International scientific research has been performed to discover the sequencing of the human genome and identification of the genes it contains. The Human Genome Project (HGP) was initiated in 1990 through funding from the US Department of Energy (DOE) and the National Institutes of Health (NIH). The three billion dollar project was completed in April 2003, which was 2 years ahead of their expected completion date.Findings of the project revealed 20,500 numbers of protein-coding human genes.
This detailed information gives the basic set of inheritable “instructions” for the development and function of a human being. It is predicted that by 2020, the impact of genetics on medicine meaning drug responsiveness, will be even more widespread with this dramatic change.The ethical, legal and social implications of the knowledge learned form the project includes discriminating practices, synthetic biology, and emerging technologies. The National Human Genome Research Institute (NHGRI) role in the future of Genomic Research is implementation in large-scale production of genomic data sets, pilot-scale efforts, technology development, ethical, legal and social research, longitudinal population cohorts, non-genetic factors in health and disease, use of genomic information to improve health, improving the health of all people, and policy development.The Risk Management Plan defines how risked associated with the Identification of the Human Genome Project will be identified, analyzed, and managed.
The sources of risks identified during the initiation of the project lifecycle were timing and schedule, technical and performance, capital requirements, and human resources. The project risk characteristics are constructed in the following table: Table 1Technical risk and hazard assessments: Hazard Analysis will be performed to review the concept design and identify significant hazards to provide an opportunity for their elimination or minimization by changes to the fundamental concepts, re-design or by incorporating protective measures. A feasibility study will be conducted as a risk assessment and will be incorporated in the project risk register. Value improvement exercised may be conducted in this phase.Catastrophic: extreme event, potential for large financial cost or delays, or damage to the organization reputation.Operational Risk Management (ORM) and Risk Analytics & Instruments (RAI) develop and maintain key risk measurements methods.
The IT system failures fall within the remit of ORM, which provides the framework to ensure consistent remediation or acceptance of these risks. Development and implementation of internal regulatory risk measurement methodologies for operational risk are needed in order to support accurate management of risks. Reduce, Mitigate and Avoiding Risks.The following steps should be considered to prevent and mitigate the risks and uncertainties once the risk assessment has been performed: Early Consultation: Identifying needs at the outset and avoid cost increasing later due to poor initial understanding or requirements. Deferring irreversible decisions – Allowing more time to investigate mitigating measures or alternative ways to achieve objectives.
Pilot Studies: Acquiring more information about risks and taking steps to mitigate adverse consequences or increase benefits.Design Flexibility – Increasing the flexibility of designs to make proposal more robust against changes in future demand. Taking Precautionary Action –Reducing the risk of a very bad outcome, even where the probability is considered small. Transferring Risk to Private Sector – Contractual arrangements (i.e.
insurance) >> Making less use of Leading Edge Technology – utilizing simpler methods can reduce risk considerably. Reinstating or Developing Different Options – Suggested options for identified risk within the risk analysis. Commissioning Research – Confirming or disproving the reliability of new technology, or to reassess the nature of a danger. Undertaking Site Investigations – Reducing risks from unforeseen ground conditions or refurbishments costs. Staging a Project – Can be altered at successive review points.
Abandoning the Project – Too risky.The misuse of genetic information is a risk that is a common concern for those who are considering genetic testing. The population-based research tool reveals gene mutations that causes or increases the risk of inherited disorders. Many believe the knowing this information can lead to potential loss of health insurance and/or employment opportunities and because of this concern, federal and state laws are on place.
One example of a federal law is the Genetic Information Nondiscrimination Act of 2008 (GINA), which was designed to prohibit genetic discrimination in health insurance (Title I) and employment (Title II).The ethical issues related to genetic testing as it relates to unborn fetuses includes individual rights and confidentiality concerns. This medical test identifies changes in chromosomes, genes, or proteins, which can confirm or rule out a suspected genetic condition or genetic disorder. Early detection of rare inherited diseases in an unborn fetus has risks factors that increase the rate of death of unborn fetuses globally.
Pregnant mothers the have been identified as “high-risk” carriers, have the option of conducting a genetic. The results can be beneficial (either positive or negative), since there is a relief of uncertainty that allows the parents to make informed decisions for having a child.The National Human Genome Institute’s (NHGRI) Ethical, Legal and Social implications (ELSI) Research Program was established as an integral part of the HGP to foster basic and applied research on ethical, legal, social implications of genetic and genomic research for individuals, families and communities. Information is currently available through the Internet.
