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Policy Issues

Genome editing is currently being applied to research on cancer, mental health, rare diseases, and many other disease areas.

… on cancer, mental health, rare diseases, and many other disease areas. … Basic research exploring human and nonhuman … to help scientists understand the basic biology underlying disease, as well as to discover new possible therapeutic … begin evaluating the safety of potential treatments. The risk of off-target edits, or unintended edits, and their …

Policy Issues

Participating in Genomics Research

Participating in genomics research is an opportunity to support exploration of the genome and help scientists understand, prevent, detect and treat disease.

… mission to understand, prevent, detect and better treat disease. In some cases, research participants may also gain some individual benefit, such as diagnosis of a disease or access to a treatment in development. … A wide … purpose of any study and any potential personal benefit or risk from participation. Consider the following list of …

Policy Issues

What do People Think About Genome Editing?

Patients with genetic disorders and members of the public have diverse about germline genome editing.

… patients suffering from conditions such as Huntington disease believe strongly that it should be used to prevent … gene editing for newborns that would give them a reduced risk of serious diseases during their lives. The survey noted … DNA Editing, Gene Therapy, Genetic Disorder, Genetic Disease, CRISPR-Cas9, CRISPR … Patients with genetic …

Policy Issues

Genome Statute and Legislation Database OLD

The Genome Statute and Legislation Database is comprised of state statutes and bills introduced during U.S. state legislative sessions.

… Genetic Information Non-discrimination Act, GINA, Genetic Disease, Workplace Discrimination, Laws About Genetics, Gene …

Policy Issues

What is genome editing?

Genome editing is a method that lets scientists change the DNA of many organisms, including plants, bacteria, and animals.

… lead to changes in physical traits, like eye color, and disease risk. Scientists use different technologies to do this. … … leading to changes in physical traits, like eye color, and disease risk. Scientists use different technologies to do …

The Informed Consent Resource

Special Considerations for Genomics Research

Explore genomics-relevant considerations for informed consent and guidance on how to approach them.

… in which genomics is the primary aim, and for some disease-specific research that considers genomics, … they are being recruited because they have a disease risk, which could come as a surprise to them. Writing consent … about their participation in genomics research on assessments of the risks and benefits of a given study for …

Policies and Guidance

Data Sharing Policies and Expectations

A webpage with information and associated FAQs that describe various expectations for data sharing that are specific to NHGRI-supported studies.

… of research participants, maintain privacy, and mitigate risk, especially for vulnerable or marginalized groups. NHGRI … would be compromised or would place them at greater risk of re-identification or suffering harm, and 2) … and for what purposes (e.g., general research use, disease-specific research use) and whether sharing will occur …

Policy Issues

Coverage and Reimbursement of Genetic Tests

Payers such as insurance companies and Medicare need systematic ways of evaluating genetic tests for reimbursement.

… for genetic tests to predict, prevent and treat disease. Tests for breast cancer and for hereditary forms of colorectal cancer can assess disease risk and guide screening and preventive measures. Other tests …

Policy Issues

Highlights of Revisions to the Common Rule

Revisions to the Common Rule modernize, simplify, and enhance oversight for human subjects research in the United States.

… tailor review and research protections to the level of risk posed by a study to enhance protection when necessary and reduce burdens to researchers and IRBs when risk is minimal. In the Final Rule, this is accomplished … or investigate potential public health signals, onset of disease outbreaks, or conditions of public health …

Policy Issues

Regulation of Genetic Tests

Most genetic tests today are not regulated, meaning that they go to market without any independent analysis to verify the claims of the seller.

… being analyzed is related to the presence, absence, or risk of a specific disease. Has having a specific genetic variant been … shown to increase the risk or likelihood of having a disease or eventually developing a disease? Clinical Utility: …