This document summarizes a presentation about the history of biowarfare research and biodefense efforts at US Army facilities including Camp Detrick and USAMRIID. It describes how early efforts focused on developing safety practices to protect workers. It discusses the establishment of programs like Operation Whitecoat which used volunteer subjects for biodefense research following ethical standards established in the Nuremberg Code. The presentation provides details on the facilities, organizations, and human subject research that contributed to the development of biodefense at these installations over time.
PR 15-149 (+) Ethical Use of Human Subjects in Infectious Disease Research - ...Arthur O Anderson MD
This document provides an overview of ethical considerations related to human subject research on infectious diseases. It discusses key principles from the Nuremberg Code, the importance of voluntary informed consent, and how Operation Whitecoat conducted ethical research on human subjects to test defenses against biological weapons. The research minimized risks by only using agents with known treatments and obtained community approval from volunteer subjects. The document also reviews how later regulations like the Common Rule incorporated ethical principles to strengthen protections for human subjects.
The document summarizes the history and key principles of the Nuremberg Code, which was established after World War II in response to unethical medical experiments conducted by Nazi doctors on concentration camp prisoners without consent. The Nuremberg Code set forth 10 ethical principles for human experimentation, including requirements for voluntary and informed consent, that experiments yield socially useful results not obtainable by other means, and that risks to subjects be avoided wherever possible. It had a significant influence on later guidelines for ethical clinical research involving human subjects.
This document provides an introduction to medical ethics, including definitions, basic principles, and examples throughout history of unethical medical experiments that violated principles of ethics. It discusses key concepts like beneficence, respect for human dignity, autonomy, justice and informed consent. It summarizes notorious cases of unethical human experimentation like the Lübeck disaster, Dr. J. Marion Sims' experiments on slave women, Nazi human experiments during World War II, and guidelines developed in response like the Nuremberg Code and Declaration of Helsinki to protect human subjects in research.
Ethics in Clinical Research and Historical Perspective of Nazi Trials, Nuremb...ShantanuThakre3
What is Ethics ?
The word ‘ethics’ is derived from the Greek word,
ethos, which means custom or character. Ethics is
the systematic study of values, so as to decide
what is right and what is wrong. Ethics is concerned
with what is good for individuals and society.
What is Clinical Research ?
Clinical Research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.
Importance of Ethics in Clinical Research :-
1. Ethics is important in clinical research because it keeps the researcher from committing errors while seeking knowledge and truth.
2. Ethical guidelines for clinical research were formulated only after discovery of inhumane behavior with participants during research experiments.
3. In clinical research human beings are involved, as opposed to animals, atoms or asteroids, as the object of study.
4. It focuses on improving human health and well-being, typically by identifying better methods to treat, cure or prevent illnesses.
5. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country
1. The Nuremberg Code established ethical guidelines for human experimentation after Nazi doctors were tried for war crimes for medical experiments without consent. It included requirements for voluntary and informed consent.
2. The Declaration of Helsinki expanded on informed consent and emphasized that subjects' welfare takes precedence over scientific interests.
3. The Belmont Report summarized ethical principles of respect for persons, beneficence, and justice in research involving human subjects. It addressed informed consent, risk-benefit assessment, and fair subject selection.
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War
This document discusses the evolution of ethics in research from ancient times to modern day. It covers several important historical cases that shaped research ethics, including the Nazi medical experiments, the Tuskegee Syphilis Study, and the Willowbrook Hepatitis studies. It also outlines some key ethical guidelines and codes developed over time, such as the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report. Overall, the document examines how medical ethics and standards for ethical research involving human subjects have developed in response to scandals and abuses.
The document provides an overview of the history of research ethics and key events that led to the establishment of ethical guidelines and regulations. It discusses scandals such as the Tuskegee Syphilis Study and experiments conducted by Nazi Germany. These events prompted milestones like the Nuremberg Code, Declaration of Helsinki, and Belmont Report. The Belmont Report outlines basic ethical principles including respect for persons, beneficence, and justice that provide a framework for resolving issues in human subjects research.
PR 15-149 (+) Ethical Use of Human Subjects in Infectious Disease Research - ...Arthur O Anderson MD
This document provides an overview of ethical considerations related to human subject research on infectious diseases. It discusses key principles from the Nuremberg Code, the importance of voluntary informed consent, and how Operation Whitecoat conducted ethical research on human subjects to test defenses against biological weapons. The research minimized risks by only using agents with known treatments and obtained community approval from volunteer subjects. The document also reviews how later regulations like the Common Rule incorporated ethical principles to strengthen protections for human subjects.
The document summarizes the history and key principles of the Nuremberg Code, which was established after World War II in response to unethical medical experiments conducted by Nazi doctors on concentration camp prisoners without consent. The Nuremberg Code set forth 10 ethical principles for human experimentation, including requirements for voluntary and informed consent, that experiments yield socially useful results not obtainable by other means, and that risks to subjects be avoided wherever possible. It had a significant influence on later guidelines for ethical clinical research involving human subjects.
This document provides an introduction to medical ethics, including definitions, basic principles, and examples throughout history of unethical medical experiments that violated principles of ethics. It discusses key concepts like beneficence, respect for human dignity, autonomy, justice and informed consent. It summarizes notorious cases of unethical human experimentation like the Lübeck disaster, Dr. J. Marion Sims' experiments on slave women, Nazi human experiments during World War II, and guidelines developed in response like the Nuremberg Code and Declaration of Helsinki to protect human subjects in research.
Ethics in Clinical Research and Historical Perspective of Nazi Trials, Nuremb...ShantanuThakre3
What is Ethics ?
The word ‘ethics’ is derived from the Greek word,
ethos, which means custom or character. Ethics is
the systematic study of values, so as to decide
what is right and what is wrong. Ethics is concerned
with what is good for individuals and society.
What is Clinical Research ?
Clinical Research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease.
Importance of Ethics in Clinical Research :-
1. Ethics is important in clinical research because it keeps the researcher from committing errors while seeking knowledge and truth.
2. Ethical guidelines for clinical research were formulated only after discovery of inhumane behavior with participants during research experiments.
3. In clinical research human beings are involved, as opposed to animals, atoms or asteroids, as the object of study.
4. It focuses on improving human health and well-being, typically by identifying better methods to treat, cure or prevent illnesses.
5. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country
1. The Nuremberg Code established ethical guidelines for human experimentation after Nazi doctors were tried for war crimes for medical experiments without consent. It included requirements for voluntary and informed consent.
