This document provides an introduction to bioethics and ethical issues in biomedical research. It discusses key concepts in bioethical theory like principlism, deontology, utilitarianism and virtue ethics. It outlines prominent ethical codes and guidelines for research involving human subjects. It also analyzes ethical benchmarks for clinical research including informed consent, risk-benefit assessment, and independent review. The document uses case studies to illustrate how ethical principles can conflict in research and need to be balanced. It emphasizes that the goal of bioethics is to promote trustworthy research while protecting participants.
For my Capstone Course (Contemporary issues in Organizational Leadership) my group decided to discuss the ethics in regards to medical research and treatment, which has been an ongoing debate in our society.
This document provides an overview of bioethics and its key principles. It begins by defining bioethics as the interdisciplinary study of problems created by biological and medical progress and its impact on society. It then discusses the history and birth of bioethics, noting it was preceded by medical ethics and drew upon ancient Hippocratic principles. Four main bioethical principles are introduced: autonomy, beneficence, non-maleficence, and justice. These principles establish obligations and duties to maximize benefits and minimize harms for individuals and society. An example is given of a historical clinical trial that violated ethics through non-consensual experimentation.
This document discusses several topics in bioethics including:
1. The definition and history of bioethics as a field emerging from advances in medicine and technology.
2. The four principles of bioethics: confidentiality, beneficence, justice, and autonomy.
3. Issues raised by genetic testing and prenatal diagnosis including social stigma, employment discrimination, insurance coverage, and decisions around abortion.
4. Concerns regarding gene therapy and playing God by tampering with human genes.
This document provides an overview of the field of bioethics. It discusses four key principles of bioethics: autonomy, beneficence, non-maleficence, and justice. The scope of bioethics is explained as including issues raised by advances in fields like genetics and reproductive technologies. Five major issues in bioethics are outlined: abortion, euthanasia, eugenics, human cloning, and stem cell research. Each issue is described in 1-2 sentences. The document concludes with two brief ethical case analyses involving trolley problems and organ transplantation.
Ethical implication of Human genome project,
International ethical & legal issues connected with human genome diversity research,
Genetic studies of ethnic races.
1. Bioethics examines ethical issues that emerge from advances in science and medicine. It addresses dilemmas that arise when different parties hold conflicting values regarding appropriate care for patients.
2. Major historical events that shaped the field include the Nuremberg trials, which established standards of informed consent after Nazi human experiments, and the development of key principles like autonomy, non-maleficence, and beneficence.
3. Resolving bioethical dilemmas requires a systematic approach, including clarifying the medical facts and stakeholders' preferences, analyzing which values are most relevant, and making recommendations through shared decision-making.
Concepts and principles of bioethics for the students of health professionsK Raman Sethuraman
Students and many educators have difficulty in differentiating among Legal, Ethical and Moral viewpoints. After explaining these terms, the concept of biomedical ethics, a brief history of its origin in the post-War period and the components of ethics are explained. The final part is on Nursing ethics, attributes of an ethical nurse and ethical challenges faced by the nursing profession.
This document discusses ethics and bioethics. It defines ethics as determining the best course of action and providing reasons for moral behavior. Bioethics explores ethical issues related to life sciences. When addressing bioethical questions, it is important to consider: what is the ethical question being asked, what are the relevant facts, who may be affected by how the question is resolved, and what ethical principles like respect for persons, minimizing harm and maximizing benefit, and fairness apply. Proper ethical reasoning requires considering multiple perspectives, weighing different considerations, and justifying one's position without relying on moral absolutism or ethical relativism. The document provides several examples of controversial bioethical issues.
For my Capstone Course (Contemporary issues in Organizational Leadership) my group decided to discuss the ethics in regards to medical research and treatment, which has been an ongoing debate in our society.
This document provides an overview of bioethics and its key principles. It begins by defining bioethics as the interdisciplinary study of problems created by biological and medical progress and its impact on society. It then discusses the history and birth of bioethics, noting it was preceded by medical ethics and drew upon ancient Hippocratic principles. Four main bioethical principles are introduced: autonomy, beneficence, non-maleficence, and justice. These principles establish obligations and duties to maximize benefits and minimize harms for individuals and society. An example is given of a historical clinical trial that violated ethics through non-consensual experimentation.
This document discusses several topics in bioethics including:
1. The definition and history of bioethics as a field emerging from advances in medicine and technology.
2. The four principles of bioethics: confidentiality, beneficence, justice, and autonomy.
3. Issues raised by genetic testing and prenatal diagnosis including social stigma, employment discrimination, insurance coverage, and decisions around abortion.
4. Concerns regarding gene therapy and playing God by tampering with human genes.
This document provides an overview of the field of bioethics. It discusses four key principles of bioethics: autonomy, beneficence, non-maleficence, and justice. The scope of bioethics is explained as including issues raised by advances in fields like genetics and reproductive technologies. Five major issues in bioethics are outlined: abortion, euthanasia, eugenics, human cloning, and stem cell research. Each issue is described in 1-2 sentences. The document concludes with two brief ethical case analyses involving trolley problems and organ transplantation.
Ethical implication of Human genome project,
International ethical & legal issues connected with human genome diversity research,
Genetic studies of ethnic races.
1. Bioethics examines ethical issues that emerge from advances in science and medicine. It addresses dilemmas that arise when different parties hold conflicting values regarding appropriate care for patients.
2. Major historical events that shaped the field include the Nuremberg trials, which established standards of informed consent after Nazi human experiments, and the development of key principles like autonomy, non-maleficence, and beneficence.
3. Resolving bioethical dilemmas requires a systematic approach, including clarifying the medical facts and stakeholders' preferences, analyzing which values are most relevant, and making recommendations through shared decision-making.
