StemCell Therapy

Genetic Discrimination

Many Americans fear that participating in research or undergoing genetic testing will lead to them being discriminated against based on their genetics. Such fears may dissuade patients from volunteering to participate in the research necessary for the development of new tests, therapies and cures, or refusing genomics-based clinical tests. To address this, in 2008 the Genetic Information Nondiscrimination Act was passed into law, prohibiting discrimination in the workplace and by health insurance issuers. In addition, there are other legal protections against genetic discrimination by employers, issuers of health insurance, and others.

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GINA protects Americans from discrimination based on their genetic information in both health insurance (Title I) and employment (Title II). Title I amends the Employee Retirement Income Security Act of 1974 (ERISA), the Public Health Service Act (PHSA), and the Internal Revenue Code (IRC), through the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as well as the Social Security Act, to prohibit health insurers from engaging in genetic discrimination.

GINA prohibits issuers of health insurance from discrimination on the basis of the genetic information of enrollees. Specifically, health insurance issuers may not use genetic information to make eligibility, coverage, underwriting or premium-setting decisions. Furthermore, issuers may not request or require individuals or their family members to undergo genetic testing or to provide genetic information. As defined in the law, genetic information includes family medical history and information regarding individuals' and family members' genetic tests.

The regulations governing implementation of GINA in health insurance[hhs.gov]took effect on December 7, 2009 and are implemented by the Internal Revenue Service, Department of Labor, and Department of Health and Human Services. GINA amends HIPAA to clarify that genetic information is health information and provides a finalized rule [hhs.gov] that went into effect March 26, 2013.

GINA prevents employers from using genetic information in employment decisions such as hiring, firing, promotions, pay, and job assignments. Furthermore, GINA prohibits employers or other covered entities (employment agencies, labor organizations, joint labor-management training programs, and apprenticeship programs) from requiring or requesting genetic information and/or genetic tests as a condition of employment. Theregulations [gpo.gov] governing implementation of GINA in employment took effect on January 10, 2011 and are implemented by the Equal Employment Opportunity Commission (EEOC).

GINA has implications for individuals participating in research studies. The Office of Human Research Protections (OHRP) within the Department of Health and Human Services has issuedguidance on integrating GINA into clinical research, including information on GINA's research exemption, considerations for Institutional Review Boards, and integrating information on GINA into informed consents.

Informed Consent Forms To comply with GINA, informed consent forms should include information on any risks associated with participation in the research project and a statement describing how the confidentiality of records will be maintained. NHGRI has developed guidance for informed consent forms for participants in genomics research.

Follow this link:
Genetic Discrimination - Genome.gov

This entry was posted on May 19, 2015 at 6:49 pm and is filed under Legal Issues Genetic Medicine. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |