The document discusses ethics in research and provides historical context. It covers:
- The Nuremberg Code established voluntary consent as essential after Nazi experiments.
- The Tuskegee Syphilis Study withheld treatment from black men for decades without consent.
- Key principles include respect for autonomy, beneficence, nonmaleficence, and justice. Informed consent requires competence, disclosure, understanding, voluntariness, and consent.
- Guidelines like the Declaration of Helsinki aim to apply ethics principles to clinical research internationally. Maintaining confidentiality is also important.
Introduction
working principle
fragmentation process
general rules for fragmentation
general modes of fragmentation
metastable ions
isotopic peaks
applications
This document presents a summary of the Declaration of Helsinki by Miss. Joshi U.L. It discusses the history and development of the Declaration of Helsinki, which was first adopted in 1964 by the World Medical Association to provide ethical principles for human experimentation. It outlines the basic ethical principles that should be followed in all medical research involving human subjects, including the principles of consent, beneficence, and justice. It also describes additional principles that apply to research combined with medical care. In the end, it emphasizes that the Nuremberg Code and Declaration of Helsinki are the basis for research ethics regulations worldwide.
M. Pharm: Research Methodology and biostatics SONALI PAWAR
This document outlines the contents of a lecture on research methodology and biostatistics delivered by Prof. Sonali R. Pawar. It covers various topics in medical ethics including: the history of medical ethics traced back to guidelines like the Hippocratic Oath; core values like autonomy, beneficence, non-maleficence; concepts like informed consent and confidentiality; criticisms of orthodox medical ethics; the importance of communication and guidelines/ethics committees; cultural concerns and conflicts of interest. It also discusses principles like double effect and end of life issues like futility.
The document presents information on the Declaration of Helsinki (DoH), including its history, development, scope, and basic ethical principles for medical research involving human subjects. It notes that the DoH is a cornerstone document developed by the World Medical Association that has undergone several revisions since 1964 to update principles for ethical human research. The summary provides an overview of the key topics covered in the document.
Factorial design ,full factorial design, fractional factorial designSayed Shakil Ahmed
This document discusses factorial designs and their application in formulation. It defines factorial experiments as those involving two or more factors, each with different levels. Full factorial designs involve every combination of all factors and levels, while fractional factorial designs examine multiple factors efficiently with fewer runs. Applications mentioned include formulation and processing, clinical chemistry, and studying the effects of factors like disintegrant and lubricant concentration on tablet dissolution. IVIVC and BCS classification are also discussed in relation to predicting oral absorption of immediate release formulations.
This document provides an overview of general research methodology. It defines key terms like research methods and methodology. It discusses the objectives, types, and requirements of research like developing a problem statement, reviewing literature, and study design. It describes different types of studies like descriptive, analytical, and applied. The document emphasizes that research must be systematic, logical, empirical, and replicable to be considered good. It provides examples of various parts of the research process and criteria for evaluating research.
Social health program; role of world health organization in Indian national p...Dr. Sharad Chand
This topic explains the Social health program; the role of the world health organization in the Indian national program. This is useful for understanding the importance of social health and the role of WHO.
Introduction
working principle
fragmentation process
general rules for fragmentation
general modes of fragmentation
metastable ions
isotopic peaks
applications
This document presents a summary of the Declaration of Helsinki by Miss. Joshi U.L. It discusses the history and development of the Declaration of Helsinki, which was first adopted in 1964 by the World Medical Association to provide ethical principles for human experimentation. It outlines the basic ethical principles that should be followed in all medical research involving human subjects, including the principles of consent, beneficence, and justice. It also describes additional principles that apply to research combined with medical care. In the end, it emphasizes that the Nuremberg Code and Declaration of Helsinki are the basis for research ethics regulations worldwide.
M. Pharm: Research Methodology and biostatics SONALI PAWAR
This document outlines the contents of a lecture on research methodology and biostatistics delivered by Prof. Sonali R. Pawar. It covers various topics in medical ethics including: the history of medical ethics traced back to guidelines like the Hippocratic Oath; core values like autonomy, beneficence, non-maleficence; concepts like informed consent and confidentiality; criticisms of orthodox medical ethics; the importance of communication and guidelines/ethics committees; cultural concerns and conflicts of interest. It also discusses principles like double effect and end of life issues like futility.
The document presents information on the Declaration of Helsinki (DoH), including its history, development, scope, and basic ethical principles for medical research involving human subjects. It notes that the DoH is a cornerstone document developed by the World Medical Association that has undergone several revisions since 1964 to update principles for ethical human research. The summary provides an overview of the key topics covered in the document.
Factorial design ,full factorial design, fractional factorial designSayed Shakil Ahmed
This document discusses factorial designs and their application in formulation. It defines factorial experiments as those involving two or more factors, each with different levels. Full factorial designs involve every combination of all factors and levels, while fractional factorial designs examine multiple factors efficiently with fewer runs. Applications mentioned include formulation and processing, clinical chemistry, and studying the effects of factors like disintegrant and lubricant concentration on tablet dissolution. IVIVC and BCS classification are also discussed in relation to predicting oral absorption of immediate release formulations.
This document provides an overview of general research methodology. It defines key terms like research methods and methodology. It discusses the objectives, types, and requirements of research like developing a problem statement, reviewing literature, and study design. It describes different types of studies like descriptive, analytical, and applied. The document emphasizes that research must be systematic, logical, empirical, and replicable to be considered good. It provides examples of various parts of the research process and criteria for evaluating research.
Social health program; role of world health organization in Indian national p...Dr. Sharad Chand
This topic explains the Social health program; the role of the world health organization in the Indian national program. This is useful for understanding the importance of social health and the role of WHO.
