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The Informed Consent Resource

Special Considerations for Genomics Research

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

… This webpage discusses genomics-relevant considerations for informed consent and … with obtaining specific consent for research in which genomics is the primary aim, and for some disease-specific research that considers genomics, participants can be asked to agree to storage of …

Policy Issues

Genome Statute and Legislation Database

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

… Building a Sound Legal Foundation for Translating Genomics into Clinical Application” (grant #: R01HG008605 ; …

Policy Issues

What’s Happening in Genome Editing Right Now?

Scientific institutions are developing recommendations to support the responsible use of human gene-editing research.

… 1 , 2 Because CRISPR is an important tool for basic genomics research, NHGRI currently conducts and funds …

Policy Issues

Investigative Genomics

Genetic information is used by law enforcement to investigate criminal acts and exonerate those who have been convicted of crimes they did not commit.

… scene) profile into publicly available open-data, personal genomics DNA databases or private companies that offer IGG … … Explore This Page … Related Content … Investigative Genomics … Genetic information is used by law enforcement to …

Policy Issues

Intellectual Property in Genomics

In June 2013, the Supreme Court determined that DNA in its natural form cannot be patented.

… of open access to the genome has been a core ethos of genomics ever since. Over the years that this debate has … … The Courts and Gene Patents … Intellectual Property in Genomics … In June 2013, the Supreme Court determined that …

The Informed Consent Resource

Required Elements of the Consent Form

Explore the basic elements of informed consent that are required by the Common Rule and that are relevant to genomics.

… Rule (45 CFR 46, Subpart A) and that are relevant to genomics. It also provides sample language that can be used … need to be informed of the risks associated with genomics research , including of course risks related to … from standard of care. Physical risks are minimal for most genomics research. Psychological or social risks could …

Policy Issues

Synthetic Biology

Synthetic biology is a field of science that involves redesigning organisms for useful purposes by engineering them to have new abilities.

Policy Issues

Glossary of Statutory, Legislative and Regulatory Terms

This glossary contains definitions for commonly used terms (such as "bill", "statute", "regulation" and more) found in the Genome Statue and Legislative Database.

Policy Issues

Coverage and Reimbursement of Genetic Tests

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

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.

… As the field of genomics advances, genetic and genomic tests are becoming … of medical treatments and procedures. Since clinical genomics is a relatively new field, frameworks to evaluate … tests, the FTC has made available the following consumer education resources: Consumer Education, Direct-to-Consumer …