This document discusses ethics in biomedical informatics. It begins with an introduction to ethics and bioethics, defining key terms like ethics, morals, and norms. It then discusses ethical issues that can arise in health informatics, including issues with clinical decision support systems. The document reviews several important historical cases in bioethics that helped develop core ethical principles, such as informed consent and minimizing harm. These include the Nuremberg Code, Beecher's research ethics violations, and the Tuskegee Syphilis Study. It concludes with discussing the three principles from the Belmont Report - respect for persons, beneficence, and justice.
This document discusses several key concepts in nursing ethics including:
- Definitions of ethics and codes of ethics in nursing.
- Ethical principles like respect for persons, autonomy, and beneficence that guide nurses' decisions.
- Common ethical dilemmas nurses face and the importance of ethical decision making.
- Major ethical theories in nursing including teleology, deontology, intuitionism, and caring/agapeistic theories that provide frameworks for understanding ethical issues.
Medical ethics in China can be traced back to ancient times when an independent medical profession developed during the Zhou Dynasty. Ancient physicians emphasized experience over magic and paid attention to prognosis and whether a patient was treatable. During the Han Dynasty, Confucianism shaped Chinese culture and medicine, emphasizing benevolence or universal love and treating all patients equally regardless of status. These traditional values of caring for patients and virtue continue to influence medical ethics in China today alongside introduced Western theories and standards.
Beneficence and non-maleficence are two important principles of bioethics. Beneficence refers to actions that are intended to benefit others, including preventing and removing harm. It can be seen through kindness, charity, and love. Beneficence includes benevolence and provenance. Non-maleficence means not inflicting harm. It focuses on not killing, causing pain, offense, or incapacitating others. These principles guide ethical decisions around treatment, such as withholding or withdrawing care when it will not benefit patients. They also distinguish between killing and letting die, where letting die may be acceptable if treatment is futile or refused but killing generally is not. Both principles aim to do
This presentation is an introduction to telemedicine and telehealth. It explains common terminology and the different types of technology used. It concludes with findings from the American Medical Association on national physician use and links to additional resources.
Ethics in healthcare go beyond what is legal and provide moral guidelines to assist in complex decision making. Some examples of ethical issues include deciding who receives organ transplants, discontinuing life support, and how much care to provide uninsured patients. Ethics principles include doing no harm, preserving life, treating all patients equally, respecting patient choices, and maintaining professional standards of care. Patients have rights to considerate care, informed consent, privacy, and participation in advanced directives to refuse treatment.
1) Medical technology and health information technology aim to advance patient care but also raise ethical issues that require consideration. New innovations are often adopted without fully evaluating ethical implications.
2) Proper informed consent and adherence to ethical guidelines are important for ethical medical research and evaluation of new technologies. However, past examples like the Tuskegee Syphilis study show a lack of focus on ethics.
3) While electronic health records increase efficiency and quality of care, their use also risks patient confidentiality and could divert attention away from patients if not implemented carefully with ethical use in mind. Health organizations have an obligation to prioritize patient well-being and safety.
Confidentiality in healthcare involves keeping patient information private without their consent for disclosure. Maintaining confidentiality is important to build trust in the physician-patient relationship and encourage patients to seek care. Personal information like names, addresses, diagnoses and social security numbers should be kept private. HIPAA provides federal laws protecting the confidentiality and security of patient healthcare information. Healthcare workers should only discuss patients in private settings and properly dispose of documents with identifying patient information to uphold patient confidentiality.
This document discusses several key concepts in nursing ethics including:
- Definitions of ethics and codes of ethics in nursing.
- Ethical principles like respect for persons, autonomy, and beneficence that guide nurses' decisions.
- Common ethical dilemmas nurses face and the importance of ethical decision making.
- Major ethical theories in nursing including teleology, deontology, intuitionism, and caring/agapeistic theories that provide frameworks for understanding ethical issues.
Medical ethics in China can be traced back to ancient times when an independent medical profession developed during the Zhou Dynasty. Ancient physicians emphasized experience over magic and paid attention to prognosis and whether a patient was treatable. During the Han Dynasty, Confucianism shaped Chinese culture and medicine, emphasizing benevolence or universal love and treating all patients equally regardless of status. These traditional values of caring for patients and virtue continue to influence medical ethics in China today alongside introduced Western theories and standards.
Beneficence and non-maleficence are two important principles of bioethics. Beneficence refers to actions that are intended to benefit others, including preventing and removing harm. It can be seen through kindness, charity, and love. Beneficence includes benevolence and provenance. Non-maleficence means not inflicting harm. It focuses on not killing, causing pain, offense, or incapacitating others. These principles guide ethical decisions around treatment, such as withholding or withdrawing care when it will not benefit patients. They also distinguish between killing and letting die, where letting die may be acceptable if treatment is futile or refused but killing generally is not. Both principles aim to do
This presentation is an introduction to telemedicine and telehealth. It explains common terminology and the different types of technology used. It concludes with findings from the American Medical Association on national physician use and links to additional resources.
Ethics in healthcare go beyond what is legal and provide moral guidelines to assist in complex decision making. Some examples of ethical issues include deciding who receives organ transplants, discontinuing life support, and how much care to provide uninsured patients. Ethics principles include doing no harm, preserving life, treating all patients equally, respecting patient choices, and maintaining professional standards of care. Patients have rights to considerate care, informed consent, privacy, and participation in advanced directives to refuse treatment.
1) Medical technology and health information technology aim to advance patient care but also raise ethical issues that require consideration. New innovations are often adopted without fully evaluating ethical implications.
2) Proper informed consent and adherence to ethical guidelines are important for ethical medical research and evaluation of new technologies. However, past examples like the Tuskegee Syphilis study show a lack of focus on ethics.
3) While electronic health records increase efficiency and quality of care, their use also risks patient confidentiality and could divert attention away from patients if not implemented carefully with ethical use in mind. Health organizations have an obligation to prioritize patient well-being and safety.
Confidentiality in healthcare involves keeping patient information private without their consent for disclosure. Maintaining confidentiality is important to build trust in the physician-patient relationship and encourage patients to seek care. Personal information like names, addresses, diagnoses and social security numbers should be kept private. HIPAA provides federal laws protecting the confidentiality and security of patient healthcare information. Healthcare workers should only discuss patients in private settings and properly dispose of documents with identifying patient information to uphold patient confidentiality.