Ich guidelines Seminar ( Efficacy & Multidisciplinary)VivekWagh13
The International Conference on Harmonisation (ICH) brings together regulators and industry representatives from the European Union, Japan, and the United States to discuss scientific and technical aspects of pharmaceutical product registration. The goal of ICH is to promote international harmonization of technical requirements through the development of common guidelines. ICH guidelines cover various topics including quality, safety, efficacy, and multidisciplinary issues. The guidelines provide recommendations on nonclinical studies, clinical trial design and analysis, and the format and content of registration documents to harmonize the technical requirements for pharmaceuticals across ICH regions.
National tobacco control program (ntcp) in india AhmadAbdussalam1
The National Tobacco Control Program was launched in India in 2007-2008 in response to high tobacco use rates. It aims to reduce tobacco production and use, enforce advertising bans, help people quit, and implement the WHO Framework Convention on Tobacco Control. The program is implemented through a three-tier structure at the national, state, and district levels. Activities include education, cessation services, enforcement of laws, and coordination with local governments. Evaluation found the program helped reduce tobacco use by over 8 million people between 2009-2010 and its second survey period.
The National Tobacco Control Program aims to eliminate exposure to secondhand smoke, promote quitting among adults and youth, and prevent tobacco initiation among youth. Tobacco use is the leading cause of preventable disease and death in the United States, responsible for over 480,000 deaths per year. The program monitors outcomes through several national and state surveys to track objectives like decreasing secondhand smoke exposure and increasing tobacco cessation attempts. The goals of the program help promote sustainability and accountability over the next 10 years as outlined in Healthy People 2020.
BIS specification and Analytical Methods for shampooGulfisha Shaikh
The document outlines Bureau of Indian Standards (BIS) specifications for shampoo. It notes that cosmetics in India are regulated under the Drugs and Cosmetics Act of 1940 and Rules of 1945. BIS sets standards for listed cosmetics and has provided specifications for skin creams and lipstick. The specifications restrict dyes, colors, and pigments in cosmetics to certain limits of arsenic, lead, and heavy metals. It then discusses IS 7884 (2004) which provides the specification for surfactant-based shampoos, including requirements for raw materials, packaging and marking, sampling, reagent quality, and determination of non-volatile alcohol soluble matter, pH, and foam
This document summarizes the Sebumeter, a device that objectively measures the amount of sebum on the skin. The Sebumeter was invented by Antoine Kawam in 1992. It works by using a special tape in its measuring head cassette that becomes more transparent with greater amounts of deposited sebum. The cassette is placed on the skin, then inserted into the device, which uses light and a photoelectric receiver to measure the transparency of the sebum-coated tape. The microprocessor then calculates and displays the sebum level in mg/cm2. The Sebumeter provides an objective way to measure skin oiliness, which is important for determining the proper skincare regimen.
The screening of chemical libraries with traditional methods, such as high-throughput screening (HTS), is expensive and time consuming. Quantitative structure–activity relation (QSAR) modeling is an alternative method that can assist in the selection of lead molecules by using the information from
reference active and inactive compounds. This approach requires good molecular descriptors that are representative of the molecular features responsible for the relevant molecular activity.
This document outlines the key components and structure of clinical research protocols. It discusses that protocols provide a written description and scientific rationale for research involving human subjects. Protocols ensure sufficient information is gathered on safety and receive approval from health authorities and ethics committees. The document then lists and describes the typical parts of a protocol, including the title page, objectives, study design, safety considerations, statistical analysis plan, and informed consent section. It emphasizes protocols clarify the research question, existing knowledge, objectives, study design, and provide guidelines for the research team.
This document discusses the social problems faced by sick individuals that hinder their ability to mingle with society. It identifies 7 main problems: 1) illiteracy, 2) brain drain, 3) lack of employment opportunities, 4) difficulties with social relationships, 5) loss of independence, 6) communication problems, and 7) issues with dining. These problems can cause stress that leads individuals to feel guilty and isolated from society, and in some cases become mentally ill. Addressing these social factors is important to improving the conditions of the sick.
Medical Research - Cultural concerns, Truth telling & Conflict of interestPratik Parikh
The document summarizes key topics from Pratik Umesh Parikh's seminar on medical research methodology and biostatistics. It discusses cultural concerns in medical research, including how language and religion can create barriers. It also covers the importance of truth telling in medical care, managing conflicts of interest, and references several sources that informed the seminar topics.
National Urban Health Mission ( Social and Preventive Pharmacy)Abul Hassan Junaid
As per B. Pharmacy syllabus this ppt has been made. This deals with the health schemes and measures taken by Government of India to improve Urban health facility.
This document discusses factorial design, which is an experimental design technique used for optimization. It involves studying the effects of two or more factors simultaneously. There are two main types: full factorial design, which tests all possible combinations of factors and levels, and fractional factorial design, which reduces the number of runs when there are many factors. Factorial designs allow evaluation of both main effects and interaction effects. They are useful for formulation development and method optimization in chromatography. Software is used to analyze the results of factorial experiments.
The Declaration of Helsinki is a beacon that illuminates the path to ethical and responsible medical research. It reminds us that while scientific progress is vital, it should never come at the expense of human dignity and ethical principles. This enduring declaration continues to guide the ethical conduct of research, reflecting the shared commitment to responsible research and the highest ethical standards. #DeclarationOfHelsinki #ResearchEthics #MedicalEthics #HumanResearch
Intrauterine & Intravaginal Drug Delivery SystemPRASHANT DEORE
This document discusses intrauterine and intravaginal drug delivery systems. It begins with an introduction and overview of anatomy and physiology of the female reproductive system. It then describes various types of intravaginal drug delivery systems including suppositories, bioadhesive semisolids, elastomeric rings, and solid polymeric carriers. Factors affecting vaginal drug absorption are also discussed. The document concludes by describing intrauterine drug delivery systems including non-hormonal and hormonal IUDs, and discussing advantages and disadvantages of both intravaginal and intrauterine systems.
