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GENOMICS
GENOMICS
GENOMICS
Genomics is the study of an organism's whole hereditary information that is present in its genes
(DNA) and the use of its genes. It deals with the use of genome information associated with other
information to provide answers in biology and medicine. It is a field of medicine that is rapidly growing
and developing. The details of a person's genome may provide clues or sometimes direct answers that
lead to treatment and improved care.
Genomic medicine is an emerging medical discipline that involves using genomic information
about an individual as part of their clinical care (e.g. for diagnostic or therapeutic decision-making) and
the health outcomes and policy implications of that clinical use."
Information Security
Every genome sequence produces vast amounts of data that must be stored electronically —
far more information, in fact, than is contained in most medical records.
Genetic Discrimination
Genomic medicine has the capacity to revolutionize clinical practice. The mapping of the human
genome has created new opportunities for genetic tests to predict, prevent and treat disease. There
are many examples of clinically useful information available through newly developed genetic tests. In
order for patients to have full access to the benefits of genetic testing, payers such as insurance
companies and Medicare need systematic ways of evaluating genetic tests for reimbursement.
Currently, there are barriers that make it difficult for payers to do so. Without this information, insurers
cannot properly assess how to reimburse for genetic tests.
Regulation of Genetic Tests
Genetic tests focus on an individual's inheritance of a single gene, while genomic tests (such
as genetic panels or exome/whole genome sequencing) look at an individual's wider inheritance of
various genetic traits. As the field of genomics advances, genetic and genomic tests are becoming more
common in, and out of, the clinic. Yet most genetic tests today are not regulated, meaning that they go
to market without any independent analysis to verify the claims of the seller. The landscape is evolving,
however, and it is likely that more of the genetic and genomic testing industry will face greater oversight
in the future.
Two federal agencies have the primary authority to regulate genetic tests: the Food and Drug
Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS)
Bioethics and Community Involvement
Policies and procedures must be developed so patient rights are fully protected and ethical
practices are followed. Patients, research participants or members of the public are welcome to ask
questions about any aspect of this new approach to medicine.
Health professionals need to be informed about the ethical, legal, and social issues in the
translation of genomics into health care. Health providers have a responsibility to become
knowledgeable about genomics so that they can assist patients, families, and communities to become
informed consumers of genomic-based health care. An understanding of the principles of ethics and
law, including human dignity and human rights, will help nurses as they encounter complex issues.
Knowledge of emerging genomic science that impacts practice as well as information about emerging
ethical, legal, and social issues– including but not limited to confidentiality, decision-making capacity,
informed consent, genetic testing, and research– are necessary to ensure the provision of appropriate
and equitable health care.
References:
Genetic and Genomic Healthcare: Ethical Issues of Importance to Nurses. (2008). Retrieved from
http://ojin.nursingworld.org/MainMenuCategories/ANAMarketplace/ANAPeriodicals/OJIN/Tabl
eofContents/vol132008/No1Jan08/GeneticandGenomicHealthcare.aspx, March 24, 2019.
Ethical, Legal, and Social Issues in the Translation of Genomics Into Health Care. (2012). Retrieved
from https://sigmapubs.onlinelibrary.wiley.com/doi/pdf/10.1111/jnu.12000, March 24, 2019.
https://www.genome.gov/issues/
https://www.genome.gov/10001740/ethical-legal-and-social-issues-in-genomic-medicine/
http://mayoresearch.mayo.edu/center-for-individualized-medicine/issues-in-genomic-medicine-and-
research.asp