This document provides an overview of ethical and social issues related to health information technology. It discusses how emergency rooms have unique information needs and how health IT can provide value through functions like electronic health records and clinical decision support systems. However, it also notes there are socio-technical considerations and risks of unintended consequences to properly manage health IT implementations. The document outlines issues like ensuring user involvement, managing workflow changes and addressing communication challenges. It also discusses principles of privacy, security and informed consent as they relate to ethical use of personal health information through health IT.
This document provides a history of the development of bioethics and medical ethics from ancient civilizations to modern times. It describes some of the earliest ethical codes from ancient Egypt, Babylon, India, Greece, Rome, and Islamic and Jewish traditions. It then outlines the progression of medical ethics standards over time, including influential codes and guidelines developed in response to unethical human experimentation, with a focus on the atrocities that occurred in the United States in the 20th century. Key milestones discussed include the Nuremberg Code, Declaration of Helsinki, and Belmont Report.
Confidentiality can be defined as the
ethical principle or legal right that a
physician or other health professional will
hold secret all information relating to a
patient, unless the patient gives consent
permitting disclosure.
This document discusses ethical issues in healthcare. It begins by defining ethics and bioethics. It then outlines the basic principles of medical ethics including autonomy, veracity, privacy/confidentiality, fidelity, beneficence, non-maleficence, and justice. Several case studies are presented that illustrate challenges with applying these principles in practice. Major ethical issues like physician assisted suicide and euthanasia, organ transplants, abortion, and ethical decision making are also examined. Finally, the document discusses how a pharmacist can protect a patient's right to privacy by obtaining consent, only collecting necessary information, and providing limited disclosure.
The document discusses several key concepts relating to ethics and morality. It defines ethics as involving standards of right and wrong that govern human conduct. Morality is derived from social consensus about moral behavior. The formation of one's conscience begins in childhood based on experiences with caregivers and influences moral development throughout life. Several theories on moral development are discussed, including Piaget's two-stage theory involving progression from fixed rules to relativism, and Kohlberg's six-stage model involving three levels of pre-conventional, conventional, and post-conventional morality. The document provides an overview of important ethical concepts.
Lecture 13 privacy, confidentiality and medical recordsDr Ghaiath Hussein
A lecture on privacy, confidentiality and medical records delivered to Alfarabi Medical College undergraduate medical students in the week starting 27.11.2016
This document provides an overview of key topics in medical ethics, including basic rights and ethical duties, important values like autonomy and beneficence, guidelines, ethics committees, codes of ethics, cultural concerns, truth telling, conflicts of interest, treatment of family members, and issues around futility. It discusses the importance of communication and resolving ethical issues, and notes that medical ethics aims to balance the responsibilities of healthcare professionals to individual patients and society as a whole.
Telemedicine uses telecommunication and information technologies to provide clinical healthcare remotely. It allows communication between patients and medical staff for both convenience and transmission of medical data. Telemedicine works through video conferencing systems between hub and remote sites connected by technologies like T1 lines, satellites, or the internet. It has benefits like improved access to care and quality of care through collaborative consultations, but faces barriers like costs of equipment and connectivity as well as reimbursement issues. The technologies and applications of telemedicine continue to evolve to better serve patients.
The history of medical ethics in research and its relation to clinical practiceSCGH ED CME
This document discusses the history of medical ethics in research and its relation to clinical practice. It covers several topics including the importance of research and ethics, premodern versus modern research, examples of unethical research, the development of ethics codes, and the application of research ethics to clinical medicine. Key points addressed are the benefits of research for improving health and helping patients and communities, as well as the need to prevent exploitation and protect subjects.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was enacted to protect patients' confidentiality and regulate access to personal health information. HIPAA covers identifiable protected health information, such as names, birthdates, medical records, and social security numbers. The act gives patients rights to access and correct their medical records. Healthcare providers are responsible for securely protecting patients' personal health information and instituting privacy policies according to HIPAA guidelines. Non-compliance with HIPAA privacy rules can result in civil and criminal penalties including fines and prison sentences depending on the offense.
This is a slideshow explaining the importance of protecting patient privacy and confidentiality. This slideshow is for education and training purposes only.
This document discusses the history and principles of healthcare ethics. It outlines key events that led to the establishment of international ethical standards for research involving human subjects, such as the Nuremberg Code and Declaration of Helsinki. The four main principles of healthcare ethics are also presented: autonomy, beneficence, non-maleficence, and justice. A case study example shows how a doctor must consider all these principles when making decisions about a patient's treatment.
This document discusses the importance of ethics in medical research. It begins by defining ethics and research, and identifies human subjects. It then reviews some unethical medical experiments from history, like the Tuskegee Syphilis Study, that lacked informed consent and caused harm. This led to various codes of ethics like the Nuremberg Code, Declaration of Helsinki, and Belmont Report to protect subjects. The three main principles of research ethics are respect for persons, beneficence, and justice. Special protections are needed for vulnerable groups. Overall, ethics aim to balance scientific advancement with subject welfare and rights.
Bioethical issues in nursing presents key concepts in bioethics including definitions of bioethics, importance of bioethics in healthcare, and common bioethical situations nurses may encounter. Some key points discussed are:
- Bioethics studies ethical implications of new biological discoveries and advances in fields like genetics and drug research.
- Understanding bioethics is important for nurses due to ever-changing medical policies, patient rights, and new clinical issues.
- Common bioethical issues addressed include reproductive situations like sterilization and abortion, human experimentation, and dealing with infectious diseases like HIV/AIDS.
- Nurses must consider ethical issues around quality of life, end-of-life care, organ
Ethical And Legal Aspects Of Health CareLajpat Rai
This document outlines several key ethical issues in telemedicine practice including maintaining patient confidentiality and avoiding harm, obtaining informed consent, establishing fees, maintaining accurate records, and ensuring access to healthcare. It also discusses privacy concerns regarding personal information disclosure and storage as well as technological risks associated with telemedicine like equipment quality and inadequate guidelines.
The document discusses the importance of confidentiality in healthcare. It defines key terms like confidentiality and breach of confidentiality. It outlines what information is considered confidential for patients, such as medical records, test results, and insurance details. It also discusses ethics standards, government regulations like HIPAA, and agencies that monitor patient privacy and confidentiality. Healthcare workers are responsible for only sharing patient information with authorized individuals and protecting private documents. Maintaining confidentiality helps ensure quality care and trust between patients and providers.