Experimental design techniques involve controlling variables to measure their effects. There are three main types of designs: pre-experimental (no control group), quasi-experimental (no random assignment), and true experimental (control group, random assignment, manipulation). True experiments allow cause-and-effect conclusions through statistical analysis and include variations like post-test only, pre-test post-test, and Solomon four-group designs. Factorial designs test multiple hypotheses simultaneously by manipulating multiple independent variables. Randomized block and cross-over designs help control for differences between subjects. The goal is to draw valid conclusions about variable relationships through controlled experimentation.
National health intervention programme for mother and childHimikaRathi
The document discusses India's national health intervention programme for mothers and children. It outlines several key interventions and objectives of the programme, including reducing maternal and child mortality, increasing access to healthcare services during pregnancy and childbirth, and improving nutrition. The major interventions discussed are the Janani Suraksha Yojana and Janani Shishu Suraksha Karyakram conditional cash transfer schemes to promote institutional deliveries, as well as programs focused on antenatal care, postnatal care, newborn care, immunizations, and addressing malnutrition among children. The overall goal of the programme is to improve health outcomes for mothers and their children.
This document discusses various optimization techniques used in pharmaceutical product development including EVOP method, statistical designs like simplex method and response surface methodology, contour design, and factorial designs. It provides details on each technique such as the basic concepts, advantages, disadvantages and examples. EVOP method involves making small repeated changes to a formulation to optimize it but requires more time. Statistical designs help optimize formulations with 1-3 variables. Contour design uses constraints to optimize multiple response variables. Response surface methodology uses statistical techniques to build empirical models and optimize responses influenced by several variables. Factorial designs study the effects of individual and interacting input parameters on experimental outcomes.
This document discusses the Woodward-Fieser rules for predicting the wavelength of maximum absorption (λmax) of organic compounds based on their molecular structure. It introduces the basic terminology and presents the parent values and incremental contributions for calculating λmax for different functional groups in conjugated dienes, aromatics, α,β-unsaturated carbonyls, and compounds with more than four conjugated double bonds. Examples are provided to demonstrate the application of the rules for each class of compounds. The document is intended as an introduction to the Woodward-Fieser rules and their use in predicting UV-vis absorption spectra based on molecular structure.
The Declaration of Helsinki is a set of ethical principles regarding human experimentation set forth by the World Medical Association. It was originally adopted in 1964 and aims to provide guidance to physicians and researchers. The Declaration establishes standards to ensure medical research involving human subjects respects their life, health, dignity, integrity, and rights. It requires voluntary informed consent and oversight by research ethics committees. The Declaration has undergone several revisions to update and clarify its guidelines as medical research has advanced. It continues to be recognized as a fundamental document for ethics in human subject research.
This document provides an overview of public health ethics. It begins by outlining the course objectives, which are to understand ethics definitions, principles, and controversies in healthcare, public health, and research. It then defines ethics and morality. The document discusses the historical perspectives of the Nazi experiments, Nuremberg Code, Tuskegee Syphilis Study, Belmont Report, Declaration of Helsinki, and other international guidelines. It also covers the general ethical principles of respect for autonomy, beneficence, nonmaleficence, and justice. The document discusses topics like informed consent, paternalism, confidentiality, and ethics in communicable disease control and epidemiological research.
This document outlines the key topics and objectives covered in a public health ethics course. It discusses the definition of ethics and morality. It then covers several important historical cases in research ethics, including the Nazi experiments, Tuskegee Syphilis Study, Nuremberg Code, Declaration of Helsinki, and Belmont Report. The four main ethical principles - respect for autonomy, beneficence, nonmaleficence, and justice - are introduced. The document also discusses ethical issues around communicable disease control and informed consent.
Ich guidelines Seminar ( Efficacy & Multidisciplinary)VivekWagh13
The International Conference on Harmonisation (ICH) brings together regulators and industry representatives from the European Union, Japan, and the United States to discuss scientific and technical aspects of pharmaceutical product registration. The goal of ICH is to promote international harmonization of technical requirements through the development of common guidelines. ICH guidelines cover various topics including quality, safety, efficacy, and multidisciplinary issues. The guidelines provide recommendations on nonclinical studies, clinical trial design and analysis, and the format and content of registration documents to harmonize the technical requirements for pharmaceuticals across ICH regions.
National tobacco control program (ntcp) in india AhmadAbdussalam1
The National Tobacco Control Program was launched in India in 2007-2008 in response to high tobacco use rates. It aims to reduce tobacco production and use, enforce advertising bans, help people quit, and implement the WHO Framework Convention on Tobacco Control. The program is implemented through a three-tier structure at the national, state, and district levels. Activities include education, cessation services, enforcement of laws, and coordination with local governments. Evaluation found the program helped reduce tobacco use by over 8 million people between 2009-2010 and its second survey period.
The National Tobacco Control Program aims to eliminate exposure to secondhand smoke, promote quitting among adults and youth, and prevent tobacco initiation among youth. Tobacco use is the leading cause of preventable disease and death in the United States, responsible for over 480,000 deaths per year. The program monitors outcomes through several national and state surveys to track objectives like decreasing secondhand smoke exposure and increasing tobacco cessation attempts. The goals of the program help promote sustainability and accountability over the next 10 years as outlined in Healthy People 2020.
