Genetics and Privacy

Oregon Genetic Research Policy and Laws

Since 1995, Oregon has laws to protect the privacy of personal genetic information and prevent misuse of genetic information in clinical, research, employment, and insurance settings. While a number of states currently have such a law, Oregon was one of the first. The law is continually being evaluated to assure that it meets the goals of assuring privacy, preventing misuse of genetic information, and keeping the legal environment amenable for genetic research and genetic health services in the state.

The Oregon Genetic Privacy Laws (OGPLs) help protect your genetic information. These laws also look to prevent the misuse of genetic information.

Current Oregon Laws and Information

• History of Oregon's Genetic Privacy Law (pdf)
• Oregon Administrative Rules (OAR) 333-025-0100 through 333-025-0165
• OAR 333-025-0140, Appendix 1 EXAMPLE Consent Form, Obtaining Genetic Information (pdf)
• OAR 333-025-0165, Appendix 2 EXAMPLE Notification and Opt-out Statement and Form (pdf)
• Oregon Genetic Privacy Laws and Statutes (pdf)
• Genetic Privacy and Research: Fact Sheet for Health Care Consumers (pdf)
  • En español: Hoja Informativa Para Usuarios de Atención Médica Privacidad Genética e Investigación (pdf)
• 2005 Legislative Changes in Oregon's Genetic Privacy Law-Fact Sheet for Health Care Providers - Opt out Provision for Genetics Research (pdf)

Federal Laws

There are also federal laws that help protect your genetic information. These laws also look to prevent the misuse of genetic information.

• The Genetic Information Nondiscrimination Act (GINA) is a federal law that makes it illegal for the following to discriminate against an individual based on their genetic information, including family history:
  • Health insurance companies
  • Group health plans
  • Employers of more than 15 employees

• The Americans with Disabilities Act of 1990 (ADA) is a federal law that makes it illegal to discrimination against a person:
  • Who is regarded as having a disability
  • With symptomatic genetic disabilities
  • With a genetic predisposition

• The Affordable Care Act (ACA) is a federal law that establishes “guaranteed issue,” meaning:
• Issuers offering insurance in either the group or individual market must provide coverage for all individuals who request it.
• Issuers of health insurance are prohibited from discriminating against patients with genetic diseases by refusing coverage because of pre-existing conditions.
• Certain health insurers may only vary premiums based on a few specified factors such as age or geographic area, thereby prohibiting the adjustment of premiums because of medical conditions, including genetic diseases.

• The Health Insurance Portability and Accountability Act (HIPAA) is a federal law that is not specific to genetics; rather the law has sweeping regulations governing all personal health information. This law:
• Applies to employer-based and commercially issued group health insurance, and:
• Prohibits group health plans from using any health status-related factor, including genetic information, as a basis for denying or limiting eligibility for coverage or for increasing premiums
• Limits exclusions for preexisting conditions in group health plans to 12 months and prohibits such exclusions if the individual has been covered previously for that condition for 12 months or more
• States explicitly that genetic information, in the absence of a current diagnosis of illness, shall not be considered a preexisting condition.
• Protects medical records and other personal health information maintained by health care providers, hospitals, health plans, health insurers and health care clearinghouses, and:
• Limits the nonconsensual use and release of private health information
• Gives patients’ rights to access their medical records and to know who else has accessed them
• Restricts most disclosure of health information to the minimum needed for the intended purpose of establishing criminal and civil sanctions for improper use or disclosure
• Establishes requirements for access to records by researchers and others

Resources related to federal genetics laws:

• "What Does GINA Mean: A Guide to the Genetics Information Nondiscrimination Act" (pdf)
  This document, written by the Coalition for Genetic Fairness (geneticfairness.org), provides guidance for individuals, employers, health care providers, and health insurers on the new federal law.
• H.R.493: Genetic Information Nondiscrimination Act of 2008 (pdf)
• Comparison of The Oregon Genetic Privacy Statutes and GINA (pdf)
• CRS Report for Congress to GINA (pdf)
• The Genetic Information Nondiscrimination Act of 2008 (pdf): Information for Researchers and Health Care Professionals, Department of Health and Human Services, April 6, 2009
• Guidance on the Genetic Information Nondiscrimination Act (pdf): Implications for Investigators and Institutional Review Boards, Department of Health and Human Service, April 6, 2009

Advisory Committee on Genetic Privacy and Research (ACGPR)

In 2001, the Oregon Legislature established the Advisory Committee on Genetic Privacy and Research (ACGPR) to provide ongoing review and guidance on genetic privacy and research issues for the legislature and the Oregon Health Authority, the agency in charge of overseeing the implementation of the genetic privacy law. The committee, which meets bi-monthly, is made up of researchers, biotechnology and pharmaceutical representatives, public health representatives, health care providers, insurance regulators, civil liberties and privacy advocates, consumers, educators, and ethicists.

• Authorizing Statute (pdf)
• ACGPR Member Roster (pdf)
• Report on Genetic Exceptionalism, 2005 (pdf)

ACGPR Guidelines

• Participation: Guests are welcome to participate in our discussions, but please note: Depending on the length of discussion and our agenda, the Chair may ask guests to refrain from participation during some periods.
• Invitations: If you are a member of the committee and are inviting a special guest to participate or present on a particular topic, please notify the ScreenWise Genetics program by calling 971-673-0273, or emailing summer.l.cox@dhsoha.state.or.us. Please also be prepared to introduce your invited guest briefly during introductions.
• Voting: This committee is composed of members that, depending on the agenda, may need to vote. If voting occurs, then only members (or their alternates) may vote.

Legislative Reports

Each biennium, the Advisory Committee on Genetic Privacy and Research is required to develop a report for the legislature on its activities and recommendations.

• 2013 ACPGR Legislative Report (pdf)
• 2011 ACPGR Legislative Report (pdf)
• 2009 ACGPR Legislative Report (pdf)
• 2007 ACGPR Legislative Report (pdf)
• 2005 ACGPR Legislative Report (pdf)

Institutional Review Board (IRB) Resources

The 2001 law required Oregon to develop a registry of all institutional review boards that review genetic research in Oregon. The purpose of this registry is to allow for sharing of information and education related to the genetic privacy law and rules. IRBs that are registered with the federal Office for the Protection of Human Research Subjects will be registered automatically.

• IRB Registration Form (pdf)
• Factsheet for IRBs and Researchers (pdf)