2. The Declaration of Helsinki expanded on informed consent and emphasized that subjects' welfare takes precedence over scientific interests.
3. The Belmont Report summarized ethical principles of respect for persons, beneficence, and justice in research involving human subjects. It addressed informed consent, risk-benefit assessment, and fair subject selection.
The Nuremberg Code is a set of research ethics principles for human experimentation set as a result of the Subsequent Nuremberg Trials at the end of the Second World War
This document discusses the evolution of ethics in research from ancient times to modern day. It covers several important historical cases that shaped research ethics, including the Nazi medical experiments, the Tuskegee Syphilis Study, and the Willowbrook Hepatitis studies. It also outlines some key ethical guidelines and codes developed over time, such as the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report. Overall, the document examines how medical ethics and standards for ethical research involving human subjects have developed in response to scandals and abuses.
The document provides an overview of the history of research ethics and key events that led to the establishment of ethical guidelines and regulations. It discusses scandals such as the Tuskegee Syphilis Study and experiments conducted by Nazi Germany. These events prompted milestones like the Nuremberg Code, Declaration of Helsinki, and Belmont Report. The Belmont Report outlines basic ethical principles including respect for persons, beneficence, and justice that provide a framework for resolving issues in human subjects research.
The document discusses the Nuremberg Code, which was established after the Nuremberg Trials in response to unethical medical experiments conducted by Nazi doctors during World War II without participants' consent. The Code established ethical research principles including voluntary informed consent, beneficence, and that experiments should avoid unnecessary harm or injury. It also states that researchers must be qualified and participants can withdraw at any time if they feel unable to continue. The 10-point Nuremberg Code was the first international code of research ethics.
The document discusses the history and ethical principles of human subjects research. It begins with the Nuremberg Code established after World War II to protect human subjects from abusive medical experiments. The three main ethical principles outlined in the Belmont Report are respect for persons, beneficence, and justice. The document then provides definitions of human subjects research and the levels of IRB review from exempt to expedited to full committee. It discusses considerations for vulnerable populations and risks of research. Informed consent is an ongoing process rather than a single event.
The document discusses the historical evolution of ethics guidelines for research involving human subjects. It begins with the Hippocratic Oath from ancient Greece which established early standards of medical ethics. It then discusses the Nuremberg Code created after World War II which focused on informed consent and avoiding harming subjects. Finally, it examines the Declaration of Helsinki which recognized the need for institutional review and emphasized informed consent, assessing risks/benefits, and protecting subject well-being.
Research ethics evolved in response to unethical human experimentation. The Tuskegee Syphilis Study and Nazi human experiments violated principles of informed consent and caused harm. This led to the Nuremberg Code which established standards of voluntary consent and that risks must not outweigh benefits. Subsequent declarations further developed ethical guidelines regarding subjects' rights, like privacy and confidentiality. Institutional review boards now oversee research to protect human participants.
Mass disaster management involves a team effort between police, military, medical experts, and civil authorities. At the disaster site, bodies are identified if possible and the area is isolated, documented with photos and maps, and protected. Bodies are then transported to a temporary morgue for documentation with fingerprints, photos, and radiological exams to find clues. An autopsy examines both external and internal features to determine the cause of death and identify injuries to establish the nature of the disaster. Records are compared to prior information to identify the deceased through matching at least 7-8 identifying details.
The document provides an overview of Good Clinical Practice (GCP) guidelines. It discusses the history and principles of GCP, as well as the roles and responsibilities of ethics committees, investigators, and sponsors in ensuring clinical trials are conducted properly and that patient rights and safety are protected. The document also summarizes the different phases of clinical trials and essential documents required for GCP compliance.
The document summarizes key ethical codes related to human subjects research over time, including the Nuremberg Code. It begins with early codes from ancient Egypt, India, and Greece. The Nuremberg Code established 10 principles for ethical human experimentation after World War II, including requiring voluntary consent and that risk not exceed benefit. The Declaration of Helsinki further expanded on ethical principles for medical research involving human subjects and is intended to be read as a whole with its 20 defined principles focused on protecting subjects.
Human experimentation involves conducting medical experiments on human subjects. There are three main types: therapeutic, research, and innovative. Key events in the history of establishing ethics for human experimentation include the Nuremberg Code established in 1947 following cruel Nazi experiments, the Declaration of Helsinki in 1964 which aimed to protect physicians and vulnerable populations, and the ICMR guidelines in India in 2006 which outline 12 principles like voluntary consent, risk minimization, and accountability. The document provides definitions and outlines the types of experiments as well as major guidelines to ensure ethics and minimize risks to human subjects in medical research experiments.
The Evolution of the Clinical Trials Process – A Brief History LessonPradeep H
The clinical trials process has evolved over centuries as researchers have sought to more rigorously test medical interventions. Some key events include:
1) Early examples from the Bible and 10th century physician Ibn Sina established basic principles like testing on animals first, but trials lacked control groups.
2) In the 18th century, James Lind introduced the use of control groups by comparing scurvy treatments.
3) Randomization was gradually introduced starting in the early 20th century to reduce bias.
4) Post-WWII atrocities led to regulations like the Nuremberg Code to protect human subjects.
5) Government agencies like the FDA were formed to oversee drug development and approval
The term sulfonamides also known as (sulphonamides, sulfa drugs or sulpha drugs) are used for are a group of drugs ranging in clinical use from antibacterial to diuretic activity that share the sulfonamide functional group.
Chemically, the sulfonamide functional group is -S (=O)2-NH2 , i.e. a sulfonyl group connected to an amine group.
The original sulfonamides were synthetic antimicrobial agents but now newer groups have been developed from them .
.The journey of these drugs is a remarkable one and their discovery represents one of the important breakthroughs of medicine of the 20th century
This document provides a summary of several unethical human and animal experimentation projects throughout history. It describes experiments conducted by the Nazis, Japanese Unit 731, Soviets, Americans and others. Many involved deliberately infecting or injuring prisoners and concentration camp inmates without consent. The goal of many was to study disease progression, test weapons/toxins, or advance racial ideology. Notable projects included Nazi twin and hypothermia experiments, Japanese plague dispersal tests, US syphilis studies and more. Overall, the document outlines some of the worst violations of medical ethics in history.