BIS specification and Analytical Methods for shampooGulfisha Shaikh
The document outlines Bureau of Indian Standards (BIS) specifications for shampoo. It notes that cosmetics in India are regulated under the Drugs and Cosmetics Act of 1940 and Rules of 1945. BIS sets standards for listed cosmetics and has provided specifications for skin creams and lipstick. The specifications restrict dyes, colors, and pigments in cosmetics to certain limits of arsenic, lead, and heavy metals. It then discusses IS 7884 (2004) which provides the specification for surfactant-based shampoos, including requirements for raw materials, packaging and marking, sampling, reagent quality, and determination of non-volatile alcohol soluble matter, pH, and foam
This document summarizes the Sebumeter, a device that objectively measures the amount of sebum on the skin. The Sebumeter was invented by Antoine Kawam in 1992. It works by using a special tape in its measuring head cassette that becomes more transparent with greater amounts of deposited sebum. The cassette is placed on the skin, then inserted into the device, which uses light and a photoelectric receiver to measure the transparency of the sebum-coated tape. The microprocessor then calculates and displays the sebum level in mg/cm2. The Sebumeter provides an objective way to measure skin oiliness, which is important for determining the proper skincare regimen.
The screening of chemical libraries with traditional methods, such as high-throughput screening (HTS), is expensive and time consuming. Quantitative structure–activity relation (QSAR) modeling is an alternative method that can assist in the selection of lead molecules by using the information from
reference active and inactive compounds. This approach requires good molecular descriptors that are representative of the molecular features responsible for the relevant molecular activity.
This document outlines the key components and structure of clinical research protocols. It discusses that protocols provide a written description and scientific rationale for research involving human subjects. Protocols ensure sufficient information is gathered on safety and receive approval from health authorities and ethics committees. The document then lists and describes the typical parts of a protocol, including the title page, objectives, study design, safety considerations, statistical analysis plan, and informed consent section. It emphasizes protocols clarify the research question, existing knowledge, objectives, study design, and provide guidelines for the research team.
This document discusses the social problems faced by sick individuals that hinder their ability to mingle with society. It identifies 7 main problems: 1) illiteracy, 2) brain drain, 3) lack of employment opportunities, 4) difficulties with social relationships, 5) loss of independence, 6) communication problems, and 7) issues with dining. These problems can cause stress that leads individuals to feel guilty and isolated from society, and in some cases become mentally ill. Addressing these social factors is important to improving the conditions of the sick.
Medical Research - Cultural concerns, Truth telling & Conflict of interestPratik Parikh
The document summarizes key topics from Pratik Umesh Parikh's seminar on medical research methodology and biostatistics. It discusses cultural concerns in medical research, including how language and religion can create barriers. It also covers the importance of truth telling in medical care, managing conflicts of interest, and references several sources that informed the seminar topics.
National Urban Health Mission ( Social and Preventive Pharmacy)Abul Hassan Junaid
As per B. Pharmacy syllabus this ppt has been made. This deals with the health schemes and measures taken by Government of India to improve Urban health facility.
This document discusses factorial design, which is an experimental design technique used for optimization. It involves studying the effects of two or more factors simultaneously. There are two main types: full factorial design, which tests all possible combinations of factors and levels, and fractional factorial design, which reduces the number of runs when there are many factors. Factorial designs allow evaluation of both main effects and interaction effects. They are useful for formulation development and method optimization in chromatography. Software is used to analyze the results of factorial experiments.
The Declaration of Helsinki is a beacon that illuminates the path to ethical and responsible medical research. It reminds us that while scientific progress is vital, it should never come at the expense of human dignity and ethical principles. This enduring declaration continues to guide the ethical conduct of research, reflecting the shared commitment to responsible research and the highest ethical standards. #DeclarationOfHelsinki #ResearchEthics #MedicalEthics #HumanResearch
Intrauterine & Intravaginal Drug Delivery SystemPRASHANT DEORE
This document discusses intrauterine and intravaginal drug delivery systems. It begins with an introduction and overview of anatomy and physiology of the female reproductive system. It then describes various types of intravaginal drug delivery systems including suppositories, bioadhesive semisolids, elastomeric rings, and solid polymeric carriers. Factors affecting vaginal drug absorption are also discussed. The document concludes by describing intrauterine drug delivery systems including non-hormonal and hormonal IUDs, and discussing advantages and disadvantages of both intravaginal and intrauterine systems.
Experimental design techniques involve controlling variables to measure their effects. There are three main types of designs: pre-experimental (no control group), quasi-experimental (no random assignment), and true experimental (control group, random assignment, manipulation). True experiments allow cause-and-effect conclusions through statistical analysis and include variations like post-test only, pre-test post-test, and Solomon four-group designs. Factorial designs test multiple hypotheses simultaneously by manipulating multiple independent variables. Randomized block and cross-over designs help control for differences between subjects. The goal is to draw valid conclusions about variable relationships through controlled experimentation.
National health intervention programme for mother and childHimikaRathi
The document discusses India's national health intervention programme for mothers and children. It outlines several key interventions and objectives of the programme, including reducing maternal and child mortality, increasing access to healthcare services during pregnancy and childbirth, and improving nutrition. The major interventions discussed are the Janani Suraksha Yojana and Janani Shishu Suraksha Karyakram conditional cash transfer schemes to promote institutional deliveries, as well as programs focused on antenatal care, postnatal care, newborn care, immunizations, and addressing malnutrition among children. The overall goal of the programme is to improve health outcomes for mothers and their children.