Concepts and principles of bioethics for the students of health professionsK Raman Sethuraman
Students and many educators have difficulty in differentiating among Legal, Ethical and Moral viewpoints. After explaining these terms, the concept of biomedical ethics, a brief history of its origin in the post-War period and the components of ethics are explained. The final part is on Nursing ethics, attributes of an ethical nurse and ethical challenges faced by the nursing profession.
This document discusses ethics and bioethics. It defines ethics as determining the best course of action and providing reasons for moral behavior. Bioethics explores ethical issues related to life sciences. When addressing bioethical questions, it is important to consider: what is the ethical question being asked, what are the relevant facts, who may be affected by how the question is resolved, and what ethical principles like respect for persons, minimizing harm and maximizing benefit, and fairness apply. Proper ethical reasoning requires considering multiple perspectives, weighing different considerations, and justifying one's position without relying on moral absolutism or ethical relativism. The document provides several examples of controversial bioethical issues.
The document discusses bioethics and research ethics. It begins with definitions of ethics, biomedical research, and clinical research. It then outlines the history of international ethical guidelines, including the Nuremberg Code, Declaration of Helsinki, and others. The document defines types of research involving human participants and discusses the importance of research ethics in promoting values like honesty, accountability, and minimizing harm. It concludes by outlining several codes for research ethics regarding topics like informed consent, confidentiality, and protecting human subjects.
Ethical considerations in molecular & biotechnology researchDr Ghaiath Hussein
A lecture presented by Dr. Ghaiath Hussein in University of Khartoum for the students of the MSc programme in Genetics/Molecular Biology.
Session 1 (Introduction): Definition of ethics, bioethics and medical ethics.
What is an ethical issue?
International approaches to medical ethics
Islamic approaches to medical ethics
This document introduces the topic of bioethics. It defines key terms such as ethics, biology, bioethics, health ethics, and professional ethics. It explains that bioethics education is important for medical practitioners because medical policies and patient rights are constantly changing, health care systems have evolved, and clinicians now face many new issues. The document also lists some common ethical issues addressed in bioethics such as abortion, euthanasia, cloning, and stem cell technology.
This document discusses several key topics in medical ethics including:
1. The basic concepts of medical ethics including beneficence, non-maleficence, autonomy, justice, and informed consent.
2. Historical events that shaped modern medical ethics such as the Tuskegee Syphilis Study and the Doctors' Trial at Nuremberg.
3. The role of Institutional Review Boards in ensuring ethical research and protecting human subjects.
4. Common ethical issues in healthcare like end-of-life care, advance directives, withdrawal of life-sustaining treatment, and resolving disagreements between patients/families and physicians.
This document discusses bioethics and biosafety. It begins with an introduction to bioethics, defining it as the study of ethical implications of biological discoveries and advances in fields like genetic engineering. It then covers ethics and morals, the importance of bioethics, principles of bioethics like autonomy, beneficence, non-maleficence and justice. The document addresses bioethics in patient care, research, teamwork and lists UNESCO's 15 bioethical principles.
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.
Basics of BioSafety
This lesson will define and present information on
methods used to provide biosafety in facilities
where potentially infectious agents are used.
These include:
Containment
Biological safety cabinets
Personal protection equipment
The facility as barrier
Secondary barriers
This document provides an overview of the history and concepts of medical bioethics. It defines key terms like ethics, morals, bioethics, and medical ethics. It discusses normative ethics and applied ethics. It outlines the objectives of ethics as understanding moral conflicts and resolving problems. Knowledge and technology are discussed in the context of bioethics. The document also covers metaethics, biomedical ethics, and the profession of medicine. Overall it comprehensively introduces the reader to the important concepts and evolution of the field of medical bioethics.
This document discusses the ethical issues surrounding modern biotechnology. It begins with an introduction to biotechnology and bioethics. It then discusses the various categories of ethical issues, including socio-economic issues, cultural issues, environmental issues, legal issues, religious issues, and the demerits of biotechnology tools and products. Specifically, it outlines concerns regarding animal biotechnology such as risks to human and animal welfare, and concerns regarding plant biotechnology such as potentially reducing biological diversity and disrupting ecosystems.
This document discusses biosafety guidelines for laboratories working with genetically modified organisms (GMOs). It outlines different levels of biosafety containment from levels 1 to 4, with higher levels required for more dangerous pathogens. Physical and biological containment methods are described, including air filtration, sterilization lights, waste disposal procedures, and making organisms unable to survive outside the lab. Guidelines for safe practices in biosafety level 1 and 2 labs are provided. Several databases for finding biosafety information are also mentioned.
Bioethics and biosafety in biotechnologysanguru1977
This document discusses biosafety regulations for biotechnology. It covers national and international biosafety regulations, field trials of genetically modified organisms, and capacity building in developing countries. Key topics include agriculture/food systems, market/consumer issues, business/institutional impacts, and social issues related to biotechnology applications. Establishing appropriate biosafety regulations is important for safely developing and sharing biotechnology, especially in developing nations.
Biosafety is the application of safety precautions that reduce a Laboratory based risk of exposure to a potentially infectious material and limit contamination of the working and surrounding environment.
The primary principle of biosafety is “Containment”.
Containment
The action of keeping harmful things under control and within limits
Or
A series of safe methods for managing infectious bacteria in the laboratory.
Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health. These prevention mechanisms include conduction of regular reviews of the biosafety in laboratory settings, as well as strict guidelines to follow. Biosafety also means safety from exposure to infectious agents.
Necessity
In order to avoid infection/biohazard to the laboratory personnel & the environment, biosafety levels are very important.