Ethical guidelines for biomedical research in human participantsgangireddysaisneha
This document provides ethical guidelines for biomedical research involving human participants. It discusses the history of human research ethics beginning with the Nuremberg Code and Declaration of Helsinki. It establishes the role of institutional ethics committees in reviewing all proposed research and provides general ethical principles of respect for persons, beneficence, and justice. It outlines 12 basic principles and specific ethical principles for informed consent, vulnerable populations, privacy/confidentiality, and more. The document aims to ensure the ethical conduct of research and protection of human subjects.
This document discusses the importance and history of informed consent in clinical research. It provides definitions of informed consent from international guidelines and outlines the key principles of voluntary participation, comprehension, and disclosure of information. The summary also highlights some notable events that shaped standards of informed consent, including the Nuremberg Code, Declaration of Helsinki, Belmont Report, and controversies like the Tuskegee Syphilis Study. Required components of informed consent forms are listed from ICMR guidelines in India.
Human experimentation has a long history dating back to ancient times. Notable events include the unethical human experiments conducted by Nazi Germany during World War II which led to the development of the Nuremberg Code in 1946. The code established standards for human experimentation including requiring voluntary consent. There are ongoing debates around the ethics of experimentation and whether the potential benefits to society through medical advances justify exposing human subjects to risks. Different types of experiments, such as those involving placebos, fetuses, children, prisoners and blind/double-blind designs, each raise additional complex issues around informed consent and protecting vulnerable populations.
ROLE OF CAVEOLIN-1 AND NRF2 IN NUTRITIONAL MODULATION OF PCB TOXIMichael Petriello
This dissertation examines the role of caveolin-1 and Nrf2 in modulating polychlorinated biphenyl (PCB) toxicity through nutritional interventions. Studies using endothelial cells from caveolin-1 deficient mice and in vitro silencing assays found that loss of caveolin-1 increases antioxidant enzymes by upregulating Nrf2. Mice fed a green tea polyphenol-enriched diet and exposed to PCBs exhibited lower oxidative stress and higher antioxidant enzyme levels than controls. Pretreating endothelial cells with nitro-linoleic acid altered caveolin-1 and Nrf2 proteins, modifying responses to PCB exposure. Together these findings support that nutritional modulation may reduce disease risks from environmental pollutants.
Human experimentation involves medical experiments performed on human subjects. It is an important part of medical research but requires great responsibility to prevent abuses. All human subjects must provide fully free and informed consent, and have the right to withdraw from experiments at any time to protect their well-being and rights.
Dr. Eman Mortada discusses research ethics and provides an outline on the topic. The document outlines key concepts such as defining research ethics, the consequences of scientific misconduct, and the need and objectives for research ethics. It also provides a historical perspective on unethical practices through examples like the Tuskegee Syphilis Study and Nazi experiments. The development of ethics codes is reviewed, including the Nuremberg Code, Declaration of Helsinki, and Belmont Report. Ethical principles and dilemmas in research are also discussed.
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.
The document summarizes key historical events in medical research ethics and the development of protections for human subjects. It describes atrocities like the Nazi experiments and Tuskegee Syphilis Study that lacked informed consent. This led to regulations like the Nuremberg Code and Belmont Report, which established ethical principles of respect for persons, beneficence, and justice. The Belmont Report specifically aimed to provide guidelines for research ethics through its principles and considerations for informed consent, risk-benefit assessments, and fair subject selection.
The document discusses the Nuremberg Code, which was established after the Nuremberg Trials in response to unethical medical experiments conducted by Nazi doctors during World War II without participants' consent. The Code established ethical research principles including voluntary informed consent, beneficence, and that experiments should avoid unnecessary harm or injury. It also states that researchers must be qualified and participants can withdraw at any time if they feel unable to continue. The 10-point Nuremberg Code was the first international code of research ethics.
The document discusses the history and ethical principles of human subjects research. It begins with the Nuremberg Code established after World War II to protect human subjects from abusive medical experiments. The three main ethical principles outlined in the Belmont Report are respect for persons, beneficence, and justice. The document then provides definitions of human subjects research and the levels of IRB review from exempt to expedited to full committee. It discusses considerations for vulnerable populations and risks of research. Informed consent is an ongoing process rather than a single event.
The document discusses the historical evolution of ethics guidelines for research involving human subjects. It begins with the Hippocratic Oath from ancient Greece which established early standards of medical ethics. It then discusses the Nuremberg Code created after World War II which focused on informed consent and avoiding harming subjects. Finally, it examines the Declaration of Helsinki which recognized the need for institutional review and emphasized informed consent, assessing risks/benefits, and protecting subject well-being.
Research ethics evolved in response to unethical human experimentation. The Tuskegee Syphilis Study and Nazi human experiments violated principles of informed consent and caused harm. This led to the Nuremberg Code which established standards of voluntary consent and that risks must not outweigh benefits. Subsequent declarations further developed ethical guidelines regarding subjects' rights, like privacy and confidentiality. Institutional review boards now oversee research to protect human participants.
Mass disaster management involves a team effort between police, military, medical experts, and civil authorities. At the disaster site, bodies are identified if possible and the area is isolated, documented with photos and maps, and protected. Bodies are then transported to a temporary morgue for documentation with fingerprints, photos, and radiological exams to find clues. An autopsy examines both external and internal features to determine the cause of death and identify injuries to establish the nature of the disaster. Records are compared to prior information to identify the deceased through matching at least 7-8 identifying details.
The document provides an overview of Good Clinical Practice (GCP) guidelines. It discusses the history and principles of GCP, as well as the roles and responsibilities of ethics committees, investigators, and sponsors in ensuring clinical trials are conducted properly and that patient rights and safety are protected. The document also summarizes the different phases of clinical trials and essential documents required for GCP compliance.
The document summarizes key ethical codes related to human subjects research over time, including the Nuremberg Code. It begins with early codes from ancient Egypt, India, and Greece. The Nuremberg Code established 10 principles for ethical human experimentation after World War II, including requiring voluntary consent and that risk not exceed benefit. The Declaration of Helsinki further expanded on ethical principles for medical research involving human subjects and is intended to be read as a whole with its 20 defined principles focused on protecting subjects.
Human experimentation involves conducting medical experiments on human subjects. There are three main types: therapeutic, research, and innovative. Key events in the history of establishing ethics for human experimentation include the Nuremberg Code established in 1947 following cruel Nazi experiments, the Declaration of Helsinki in 1964 which aimed to protect physicians and vulnerable populations, and the ICMR guidelines in India in 2006 which outline 12 principles like voluntary consent, risk minimization, and accountability. The document provides definitions and outlines the types of experiments as well as major guidelines to ensure ethics and minimize risks to human subjects in medical research experiments.
