|Advocating for Genetic Information Nondiscrimination|
President George W. Bush signed the Genetic Information Nondiscrimination Act (GINA) into law on May 21, 2008. GINA prohibits discrimination against individuals on the basis of genetic information in both health insurance and employment. The Coalition for Genetic Fairness informs the GINA regulatory process, addresses the needs of stakeholders, and creates and disseminates a variety of educational materials, resources, and tools.
The Coalition for Genetic Fairness: What's New?
The consumer needs an understanding of the science, the privacy risks involved in releasing genetic information in various contexts, and the degree of legal and regulatory protection available. The Council for Responsible Genetics’ Genetic Privacy Manual is a comprehensive, electronic source of information for the consumer on these issues.
Genetic Alliance, the Genetics and Public Policy Center at Johns Hopkins University, and the National Coalition for Health Professional Education in Genetics announce the release of educational materials about the Genetic Information Nondiscrimination Act (GINA). View the press release announcing the materials.
Genetic Alliance crafted the public-oriented materials: an interactive website—www.GINAHelp.org, “GINA & You” Information sheet, and slide set for advocacy organizations. All materials are available at www.GINAHelp.org and are available in the Genetic Alliance Resource Repository.
The National Coalition for Health Professional Education in Genetics (NCHPEG) developed the materials for healthcare providers, including background documents, a discussion guide suggesting how and when to talk about GINA with patients, a teaching slide set, and case studies that describe how the law works in a variety of real-world, clinical settings. These materials are available on the NCHPEG website, at www.nchpeg.org.
All materials are available on the Genetics and Public Policy Center website.
In the November 2009 issue of Clinical Pharmacology & Therapeutics, Sharon Terry, Genetic Alliance President & CEO and Chair of the Coalition for Genetic Fairness Executive Committee, and Lynn Dressler, University of North Carolina Institute for Pharmacogenomics and Individualized Therapy, partner to explore the impact of the Genetic Information Nondiscrimination Act (GINA) on pharmacogenomics. In the article, entitled "How Will GINA Influence Participation in Pharmacogenomics Research and Clinical Testing?" Terry and Dressler discuss the inclusion of genetic services and genetic research in GINA and the role fear of discrimination has played in the advancement of pharmacogenomics research. The authors outline actions investigators and clinicians can take regarding GINA, including how to participate in the rule-making process for the health insurance and employment provisions of the law.
Access the article here.
On October 1, the Departments of Health and Human Services, Labor, and the Treasury released an interim final rule, in conjunction with a notice of proposed rulemaking and request for comments, that implements Title I, or the health insurance provisions, of the Genetic Information Nondiscrimination Act (GINA) of 2008. Under Title I of GINA and the interim final rule, group health plans and issuers of group and individual health insurance cannot deny enrollment, raise premiums, or impose pre-existing condition exclusions based upon genetic information. Health insurance issuers are also prohibited from requesting or requiring genetic information or genetic tests for underwriting or enrollment purposes. The associated notice of public comment opened a 90-day public comment period for the public to respond to the interim final rule.
Read the HHS press release here.
On February 25, the Equal Employment Opportunity Commission (EEOC) released a notice of proposed rulemaking (NPRM) for Title II of the Genetic Information Nondiscrimination Act (GINA). Title II of the law protects individuals from genetic discrimination in employment, and these provisions will be in effect in November 2009. The NPRM opened a 60-day comment period that allowed the public to provide input regarding the implementation of GINA. Utilizing model comments crafted by the Genetics and Public Policy Center, the CGF Executive Committee developed a response to the NPRM. The deadline for submitting comments to the NPRM was May 1, 2009.
Learn more about the NPRM here.
View the CGF response to the NPRM here.
On April 22, Genetic Alliance hosted an informational webinar, presented in part by the Coalition for Genetic Fairness, which provided an update on the implementation of the Genetic Information Nondiscrimination Act (GINA), highlighting recent activities surrounding the employment provisions (Title II) of the law. Presenters discussed the benefits and limitations of the law, utilizing the framework of the notice of proposed rulemaking (NPRM) released on February 25 by the Equal Employment Opportunity Commission (EEOC). Webinar participants learned how to submit comments for the NPRM to inform the regulatory process. The 60-day comment period for the public to respond to the EEOC NPRM ended May 1, 2009.
