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ETHICAL CONSIDERATIONS IN PRECISION MEDICINE
RESEARCH
SAHITHI VADDIGANTI
Pharm D
Student ID : 236/122023
10/18/2022
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Index:
• Definitions
• Introduction to precision medicine
• Difference between Precision Medicine and Personalized Medicine.
• Components of Precision Medicine
• Ethical Considerations
• Positions
• Conclusion
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Definition:
• Precision - the quality or state of being precise : exactness.
• The National Research Council’s Toward Precision Medicine (1) adopted the
definition of precision medicine from the President’s Council of Advisors on
Science and Technology in 2008 as: “The tailoring of medical treatment to the
individual characteristics of each patient…to classify individuals into
subpopulations that differ in their susceptibility to a particular disease or their
response to a specific treatment. Preventative or therapeutic interventions can
then be concentrated on those who will benefit, sparing expense and side effects
for those who will not”.
• As the definition suggests, the power of precision medicine lies in its ability to
guide health care decisions toward the most effective treatment for a given
patient, and thus, improve care quality, while reducing the need for unnecessary
diagnostic testing and therapies.
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• Precision medicine is a broad term that includes a variety different uses of genetic
information, such as molecular profiling of tumors, population screening, direct-to-
consumer genetic testing, pharmacogenomics, diagnostic testing, risk assessment,
and predictive risk testing. Precision medicine is defined as personalized care
based on an individual's genetic makeup, lifestyle, and environment.
Difference Between Precision Medicine and
Personalised Medicine:
• While precision medicine implies to a health care delivery model that relies
heavily on data, analytics, and knowledge, and where as personalized medicine
refers to an approach to patients that takes into account their genetic make-up
while also paying attention to their preferences, opinions, knowledge, and social
context.
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Components of Precision Medicine:
• The ideal precision medicine ecosystem connects clinicians, researchers, clinical
laboratories, and patients. With the introduction of EMRs and sophisticated IT
systems that support both research and health care delivery, patients (and
research participants) who agree to donate bio specimens and share their clinical
and research data are at the forefront of research contributions. Researchers use
data from samples associated with digital phenotypes, family histories, and
environmental exposure all of which are recorded during clinical care to produce
novel discoveries. A rising body of information gathered from clinical laboratory
is used by clinicians.
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• This compilation of data from multiple sources creates the foundation for
a potent precision medicine ecosystem, which when combined with other
ecosystems, results in the spread of knowledge that benefits other
systems. The government sponsors precision medicine research and
regulates precision medicine products; industry collaborates in the
development and commercialization of precision medicine products;
professional societies facilitate the training of the next generation of
researchers, clinicians, and policy analysts; and payers assess the
suitability of precision medicine interventions and the funding that
explains their use in healthcare. This is the extended precision medicine
ecosystem.
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Ethical Considerations:
• Def: A set of guidelines that direct your research ideas and procedures are
known as ethical considerations in research. There is a code of conduct that
scientists and researchers must always follow when getting information from
subjects.
• Precision medicine raises issues of patient and physician education, counseling,
privacy, confidentiality, cost, the patient's best interests, and justice.
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The Position Paper:
• Lisa Soleymani Lehmann, MD, PhD, led investigators in constructing a
document on behalf of the ACP Ethics, Professionalism and Human Rights
Committee (EPHRC).
• The paper consists of an executive summary of 4 positions on the subject
that's been revised to incorporate feedback from any and all included groups.
It was approved by the ACP Board of Regents on February 15, 2022.
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The 4 Positions of Precision Medicine :
• Position 1: Patient Interests, Evidence & Ethical Standards-
Like any testing, genetic testing needs to be conducted with the patient's best
interests, empirical data, and moral principles in mind. In order to fulfill their
ethical duty to provide high-quality treatment, doctors must weigh the advantages
and disadvantages of any test in light of the available scientific data.
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Position 2: Discussions About Opportunities &
Challenges
Doctors should be ready to discuss the ethical issues and potential benefits of
genetic testing and precision medicine with their patients.
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Position 3: Physician Assistance with Direct-to-
Consumer Genetic Testing
In order to comprehend the advantages, disadvantages, and uncertainty
surrounding direct-to-consumer genetic medical testing, patients will want support
from their doctors.
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Position 4: Safeguarding the Privacy of Patient
Information
Patients' privacy, confidentiality, and security including that of their genetic
information should be protected by medical professionals, health care systems, and
other parties having access to patient data.