The Evolution of the Clinical Trials Process – A Brief History LessonPradeep H
The clinical trials process has evolved over centuries as researchers have sought to more rigorously test medical interventions. Some key events include:
1) Early examples from the Bible and 10th century physician Ibn Sina established basic principles like testing on animals first, but trials lacked control groups.
2) In the 18th century, James Lind introduced the use of control groups by comparing scurvy treatments.
3) Randomization was gradually introduced starting in the early 20th century to reduce bias.
4) Post-WWII atrocities led to regulations like the Nuremberg Code to protect human subjects.
5) Government agencies like the FDA were formed to oversee drug development and approval
The term sulfonamides also known as (sulphonamides, sulfa drugs or sulpha drugs) are used for are a group of drugs ranging in clinical use from antibacterial to diuretic activity that share the sulfonamide functional group.
Chemically, the sulfonamide functional group is -S (=O)2-NH2 , i.e. a sulfonyl group connected to an amine group.
The original sulfonamides were synthetic antimicrobial agents but now newer groups have been developed from them .
.The journey of these drugs is a remarkable one and their discovery represents one of the important breakthroughs of medicine of the 20th century
This document provides a summary of several unethical human and animal experimentation projects throughout history. It describes experiments conducted by the Nazis, Japanese Unit 731, Soviets, Americans and others. Many involved deliberately infecting or injuring prisoners and concentration camp inmates without consent. The goal of many was to study disease progression, test weapons/toxins, or advance racial ideology. Notable projects included Nazi twin and hypothermia experiments, Japanese plague dispersal tests, US syphilis studies and more. Overall, the document outlines some of the worst violations of medical ethics in history.
Ethical guidelines for biomedical research in human participantsgangireddysaisneha
This document provides ethical guidelines for biomedical research involving human participants. It discusses the history of human research ethics beginning with the Nuremberg Code and Declaration of Helsinki. It establishes the role of institutional ethics committees in reviewing all proposed research and provides general ethical principles of respect for persons, beneficence, and justice. It outlines 12 basic principles and specific ethical principles for informed consent, vulnerable populations, privacy/confidentiality, and more. The document aims to ensure the ethical conduct of research and protection of human subjects.
This document discusses the importance and history of informed consent in clinical research. It provides definitions of informed consent from international guidelines and outlines the key principles of voluntary participation, comprehension, and disclosure of information. The summary also highlights some notable events that shaped standards of informed consent, including the Nuremberg Code, Declaration of Helsinki, Belmont Report, and controversies like the Tuskegee Syphilis Study. Required components of informed consent forms are listed from ICMR guidelines in India.
Human experimentation has a long history dating back to ancient times. Notable events include the unethical human experiments conducted by Nazi Germany during World War II which led to the development of the Nuremberg Code in 1946. The code established standards for human experimentation including requiring voluntary consent. There are ongoing debates around the ethics of experimentation and whether the potential benefits to society through medical advances justify exposing human subjects to risks. Different types of experiments, such as those involving placebos, fetuses, children, prisoners and blind/double-blind designs, each raise additional complex issues around informed consent and protecting vulnerable populations.
ROLE OF CAVEOLIN-1 AND NRF2 IN NUTRITIONAL MODULATION OF PCB TOXIMichael Petriello
This dissertation examines the role of caveolin-1 and Nrf2 in modulating polychlorinated biphenyl (PCB) toxicity through nutritional interventions. Studies using endothelial cells from caveolin-1 deficient mice and in vitro silencing assays found that loss of caveolin-1 increases antioxidant enzymes by upregulating Nrf2. Mice fed a green tea polyphenol-enriched diet and exposed to PCBs exhibited lower oxidative stress and higher antioxidant enzyme levels than controls. Pretreating endothelial cells with nitro-linoleic acid altered caveolin-1 and Nrf2 proteins, modifying responses to PCB exposure. Together these findings support that nutritional modulation may reduce disease risks from environmental pollutants.
Human experimentation involves medical experiments performed on human subjects. It is an important part of medical research but requires great responsibility to prevent abuses. All human subjects must provide fully free and informed consent, and have the right to withdraw from experiments at any time to protect their well-being and rights.
Dr. Eman Mortada discusses research ethics and provides an outline on the topic. The document outlines key concepts such as defining research ethics, the consequences of scientific misconduct, and the need and objectives for research ethics. It also provides a historical perspective on unethical practices through examples like the Tuskegee Syphilis Study and Nazi experiments. The development of ethics codes is reviewed, including the Nuremberg Code, Declaration of Helsinki, and Belmont Report. Ethical principles and dilemmas in research are also discussed.
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.
The document summarizes key historical events in medical research ethics and the development of protections for human subjects. It describes atrocities like the Nazi experiments and Tuskegee Syphilis Study that lacked informed consent. This led to regulations like the Nuremberg Code and Belmont Report, which established ethical principles of respect for persons, beneficence, and justice. The Belmont Report specifically aimed to provide guidelines for research ethics through its principles and considerations for informed consent, risk-benefit assessments, and fair subject selection.
This document discusses ethics in nursing research. It provides an overview and defines key terms like ethics. It then discusses examples of unethical medical experiments conducted in Germany and the US in the past. It outlines the development of ethical codes and guidelines like the Nuremberg Code and Belmont Report. It also covers important aspects of ethical research like informed consent, protecting vulnerable groups, and the nurse researcher's role as an advocate.
This document discusses ethics in health research. It provides an overview of the origins and principles of ethics, including teleological and deontological perspectives. It then discusses ethics specifically in the context of health research, including how research must be useful and avoid harm. The document outlines several historical examples of unethical human experimentation, such as the Nazi experiments and Unit 731 tests during WWII. It also discusses international efforts to establish ethical guidelines, including the Nuremberg Code, Declaration of Helsinki, and Belmont Report. The core ethical principles of autonomy, beneficence, justice, and respect for the environment are covered. Elements of informed consent and protections for vulnerable populations are also summarized.
Ethical Concerns Regarding Research on Human SubjectsClinosolIndia
This document discusses the ethics of conducting research on human subjects. It begins with an introduction noting the troubled history of human experimentation and the need to carefully address ethical concerns to protect participants. It then outlines some of the key codes and guidelines for ethical research, like the Nuremberg Code and Declaration of Helsinki. The main body discusses the ethical framework, including principles like informed consent, minimizing harm, and fair participant selection. It also examines the roles of institutional review boards and transparency. Examples of past unethical trials like the Thalidomide tragedy and Tuskegee syphilis study are provided. The document concludes by discussing how to balance risks and benefits in research.