This document discusses patient privacy and confidentiality in healthcare. It states that a patient's health information is private and sensitive data. Most governments have policies to balance a patient's right to privacy with the need for medical professionals to share health information. These policies regulate how health information can circulate and be accessed. Medical professionals are trained to collect only relevant patient information with consent. They must protect the privacy and confidentiality of patient health records according to guidelines and privacy laws. Patient consent is required before disclosing information to other parties, except in emergencies or as required by law.
This document discusses various topics relating to medical ethics theories and principles, including:
- The scope of ethics in medical practice and various theories like deontological and consequentialist.
- Key principles like beneficence, non-maleficence, autonomy, truth-telling, confidentiality, and preservation of life.
- Issues around euthanasia, living wills, resource allocation, and contraception for minors.
This document provides an introduction to research ethics and ethics for health informaticians. It discusses key topics like the introduction to ethics and bioethics, ethical issues in health informatics, information ethics and clinical decision making. It also includes case studies of historic cases in research ethics like the Nazi human experimentation, Milgram study, Stanford prison experiment and Tuskegee study. The document discusses principles like respect for persons, beneficence, justice from the Belmont report. It also covers ethical, legal and social issues and clinical decision support systems.
Presented at the Health Informatics and Health Information Technology Course, Doctor of Philosophy and Master of Science Programs in Data Science for Health Care (International Program), Faculty of Medicine Ramathibodi Hospital, Mahidol University on October 31, 2017
This document provides an overview of ethical and social issues related to health information technology. It discusses how emergency rooms have unique information needs and how health IT can provide value through functions like electronic health records and clinical decision support systems. However, it also notes there are socio-technical considerations and risks of unintended consequences to properly manage health IT implementations. The document outlines issues like ensuring user involvement, managing workflow changes and addressing communication challenges. It also discusses principles of privacy, security and informed consent as they relate to ethical use of personal health information through health IT.
This document provides a history of the development of bioethics and medical ethics from ancient civilizations to modern times. It describes some of the earliest ethical codes from ancient Egypt, Babylon, India, Greece, Rome, and Islamic and Jewish traditions. It then outlines the progression of medical ethics standards over time, including influential codes and guidelines developed in response to unethical human experimentation, with a focus on the atrocities that occurred in the United States in the 20th century. Key milestones discussed include the Nuremberg Code, Declaration of Helsinki, and Belmont Report.
Confidentiality can be defined as the
ethical principle or legal right that a
physician or other health professional will
hold secret all information relating to a
patient, unless the patient gives consent
permitting disclosure.
This document discusses ethical issues in healthcare. It begins by defining ethics and bioethics. It then outlines the basic principles of medical ethics including autonomy, veracity, privacy/confidentiality, fidelity, beneficence, non-maleficence, and justice. Several case studies are presented that illustrate challenges with applying these principles in practice. Major ethical issues like physician assisted suicide and euthanasia, organ transplants, abortion, and ethical decision making are also examined. Finally, the document discusses how a pharmacist can protect a patient's right to privacy by obtaining consent, only collecting necessary information, and providing limited disclosure.
The document discusses several key concepts relating to ethics and morality. It defines ethics as involving standards of right and wrong that govern human conduct. Morality is derived from social consensus about moral behavior. The formation of one's conscience begins in childhood based on experiences with caregivers and influences moral development throughout life. Several theories on moral development are discussed, including Piaget's two-stage theory involving progression from fixed rules to relativism, and Kohlberg's six-stage model involving three levels of pre-conventional, conventional, and post-conventional morality. The document provides an overview of important ethical concepts.
Lecture 13 privacy, confidentiality and medical recordsDr Ghaiath Hussein
A lecture on privacy, confidentiality and medical records delivered to Alfarabi Medical College undergraduate medical students in the week starting 27.11.2016
This document provides an overview of key topics in medical ethics, including basic rights and ethical duties, important values like autonomy and beneficence, guidelines, ethics committees, codes of ethics, cultural concerns, truth telling, conflicts of interest, treatment of family members, and issues around futility. It discusses the importance of communication and resolving ethical issues, and notes that medical ethics aims to balance the responsibilities of healthcare professionals to individual patients and society as a whole.
Telemedicine uses telecommunication and information technologies to provide clinical healthcare remotely. It allows communication between patients and medical staff for both convenience and transmission of medical data. Telemedicine works through video conferencing systems between hub and remote sites connected by technologies like T1 lines, satellites, or the internet. It has benefits like improved access to care and quality of care through collaborative consultations, but faces barriers like costs of equipment and connectivity as well as reimbursement issues. The technologies and applications of telemedicine continue to evolve to better serve patients.
The history of medical ethics in research and its relation to clinical practiceSCGH ED CME
This document discusses the history of medical ethics in research and its relation to clinical practice. It covers several topics including the importance of research and ethics, premodern versus modern research, examples of unethical research, the development of ethics codes, and the application of research ethics to clinical medicine. Key points addressed are the benefits of research for improving health and helping patients and communities, as well as the need to prevent exploitation and protect subjects.
The Health Insurance Portability and Accountability Act of 1996 (HIPAA) was enacted to protect patients' confidentiality and regulate access to personal health information. HIPAA covers identifiable protected health information, such as names, birthdates, medical records, and social security numbers. The act gives patients rights to access and correct their medical records. Healthcare providers are responsible for securely protecting patients' personal health information and instituting privacy policies according to HIPAA guidelines. Non-compliance with HIPAA privacy rules can result in civil and criminal penalties including fines and prison sentences depending on the offense.
This is a slideshow explaining the importance of protecting patient privacy and confidentiality. This slideshow is for education and training purposes only.
This document discusses the history and principles of healthcare ethics. It outlines key events that led to the establishment of international ethical standards for research involving human subjects, such as the Nuremberg Code and Declaration of Helsinki. The four main principles of healthcare ethics are also presented: autonomy, beneficence, non-maleficence, and justice. A case study example shows how a doctor must consider all these principles when making decisions about a patient's treatment.
This document discusses the importance of ethics in medical research. It begins by defining ethics and research, and identifies human subjects. It then reviews some unethical medical experiments from history, like the Tuskegee Syphilis Study, that lacked informed consent and caused harm. This led to various codes of ethics like the Nuremberg Code, Declaration of Helsinki, and Belmont Report to protect subjects. The three main principles of research ethics are respect for persons, beneficence, and justice. Special protections are needed for vulnerable groups. Overall, ethics aim to balance scientific advancement with subject welfare and rights.