This document discusses various optimization techniques used in pharmaceutical product development including EVOP method, statistical designs like simplex method and response surface methodology, contour design, and factorial designs. It provides details on each technique such as the basic concepts, advantages, disadvantages and examples. EVOP method involves making small repeated changes to a formulation to optimize it but requires more time. Statistical designs help optimize formulations with 1-3 variables. Contour design uses constraints to optimize multiple response variables. Response surface methodology uses statistical techniques to build empirical models and optimize responses influenced by several variables. Factorial designs study the effects of individual and interacting input parameters on experimental outcomes.
This document discusses the Woodward-Fieser rules for predicting the wavelength of maximum absorption (λmax) of organic compounds based on their molecular structure. It introduces the basic terminology and presents the parent values and incremental contributions for calculating λmax for different functional groups in conjugated dienes, aromatics, α,β-unsaturated carbonyls, and compounds with more than four conjugated double bonds. Examples are provided to demonstrate the application of the rules for each class of compounds. The document is intended as an introduction to the Woodward-Fieser rules and their use in predicting UV-vis absorption spectra based on molecular structure.
The Declaration of Helsinki is a set of ethical principles regarding human experimentation set forth by the World Medical Association. It was originally adopted in 1964 and aims to provide guidance to physicians and researchers. The Declaration establishes standards to ensure medical research involving human subjects respects their life, health, dignity, integrity, and rights. It requires voluntary informed consent and oversight by research ethics committees. The Declaration has undergone several revisions to update and clarify its guidelines as medical research has advanced. It continues to be recognized as a fundamental document for ethics in human subject research.
This document provides an overview of public health ethics. It begins by outlining the course objectives, which are to understand ethics definitions, principles, and controversies in healthcare, public health, and research. It then defines ethics and morality. The document discusses the historical perspectives of the Nazi experiments, Nuremberg Code, Tuskegee Syphilis Study, Belmont Report, Declaration of Helsinki, and other international guidelines. It also covers the general ethical principles of respect for autonomy, beneficence, nonmaleficence, and justice. The document discusses topics like informed consent, paternalism, confidentiality, and ethics in communicable disease control and epidemiological research.
This document outlines the key topics and objectives covered in a public health ethics course. It discusses the definition of ethics and morality. It then covers several important historical cases in research ethics, including the Nazi experiments, Tuskegee Syphilis Study, Nuremberg Code, Declaration of Helsinki, and Belmont Report. The four main ethical principles - respect for autonomy, beneficence, nonmaleficence, and justice - are introduced. The document also discusses ethical issues around communicable disease control and informed consent.
Unit 8. Ethical Considerations in Reseaerch.pptxshakirRahman10
Ethical Consideration in Research:
Objectives:
1. Define the terms related to ethics in research
2. Discuss historical events of ethical mischiefs and evolution of ethics as protecting human rights
3. Discuss the ethical principles, declaration of Helsinki and research code of ethics
4. Describe different types of informed consent, i.e. verbal, written, individual and institutional consent.
5. Produce a meaningful informed consent form.
6. Identify role and importance of ethical considerations in research.
Ethical Considerations in Research:
Ethical considerations in research are a set of principles that guide the research designs and practices.
Scientists and researchers must always adhere to a certain code of conduct when collecting data from people.
The goals of human research often include understanding real-life phenomena, studying effective treatments, investigating behaviors, and improving lives in other ways.
What you decide to research and how you conduct that research involve key ethical considerations.
Ethical considerations work to:
Protect the rights of research participants
Enhance research validity
Maintain scientific or academic integrity.
History of Research Ethics:
Nuremberg Code
Dec. 9, 1946, when an American military tribunal opened criminal proceedings against 23 leading German physicians and administrators for their willing participation in war crimes and crimes against humanity.
Among the charges were that German physicians conducted medical experiments on thousands of concentration camp prisoners without their consent. Most of the subjects of these experiments died or were permanently crippled as a result.
As a direct result of the trial, the Nuremberg Code was established in 1948, stating that “The voluntary consent of the human subject is absolutely essential,” making it clear that subjects should give consent and that the benefits of research must outweigh the risks.
Although it did not carry the force of law, the Nuremberg Code was the first international document which advocated voluntary participation and informed consent.
Thalidomide
In the late 1950s, thalidomide was approved as a sedative in Europe; it was not approved in the United States by the FDA.
The drug was prescribed to control sleep and nausea throughout pregnancy, but it was soon found that taking this drug during pregnancy caused severe deformities in the fetus.
Many patients did not know they were taking a drug that was not approved for use by the FDA, nor did they give informed consent. Some 12,000 babies were born with severe deformities due to thalidomide.
U.S. Senate hearings followed and in 1962 the so-called “Kefauver Amendments” to the Food, Drug, and Cosmetic Act were passed into law to ensure drug efficacy and greater drug safety.
For the first time, drug manufacturers were required to prove to the FDA the effectiveness of their products before marketing them.
EMPHNET-PHE Course: Module seven ethical issues in public health research& in...Dr Ghaiath Hussein
This is a series of presentations I gave in the Eastern Mediterranean Public Health Network (EMPHNET)'s Public Health Ethics (PHE) that was held in Amman in June 2014.
This presentation outlines the ethical issues in research, especially the international research in low-middle income countries
Ethics are crucial in nursing research to protect participants and establish standards of care. Unethical studies in the past showed exploitation and harm. The Nuremberg Code and Belmont Report established principles of respect for persons, beneficence, and justice. Informed consent and IRB oversight now safeguard participants' rights and welfare.
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.
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.
medical ethics is a very important topic when it comes to conducting of clinical trials. this presentation covers the important facts that most of the clinicians should be aware of
The document discusses several key topics related to research ethics including definitions of ethics, important ethical principles like beneficence, respect for human dignity and justice, historical events that shaped modern research ethics like the Nazi experiments and Tuskegee study, informed consent, vulnerable populations, and codes of ethics. It also addresses ethical issues in different research methodologies and the role of institutional review boards in research oversight.