History ethical guide lines to clinical trialAnju Thejkumar
The document summarizes the history of ethical guidelines for clinical trials. It discusses several key documents and events that shaped modern research ethics, including the Nuremberg Code established after World War 2 Nazi experiments, the Declaration of Helsinki, Belmont Report, ICH GCP guidelines, and India's Ethical Guidelines for Biomedical Research in Human Subjects. Overall it provides an overview of the evolution of clinical trial ethics from the 1940s to 2000 to protect human subjects and ensure scientific integrity.
2013 evolution of irb regulations 1900 - 2002 bioshield-36OHU&E at USAMRIID
This document summarizes the evolution of regulations governing research with human subjects from 1900 to present day. It traces key events that led to more formalized ethics standards and protections, including the Nuremberg Code established after World War II and the Common Rule of 1981. Milestone regulations addressed issues like informed consent, risk-benefit analysis, and oversight of research through institutional review boards. The document discusses both proactive and reactive regulatory approaches and how certain incidents, like the Tuskegee Syphilis Study, prompted new protections for research subjects.
This document provides an overview of research ethics and scientific misconduct. It begins with the history of research ethics, covering developments from the 18th century through World War II and the Nuremberg Code. It then discusses key documents and guidelines that shape modern research ethics like the Declaration of Helsinki and Belmont Report. The document defines informed consent and its key components. It also covers conflicts of interest and provides examples of scientific misconduct like fabrication, falsification and plagiarism. Overall, the document provides important context on the evolution of research ethics and outlines the key ethical principles and guidelines that researchers must follow.
2. Lecture on Research Ethics for Epid 2022 (2).pdfAnaolAbebe
This document provides an introduction to health research ethics. It begins with definitions of key terms like ethics, bioethics, and informed consent. It then discusses the historical events that led to modern research ethics guidelines, such as the unethical Nazi experiments and Tuskegee Syphilis study. The document outlines international codes of ethics like the Nuremberg Code, Declaration of Helsinki, and Belmont Report. It also discusses ethical principles of respect for persons, beneficence, and justice. The remainder of the document focuses on research ethics guidelines and regulations in Ethiopia, including requirements for research ethics committees, informed consent processes, and protecting vulnerable groups.
The document provides a history of clinical trials and discusses several important studies that helped establish modern ethics guidelines for human subject research. It describes the unethical medical experiments performed by Nazi doctors on concentration camp prisoners. It then discusses the Nuremberg Code established after World War 2 that set the first comprehensive standards for ethical clinical research. Several controversial US studies from the mid-20th century are also summarized, including the Tuskegee Syphilis Study and experiments that deliberately infected children. This led to increased regulations and standards like the Belmont Report to better protect human research participants.
This document provides definitions and explanations of key concepts in clinical research involving human subjects. It defines human subject research according to the Department of Health and Human Services as involving systematic investigation designed to contribute to generalizable knowledge and obtaining data from living individuals through intervention, interaction, or access to private information. The history of regulations is summarized, from early events like the Tuskegee Syphilis Study to key documents like the Belmont Report that established ethical principles of respect for persons, beneficence, and justice. Common definitions and types of research designs are also outlined.
This document provides definitions and explanations of key concepts in clinical research. It defines human subject research according to the Department of Health and Human Services as involving systematic investigation designed to develop generalizable knowledge and obtaining data from living individuals through intervention or identifiable private information. The document outlines the history of regulations protecting human subjects from the Nuremberg Code to the Belmont Report. It also describes types of study designs including observational studies like cohorts and case-controls and experimental designs involving interventions. Resources for conducting research like the IRB and Human Immunology Research Office are presented.
This document discusses ethical considerations in research. It provides historical background on the development of ethics codes from the 1700s experiments of Edward Jenner to the atrocities of Nazi human experiments during World War II. This led to the establishment of the Nuremberg Code in 1949 and the Declaration of Helsinki in 1964 to provide ethical standards for research involving human subjects. Subsequent guidelines discussed include the National Research Act of 1974, Belmont Report of 1979, Common Rule, and HIPAA of 1996. Examples are given of unethical research studies and violations of ethics over time.
A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.
Unit 2,ethical consideration in researchChanda Jabeen
This document discusses ethical considerations in research. It covers objectives like defining ethics terms, discussing historical events that shaped research ethics, and describing informed consent. Key topics include the Nuremberg Code, Declaration of Helsinki, principles of beneficence and respecting human dignity. Research ethics aim to protect participants and ensure their voluntary consent, privacy, and fair distribution of risks and benefits.
This document discusses research ethics and principles of medical ethics. It provides examples of unethical medical experiments that violated principles of consent, beneficence and justice. These include the Tuskegee Syphilis Experiment, research at Willowbrook State Hospital, and experiments conducted by Dr. Josef Mengele and the US military. It also summarizes several important ethical codes and declarations related to human subjects research, including the Nuremberg Code, Declaration of Helsinki, Belmont Report and regulations from the National Committee of BioEthics in Saudi Arabia.
Scientific Research And Ethics by Manu ShreshthaManu Shreshtha
This document presents an overview of ethics with respect to science and research. It begins with definitions of ethics and discusses ethical theories like deontology, teleology, and utilitarianism. It then examines important historical events that shaped modern research ethics like the Nazi medical experiments and the Nuremberg Code. The document outlines principles for ethical research like informed consent and protecting vulnerable subjects. It discusses ethical concerns in qualitative and quantitative research and emphasizes the importance of ethics in protecting participants and ensuring research is conducted safely and for the benefit of all.
The document discusses the background and definition of research ethics. It defines ethics as norms for conduct that distinguish acceptable from unacceptable behavior. Research ethics refers to rules that define proper conduct for researchers and are aimed at protecting human subjects. The history of modern research ethics is traced back to unethical medical experiments conducted by Nazi doctors during World War 2, which led to the Nuremberg Code establishing ethical principles for research involving human subjects. Other influential documents discussed include the Helsinki Declaration, Belmont Report, and controversies like the Tuskegee Syphilis Study.
This document summarizes the history of bioethics guidelines including the Hippocratic Oath, Nuremberg Code, Declaration of Helsinki, and international and national ethical guidelines for research. It discusses landmark events that shaped ethical standards such as the Nuremberg Trials and the Tuskegee Syphilis Study scandal. Key principles from various guidelines are outlined, such as voluntary consent, community engagement, and fair participant selection. Ethical theories of teleology and deontology in evaluating medical practices are also introduced.