The document provides an introduction to biosafety, explaining that it aims to reduce risk of exposure to infectious materials through proper safety precautions and procedures. It discusses the need for biosafety in laboratories processing infectious agents and around recombinant DNA to protect workers and the environment. The document also outlines different biosafety levels and associated practices, containment facilities, risk groups of pathogens, and considerations for risk assessments.
This document provides an introduction to ethics in health care. It discusses the importance of health care professionals developing both scientific and ethical conduct skills. It outlines key terms related to ethics and discusses changes in health care over time, including increased specialization and technology. The document notes that in addition to technical skills, health care workers must meet legal, ethical and professional etiquette requirements to avoid sanctions. It discusses different approaches to ethics and emphasizes that involvement in unethical practice can harm patients, fellow practitioners and the community.
Biosafety refers to ensuring safety when working with biological organisms. This document discusses biosafety concepts and issues including containment levels, biosafety cabinets, and risk assessment. The four biosafety levels range from level 1 posing minimal risk to level 4 posing high individual risk without vaccines or treatments. Biosafety cabinets are used to protect workers and the environment, with class I protecting environment, class II protecting samples and environment, and class III providing maximum protection in BSL-4 labs. Risk assessment considers an organism's pathogenicity, virulence, proliferation ability, and transmission route. Guidelines for recombinant DNA research emphasize risk-based containment and avoiding unnecessary regulation.
This document discusses genetic modification and genetically modified organisms (GMOs). It notes that genetic modification involves altering the genetic makeup of living organisms using genetic engineering techniques. The document then outlines some of the environmental concerns with GMOs, including increased pesticide use leading to soil and water pollution, as well as imbalances in ecosystems. It also discusses specific concerns with the herbicide glyphosate and its effects on soil, water, and human health. The document concludes by mentioning some international agreements and laws around GMOs and environmental protection.
This document discusses ethics in research involving human subjects. It emphasizes that researchers have a responsibility to protect the rights and welfare of research participants. Participants have a fundamental right to health and human rights that must be respected in any research. The core ethical principles of autonomy, beneficence, non-maleficence, and justice provide guidance for ethical research. Researchers must obtain informed consent, minimize risks and maximize benefits, and have their research approved by an Institutional Review Board to ensure the ethics of any studies involving human subjects.
The document discusses bioethics and research ethics. It begins with definitions of ethics, biomedical research, and clinical research. It then outlines the history of international ethical guidelines, including the Nuremberg Code, Declaration of Helsinki, and others. The document defines types of research involving human participants and discusses the importance of research ethics in promoting values like honesty, accountability, and minimizing harm. It concludes by outlining several codes for research ethics regarding topics like informed consent, confidentiality, and protecting human subjects.
Ethical considerations in molecular & biotechnology researchDr Ghaiath Hussein
A lecture presented by Dr. Ghaiath Hussein in University of Khartoum for the students of the MSc programme in Genetics/Molecular Biology.
Session 1 (Introduction): Definition of ethics, bioethics and medical ethics.
What is an ethical issue?
International approaches to medical ethics
Islamic approaches to medical ethics
This document introduces the topic of bioethics. It defines key terms such as ethics, biology, bioethics, health ethics, and professional ethics. It explains that bioethics education is important for medical practitioners because medical policies and patient rights are constantly changing, health care systems have evolved, and clinicians now face many new issues. The document also lists some common ethical issues addressed in bioethics such as abortion, euthanasia, cloning, and stem cell technology.
This document discusses several key topics in medical ethics including:
1. The basic concepts of medical ethics including beneficence, non-maleficence, autonomy, justice, and informed consent.
2. Historical events that shaped modern medical ethics such as the Tuskegee Syphilis Study and the Doctors' Trial at Nuremberg.
3. The role of Institutional Review Boards in ensuring ethical research and protecting human subjects.
4. Common ethical issues in healthcare like end-of-life care, advance directives, withdrawal of life-sustaining treatment, and resolving disagreements between patients/families and physicians.
This document discusses bioethics and biosafety. It begins with an introduction to bioethics, defining it as the study of ethical implications of biological discoveries and advances in fields like genetic engineering. It then covers ethics and morals, the importance of bioethics, principles of bioethics like autonomy, beneficence, non-maleficence and justice. The document addresses bioethics in patient care, research, teamwork and lists UNESCO's 15 bioethical principles.
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.
Basics of BioSafety
This lesson will define and present information on
methods used to provide biosafety in facilities
where potentially infectious agents are used.
These include:
Containment
Biological safety cabinets
Personal protection equipment
The facility as barrier
Secondary barriers
This document provides an overview of the history and concepts of medical bioethics. It defines key terms like ethics, morals, bioethics, and medical ethics. It discusses normative ethics and applied ethics. It outlines the objectives of ethics as understanding moral conflicts and resolving problems. Knowledge and technology are discussed in the context of bioethics. The document also covers metaethics, biomedical ethics, and the profession of medicine. Overall it comprehensively introduces the reader to the important concepts and evolution of the field of medical bioethics.
This document discusses the ethical issues surrounding modern biotechnology. It begins with an introduction to biotechnology and bioethics. It then discusses the various categories of ethical issues, including socio-economic issues, cultural issues, environmental issues, legal issues, religious issues, and the demerits of biotechnology tools and products. Specifically, it outlines concerns regarding animal biotechnology such as risks to human and animal welfare, and concerns regarding plant biotechnology such as potentially reducing biological diversity and disrupting ecosystems.