The document discusses ethical issues in research. It defines key concepts like ethics, ethical issues, and research ethics. It outlines important ethical principles like non-maleficence, beneficence, autonomy, and justice. It examines major ethical issues such as informed consent, risks and benefits, confidentiality, vulnerable groups, and communicating results. It analyzes historical examples that violated ethics like the Nazi experiments and Tuskegee syphilis study. In summary, the document outlines the importance of addressing ethical considerations in research to protect participants and build trust.
The document summarizes a 1963 study at the Jewish Chronic Disease Hospital that injected live cancer cells into patients without fully informing them. This led to allegations of fraud and deceit against the investigators. It sparked reforms that established modern research ethics regulations, including requiring proper informed consent and review by institutional review boards. Key results were the Nuremberg Code, Declaration of Helsinki, and regulations from the Department of Health and Human Services and Food and Drug Administration.
Presented at the M.S. and Ph.D. Programs in Data Science for Health Care, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand on November 14, 2019
Presented at the Health Informatics and Health Information Technology Course, Doctor of Philosophy and Master of Science Programs in Data Science for Health Care (International Program), Faculty of Medicine Ramathibodi Hospital, Mahidol University on October 31, 2017
This document provides an overview of ethical issues in medical research. It discusses the history of unethical human experimentation including the Nazi experiments and the Tuskegee Syphilis Study. It outlines key documents that established ethical research standards like the Nuremberg Code, Declaration of Helsinki, and Belmont Report. The Belmont Report identified three core ethical principles: respect for persons, beneficence, and justice. It also discusses the role of institutional review boards in protecting research participants and reviewing research proposals to ensure compliance with ethical standards.
This document outlines the key ethical issues in conducting research. It begins by defining research and explaining where research fits within the knowledge management cycle. It then discusses what makes research ethical, outlining principles such as social or scientific value, scientific validity, fair subject selection, favorable risk-benefit ratio, independent review, and informed consent.
The document goes on to discuss specific ethical issues in research, including benefit-harm analysis, vulnerability and the risk-vulnerability matrix, informed consent, fairness and equity, privacy and confidentiality, conflicts of interest, and ethical issues after research is conducted. It provides examples of vulnerable populations like women, pregnant women, and children.
This document provides an introduction to research ethics and ethics for health informaticians. It begins with definitions of ethics, morals, and norms. It then discusses the role of law, professional codes of conduct, and ethics in establishing standards of acceptable behavior. Key topics in research ethics are introduced through discussions of historic cases like the Nazi human experiments, Beecher's research ethics violations, and the Tuskegee Syphilis Study. The document outlines the Belmont Report's three ethical principles of respect for persons, beneficence, and justice. Ethical issues in health informatics like alerts fatigue from clinical decision support systems and unintended consequences of health IT are also discussed.
This document discusses ethics in clinical research and provides a historical perspective. It summarizes key events that shaped modern research ethics like the Nuremberg trials, Declaration of Helsinki, and Belmont Report. The core ethical principles of respect for persons, beneficence, and justice are explained. Challenges in clinical research in India like ensuring proper informed consent and oversight by ethics committees are also covered.
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.
This document provides an introduction to research ethics and ethics for health informaticians. It discusses key topics like the introduction to ethics and bioethics, ethical issues in health informatics, information ethics and clinical decision making. It also includes case studies of historic cases in research ethics like the Nazi human experimentation, Milgram study, Stanford prison experiment and Tuskegee study. The document discusses principles like respect for persons, beneficence, justice from the Belmont report. It also covers ethical, legal and social issues and clinical decision support systems.
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2. Learning Objectives
• At the end of this session the student will
be able to:
• Understand the historical development of
ethics in health research
• Understand the major ethical principles of
research
• Develop consent forms
3. References
1. Robert B. Wallace, Nearl Kohatsu, Brownson, Schetcer, Scutchfield, Zaza. Public health and
preventive Medicine
2. Tom L. Beauchamp, James F. Childress. Principles of biomedical Ethcs, 5th Edition, Oxford
University Press, 2001
3. Ann Aschengrau, George R. Seage III. Essentials of Epidemiology in Public Health (2nd edn).
Jones and Bartlet Publishers,2008
4. Ethical Considerations
• Professional obligation to safeguard the safety of
study subjects
• Refer to national and international guidelines
• Describe potential ethical concerns and
mechanisms to minimize harm and maximize
benefits
• Remember: every research can potentially cause ethical
concerns!!
5. Ethics
Ethics – is the branch of philosophy that
deals with distinctions between right and
wrong-with the moral consequences of
human actions.
6. Historical Perspectives
Nazi War Crimes and the Nuremberg Code
• Prior to and during the World War II (1940s), Nazi
physicians and scientists conducted experiments on
concentration camp prisoners without their consent
• Many of these experiments involved exposing subjects
to extreme suffering for observational purposes such as:
– To determine the time to death for individuals
submerged in freezing water
– To determine the ability of subjects to withstand high
altitude conditions by forcing them into low-pressure
chambers
7. Historical Perspectives cont…
• Other experiments
– Deliberately inflicting wounds or burns;
– Infecting subjects with diseases;
– Poisoning them;
in order to test various treatments or to perform
autopsies afterwards….
8. Historical Perspectives cont…
• During the Nuremberg Military Tribunals at
the end of World War II,
– the scientists who conducted these
experiments were held accountable for their
actions, and
– many issues in research ethics received
public scrutiny….