The document discusses the history and ethics of clinical research involving human subjects. It summarizes key codes and guidelines such as the Nuremberg Code, Declaration of Helsinki, and ICH Good Clinical Practice guidelines. It outlines the dual responsibilities of physician-investigators to provide care for individual patients while also conducting research for the benefit of society. The role and 13 responsibilities of the principal investigator are then described in detail according to ICH Good Clinical Practice guidelines, including obtaining informed consent, ensuring safety monitoring, adherence to protocols, and independent ethics review.
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Biowarfare to biodefense operation whitecoat & usamriid history
1. PR-13-015
Lecture for FDA 27 February 2013
Biowarfare to Biodefense:
Operation Whitecoat &
USAMRIID History
Arthur O. Anderson MD
Office of Human Use and Ethics
This presentation represents the views of the author. The information or content presented does not
represent the official position or policy of the U.S. Army Medical Research and Materiel Command,
the U.S. Army Medical Department, the Department of Defense, or the U.S. Government.
CD-22 Exp 25 Jan 1955, USAMU Est 20 Jun 1956, USAMRIID Est 27 Jan 1969
2. U.S. Not Prepared For BW in 1941
Europeans Had Chemical Warfare Experience in WWI. As WW II
Approached, U.S. Worried That Nazis Had Prepared For BioWarfare
3. Detrick Field Was An It Became A Bio-
Air National Guard Warfare Center
Training Center as Camp Detrick
1931 April 1943
Scientific Director, Dr. Ira Baldwin, [U.Wisc] planned operations 1942-44
LTC William S. Bacon, CMLC was first Commander of Camp Detrick
4. Organizational Ethics: Biosafety invented at
Camp Detrick before
bioweapons developed
A.G. Wedum MD - Safety “S” Division - first division to be activated in 1943
5. Nonpathogenic Simulants were used
in Human Studies of Safety Practices
Worker safety tests
were done to test air
purification systems
such as mechanical
and electrostatic
filters, air incinerators
and washers
Environmental Safety
by Regulation of
Ambient Air Pressures Masks and biohazard
was developed and suits were developed
tested at Detrick. and tested at Detrick
6. Camp Detrick – Worker Safety
Practices: Organizational Ethics
Occupational Safety by “S” Division 1943
Training Program, Posters, Constant
Survey of Safety Practices
Personnel Inspection and First Aid
First Aid room near hot suite change rooms
held personnel who inspected workers
leaving suites for breaks in skin or clinical
signs and symptoms of disease
7. WWII Human Experimentation
Camp Detrick - Safety Practices
Immunization*
Vaccination routine called “special procedures”
instituted by Biological Protection Branch of S Division
Primary Objective was to protect workers
Secondary Objectives:
Determine most efficacious immunization methods
Determine effectiveness of available preparations
No existing vaccines for some agents
Only experimental vaccines available for others
* Ltr (S), CO CD to Post Surgeon CD, 22 Jan 44, Sub: Immunization. SPCYF 400.12. In Hq CD (720.3)
* Sp Rpt 15, Immunological Protection of Personnel Against B.W. Agents (Oct 46), p.2
8. Special Procedures - SIP
Most 1950’s Fort Detrick
alumni remember Nurse
Betty Grable, Dr. Paul
Kadull & the “shot shop”,
which is what they called
the building where all
workers and research
subjects received their
vaccines prescribed by
“Special Procedures”.
Both groups got the same IND vaccines but only the research
volunteers were given the choice with informed consent
9. Fort Detrick - Fully Engaged
Equipment needed was
invented on site by a brilliant
design and fabrication team
10. Human Subjects Research
at Fort Detrick 1943 - 1946
The station hospital, originally activated in 1943,
provided a “unique opportunity to study the
inception, course and therapeutics of many rare
diseases in patients whose baseline health data
was known” LTC Abram Benenson MC
This was primarily “opportunist” research that
depended upon occupational incidents among
workers in the various biowarfare facilities
11. Nuremberg War Crimes Trial
By 1947 Andrew Ivy’s list
of ten conditions required
for permissible medical
experiments in healthy
subjects became the
Nuremberg Code.
23 Nazi Doctors were The Code became the
convicted of Murder at standard for ethical
The Nuremberg Trials research with humans
12. Nuremberg Code of 1947
1. Voluntary Consent absolutely essential.
2. Valid research for good of society – by no other means.
3. Human studies preceded by knowledge survey & research
with animal models to identify potential risks and benefits.
4. Avoid unnecessary physical and mental suffering & injury.
5. Prohibits research with apriori risk of death or disabling
injury.
6. Degree of risk never to exceed benefit or humanitarian
value
7. Prepare to minimize risk of injury, disability or death
8. Investigator must have credentials appropriate to study
9. Subjects must have freedom to withdraw
10. Scientist may terminate study to reduce serious risk
13. What is Voluntary Consent?
• This means that the person involved should have legal capacity to
give consent; should be so situated as to be able to exercise free
power of choice, without the intervention of any element of force,
fraud, deceit, duress, over-reaching, or other ulterior form of
constraint or coercion; and should have sufficient knowledge and
comprehension of the elements of the subject matter involved as to
enable him to make an understanding and enlightened decision.
• This latter element requires that before the acceptance of an
affirmative decision by the experimental subject there should be
made known to him: the nature, duration, and purpose of the
experiment; the method and means by which it is to be conducted;
all inconveniences and hazards reasonably to be expected; and
the effects upon his health or person which may possibly come
from his participation in the experiment.
• The duty and responsibility for ascertaining the quality of the
consent rests upon each individual who initiates, directs or
engages in the experiment. It is a personal duty and responsibility
which may not be delegated to another with impunity.
14. Human Vulnerability to BW
Aerosols Not Previously Tested
In 1952, the Armed Forces Medical Policy
Council wanted information on human
vulnerability and countermeasures to
biological warfare
Army SG met with Chief Chemical Officer
at the same time that Secretaries of
Defense & Army, Army Chief of Staff and
Chemical and Medical elements were
meeting to discuss possible use of humans
in biowarfare defense research.