This document discusses biosafety guidelines for laboratories working with genetically modified organisms (GMOs). It outlines different levels of biosafety containment from levels 1 to 4, with higher levels required for more dangerous pathogens. Physical and biological containment methods are described, including air filtration, sterilization lights, waste disposal procedures, and making organisms unable to survive outside the lab. Guidelines for safe practices in biosafety level 1 and 2 labs are provided. Several databases for finding biosafety information are also mentioned.
Bioethics and biosafety in biotechnologysanguru1977
This document discusses biosafety regulations for biotechnology. It covers national and international biosafety regulations, field trials of genetically modified organisms, and capacity building in developing countries. Key topics include agriculture/food systems, market/consumer issues, business/institutional impacts, and social issues related to biotechnology applications. Establishing appropriate biosafety regulations is important for safely developing and sharing biotechnology, especially in developing nations.
Biosafety is the application of safety precautions that reduce a Laboratory based risk of exposure to a potentially infectious material and limit contamination of the working and surrounding environment.
The primary principle of biosafety is “Containment”.
Containment
The action of keeping harmful things under control and within limits
Or
A series of safe methods for managing infectious bacteria in the laboratory.
Biosafety is the prevention of large-scale loss of biological integrity, focusing both on ecology and human health. These prevention mechanisms include conduction of regular reviews of the biosafety in laboratory settings, as well as strict guidelines to follow. Biosafety also means safety from exposure to infectious agents.
Necessity
In order to avoid infection/biohazard to the laboratory personnel & the environment, biosafety levels are very important.
The document provides an introduction to biosafety, explaining that it aims to reduce risk of exposure to infectious materials through proper safety precautions and procedures. It discusses the need for biosafety in laboratories processing infectious agents and around recombinant DNA to protect workers and the environment. The document also outlines different biosafety levels and associated practices, containment facilities, risk groups of pathogens, and considerations for risk assessments.
This document provides an introduction to ethics in health care. It discusses the importance of health care professionals developing both scientific and ethical conduct skills. It outlines key terms related to ethics and discusses changes in health care over time, including increased specialization and technology. The document notes that in addition to technical skills, health care workers must meet legal, ethical and professional etiquette requirements to avoid sanctions. It discusses different approaches to ethics and emphasizes that involvement in unethical practice can harm patients, fellow practitioners and the community.
Biosafety refers to ensuring safety when working with biological organisms. This document discusses biosafety concepts and issues including containment levels, biosafety cabinets, and risk assessment. The four biosafety levels range from level 1 posing minimal risk to level 4 posing high individual risk without vaccines or treatments. Biosafety cabinets are used to protect workers and the environment, with class I protecting environment, class II protecting samples and environment, and class III providing maximum protection in BSL-4 labs. Risk assessment considers an organism's pathogenicity, virulence, proliferation ability, and transmission route. Guidelines for recombinant DNA research emphasize risk-based containment and avoiding unnecessary regulation.
This document discusses genetic modification and genetically modified organisms (GMOs). It notes that genetic modification involves altering the genetic makeup of living organisms using genetic engineering techniques. The document then outlines some of the environmental concerns with GMOs, including increased pesticide use leading to soil and water pollution, as well as imbalances in ecosystems. It also discusses specific concerns with the herbicide glyphosate and its effects on soil, water, and human health. The document concludes by mentioning some international agreements and laws around GMOs and environmental protection.
This document discusses ethics in research involving human subjects. It emphasizes that researchers have a responsibility to protect the rights and welfare of research participants. Participants have a fundamental right to health and human rights that must be respected in any research. The core ethical principles of autonomy, beneficence, non-maleficence, and justice provide guidance for ethical research. Researchers must obtain informed consent, minimize risks and maximize benefits, and have their research approved by an Institutional Review Board to ensure the ethics of any studies involving human subjects.
This document discusses ethical issues in scientific research involving human subjects. It outlines several key principles of research ethics including informed consent, minimizing harm, protecting privacy and confidentiality, ensuring justice and beneficence, and maintaining integrity. International codes like the Nuremberg Code, Helsinki Declaration, and Belmont Report established foundational ethical standards. Indian guidelines also adhere to strict ethical protocols for research involving human participants. Institutional ethics committees play an important role in reviewing research proposals and protocols to ensure compliance with ethical standards.
EMPHNET Public Health Ethics (PHE): Introduction to public health ethics (phe)Dr Ghaiath Hussein
This is a series of presentations I gave in the Eastern Mediterranean Public Health Network (EMPHNET)'s Public Health Ethics (PHE) course that was held in Amman in June 2014.
It is a revised introduction to public health ethics.
This document discusses case studies and clinical studies as research methods. It provides information on what case studies and clinical studies are, how they are conducted in different fields like business and psychology, and the typical components of a case study or clinical study such as facts from interviews, tests administered, and recommendations. The key aspects covered are that case studies involve an in-depth analysis of a limited number of situations while clinical studies involve research with human participants to further medical knowledge.
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.
Lecture 7-research ethics and engaging culture.pptxXiaolanDeng1
This document outlines the key aspects of research ethics and procedures for protecting study participants. It discusses definitions of ethics and human research, why research ethics are important, and the ethical principles of human dignity, consent, protecting vulnerable groups, privacy/confidentiality, balancing risks and benefits, and justice/inclusiveness. It describes procedures like risk-benefit assessments and issues around participants. It also focuses on the ethical treatment of vulnerable groups like children, disabled people, the severely ill, terminally ill, and institutionalized individuals.
This document discusses ethics in research and provides guidelines for responsible and ethical conduct of research involving human subjects. It outlines the need for research ethics to protect participants and ensure research benefits society. Key principles discussed include voluntary informed consent, assessment of risks and benefits, and oversight by independent ethics committees. Several landmark declarations that established ethical guidelines for research are summarized, including the Nuremberg Code, Declaration of Helsinki, Belmont Report, and ICMR Code. Mechanisms like institutional review committees are described which review research proposals to ensure compliance with ethical standards.