Bioethical issues in nursing presents key concepts in bioethics including definitions of bioethics, importance of bioethics in healthcare, and common bioethical situations nurses may encounter. Some key points discussed are:
- Bioethics studies ethical implications of new biological discoveries and advances in fields like genetics and drug research.
- Understanding bioethics is important for nurses due to ever-changing medical policies, patient rights, and new clinical issues.
- Common bioethical issues addressed include reproductive situations like sterilization and abortion, human experimentation, and dealing with infectious diseases like HIV/AIDS.
- Nurses must consider ethical issues around quality of life, end-of-life care, organ
Ethical And Legal Aspects Of Health CareLajpat Rai
This document outlines several key ethical issues in telemedicine practice including maintaining patient confidentiality and avoiding harm, obtaining informed consent, establishing fees, maintaining accurate records, and ensuring access to healthcare. It also discusses privacy concerns regarding personal information disclosure and storage as well as technological risks associated with telemedicine like equipment quality and inadequate guidelines.
The document discusses the importance of confidentiality in healthcare. It defines key terms like confidentiality and breach of confidentiality. It outlines what information is considered confidential for patients, such as medical records, test results, and insurance details. It also discusses ethics standards, government regulations like HIPAA, and agencies that monitor patient privacy and confidentiality. Healthcare workers are responsible for only sharing patient information with authorized individuals and protecting private documents. Maintaining confidentiality helps ensure quality care and trust between patients and providers.
This document discusses patient privacy and confidentiality in healthcare. It states that a patient's health information is private and sensitive data. Most governments have policies to balance a patient's right to privacy with the need for medical professionals to share health information. These policies regulate how health information can circulate and be accessed. Medical professionals are trained to collect only relevant patient information with consent. They must protect the privacy and confidentiality of patient health records according to guidelines and privacy laws. Patient consent is required before disclosing information to other parties, except in emergencies or as required by law.
This document discusses various topics relating to medical ethics theories and principles, including:
- The scope of ethics in medical practice and various theories like deontological and consequentialist.
- Key principles like beneficence, non-maleficence, autonomy, truth-telling, confidentiality, and preservation of life.
- Issues around euthanasia, living wills, resource allocation, and contraception for minors.
This document provides an introduction to research ethics and ethics for health informaticians. It discusses key topics like the introduction to ethics and bioethics, ethical issues in health informatics, information ethics and clinical decision making. It also includes case studies of historic cases in research ethics like the Nazi human experimentation, Milgram study, Stanford prison experiment and Tuskegee study. The document discusses principles like respect for persons, beneficence, justice from the Belmont report. It also covers ethical, legal and social issues and clinical decision support systems.
Presented at the Health Informatics and Health Information Technology Course, Doctor of Philosophy and Master of Science Programs in Data Science for Health Care (International Program), Faculty of Medicine Ramathibodi Hospital, Mahidol University on October 31, 2017
Presented at the M.S. and Ph.D. Programs in Data Science for Health Care, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on November 14, 2019
This document provides an introduction to research ethics and ethics for health informaticians. It begins with definitions of ethics, morals, and norms. It then discusses the role of law, professional codes of conduct, and ethics in establishing standards of acceptable behavior. Key topics in research ethics are introduced through discussions of historic cases like the Nazi human experiments, Beecher's research ethics violations, and the Tuskegee Syphilis Study. The document outlines the Belmont Report's three ethical principles of respect for persons, beneficence, and justice. Ethical issues in health informatics like alerts fatigue from clinical decision support systems and unintended consequences of health IT are also discussed.
This document provides an outline and slides for a course on information ethics and clinical decision making. The course introduction discusses the topics to be covered, including information ethics, privacy, security, and case studies. An introduction to ethics and bioethics defines key terms and discusses the relationships between law, professional codes, and ethics. The document then reviews several important historical cases in bioethics that shaped modern ethical principles, such as the Nuremberg Code, Beecher's research ethics violations, and the Tuskegee Syphilis Study. It introduces models of clinical decision making and describes how clinical decision support systems can integrate into decision making processes.
The document outlines a course on information ethics and clinical decision making, beginning with an introduction to ethics, bioethics, and historical cases that shaped principles of research ethics like informed consent and protecting vulnerable groups. It then discusses challenges around reconciling laws, professional codes, and ethics, as well as core ethical principles like respect for persons, beneficence, and justice established in the Belmont Report. The course aims to help students apply these ethical frameworks to issues in health informatics and clinical decision making.
This document provides an overview of public health ethics. It begins by outlining the course objectives, which are to understand ethics definitions, principles, and controversies in healthcare, public health, and research. It then defines ethics and morality. The document discusses the historical perspectives of the Nazi experiments, Nuremberg Code, Tuskegee Syphilis Study, Belmont Report, Declaration of Helsinki, and other international guidelines. It also covers the general ethical principles of respect for autonomy, beneficence, nonmaleficence, and justice. The document discusses topics like informed consent, paternalism, confidentiality, and ethics in communicable disease control and epidemiological research.
EMPHNET-PHE Course: Module seven ethical issues in public health research& in...Dr Ghaiath Hussein
This is a series of presentations I gave in the Eastern Mediterranean Public Health Network (EMPHNET)'s Public Health Ethics (PHE) that was held in Amman in June 2014.
This presentation outlines the ethical issues in research, especially the international research in low-middle income countries
This document provides an overview of ethical issues in medical research. It discusses the history of unethical human experimentation including the Nazi experiments and the Tuskegee Syphilis Study. It outlines key documents that established ethical research standards like the Nuremberg Code, Declaration of Helsinki, and Belmont Report. The Belmont Report identified three core ethical principles: respect for persons, beneficence, and justice. It also discusses the role of institutional review boards in protecting research participants and reviewing research proposals to ensure compliance with ethical standards.
This document outlines the key topics and objectives covered in a public health ethics course. It discusses the definition of ethics and morality. It then covers several important historical cases in research ethics, including the Nazi experiments, Tuskegee Syphilis Study, Nuremberg Code, Declaration of Helsinki, and Belmont Report. The four main ethical principles - respect for autonomy, beneficence, nonmaleficence, and justice - are introduced. The document also discusses ethical issues around communicable disease control and informed consent.