15. Wilson Memorandum of 1953
The Nuremberg Code* was incorporated into the Wilson
Memorandum to the Secretaries of the Army, Navy and Air
Force dated 26 February 1953
* Use of its principles was promoted before any
human research related to biological warfare
defense were officially planned or conducted
Army Directive CS-385 issued 30 June 1953 added
consent in writing, additional safeguards, and instructions
for compensating subjects for injuries resulting from
participation in research
AR70-25 was Nuremberg Code Based from 1962-1990
16. CS-385 (30 June 1953)
“Use of Volunteers in Research”
This document, prepared for
the Army Chief of Staff by
BG John C. Oakes, became
the first government directive
prescribing policies and
procedures for ethical use of
volunteers in atomic
biological and chemical
warfare defense research.
The original document
resides at USAMRIID. Five
carbon copies went to other
USAMRDC Laboratories.
17. Multifaceted CD-22 (1954-55)
was designed to determine:
Human vulnerability in realistic BW scenarios,
i.e. outdoor aerosol delivery to human subjects
Effective prevention and treatment of BW casualties.
Determination of minimal infective doses.
Effectiveness of vaccines and drugs.
Serological responses to infections, and.
Clinical effects of various doses of infectious agents.
18. The CD-22 program focused on
Human responses to prototypes:
Q fever and Tularemia were regarded by
CES of AFEB as acceptable prototypical
BW agents for testing in Humans that
satisfied limiting characteristics* of low
lethality, no serious chronicity
anticipated, effective therapy available
and there was adequate animal
experimental data on safety and
protective efficacy *[also described in cs-385].
19. The US Army Medical Unit at Fort Detrick
USAMU was established in 1956 to develop the means to diagnose,
treat and prevent diseases caused by biological warfare agents.
Approval of the cs-385 directive for ethical operation, plans for
organization of the institute, preparation of CD-22 protocols and the
Dugway study preceded by 3-6 months the creation of USAMU.
20. USAMU - USAMRIID
The station hospital was built in 1957. It was linked via walkways to
support laboratories (vir, bact, clin lab, etc) and USAMU. The 8-ball is
at upper left and the BL-4 suite called ”black moriah” is at upper right.
21. COL W.D. Tigertt USAMU
Community Consultation
October 1954 Colonel
Tigertt contacted Dr.
Theodore R. Flaiz of
Seventh Day Adventist
General Conference
about seeking 1A-O SDA
volunteer subjects.
General Conference of
SDA Church approved
recruitment of drafted
SDA volunteer subjects
into Operation Whitecoat
22. Operation Whitecoat Volunteers were SDA
“Conscientious Objectors” recruited from
Medic Training school at Fort Sam Houston
Operation Whitecoat Volunteers
at Forest Glenn Ballroom 1956
Between 1954 and 1973 2,300 Seventh Day Adventist participants of
Operation Whitecoat served at Fort Detrick and associated locations.
23. Protocol Review
during Operation Whitecoat
• The Medical investigator prepared protocol.
• It was Reviewed for approval at a “Protocol Meeting”
attended by Commander, Scientific Advisor, and the
Research Division Chiefs.
• Approved protocols were forwarded to HQDA (SGRD-DR)
for further approval. This could have entailed review by CES
of AFEB (before 1962) or HSRRB (after 1962 *).
• When final approval was given, Whitecoat volunteers were
briefed, attended a project interview, and informed consent
documents were signed after at least 24 hours.
•*AR 70-25 published in 1962 was identical to cs-385.
24. Review and Approval Process
USAMU 1955-73 vs USAMRIID
1955 – 73 USAMU Protocol
Meeting Minutes were one page
long with only one sentence for
the committee decision. Issues
were not documented.
1976 – USAMRIID IRB Minutes 5
pages long, 4 of which were Q&A
that documented issues.
Presently – USAMRIID IRB
Minutes are > 14 pages long with
2 pages of narrative summary, 2.5
pages of Q&A per protocol with
decision plus 9 pages of expedite
approval ratifications, continuing
review and SAE discussion.
26. Operation Whitecoat served as a
model of the ethical use of human
subjects in research. The three
step process of informed consent
- by which research subjects
become familiar with the purpose
of a study in order to understand
the risks and potential benefits
involved before agreeing to
participate - was successfully
implemented from the program’s
inception. The soldiers were not
required to participate in any of
the studies, only to be present for
briefings by principal investigators
seeking volunteers. Two more
steps occurred before subjects
were asked to consent. About 20
percent of the men did not
participate in any studies during
their tenure at Fort Detrick.
27. Vaccines that were tested under approved protocols included
those for Q fever, Tularemia (safety & efficacy), Yellow Fever,
Eastern, Western and Venezuelan equine encephalitis (EEE,
WEE & VEE), Hepatitis, Plague and Rift Valley fever (safety only).
28. Aerosol Efficacy Studies in 8 Ball
Q-fever and Tularemia were approved for these studies
because safety criteria were met and cure was assured.
29. 1955 Whitecoat: Aerosol Human
Study in Realistic BW Scenario
Dugway Q-fever trial men seemed
to have mysteriously disappeared
Merlin Neff described being in the study
at Dugway. "They put two of us at
each station along with several
monkeys and guinea pigs and mice
and air sampling apparatus,“ This
study satisfied the AFMPC and outdoor
Outdoor Q-fever Study - Dugway studies like this were never done again.
30. Experimental Risks Minimized by
Availability of Effective Treatment
The men were
assured that no dose
of bacteria would be
fatal, and effective
antibiotics would stop
infection immediately
after it developed.
"They knew that they were going to inhale a certain
number of organisms, and that as soon as they
became ill, they would be treated with appropriate
antibiotics," said Dr. Peter Bartelloni, who was
involved in the research.
31. In addition to the advances made in vaccine and drug development, Operation
Whitecoat volunteers contributed to a better understanding of the signs,
symptoms, and clinical diagnostic parameters in human disease associated
with Q-fever, Tularemia, Sandfly fever, and staphylococcal enterotoxins.
32. Ethical Accomplishments of
CD-22 & Operation Whitecoat
Effectively Used Nuremberg Code Principles
Created Effective Informed Consent Process
Involved “Community” of the SDA Volunteers
Local and Extramural Oversight / Monitoring
33. Medical Accomplishments:
Operation Whitecoat
Licensed vaccines were developed, including
yellow fever, hepatitis, and plague.
Investigational New Drug (IND) vaccines were
developed, including those for Venezuelan
equine encephalitis (VEE), Rift Valley fever, Q
fever, and tularemia.
Effective systems for biological hazard
containment were developed
Rift Valley Fever Virus vaccine; used in 1977
outbreak in Egypt, effected 200,000 humans
(2,000 deaths) and entire sheep population.
