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Ch. 20 - Recombinant DNA Technology
Chapter 19, Problem 18

The National Institutes of Health created the Genetic Testing Registry (GTR) to increase transparency by publicly sharing information about the utility of their tests, research for the general public, patients, health-care workers, genetic counselors, insurance companies, and others. The Registry is intended to provide better information to patients, but companies involved in genetic testing are not required to participate. Should company participation be mandatory? Why or why not? Explain your answers.

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span>1. Understand the purpose of the Genetic Testing Registry (GTR): The GTR is designed to increase transparency and provide comprehensive information about genetic tests to various stakeholders, including patients, healthcare providers, and researchers.</span
span>2. Consider the benefits of mandatory participation: Mandatory participation could ensure that all available genetic tests are listed, providing a complete resource for patients and healthcare providers to make informed decisions.</span
span>3. Evaluate potential drawbacks: Consider the implications for companies, such as the burden of compliance, potential exposure of proprietary information, and the impact on innovation and competition.</span
span>4. Analyze ethical considerations: Reflect on the ethical responsibility of companies to contribute to public health and the potential benefits of increased transparency for patient care and research.</span
span>5. Formulate a balanced conclusion: Weigh the pros and cons of mandatory participation, considering the perspectives of all stakeholders involved, and determine whether the benefits to public health and transparency outweigh the potential drawbacks for companies.</span

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Key Concepts

Here are the essential concepts you must grasp in order to answer the question correctly.

Genetic Testing

Genetic testing involves analyzing an individual's DNA to identify genetic disorders, predispositions to diseases, or carrier status for certain conditions. This testing can provide valuable information for personal health management and family planning. Understanding the implications of genetic testing is crucial for evaluating its utility and the ethical considerations surrounding it.
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Informed Consent

Informed consent is a fundamental ethical principle in healthcare that requires patients to be fully informed about the risks, benefits, and alternatives of a procedure or test before agreeing to it. In the context of genetic testing, it ensures that individuals understand how their genetic information will be used and the potential consequences of the results. This concept is vital for protecting patient autonomy and privacy.
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Regulatory Framework

The regulatory framework for genetic testing encompasses the laws and guidelines that govern the development, approval, and marketing of genetic tests. This includes oversight by agencies like the FDA and the necessity for companies to adhere to standards that ensure test accuracy and reliability. Understanding this framework is essential for discussing whether participation in registries like the GTR should be mandatory for companies.
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Related Practice
Textbook Question
The Age of Genetics was created by remarkable advances in the use of biotechnology to manipulate plant and animal genomes. Given that the world population reached 7.5 billion people in 2017 and is expected to reach 9.7 billion in 2050, some scientists have proposed that only the worldwide introduction of genetically modified (GM) foods will increase crop yields enough to meet future nutritional demands. Pest resistance, herbicide, cold, drought, and salinity tolerance, along with increased nutrition, are seen as positive attributes of GM foods. However, others caution that unintended harm to other organisms, reduced effectiveness to pesticides, gene transfer to nontarget species, allergenicity, and as yet unknown effects on human health are potential concerns regarding GM foods. If you were in a position to control the introduction of a GM primary food product (rice, for example), what criteria would you establish before allowing such introduction?
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Textbook Question
Variable number tandem repeats (VNTRs) are repeating DNA sequences of about 15–100 bp in length, found both within and between genes. Why are they commonly used in forensics?
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Textbook Question

To estimate the number of cleavage sites in a particular piece of DNA with a known size, you can apply the formula N/4ⁿ where N is the number of base pairs in the target DNA and n is the number of bases in the recognition sequence of the restriction enzyme. If the recognition sequence for BamHI is GGATCC and the  phage DNA contains approximately 48,500 bp, how many cleavage sites would you expect?

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Textbook Question

In a typical PCR reaction, describe what is happening in stages occurring at temperature ranges (a) 92-26 °C, (b) 45-65 °C, and (c) 65-75 °C.

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Textbook Question

Should the FDA regulate direct-to-consumer genetic tests, or should these tests be available as a 'buyer beware' product?

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Textbook Question

We usually think of enzymes as being most active at around 37°C, yet in PCR the DNA polymerase is subjected to multiple exposures of relatively high temperatures and seems to function appropriately at 65–75°C. What is special about the DNA polymerase typically used in PCR?

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