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Thank You!
www.clinosol.com
(India | Canada)
9121151622/623/624
info@clinosol.com
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Ethical Considerations in Precision Medicine Research

  • 1. Welcome ETHICAL CONSIDERATIONS IN PRECISION MEDICINE RESEARCH SAHITHI VADDIGANTI Pharm D Student ID : 236/122023 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 1
  • 2. Index: • Definitions • Introduction to precision medicine • Difference between Precision Medicine and Personalized Medicine. • Components of Precision Medicine • Ethical Considerations • Positions • Conclusion 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 2
  • 3. Definition: • Precision - the quality or state of being precise : exactness. • The National Research Council’s Toward Precision Medicine (1) adopted the definition of precision medicine from the President’s Council of Advisors on Science and Technology in 2008 as: “The tailoring of medical treatment to the individual characteristics of each patient…to classify individuals into subpopulations that differ in their susceptibility to a particular disease or their response to a specific treatment. Preventative or therapeutic interventions can then be concentrated on those who will benefit, sparing expense and side effects for those who will not”. • As the definition suggests, the power of precision medicine lies in its ability to guide health care decisions toward the most effective treatment for a given patient, and thus, improve care quality, while reducing the need for unnecessary diagnostic testing and therapies. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 3
  • 4. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 4 • Precision medicine is a broad term that includes a variety different uses of genetic information, such as molecular profiling of tumors, population screening, direct-to- consumer genetic testing, pharmacogenomics, diagnostic testing, risk assessment, and predictive risk testing. Precision medicine is defined as personalized care based on an individual's genetic makeup, lifestyle, and environment.
  • 5. Difference Between Precision Medicine and Personalised Medicine: • While precision medicine implies to a health care delivery model that relies heavily on data, analytics, and knowledge, and where as personalized medicine refers to an approach to patients that takes into account their genetic make-up while also paying attention to their preferences, opinions, knowledge, and social context. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 5
  • 6. Components of Precision Medicine: • The ideal precision medicine ecosystem connects clinicians, researchers, clinical laboratories, and patients. With the introduction of EMRs and sophisticated IT systems that support both research and health care delivery, patients (and research participants) who agree to donate bio specimens and share their clinical and research data are at the forefront of research contributions. Researchers use data from samples associated with digital phenotypes, family histories, and environmental exposure all of which are recorded during clinical care to produce novel discoveries. A rising body of information gathered from clinical laboratory is used by clinicians. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 6
  • 7. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 7 • This compilation of data from multiple sources creates the foundation for a potent precision medicine ecosystem, which when combined with other ecosystems, results in the spread of knowledge that benefits other systems. The government sponsors precision medicine research and regulates precision medicine products; industry collaborates in the development and commercialization of precision medicine products; professional societies facilitate the training of the next generation of researchers, clinicians, and policy analysts; and payers assess the suitability of precision medicine interventions and the funding that explains their use in healthcare. This is the extended precision medicine ecosystem.
  • 8. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 8
  • 9. Ethical Considerations: • Def: A set of guidelines that direct your research ideas and procedures are known as ethical considerations in research. There is a code of conduct that scientists and researchers must always follow when getting information from subjects. • Precision medicine raises issues of patient and physician education, counseling, privacy, confidentiality, cost, the patient's best interests, and justice. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 9
  • 10. The Position Paper: • Lisa Soleymani Lehmann, MD, PhD, led investigators in constructing a document on behalf of the ACP Ethics, Professionalism and Human Rights Committee (EPHRC). • The paper consists of an executive summary of 4 positions on the subject that's been revised to incorporate feedback from any and all included groups. It was approved by the ACP Board of Regents on February 15, 2022. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 10
  • 11. The 4 Positions of Precision Medicine : • Position 1: Patient Interests, Evidence & Ethical Standards- Like any testing, genetic testing needs to be conducted with the patient's best interests, empirical data, and moral principles in mind. In order to fulfill their ethical duty to provide high-quality treatment, doctors must weigh the advantages and disadvantages of any test in light of the available scientific data. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 11
  • 12. Position 2: Discussions About Opportunities & Challenges Doctors should be ready to discuss the ethical issues and potential benefits of genetic testing and precision medicine with their patients. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 12
  • 13. Position 3: Physician Assistance with Direct-to- Consumer Genetic Testing In order to comprehend the advantages, disadvantages, and uncertainty surrounding direct-to-consumer genetic medical testing, patients will want support from their doctors. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 13
  • 14. Position 4: Safeguarding the Privacy of Patient Information Patients' privacy, confidentiality, and security including that of their genetic information should be protected by medical professionals, health care systems, and other parties having access to patient data. 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 14
  • 15. Thank You! www.clinosol.com (India | Canada) 9121151622/623/624 info@clinosol.com 10/18/2022 www.clinosol.com | follow us on social media @clinosolresearch 15