35. RVF Vaccine caused Peace to
break out in the middle east
Therefore, a little
known benefit that
Operation Whitecoat
Volunteers provided
was to enable peace
between Egypt and
Israel to “break out”
because obtaining
Emissaries from Egypt RVF Vaccine was an
and Israel requested important bargaining
RVFV as Sadat & Begin chip to both parties.
met at Camp David. N Meyers - Nature 1986 Jan 9; v319(6049): p91
36. FDA Milestone
Kefauver-Harris
Drug Amendments
passed in 1962 to
ensure drug efficacy
and greater drug
safety. For the first
time, manufacturers of
drugs are required to
show proof to the FDA
of the efficacy of their
products before they
may be approved for
marketing.
37. Moral Dilemma: Comply with FDA law
vs Intent to Benefit in BW Emergency
1962 Amendments to the
FD&C Act requiring proof
of efficacy of drugs and
vaccines created a moral
dilemma:
Risk killing subjects in a
valid clinical trial, versus
Withholding potentially life
saving drugs or vaccines
because they lacked
substantial evidence of
human clinical efficacy.
38. 1962 Exemptions to AR 70-25:
Double Edged Sword of Definitions
3. Exemptions to AR 70-25 (26 March 1962). The following categories of activities and
investigative programs are exempt from the provisions of these regulations:
a. Research and non-research programs, tasks, and tests which may involve inherent occupational
hazards to health or exposure of personnel to potentially hazardous situations encountered as
part of training or other normal duties, e.g., flight training, jump training, marksmanship training,
ranger training, fire drills, gas drills, and handling of explosives.
*exposure to chemical agent , cabin decompression and A-bomb blast were “training exercises”
b. That portion of human factors research which involves normal training or other military duties as
part of an experiment, wherein disclosure of experimental conditions to participating personnel
would reveal the artificial nature of such conditions and defeat the purpose of the investigation.
*unethical LSD experiments tested vulnerability to espionage.
c. Ethical medical and clinical investigations involving the basic disease process or new treatment
procedures conducted by the Army Medical Service for the benefit of patients.
*justified clinical trials, force health protection, experimental infections and vaccine efficacy.
39. 1974-1999 Research Influenced by
News Events and World Affairs
“Cold War” imperatives continued into the 1980’s
and we saw growth in Virology Research.
Anthrax Research at RIID re-started after the
outbreak in Sverdlovsk, (Ekaterinburg).
“Yellow Rain” in Cambodia and Laos signaled the
need to increase focus on Toxins and Toxinology
was created from Physical Sciences Division.
And Aum Shinrikyo warned that Bioterrorism was
on the horizon just as the “Evil Empire” was
crumbling. This prompted expansion of Rapid
Diagnosis, using PCR & other dx technologies.
MRVS Program tested WRAIR & RIID Vaccines
40. FDA Historic Milestones
1987 Investigational Drug
Regulations Revised to expand access to
experimental drugs for patients with serious diseases
with no alternative therapies. (Fast Track System –
AIDS activists)
1988 Food and Drug Administration
Act establishes FDA as an agency of DHHS with a
Commissioner of Food and Drugs appointed by the
President with the advice and consent of the Senate,
and broadly spells out the responsibilities of the
Secretary and the Commissioner for research,
enforcement, education, and information.
41. 1987 MOU with FDA Created Ethical and
Legal Dilemma: Research vs Treatment
Ability to use products labeled IND to benefit war
fighter and laboratory personnel becomes less clear.
From 1964 through 1987 MOUs with the FDA
allowed DoD to Self-Exempt certain IND products
from FDA requirements if they were to be used for
treatment of warfighter, i.e. with “intent to benefit” not
for generation of knowledge.
Clinical Research with IND products to discover new
treatment applications rigorously followed DoD and
FDA requirements.
“Special Procedures” was used for worker safety
outside of clinical research format through 1989.
42. Bioterrorism: Changed Priorities
Bioterrorism in the US was no
longer theoretical after 2001
DHS, was created for domestic
security and countermeasures
R&D for Biodefense medical
countermeasures under DHHS
Present Bioterrorism response
resembles US response to Bio-
Warfare threat during WW II
43. Ethical Dichotomy Intrinsic to
National Biodefense Program:
Emergency circumstances may affect outcomes of ethical
analyses by weighting different values, thus favoring
mitigating actions over caution
Choices:
I. Respect the rights and welfare of subjects who participate
in research designed to discover, validate and gain FDA
marketing approval for products to be used in prevention
and treatment of possible bioterrorism casualties.
Versus:
II. Urgent need to use unapproved products reasonably
thought to be beneficial for protection from - or immediate
treatment of bioterrorism when there is an emergency and
no approved alternatives are available.
44. Ethical Analysis vs Rules & Laws
HHS Common Rule Regulates Research
based on Ethical Principles but applied as
Rules
FDA Regulates Product
FD&CA Law & FDA regulates development,
labeling, marketing and use of drugs, biologics
& devices
FDA defines use of product labeled IND / IDE
as Research irrespective of intended use
Nuremberg Code provides principles that may be
applied in Ethical Analyses for Biodefense Research
45. Project BioShield
CDC, HHS & DoD may use HHS Project BioShield as
specified in the following legislation:
Passed: H.R. 2122 Project Bioshield Act - July 16 2003
Passed: S. 15 Project BioShield Act - May 19 2004
President Signed : Public Law No: 108-276 July 21 2004
Presented: H.R. 4258 Rapid Pathogen Identification to
Delivery of Cures Act - May 3, 2004
These legislative acts may resolve the dilemma associated with the
need for widespread use of FDA-unapproved products in for national
biodefense or war hazards when it is unethical to do FDA-mandated
human clinical efficacy studies. 21 CFR Part 314.600 - .650
Additional legislation may be necessary to further define how these new
laws will operate through existing agencies without damaging the fabric
of regulation protecting the public from unsafe and ineffective drugs.
Federal Food Drug and Cosmetic Act, section 564 (EUA)
46. USAMRIID still Evolving
Over the past 56 years since the start of Operation Whitecoat, the U.S.
Army Medical Research Institute of Infectious Diseases has grown
considerably from what it was as the U.S. Army Medical Unit, yet It
continues to conduct basic and applied research on biological threats
resulting in medical solutions to protect military service members.
The present building was planned by COL Dan Crozier, and is named in his honor.
47. Arthur O. Anderson MD
Director, Office of Human Use and Ethics
US Army Medical Research Institute of Infectious Diseases