Unit 8. Ethical Considerations in Reseaerch.pptxshakirRahman10
Ethical Consideration in Research:
Objectives:
1. Define the terms related to ethics in research
2. Discuss historical events of ethical mischiefs and evolution of ethics as protecting human rights
3. Discuss the ethical principles, declaration of Helsinki and research code of ethics
4. Describe different types of informed consent, i.e. verbal, written, individual and institutional consent.
5. Produce a meaningful informed consent form.
6. Identify role and importance of ethical considerations in research.
Ethical Considerations in Research:
Ethical considerations in research are a set of principles that guide the research designs and practices.
Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.
The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways.
What you decide to research and how you conduct that research involve key ethical considerations.
Ethical considerations work to:
Protect the rights of research participants
Enhance research validity
Maintain scientific or academic integrity.
History of Research Ethics:
Nuremberg Code
Dec. 9, 1946, when an American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for their willing participation in war crimes and crimes against humanity.
Among the charges were that German physicians conducted medical experiments on thousands of concentration camp prisoners without their consent. Most of the subjects of these experiments died or were permanently crippled as a result.
As a direct result of the trial, the Nuremberg Code was established in 1948, stating that “The voluntary consent of the human subject is absolutely essential,” making it clear that subjects should give consent and that the benefits of research must outweigh the risks.
Although it did not carry the force of law, the Nuremberg Code was the first international document which advocated voluntary participation and informed consent.
Thalidomide
In the late 1950s, thalidomide was approved as a sedative in Europe; it was not approved in the United States by the FDA.
The drug was prescribed to control sleep and nausea throughout pregnancy, but it was soon found that taking this drug during pregnancy caused severe deformities in the fetus.
Many patients did not know they were taking a drug that was not approved for use by the FDA, nor did they give informed consent. Some 12,000 babies were born with severe deformities due to thalidomide.
U.S. Senate hearings followed and in 1962 the so-called “Kefauver Amendments” to the Food, Drug, and Cosmetic Act were passed into law to ensure drug efficacy and greater drug safety.
For the first time, drug manufacturers were required to prove to the FDA the effectiveness of their products before marketing them.
This document provides an overview of medical ethics. It begins with definitions of ethics and discusses how ethics became important in medicine due to crimes against humanity in the 20th century. It then outlines the major developments in medical ethics codes and guidelines over time, including the Nuremberg Code, Declaration of Helsinki, and U.S. regulations. The document also covers ethical principles of beneficence, justice and respect for persons. It discusses types of ethics like professional, medical, bio and clinical ethics. Finally, it emphasizes the importance of ethical norms and codes in promoting responsible research and protecting subjects.
This document outlines the key ethical issues in conducting research. It begins by defining research and explaining where research fits within the knowledge management cycle. It then discusses what makes research ethical, outlining principles such as social or scientific value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, and informed consent.
The document goes on to discuss specific ethical issues in research, including benefit-harm analysis, vulnerability and the risk-vulnerability matrix, informed consent, fairness and equity, privacy and confidentiality, conflicts of interest, and ethical issues after research is conducted. It provides examples of vulnerable populations like women, pregnant women, and children.
This document discusses the history and evolution of ethical research practices. It outlines several key events and international guidelines that have shaped modern research ethics, including the Nuremberg Code established after World War 2. The four main principles of ethical research are described as respect for autonomy, non-maleficence, beneficence, and justice. Issues related to informed consent, privacy/confidentiality, safety, vulnerability, qualifications, and research oversight are also addressed. Research ethics committees are introduced as the institutional bodies tasked with reviewing proposed studies.
The document discusses ethical guidelines for biomedical research involving human participants as outlined by the Indian Council of Medical Research. It covers the history of ethical codes emerging from inhumane experiments, key principles of informed consent, protecting vulnerable populations, and preventing therapeutic misconception. Guidelines address general research principles, review procedures, clinical trials, and other specialized research areas. The importance of ethics committee oversight and obtaining valid informed consent is emphasized throughout.
The document discusses several key principles of ethical research:
1) Researchers must protect study participants from harm and obtain voluntary informed consent from participants.
2) Researchers should collect data anonymously or keep information confidential to protect participants' privacy.
3) Research proposals should undergo review by an Institutional Review Board to evaluate ethics.
4) Accurate reporting of research findings is important to maintain integrity.
This document discusses ethical principles in social research. It covers historical examples where ethics were not followed, such as the Tuskegee Syphilis Study and research done by Nazi Germany. Key principles discussed include obtaining informed consent, protecting participants from harm, ensuring anonymity and confidentiality, and being honest in reporting results. The document also addresses ethical dilemmas that can arise during and after data collection regarding issues like who owns the data. Researchers must consider all stakeholders and try to maximize benefits and minimize risks of any study.
This document provides an overview of ethics in research. It defines ethics and discusses key historical events that shaped modern research ethics like the Nazi experiments and the Nuremberg Code. The three primary ethical principles of beneficence, respect for human dignity, and justice are examined. Informed consent, risks/benefits analysis, and the role of institutional review boards in ensuring ethical research are covered. Challenges in vulnerable populations and qualitative/mixed methods research are also summarized.
Similar to Ethics in Biomedical Informatics (February 20, 2019) (20)
Presented at the BDMS Golden Jubilee Scientific Conference 2022 "BDMS Beyond 50 years: Looking towards the centennial," Bangkok Dusit Medical Services Public Company Limited (BDMS), Bangkok, Thailand on October 19, 2022
Telemedicine provides healthcare at a distance using telecommunications technology. It has grown from focusing on increasing access to now emphasizing convenience and cost reduction. Store-and-forward and home-based telemedicine have evidence for treating chronic diseases, while office/hospital telemedicine is effective for verbal interactions in specialties like neurology and psychiatry. Current trends include expanding telemedicine to more chronic conditions and migrating services from clinical settings to homes and mobile devices. However, reimbursement remains limited and fragmented while quality of remote care compared to in-person visits requires more evidence. Proper guidelines, standards, training and balancing innovation with risk-based regulation can maximize telemedicine's benefits while minimizing harms.
This document discusses digital health transformation and the role of health information technology. It begins by exploring concepts like artificial intelligence, blockchain, cloud computing and big data. It then examines the potential for "smart" machines in healthcare while acknowledging the complexities of digitizing such a system. The document emphasizes that clinical judgment is still necessary given variations in patients. It outlines components of healthcare systems and forms of health IT both within and beyond hospitals. Finally, it discusses using health IT to support clinical decision making and reduce errors.
