Updated On Feb 25, 2022
This information is meant to be used for educational purposes to inform providers, patients, and genetic service delivery stakeholders about genetics policy topics. Sharing of information, resources, or policy statements is no way an endorsement of stated positions by NCC.
Genetic research is an expanding field. Genetic studies can help scientists understand how genes can cause or influence diseases. Some areas of genetic research include: genetic testing, gene therapy, reproductive genomics, and pharmacogenomics. Genetic research can have implications for the patient in the study, their families, and their communities.
In the early 1900s, there were no regulations regarding the ethics of using human research participants in research studies. During WWII, there were many instances of German scientists who committed war crimes and crimes against humanity in the name of research. In the United States, the US Public Health Service withheld diagnosis and treatment from Black men in the Tuskegee Syphilis Study. These, and other cases, made it clear that human research participants needed protections. In the United States, laws and regulations have been enacted to protect human research subjects, starting with the National Research Act of 1974, which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
For a more in depth discussion of Human Subjects Research, including participation in Genomics Research, please visit the National Human Genome Research Institute’s website.
When looking specifically at human subjects participating in genetics/genomics research, some ethical questions have arising. For example:
- If a study tells all the participants in advance that they won’t get results genetic test results back, is it ethical to not release results?
- Does the specific genetic result matter? For example, it if it a mutation that has a 25% risk of causing a treatable cancer; versus a mutation that has a 90% chance of causing sudden death?
- Does the cost of returning the test result matter?
- Do researchers need to contact participants if they learn more after a study closes?
Legislation and Regulation
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