Studying ethics is important for several reasons:
1) Students will be expected to follow ethical codes when they enter their professions.
2) It allows one to responsibly address moral issues that may arise from medical laboratory activities.
3) It helps one learn how to deal with ethical dilemmas that may occur in their professional lives.
Steps and Principals of clinical research in Surgery.pptxPradeep Pande
The document outlines the basic steps and principles of clinical research in surgery. It defines research and describes the inductive and deductive approaches. Research aims to advance medical knowledge and improve patient care. The main types of research are basic science, clinical, translational, and applied. Clinical research involves studying patients and health outcomes to identify areas for improvement. Key steps include developing objectives and protocols, obtaining ethical approval, collecting and analyzing data, and disseminating findings. Important principles are informed consent, safety, validity, transparency, and avoiding bias and plagiarism.
The document summarizes key ethical principles for conducting clinical trials including: obtaining informed consent, minimizing risks and ensuring a favorable risk-benefit ratio for participants, selecting participants equitably, respecting privacy and confidentiality, having trials approved and monitored by an IRB, stopping trials if risks are found to outweigh benefits, and disseminating results. It also discusses ethical issues around placebos, randomization, choice of controls, recruitment, monitoring safety, authorship, and conflicts of interest.
Here are the answers to your questions:
1. FINER criteria of a good research question are: Feasible, Interesting, Novel, Ethical, Relevant.
2. A null hypothesis is a statistical hypothesis that predicts that no relationship exists between two variables.
3. The types of relationships that may exist between two variables are: positive, negative, or no relationship.
4. Read around comes first before read into. Read around gives a broad overview of the topic area, while read into involves an in-depth review.
5. The literature review is often called the "mother of the research" as it helps identify gaps and formulate the research question.
6. If we
Research ethics involves applying moral principles to guide research involving human subjects in a responsible way. There are four main ethical principles: avoiding harm to participants, obtaining informed consent, respecting privacy, and avoiding deception. Obtaining informed consent involves providing information on the research purpose and procedures, ensuring participation is voluntary, and maintaining privacy of data. Research should not cause harm such as distress and must have benefits such as contributing to knowledge. Upholding ethical standards is important for protecting subjects and conducting sound research.
This document provides an overview of health research. It defines health research as systematically investigating physical, mental, or social well-being. Examples include studies on injury prevention, multiple sclerosis symptoms, hearing loss and age, and college binge drinking. Health research involves carefully studying subjects to discover new information and can have both societal and personal benefits. There are two main types: laboratory and population-based research. The research process involves preparing, designing a study, collecting and analyzing data, and disseminating findings. Publication is more likely if the topic and methods are appropriate for the intended audience.
This document provides an overview of an introductory pharmacy law and ethics course at the University of Gondar in Ethiopia. The course is offered in the 2019/2020 academic year to 4th year Bpharm students. It is worth 2 credit hours and covers topics like definitions of ethics, ethical theories, principles and rules, ethical issues in healthcare, and codes of ethics for pharmacists. The course is divided into two parts - Part I focuses on ethics and Part II will cover pharmacy law.
The document discusses identifying bias in scientific studies. It states that good science minimizes bias through random sampling, minimizing measurement bias, and having a large enough sample size. Bias can influence results and different scientists may find different solutions to the same problem. The scientific community engages in quality control like independent duplication of studies and peer review to eliminate bias. Results are more reliable if verified through these methods.
The document discusses identifying bias in scientific studies. It states that good science minimizes bias through random sampling, minimizing measurement bias, and accounting for multiple factors. Bias can come from the language used, data reported, and source of the data. The scientific community engages in quality control like independent duplication of results and peer review to eliminate bias.
This document discusses medical ethics in view of medical research. It begins by noting conflicts between various stakeholders in medical institutions. It then defines what ethics are and are not, establishing that ethics are based on moral principles of right and wrong. It discusses how medical ethics regulate professional conduct and relationships. The document outlines guidelines from organizations like WHO and ICMR for ethical research involving human subjects. It emphasizes informed consent and the role of institutional ethics committees in reviewing research proposals and ensuring ethical standards are followed. Throughout, it stresses applying ethical values with human perception in medical research.
Similar to Introduction to research bioethics (20)
This document provides an overview of antigen-antibody interactions and the immune response. It discusses how antigens activate B lymphocytes to produce antibodies, the structure and types of antibodies, and how antibodies function through direct interaction with antigens and activation of the complement system. It also describes clinical applications of immunization and passive immunity. Key topics covered include antigenicity, haptens, superantigens, primary versus secondary immune responses, and tests used to detect antigen-antibody reactions.
This document provides an overview of cancer and chemotherapy. It discusses that cancer is caused by deregulation of cell proliferation and apoptotic mechanisms. Cancer develops through multiple mutations that cause uncontrolled growth. Chemotherapy aims to kill rapidly dividing cells and works through several classes of drugs including alkylating agents, antimetabolites, anthracyclins, plant alkaloids, and cytotoxic antibiotics. These drugs have various mechanisms of action but commonly cause side effects by also killing normal cells. Chemotherapy regimens typically combine multiple drugs to reduce resistance.
This document discusses pharmacodynamics and drug targets. It explains that pharmacodynamics studies how drugs work in living organisms by examining their biochemical and physiological effects. Quantitative studies allow comparison of drug concentration and effect, while qualitative studies investigate mechanisms of drug action. The document then discusses different types of drug targets, including enzymes, carrier proteins, ion channels, and receptors. It provides examples of drugs that target each of these and how they produce their effects. The document emphasizes that understanding drug targets allows for more specific and effective drugs with fewer side effects.