Presented at The Thai Medical Informatics Association Annual Conference and The National Conference on Medical Informatics (TMI-NCMedInfo) 2021, Bangkok, Thailand on November 26, 2021
The document discusses the field of health informatics and provides definitions and examples. It defines health informatics as the application of information science to healthcare and biomedical research. It describes the relationships between health informatics and other fields like computer science, engineering, and the medical sciences. The document also discusses different areas of health informatics like clinical informatics, public health informatics, and consumer health informatics. It provides examples of common health information technologies used in healthcare settings like electronic health records, computerized physician order entry, and picture archiving systems.
Consumer Health Informatics, Mobile Health, and Social Media for Health: Part...Nawanan Theera-Ampornpunt
Presented at the Master of Science and Doctor of Philosophy Programs in Data Science for Healthcare and Clinical Informatics, Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on November 10, 2021
Consumer Health Informatics, Mobile Health, and Social Media for Health: Part...Nawanan Theera-Ampornpunt
Presented at the Master of Science and Doctor of Philosophy Programs in Data Science for Healthcare and Clinical Informatics, Department of Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on November 10, 2021
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Ethics in Biomedical Informatics (February 20, 2019)
1. Ethics in Biomedical
Informatics
For Faculty of Medicine Siriraj Hospital
Nawanan Theera-Ampornpunt, M.D., Ph.D.
Faculty of Medicine Ramathibodi Hospital, Mahidol University
February 20, 2019
http://www.SlideShare.net/Nawanan
2. 2
Outline
• Introduction to Ethics & Bioethics
• Ethical Issues in Health Informatics
• Information Ethics & Clinical Decision Making
• Case Studies
4. 4
Introduction to Ethics & Bioethics
• Ethics
a set of moral principles: a theory or system of moral values
the principles of conduct governing an individual or a group
the discipline dealing with what is good and bad and with
moral duty and obligation
• Moral
of or relating to principles of right and wrong in behavior
conforming to a standard of right behavior
• Norm
A principle of right action binding upon the members of a
group and serving to guide, control, or regulate proper and
acceptable behavior
Source: Merriam-Webster Dictionary
5. 5
? Option 1
Option 2
Society’s Standard
Standard of Acceptable Behaviors in Society
10. 10
Reconciling Conflicts
• Law
Is explicit but...
Often requires interpretation
Slow to create; outdated; sometimes not keep
up with technologies or social changes
Conflicting laws
• Professional Code of Conduct
Often explicit, but similar issues with law
Only focuses on narrow & traditional
professional practice
11. 11
Reconciling Conflicts
• Ethics
Implicit
Requires interpretation, making arguments
and debates
Is often the basis when law is created
Helpful in cases where law & code of
conduct don’t cover or are conflicting
12. 12
Branches of Ethics
• Descriptive ethics
What do people think is right?
• Normative ethics
How should people act? (prescriptive)
• Applied ethics
How do we take moral knowledge and put it into
practice?
• Meta-ethics
What does “right” even mean?
Source: http://en.wikipedia.org/wiki/Outline_of_ethics
13. 13
Sample Areas in Applied Ethics
• Business ethics
• Bioethics
Study of typically controversial ethics brought about by
advances in biology and medicine
• Decision ethics
• Professional ethics
Computer ethics
Journalism ethics and standards
Research ethics
Legal ethics
Marketing ethics
Medical ethics
Nursing ethics
Source: http://en.wikipedia.org/wiki/Outline_of_ethics http://en.wikipedia.org/wiki/Bioethics
14. 14
Some Terms in Ethics
• Ethical Issue
• Ethical Dilemma
A complex situation that often involves an apparent
mental conflict between moral imperatives, in which
to obey one would result in transgressing another.
• Ethical Principle
a standard of conduct defining the kind of behavior
an ethical person should and should not engage in.
(Josephson, 2010)
Provides a guide to making decisions & establish
criteria by which decisions will be judged by others.
(Josephson, 2010)
Source: http://en.wikipedia.org/wiki/Ethical_dilemma
http://josephsoninstitute.org/business/blog/2010/12/12-ethical-principles-for-business-executives/
15. 15
Historic Cases in Bioethics
• Real cases of unethical or controversial
professional practice or research practice
• Raised important ethical issues
• Led to development of important ethical
principles in use today
17. 17
Nazi Human Experimentation & Murder
• Doctors’ Trial at
Nuremberg, Germany
• Gave rise to the
Nuremberg Code, a set
of research ethics
principles for human
subject research
Source: http://en.wikipedia.org/wiki/Doctors%27_Trial http://en.wikipedia.org/wiki/Nuremberg_Code
18. 18
Points from The Nuremberg Code (1)
• Voluntary consent of human subject is
absolutely essential
• Experiment should be to yield fruitful results
for the good of society, unprocurable by other
methods or means of study, and not random
and unnecessary in nature
• Should be based on animal study & knowledge
of natural history of disease
• Avoid all unnecessary physical & mental
suffering & injury
Source: http://en.wikipedia.org/wiki/Nuremberg_Code http://www.hhs.gov/ohrp/archive/nurcode.html
19. 19
Points from The Nuremberg Code (2)
• Avoid study where it’s believed death or
disabling injury will occur
• Risk should not exceed importance of study
problem
• Proper preparations to protect subjects against
risks
• Study conducted by qualified scientists
• Subjects can decide to terminate participation
• Researcher in charge must be prepared to
terminate study if continuing is believed to
likely to result in injury or death
Source: http://en.wikipedia.org/wiki/Nuremberg_Code http://www.hhs.gov/ohrp/archive/nurcode.html
20. 20
Beecher’s Article
• Originally published in 1966
• Described 22 examples of research studies with
controversial ethics conducted by reputable researchers
and published in major journals.
• “...unethical or questionably ethical procedures are not
uncommon” (Beecher, 1966)
• Full text reprinted in Bull World Health Organ.
2001;79(4):367-72 & available at
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2566
401/pdf/11368058.pdf
Source: Beecher HK. Ethics and clinical research. N Engl J Med. 1966 Jun 16;274(24):1354-60.
21. 21
Common Ethical Problems in Research
• Lack of informed consent
• Coercion or undue pressure on volunteers (or on a parent
to volunteer his/her child)
• Use of a vulnerable population
• Exploitation of a vulnerable population
• Withholding information
• Withholding available treatment
• Withholding information about risks
• Putting subjects at risk
• Risks to subjects outweigh benefits
• Deception
• Violation of rights
Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.
