetic information in both:

•Health insurance (Title I) and

•Employment (Title II)

• True

• False

Ethical Issues

The Genetic Information Nondiscrimination Act (GINA) of 2008

•Title I:

•Prohibits health insurers from engaging in genetic discrimination

•Amends through the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and Social Security Act

•Employee Retirement Income Security Act of 1974 (ERISA)

•Public Health Service Act (PHSA)

•Internal Revenue Code (IRC)

• True

• False

Ethical Issues

The Genetic Information Nondiscrimination Act (GINA) of 2008

•Title II:

•Prevents employers from:

•Using genetic information in employment decisions

•Requesting and requiring genetic information from employees or those applying for jobs

•Implemented by the Equal Employment Opportunity Commission (EEOC)

• True

• False

Ethical Issues

The Genetic Information Nondiscrimination Act (GINA) Implication in Clinical Research

GINA has implications for individuals participating in research studies

•Office for Human Research Protections (OHRP) within HHS issued guidance on integrating GINA into clinical research including:

•Information on GINA's research exemption

•Considerations for Institutional Review Boards (IRBs)

•Integrating information on GINA into informed consent forms

• True

• False

Ethical Issues

The Genetic Information Nondiscrimination Act (GINA) Implication in Clinical Research

•To comply with GINA informed consent forms should include:

•Information on risks associated with participation in research project and

•Statement describing how confidentiality of records will be maintained

• True

• False