This document provides an introduction to pharmacology concepts. It discusses what drugs are and how they work in the body. It covers absorption, distribution, metabolism, and excretion of drugs. Absorption involves passive diffusion, carrier-mediated transport, and endocytosis. Distribution depends on blood flow, protein binding, and accumulation in tissues. Metabolism occurs mainly in the liver through phase I and phase II reactions. Excretion involves renal and hepatic systems with water-soluble drugs or metabolites excreted in urine or bile.
Hematopoiesis is the process where blood cells are produced in the bone marrow from hematopoietic stem cells. In adults, red blood cells, white blood cells, and platelets are produced in the bone marrow from pluripotent stem cells. The stem cells differentiate into the various cell lineages through the effects of growth factors and cytokines. Erythropoietin regulates red blood cell production in response to tissue oxygen levels while granulocyte macrophage colony-stimulating factor regulates white blood cell production. T and B lymphocytes mature in different areas with T cells maturing in the thymus and B cells maturing in the bone marrow and spleen.
Higher functions of the nervous systemSufyan Akram
The document discusses higher mental functions of the brain. It describes how different cortical areas have specialized functions, with primary areas directly processing sensory and motor information, and association areas integrating information from multiple regions. Three important association areas are identified: the prefrontal area involved in planning, the parieto-occipital area in spatial processing, and the limbic area concerned with emotion and motivation. Language functions are lateralized, with Broca's and Wernicke's areas discussed. Memory formation and retrieval are also described.
The document provides tips for creating effective presentations with concise summaries in 3 sentences or less:
It discusses selecting engaging content, managing time well, and being confident while balancing various elements of a presentation. Key recommendations include identifying a few main points, respecting the audience's time, understanding the audience's knowledge and interests, practicing to build confidence, and using simple visuals and slide transitions without overdoing it. The document emphasizes that practice is essential to improving presentation skills and performance over time.
Breast cancer: Post menopausal endocrine therapyDr. Sumit KUMAR
Breast cancer in postmenopausal women with hormone receptor-positive (HR+) status is a common and complex condition that necessitates a multifaceted approach to management. HR+ breast cancer means that the cancer cells grow in response to hormones such as estrogen and progesterone. This subtype is prevalent among postmenopausal women and typically exhibits a more indolent course compared to other forms of breast cancer, which allows for a variety of treatment options.
Diagnosis and Staging
The diagnosis of HR+ breast cancer begins with clinical evaluation, imaging, and biopsy. Imaging modalities such as mammography, ultrasound, and MRI help in assessing the extent of the disease. Histopathological examination and immunohistochemical staining of the biopsy sample confirm the diagnosis and hormone receptor status by identifying the presence of estrogen receptors (ER) and progesterone receptors (PR) on the tumor cells.
Staging involves determining the size of the tumor (T), the involvement of regional lymph nodes (N), and the presence of distant metastasis (M). The American Joint Committee on Cancer (AJCC) staging system is commonly used. Accurate staging is critical as it guides treatment decisions.
Treatment Options
Endocrine Therapy
Endocrine therapy is the cornerstone of treatment for HR+ breast cancer in postmenopausal women. The primary goal is to reduce the levels of estrogen or block its effects on cancer cells. Commonly used agents include:
Selective Estrogen Receptor Modulators (SERMs): Tamoxifen is a SERM that binds to estrogen receptors, blocking estrogen from stimulating breast cancer cells. It is effective but may have side effects such as increased risk of endometrial cancer and thromboembolic events.
Aromatase Inhibitors (AIs): These drugs, including anastrozole, letrozole, and exemestane, lower estrogen levels by inhibiting the aromatase enzyme, which converts androgens to estrogen in peripheral tissues. AIs are generally preferred in postmenopausal women due to their efficacy and safety profile compared to tamoxifen.
Selective Estrogen Receptor Downregulators (SERDs): Fulvestrant is a SERD that degrades estrogen receptors and is used in cases where resistance to other endocrine therapies develops.
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Combining endocrine therapy with other treatments enhances efficacy. Examples include:
Endocrine Therapy with CDK4/6 Inhibitors: Palbociclib, ribociclib, and abemaciclib are CDK4/6 inhibitors that, when combined with endocrine therapy, significantly improve progression-free survival in advanced HR+ breast cancer.
Endocrine Therapy with mTOR Inhibitors: Everolimus, an mTOR inhibitor, can be added to endocrine therapy for patients who have developed resistance to aromatase inhibitors.
Chemotherapy
Chemotherapy is generally reserved for patients with high-risk features, such as large tumor size, high-grade histology, or extensive lymph node involvement. Regimens often include anthracyclines and taxanes.
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DECLARATION OF HELSINKI - History and principlesanaghabharat01
This SlideShare presentation provides a comprehensive overview of the Declaration of Helsinki, a foundational document outlining ethical guidelines for conducting medical research involving human subjects.