22. 22
Tea Room Trade Study
• Investigated homosexual
practices in public restrooms.
The researcher went undercover
and acted as a “look out” to
directly observe men engaging in
sexual acts.
• He then identified 100 subjects
by tracing their car license
numbers.
• A year later, he distributed a
“social health survey” throughout
the communities where the
subjects lived.
Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.
23. 23
Tea Room Trade Study
• Ethical Issues
Informed consent
Deception
Use of a vulnerable population
Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.
25. 25
Stanford Prison Experiment
• In 1971 Philip
Zimbardo, a psychology
professor at Stanford
University conducted a
study of psychological
effects of becoming a
prisoner or prison
guard.
Source: http://en.wikipedia.org/wiki/Stanford_prison_experiment http://www.prisonexp.org/
26. 26
Stanford Prison Experiment
• 24 male students
randomly assigned to
roles of prisoners and
guards in a mock prison
in a basement at
Stanford which
continued for several
days
Source: http://en.wikipedia.org/wiki/Stanford_prison_experiment http://www.prisonexp.org/
27. 27
Stanford Prison Experiment
• Participants adapted to their
roles beyond researcher’s
expectations
• Guards enforced authoritarian
measures, became
psychologically abusive &
harassed prisoners
• Some prisoners joined the
guards in the abuse
• Study stopped after 6 days
(before 2-week intended
period) when ethical issues
were raised
Source: http://en.wikipedia.org/wiki/Stanford_prison_experiment http://www.prisonexp.org/
28. 28
Stanford Prison Experiment
• Ethical Issues
Risks in terms of
psychological harms
present that should be
anticipated and
permitted to continue
for some time
Source: http://en.wikipedia.org/wiki/Stanford_prison_experiment http://www.prisonexp.org/
29. 29
Tuskegee Study (1932-1972)
• Designed to document natural
history of syphilis in African-
American men
• There was no known treatment
for syphilis at the time
• Hundreds of men with and
without syphilis were enrolled
but they were misinformed
about the need for some of the
procedures.
• Some procedures were told as
necessary and free treatment
Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.
30. 30
Tuskegee Study (1932-1972)
• After penicillin was found to be
safe & effective treatment for
syphilis in 1940s, they were not
given penicillin.
• The study continued to track
the men until 1972 when the
public became aware of study
• 28 deaths, 100 cases of
disabilities, and 19 cases of
congenital syphilis
Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.
31. 31
Tuskegee Study (1932-1972)
• Ethical issues
Lack of informed consent
Deception
Withholding information
Withholding available treatment, putting
subjects & families at risk
Exploitation of a vulnerable group of
subjects who would not benefit from
participation (black men)
Source: Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.
32. 32
The Belmont Report
• A report by the U.S. National Commission
for the Protection of Human Subjects of
Biomedical and Behavioral Research to
address ethical issues in the Tuskegee
Study
• Identifies 3 basic ethical principles for all
human subject research called “Belmont
Principles”
Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.
33. 33
Belmont Principles
• Respect for Persons (or Autonomy)
• Beneficence
• Justice
Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.
34. 34
Belmont Principles
• Respect for Persons (or Autonomy)
Treat individuals as autonomous human
beings. People must be allowed to choose
for themselves
We must also provide extra protection to
those with limited autonomy
Autonomy includes mental capacity (ability
to understand and process information)
and voluntariness (freedom from control,
coercion, or influence of others)
Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.
35. 35
Belmont Principles
• Beneficence
Minimize harms and maximize benefits
within constraints of sound research
design
Avoid research without a favorable risk-
benefit ratio
Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.
36. 36
Belmont Principles
• Justice
Treat people fairly and design studies so
that burdens and benefits are shared
equitably
Select subjects equitably
Avoid exploitation of vulnerable
populations or “populations of
convenience”
Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.
37. 37
An Additional Ethical Principle
• Non-maleficence
• Primum non nocere
• “First, do no harm.”
• Included in the Hippocratic Oath
“...Whatever houses I may visit, I will
come for the benefit of the sick...”
Source: http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html
Bankert E, Cooper JA. History and ethical principles. Collaborative Institutional Training Initiative.
39. 39
Research ethics
Leads to patient outcomes, including deaths
Provider-patient relationship threatened by IT?
“Rationing” of health care through CDS systems
Information risks
Informatics practitioners as “professionals” with
specific skills, training, & competencies?
Most common question “Who owns the data?”
Why Important in Informatics?
Source: Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.
In Shortliffe (3rd Edition).
40. 40
ELSI
• ELSI - Ethical, Legal, and Social Issues
• These three aspects are often interrelated
• ELSI in Informatics
AMIA ELSI-WG
http://www.amia.org/programs/working-groups/ethical-legal-social-issues
Professional Code of Conduct
AMIA: http://www.amia.org/about-amia/ethics/code-ethics
IMIA: http://www.imia-medinfo.org/new2/pubdocs/Ethics_Eng.pdf
41. 41
IMIA General Ethical Principles in Informatics
• Information Privacy & Disposition
• Openness
• Security
• Access
• Legitimate Infringement
• Least Intrusive Alternative
• Accountability
Source: http://www.imia-medinfo.org/new2/pubdocs/Ethics_Eng.pdf
42. 42
Some ELSI References
• Anderson JG. The role of ethics in information technology decisions: a case-
based approach to biomedical informatics education. Int J Med Inform. 2004
Mar 18;73(2):145-50.
Anderson JG & Goodman KW (2002)
Shortliffe 3rd Edition (2006)
Chapter 10 by Goodman KW &
Miller RA
44. 44
A Model of Clinical Decision Making
External Memory
Knowledge Data
Long Term Memory
Knowledge Data
Inference
DECISION
PATIENT
Perception
Attention
Working
Memory
CLINICIAN
Source: Elson RB, Faughnan JG, Connelly DP. An industrial process view of information delivery to support
clinical decision making: implications for system design and process measures. J Am Med Inform Assoc. 1997 Jul-
Aug;4(4):266-78. http://jamia.bmj.com/content/4/4/266.full.pdf+html
45. 45
Clinical Decision Support Systems (CDS)
• The real place where most of the values of
health IT can be achieved
• A variety of forms and nature of CDS
Expert systems
• Based on artificial intelligence, machine learning,
rules, or statistics
• Examples: differential diagnoses, treatment options
46. 46
Clinical Decision Support Systems (CDS)
• A variety of forms and nature of CDS
Alerts & reminders
• Based on specified logical conditions
• Examples: drug-allergy checks, drug-drug interaction
checks, drug-lab interaction checks, drug-formulary
checks, reminders for preventive services or certain
actions (e.g. smoking cessation), clinical practice
guideline integration
Evidence-based knowledge sources e.g. drug database,
literature
Simple UI designed to help clinical decision making
48. 48
Issues
• CDSS as a supplement or replacement of clinicians?