Learn more about the webinar here.
View the EEOC NPRM on Title II of GINA here.
On April 6, the National Human Genome Research Institute (NHGRI) released a fact sheet on GINA for researchers and healthcare professionals to assist in understanding how the law's protections against genetic discrimination in health insurance and employment settings impact clinical research. The resource provides an overview of GINA and its definitions, how the law will be enforced, and GINA's specific research provisions. Regarding what information about GINA should be communicated as part of the informed consent process, the fact sheet points readers to the recently released guidance on GINA for investigators and institutional review boards (IRBs) from the Office of Human Research Protections (OHRP).
View the NHGRI GINA resource for clinical research here.
View the OHRP guidance on GINA for investigators and IRBs here.
The Office of Human Research Protections (OHRP), Office of Public Health and Science announced on March 24 the release of a guidance document entitled "Guidance on the Genetic Information Nondiscrimination Act: Implications for Investigators and Institutional Review Boards." The guidance is intended primarily for investigators who conduct, and IRBs that review, genetic research as defined by GINA. The guidance document provides background information on the protections provided by GINA and discusses how those protections impact the criteria for IRB approval of research and the requirements for obtaining informed consent under the Department of Health and Human Services (HHS) regulations for the protection of human subjects.
Learn more here.
Questions about GINA? View the CGF GINA Guide here.
On February 25, the Equal Employment Opportunity Commission (EEOC) released a notice of proposed rulemaking (NPRM) for Title II of the Genetic Information Nondiscrimination Act (GINA). Title II of the law protects individuals from genetic discrimination in employment, and these provisions will be in effect in November 2009. The NPRM opened a 60-day comment period that allowed the public to provide input regarding the implementation of GINA. The Coalition for Genetic Fairness strongly encouraged individuals and organizations to engage in this policymaking process by considering the NPRM and its impact on you and your community.
Learn more about the NPRM on Title II of GINA here.
View the NPRM on the Federal Register here.
In the weeks following the December 2008 webinar entitled "GINA Implementation: What's New?", our guest speakers Susannah Baruch of the Genetics and Public Policy Center and Karen Pollitz of the Georgetown Health Policy Institute worked with the CGF to provide in-depth answers to the questions received during the webinar. The questions and answers cover various aspects of the law, including its protections in relation to direct-to-consumer genetic services, diagnosed conditions, and GINA enforcement, among other topics. Final regulations will clarify many aspects of the law, but we hope the Q&A will inspire continued dialogue and facilitate understanding of the law's impact.
View the GINA Q&A here.
On December 3, CGF and Genetic Alliance hosted an informational webinar entitled GINA Implementation: What's New? The webinar included an update on the Genetic Information Nondiscrimination Act and used the Request for Information (RFI) on Title I of GINA as an opportunity to discuss the benefits and limitations of the legislation. Furthermore, webinar participants learned how to submit comments to the RFI, which were due December 9, 2008.
Download session materials:
On October 10, the Departments of the Treasury, Labor, and Health and Human Services submitted a Request For Information (RFI) in the Federal Register, soliciting comments from the general public for Title I of GINA, pertaining to health insurers in the group, individual, and Medicare supplemental policy markets. Public comments were due December 9, 2008. The CGF undertook the process of responding to the RFI. Utilizing the comments crafted by the Genetics and Public Policy Center, (click here to view the Genetics and Public Policy Center's analysis and model comments) the members of the CGF Executive Committee developed draft comments to propose to the wide CGF membership.
View the RFI from the Departments here.
View the CGF response to the RFI here.
On November 10, the Coalition updated its online GINA resource entitled, What Does GINA Mean? A Guide to the Genetic Information Nondiscrimination Act. In addition to the outline of the legislation's protections from genetic discrimination in health insurance and employment, the updated guide includes new examples and resources to facilitate discussion about GINA and its impact. The Coalition encourages individuals to utilize the guide to answer general questions, and organizations are welcome to put the guide on their websites, link to it, or adapt and customize it to your communities. The Coalition will continue to release updates to the online and print versions of the guide as information about GINA's implementation and impact are clarified through the regulatory process.
View the Online Guide.
View a print version of the Guide.
Please contact Sharon Terry at firstname.lastname@example.org with any questions about the Coalition for Genetic Fairness and its activities.