2. • How scientists and health professionals ought to
behave in the biomedical sciences
• The attempt to understand and justify the link
between values (fundamental principles) and
actions
BIOETHICS
3. • Deontology
– One should adhere to his duties and responsibilities
• Utilitarianism (or Consequentialism)
– Based on consequences of an action
• Virtue theory
– Takes into account the person’s overall character
• Principlism
– “a mixture” based on 4 principles…
SOME ETHICAL
THEORIES
4. • ‘The four principles’ approach
– The most widely used approach in Western bioethics
• 1. Autonomy
• 2. Beneficence
• 3. Non-maleficence
• 4. Justice
PRINCIPLISM
5. – Autonomy
• Right of self-determination
– Related to ‘informed consent’
– In order to give consent:
autonomy/competency/capacity must be
possessed
– Beneficence – to do well, to promote well-being
– Non-maleficence – to do no harm, to avoid doing harm
– Justice – treat like alike
WHAT ARE THESE 4
PRINCIPLES
6. • Oath of Hippocrates (4th c BC)
• Nuremberg Code (1947): issue of human experimentation
• Declaration of Helsinki (1964) (WMA): issue of human
experimentation
– First serious attempt of medical community to regulate itself
• Declaration of Geneva (1948)
– Issued as a development on the Oath of Hippocrates
• CIOMS Guidelines (1993)
– ‘International Ethical Guidelines for Biomedical Research Involving
Human Subjects’
(CIOMS: the Council for International Organizations of Medical
Sciences)
• Universal Declaration on Bioethics and Human Rights (UNESCO)
(2005)
PROMINENT ETHICAL
CODES
8. • Basic research (also called fundamental research) is a
systematic study directed toward greater knowledge
or understanding of the fundamental aspects of
phenomena without specific applications or products
in mind
– May involve cells and tissues from animal or human
origin
• Applied research is a form of systematic inquiry
involving the practical application of science
– May involve animal experimentation
BASIC AND APPLIED
RESEARCH
9. • Translational research (or clinical research) helps to
make findings from basic science useful for practical
applications that enhance human health and well-
being (including new diagnostics and therapeutics)
• It requires testing the newly discovered technique/
drug to be tested on human subjects before
approving it for widespread use
TRANSLATIONAL
RESEARCH
10. • Informed consent
• IRB review
• Informed consent and IRB review
• Compliance with Nuremberg, Helsinki, and Belmont
• All of the above?
WHAT MAKES CLINICAL
RESEARCH ETHICAL?
12. • Clinical research develops generalizable knowledge
that improves health or increases understanding
• People who participate in clinical research are a
means to securing that generalizable knowledge
• As a means, these people can be exploited, that is be
used as a means for the benefits of others
• Ethical benchmarks for clinical research are meant to
minimize the possibility of exploitation
WHY DO WE NEED
ETHICAL GUIDELINES?
13. 1. Collaborative Partnership
2. Social Value
3. Scientific Validity
4. Fair Subject Selection
5. Favorable Risk-Benefit Ratio
6. Independent Review
7. Informed Consent
8. Respect for Human Subjects
8 ETHICAL
BENCHMARKS
14. • Clinical research should involve the community in
which it occurs
• This requires:
– Community participation in planning, conducting and
overseeing research, and integrating research results
into the health system
– Patient advocates on scientific advisory boards and IRBs
1. COLLABORATIVE
PARTNERSHIP
15. • Clinical research should lead to improvements in
health or advancement in generalizable knowledge
• Must consider how the research will affect:
– Participants in the research
– Community in which research is conducted
– World
2. SOCIAL VALUE
16. • Research should produce reliable and valid data that
can be interpreted
• Research must be conducted in a methodologically
rigorous manner that is practically feasible
• Invalid Research:
– Studies with biased endpoints, instruments or statistical
tests
– Studies that cannot enrol sufficient subjects
3. SCIENTIFIC VALIDITY
17. • Convenient groups should not be selected
• Groups should not be excluded without scientific
reasons
• Should not select rich, politically powerful or
otherwise well connected people for “promising
research” studies
4. FAIR SUBJECT
SELECTION
18. • Risks to participants should be balanced by the
benefit to individual participants
• The approach
– Risks identified, assessed and minimized
– Potential benefits to individuals enhanced
– If potential benefits to individual outweigh risks to the
individual, then proceed
– If risks outweigh the benefits to the individual then
evaluate risks against the benefits to the society
– Consider risks to the community
5. FAVOURABLE RISK-
BENEFIT RATIO
19. • Potential risks to consider include:
– Physical —death, disability, infection
– Psychological —depression and anxiety
– Social —discrimination
• Evaluate the:
– Likelihood of harm
– Magnitude of harm
• Identify mechanisms to minimize risks:
– Additional diagnostic tests
– Hospitalizations
5. FAVOURABLE RISK-
BENEFIT RATIO
20. • Because investigators have multiple legitimate
interests, they have potential conflicts of interest
• Independent review of the research minimizes these
conflicts
• Independent review also assures society it will not
benefit from abuse of subjects
6. INDEPENDENT
REVIEW
21. • Informed consent ensures individuals decide whether
they enrol in research and whether research fits with
their own values, interests, and goals.
• For those who cannot consent—such as children and
mentally impaired—must be sure research fits with
their interests
7. INFORMED CONSENT
22. • Competence/capacity of the subject
• Disclosure of information to the subject
• Understanding or comprehension by the subject
• Voluntariness of the decision
7. INFORMED CONSENT
23. • The ethical requirements of research do not end with
a signed consent document. Also include:
– Protecting confidentiality
– Permitting withdrawal
– Providing new information
– Monitoring welfare
– Informing participants what was learned from the
research
– Providing “fair benefits” for participation in research
8. RESPECT FOR HUMAN
SUBJECTS
24. • All 8 benchmarks are necessary and essential to make
clinical research ethical
• Independent review and informed consent are
procedural benchmarks to ensure certain values are
achieved
• Other procedures may achieve these values
– In some circumstances, independent review and
informed consent can be waived
8 ETHICAL
BENCHMARKS
25. • All 8 ethical benchmarks are universal. They apply to
clinical research everywhere
• The 8 ethical benchmarks must be adapted to the
local health, economic, cultural and technological
circumstances
– For instance, disease risk affects risk-benefit evaluation
8 ETHICAL
BENCHMARKS
26. • What is fair in subject selection may increase risks
• What enhances scientific validity may increase risks
• What is necessary to respect enrolled subjects or
obtain informed consent may compromise scientific
validity
BENCHMARKS MAY
CONFLICT!