9. Historical Perspectives cont…
The Nuremberg Code (1947)
• The 10 principles outlined in Nuremberg Code
were among the 1st rules for experimentation
involving human subjects
• The first and most famous principle from this
historic code states “the voluntary consent of the
human subject is absolutely essential”
10. Historical Perspectives cont…
The Nuremberg principles served to inform
the development of subsequent
professional and governmental codes that
would guide the ethical conduct of
research with human subjects
11. Historical Perspectives cont…
The Tuskegee Syphilis Study
• In 1932 the U.S Public Health Service (PHS)
began a study of the natural course of untreated
syphilis among rural black males in Macon
Country, Alabama
• About 400 men with syphilis and 200 uninfected
controls were enrolled in the study
• Informed consent was not obtained from study
participants
12. Historical Perspectives cont…
• They were not told about the study’s
objective
• Study procedures such as spinal taps
were represented as “free treatment”, and
burial stipends motivated family members
to allow autopsies on participants who
reached the study’s “endpoint”
13. Historical Perspectives cont…
• When penicillin became widely available
by 1947 as a standard cure for syphilis,
treatment was denied to these subjects
• The PHS actively sought to prevent study
subjects from obtaining treatment and
information from other sources
14. Historical Perspectives cont…
• This study was halted in 1972 when national press
reports prompted public outrage
• This was the longest non-therapeutic experiment on
human beings in medical history
• By the time the study was stopped dozens of the
participants had died of syphilis
• Many of their wives had been infected
• Many of their children had been born with congenital
syphilis
15. Historical Perspectives cont…
• The study has come to symbolize racism in
medicine and science, ethical misconduct in
research, and governmental exploitation of the
vulnerable
• The history of this study in the U.S has
contributed to persistent mistrust of public health
authorities today, particularly among racial and
ethnic minority groups
• President Clinton formally apologized for the
study’s injustices on behalf of the U.S
government in 1997.
16. Historical Perspectives cont…
• The declaration of Helsinki (1964)
• was adopted by the World Medical
Association in 1964 to guide application of
the ethical principles for clinical research
specified in the Declaration of Helsinki
17. Historical Perspectives cont…
International Ethical and Research
Practice Guidelines
• In addition to the Declaration of Helsinki,
there are a number of ethical research and
practice guidelines that are internationally
oriented. Some of these are:
– WHO/CIOMS(Council for International Organizations of Medical
Sciences) guidelines
– International conference on Harmonization Guidelines for Good
Clinical Practice
18. Historical Perspectives cont…
WHO/CIOMS Guidelines
A) International Guidelines for Biomedical
Research Involving Human Subjects –
• Published in 1982 by the WHO & CIOMS
• Addressed issues of:
– informed consent;
– standards for ethical review; and
– protections for vulnerable persons such as pregnant women,
children, people with mental illness, and communities in
resource limited countries
• Guideline revised in 1993 and 2002
19. Historical Perspectives cont…
B) “International Guidelines for the Ethical
Review of Epidemiologic Studies”.
• Published in 1991
– Outlined unique ethical considerations for
epidemiological research,
– Emphasis given to groups of people as
opposed to individual patients
20. General Ethical Principles
1. Respect for autonomy
- a norm of respecting the decision-making
capacities of autonomous persons
2. Beneficence
-a group of norms for providing benefits and
balancing benefits against risks and costs
3. Nonmaleficence
-a norm of avoiding the causation of harm
4) Justice
- a group of norms for distributing benefits,
risks, and costs fairly
21. General Ethical Principles
• These 4 principles are applied to show
how we try to arrive logically at “correct”
decisions when we are faced with ethical
tension and ambiguous situations in public
health research and practice
• There is not always a “right answer”
22. Small group work
Is the Tuskegee Syphilis Study ethical?
Comment from the perspective of the 4
ethical principles
23. Respect for autonomy
• Autonomy has diverse meanings:
– self governance
– Privacy
– individual choice
– freedom of the will
– causing one’s own behavior
– being one’s own person
24. Respect for autonomy cont…
• A person of diminished autonomy is in
some respect controlled by others or
incapable of deliberating or acting on the
basis of his/her desires and plans
• E.g prisoners and mentally retarded
individuals
• Mental incapacitation limits the autonomy
of the retarded person
• Coercive institutionalization constrains the
autonomy of prisoners
25. Respect for autonomy
Moral rules
1. tell the truth
2. respect the privacy of others
3. protect confidential information
4. obtain consent
5. when asked, help others make
important decisions
26. Informed consent
• Process of informed consent consists of:
– transfer of information
– understanding of its significance, followed by
– explicit consent of the person (or responsible proxies)
to take part in the intervention/research
27. Elements (components) of
informed consent
1. competence
2. disclosure
3. understanding
4. voluntariness
5. Consent
In other words,
One gives an informed consent if (and perhaps only if) one:
– is competent to act,
– receives a thorough disclosure,
– comprehends the disclosure,
– acts voluntarily, and
– consents to take part in the research
28. Disclosure
In research disclosures should generally
cover:
• the aims and methods of the research,
• anticipated benefits and risks,
• any anticipated inconvenience or
discomfort, and
• the subject’s right to withdraw, without
penalty, from the research
29. 29
Consent by surrogates cont…
• Parents are considered surrogates for
their minor children
• Spouses for one another
• Adult children for parents when parents
are lacking
• Adult grand children for grand parents
30. Contents of the consent form
The consent form need to include the
following (Sarantakos, 2005)
• Identification of the researcher
• Identification of the sponsoring institution
• Indication of how the participants were selected
• Identification of the purpose of the research
31. Contents cont…
• Identification of the benefits for participating
• Identification of the level and type of participant
involvement
• Notation of risks to the participant
• Guarantee of confidentiality to the participant
• Assurance that the participant can withdraw at
any time
• Provision of names of persons to contact if
questions arise
32. 32
Confidentiality
• Confidentiality is necessary in diagnostic,
therapeutic and research context
• Confidential information is both private and
voluntarily imparted in confidence and
trust
• If research subject authorizes release of
the information to others, then there is no
violation of rights or confidentiality
33. Confidentiality cont..
• Research may involve collecting and storing data
relating to individuals and groups
• such data, if disclosed to third parties, may cause harm
or distress.