The demise of the “Greek Oracle” model (Miller & Masarie,
1990)
The “Greek Oracle” Model
The “Fundamental Theorem”
Friedman CP. A "fundamental theorem" of biomedical informatics. J Am Med
Inform Assoc. 2009 Apr;16(2):169-170.
Clinical Decision Support Systems (CDSSs)
52. 52
• “Unanticipated and unwanted effect of health IT
implementation” (ucguide.org)
• Must-read resources
Ash JS, Berg M, Coiera E. Some unintended consequences of
information technology in health care: the nature of patient
care information system-related errors. J Am Med Inform Assoc.
2004 Mar-Apr;11(2):104-12.
Campbell, EM, Sittig DF, Ash JS, et al. Types of Unintended
Consequences Related to Computerized Provider Order
Entry. J Am Med Inform Assoc. 2006 Sep-Oct; 13(5): 547-556.
Koppel R, Metlay JP, Cohen A, Abaluck B, Localio AR, Kimmel SE,
Strom BL. Role of computerized physician order entry systems
in facilitating medication errors. JAMA. 2005 Mar
9;293(10):1197-203.
Unintended Consequences of Health IT
53. 53Ash et al. (2004)
Unintended Consequences of Health IT
54. 54
• Errors in the process of entering and retrieving
information
A human-computer interface that is not
suitable for a highly interruptive use context
Causing cognitive overload by
overemphasizing structured and “complete”
information entry or retrieval
• Structure
• Fragmentation
• Overcompleteness
Ash et al. (2004)
Unintended Consequences of Health IT
55. 55
• Errors in the communication and coordination process
Misrepresenting collective, interactive work as a linear, clearcut, and
predictable workflow
• Inflexibility
• Urgency
• Workarounds
• Transfers of patients
Misrepresenting communication as information transfer
• Loss of communication
• Loss of feedback
• Decision support overload
• Catching errors
Ash et al. (2004)
Unintended Consequences of Health IT
60. 60
Standard view
With uncertainties around new technology, “scientific
evidence counsels caution and prudence.”
Evidence & reason determine appropriate level of
caution
If such systems improve care at acceptable cost in
time & money, there’s an obligation to use it
Follows evolving evidence and standards of care
Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.
In Shortliffe (3rd Edition).
Appropriate Use of Health IT
61. 61
Standard view
For computer-assisted clinical diagnosis CDS, human
cognitive processes are more suited to complex task
of diagnosis than machine, and should not be
overridden or trumped by computers.
When adequate CDS tools are developed, they should
be viewed and used as supplementary and subservient
to human clinical judgment
Appropriate Use of Health IT
Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.
In Shortliffe (3rd Edition).
63. 63
Standard view
Practitioners have obligation to use tools responsibly,
through adequate training & understanding the
system’s abilities & limitations
Practitioners must not ignore their clinical judgment
reflexively when using CDS.
Appropriate Use of Health IT
Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.
In Shortliffe (3rd Edition).
64. 64
Health IT “should be used in clinical practice only
after appropriate evaluation of its efficacy and the
documentation that it performs its intended task at an
acceptable cost in time & money”
Qualified (licensed, trained & experienced) health
professionals as users
Systems should be used to augment/supplement,
rather than replace or supplant individuals’ decision
making
Adequate training
Appropriate Use of Health IT
Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.
In Shortliffe (3rd Edition).
65. 65
Follow standard of care & scientific progress
(evidence-based)
System evaluation is ethically imperative
Ethics for Developers
Goodman & Miller. Chapter 10: Ethics and Health Informatics: Users, Standards, and Outcomes.
In Shortliffe (3rd Edition).
66. 66
Why Clinical Judgment Is Still Necessary?
• Nothing is certain in medicine & health care
• Large variations exist in patient presentations,
clinical course, underlying genetic codes, patient
& provider behaviors, biological responses &
social contexts
• Human is good at pattern recognition, while
machine is good at logic & computations.
• Diagnosis is often achieved through recognizing
clinical patterns
• Not everything can be digitized or digitally
acquired
• Experience, context & human touch matters
67. 67
“Learned Intermediary” Doctrine
• A defense doctrine used in the U.S. legal
system (and some other countries) which
states that “a manufacturer of a product has
fulfilled his duty of care when he provides all
of the necessary information to a ‘learned
intermediary’ who then interacts with the
consumer of a product.” (Wikipedia)
• Primarily used by pharmaceutical & medical
device manufacturers in defense of tort
lawsuits.
Source: http://en.wikipedia.org/wiki/Learned_intermediary
68. 68
“Learned Intermediary” Doctrine
• Because health IT developers can’t expect a
CDS advice (e.g., alerts & reminders) to be
100% appropriate for each individual patient,
clinical judgment is still necessary.
• Health IT developers & manufacturers are
protected from liabilities for
poor/inappropriate advices or for bad
outcomes associated with them, as long as
there is a clinician using it that can intervene
• What about software bugs (e.g. wrong dose
calculations)?
69. 69
“Learned Intermediary” Doctrine
• Applicability of this doctrine varies based
on legal jurisdictions, context of each
case, and legal arguments
• Recently, this doctrine has been noted by
some legal and informatics experts that it
doesn’t apply to health IT cases
• It remains unclear until there are rulings
from real legal cases
70. 70
Summary
• Ethical principles are guides and standards
of practice that can help us navigate
through situations that arise.
• History was full of unethical conduct
• 4 important principles in bioethics
Respect for persons (autonomy)
Beneficence
Justice
Non-maleficence
71. 71
Summary
• Ethical issues are present in informatics
practice (whether as developers, implementers,
executives, users, researchers, etc.)
• Codes of conduct & ethics codes by
professional organizations govern acceptable
& ethical behaviors by informaticians
• In use of health IT in clinical decision
making, there are standard & appropriate
guidelines that are based on ethical principles