27. • No simple formula for resolving conflicts
• Adjust design to meet the requirements
– This is sometimes termed “balancing”, “weighing” or
“specifying” the principles
• The important point is to be clear about what is being
done and give reasons why
• Different approaches may be equally ethical !!
RESOLVING CONFLICTS
28. • The expertise necessary to implement these
benchmarks includes:
– Educated and trained investigators
– IRBs with investigators, statisticians, ethicists, and
community representatives
EXPERTISE
30. • Although codes, policies, and principals are very
important and useful, like any set of rules, they do
not cover every situation, they often conflict, and
they require considerable interpretation
• For example, consider the following case:
ETHICAL DECISION-
MAKING IN RESEARCH
31. • The research protocol for a study of a drug on
hypertension requires the administration of the drug at
different doses to 50 laboratory mice, with chemical and
behavioural tests to determine toxic effects
• Tom has almost finished the experiment. He has only 5
mice left to test. However, he really wants to finish his
work in time to go on a break with his friends
• He has injected the drug in all 50 mice but has not
completed all of the tests. He therefore decides to
extrapolate from the 45 completed results to produce the
5 additional results
CASE 1
32. • Many different research ethics policies would hold
that Tom has acted unethically by fabricating data
• Actions that nearly all researchers classify as
unethical are viewed as misconduct
• It is important to remember, however, that
misconduct occurs only when researchers intend to
deceive: honest errors related to sloppiness, poor
record keeping, miscalculations, bias, self-deception,
and even negligence do not constitute misconduct
CASE 1
33. • Also, reasonable disagreements about research
methods, procedures, and interpretations do not
constitute research misconduct. Consider the
following case:
CASE 2
34. • Dr. T has just discovered a mathematical error in a
paper that has been accepted for publication in a
journal. The error does not affect the overall results
of his research, but it is potentially misleading. The
journal has just gone to press, so it is too late to catch
the error before it appears in print
• In order to avoid embarrassment, Dr. T decides to
ignore the error
CASE 2
35. • Dr. T's error is not misconduct nor is his decision to
take no action to correct the error. Most researchers,
as well as many different policies and codes would
say that Dr. T should tell the journal about the error
and consider publishing a correction or errata
• Failing to publish a correction would be unethical
because it would violate norms relating to honesty
and objectivity in research
CASE 2
36. • Situations frequently arise in research in which
different people disagree about the proper course of
action and there is no broad consensus about what
should be done
• In these situations, there may be good arguments on
both sides of the issue and different ethical principles
may conflict
• These situations create difficult decisions for research
known as ethical dilemmas
CASE 2
37. • BY is a 46 year old post-menopausal mentally
disabled woman with DCIS
• Caregivers from her “home” with power of attorney
for health care decisions, bring her to the clinic for
enrolment in STAR trial, randomized trial of
tamoxifen vs. raloxifene for the prevention of breast
cancer in high risk women
• She fulfils all entry criteria but cannot consent
CASE 3
38. • The physician who saw BY wants the IRB to
reconsider the subject selection criteria for the STAR
trial
• The IRB debates the question:
– Is it ethical to enrol a mentally incompetent patient in a
Phase III randomized chemo-prevention trial?
CASE 3
39. • Is it ethical to enrol a mentally incompetent patient in
a Phase III randomized chemo-prevention trial?
• Is it ethical to enrol BY in a randomized trial to
determine which of two hormonal therapies is better
at preventing cancer with the fewest side effects?
CASE 3
40. • BY cannot consent
• BY is not necessary to the trial
• Enrol patients who can consent
Emphasize
informed
consent
• Informed consent is not an absolute
requirement
• The risk-benefit ratio is positive
• As long as mentally disabled patients are not
being unfairly targeted, enrol BY
Emphasize
Risk-Benefit
& Social
Value
• She meets eligibility criteria and has a similar
risk-benefit ratio to other potential
participants
• The only reason for excluding her is unrelated
to science but related to mental condition
Emphasize
Fair Subject
Selection
CASE 3
41. • What is the problem or issue?
• What is the relevant information?
• What are the different options?
• How do ethical codes or policies as well as legal rules
apply to these different options?
• Are there any people who can offer ethical advice?
HOW TO DEAL WITH
ETHICAL DILEMMAS?
42. • Many of us may think why we are required to have
training in research ethics. We may believe that we
are highly ethical and know the difference between
right and wrong
• Luckily, misconduct is rare, but it can have a
tremendous impact on research
– Consider an analogy with crime: if murderers are not
prosecuted, it will erode the community's sense of trust
and increase the community's fear and paranoia
– The same is true with the most serious crimes in science,
i.e. fabrication, falsification, and plagiarism
PROMOTING ETHICAL
CONDUCT IN SCIENCE
43. • Misconduct probably results from environmental and
individual causes, i.e. when people who are morally
weak, ignorant, or insensitive are placed in stressful
or imperfect environments
• Many of the deviations that occur in research may
occur because researchers simple do not know or
have never thought seriously about some of the
ethical norms of research
PROMOTING ETHICAL
CONDUCT IN SCIENCE
44. • Training courses in research ethics may result in
significant reduction of these incidences
• Training in research ethics should be able to help
researchers grapple with ethical dilemmas by
introducing researchers to important concepts, tools,
principles, and methods that can be useful in
resolving these dilemmas
PROMOTING ETHICAL
CONDUCT IN SCIENCE