• investigators should make arrangements for protecting
the confidentiality of such data by:
– omitting information that might lead to identification of individual
subjects
– limiting access to the data, or by other means.
• When personal identifiers remain on records used for a
study, investigators should explain why this is necessary
and how confidentiality will be protected.
34. Confidentiality cont…
Unlinked information
• Refers to information that can not be
linked, associated or connected with the
person to whom it refers.
• As this person is not known to the
investigator, confidentiality is not at stake
and the question of consent does not
arise.
35. Confidentiality cont…
Linked information may be:
• anonymous – when the information can not be
linked to the person to whom it refers except by
a code or other means known only to that
person, and the investigator can not know the
identity of that person
• non-nominal –when the information can be
linked to the person by a code which is not a
personal identifier and which is known to the
person and the investigator
• nominal or nominative – when the information
is linked to the person by means of personal
identification, usually the name
36. 36
Principle of Non-Maleficence/do no harm
Minimizing harm: considerations
•Careful use of local health resources and respect for local priorities
•Avoid stigmatization, prejudice, economic loss …
•Prepare research staff for special situations
•Propose measures against eminent risks observed during the study
•Avoid harmful publicity
•Respect local social and cultural norms
•Confidentiality
•Disclosure of conflict of interest
37. 37
Principles of beneficence/duty to do good
Is the ethical obligation to maximize benefits and to
minimize harms
the risks of research be reasonable in the light of the
expected benefits
use sound research design, and involve competent
investigators to conduct the research and to safeguard the
welfare of the research subjects
39. 39
Principle of Justice
• Is the ethical obligation to treat each person
in accordance with what is morally right and
proper
• Distributive justice - equitable distribution
of both the burdens and the benefits of
participation in research
•Special provision for the protection of the
rights and welfare of vulnerable persons.
40. Principle of Justice cont…
• Cases considered to be alike should be treated
alike
• Cases considered to be different should be
treated in ways that acknowledge the difference
41. Principle of Justice cont…
• Studies should be designed to obtain knowledge
that benefits the class of persons of which the
subjects are representative
• The class of persons bearing the burden should
receive an appropriate benefit, and
• the class primarily intended to benefit should
bear a fair proportion of the risks and burdens of
the study
42. Small group work
• Suppose you plan to conduct research on
different outcomes of HIV infected individuals
who are on treatment (ART). You preferred
collecting data from records in University of
Gondar Hospital.
• Is this research ethically acceptable? Discuss
from the perspective of the 4 ethical principles.
• If there are any ethical problems how do you
overcome these problems?
43. 43
The World Medical Association
Declaration of Helenski
• Adopted in 1964, amended in 1975, 1983, 1989,
1996, 2000, 2002
Has 32 articles under three Chapters
A. INTRODUCTION
B. BASIC PRINCIPLES FOR ALL MEDICAL
RESEARCH
C. ADDITIONAL PRINCIPLES FOR MEDICAL
RESEARCH COMBINED WITH MEDICAL
CARE
44. 44
A. INTRODUCTION
1. The World Medical Association has developed
the Declaration of Helsinki as statement of
ethical principle to provide guidance to
physicians and other participants in medical
research involving human subjects. Medical
research involving human subjects includes
research on identifiable human material or
identifiable data.
2. It is the duty of the physician to promote and
safeguard the health of the people. The
physician’s knowledge and conscience are
dedicated to the fulfilment of this duty.
45. 45
INTRODUCTION cont…
3. The Declaration of Geneva of the World Medical
Association binds the physician with the worlds,
“The health of my patient will be my first
consideration,” and the International Code of
Medical Ethics declares that, “A physician shall
act only in the patient’s interest when providing
medical care which might have the effect of
weakening the physical and mental condition of
the patient.”
4. Medical progress is based on research which
ultimately must rest in part on experimentation
involving human subjects.
46. 46
INTRODUCTION cont…
5. In medical research on human subjects, considerations
related to the well-being of the human subject should
take precedence over the interests of science and
society.
6. The primary purpose of medical research involving
human subjects is to improve prophylactic, diagnostic
and therapeutic procedures and the understanding of
the aetiology and pathogenesis of disease. Even the
best proven prophylactic, diagnostic, and therapeutic
methods must continuously be challenged through
research for their effectiveness, efficiency, accessibility
and quality.
47. 47
INTRODUCTION cont…
7. In current medical practice and in medical research, most
prophylactic, diagnostic and therapeutic procedures involve risks and
burdens.
8. Medical research is subject to ethical standards that promote respect
for all human beings and protect their health and rights. Some
research populations are vulnerable and need special protection.
The particular needs of the economically and medically
disadvantaged must be recognized. Special attention is also required
for those who cannot give or refuse consent for themselves, for those
who may be subject to giving consent under duress, for those who
will not benefit personally from the research and for those for whom
the research is combined with care.
48. 48
INTRODUCTION cont…
9. Research Investigators should be aware
of the ethical, legal and regulatory
requirements for research on human
subjects in their own countries as well as
applicable international requirements. No
national ethical, legal or regulatory
requirement should be allowed to reduce
or eliminate any of the protections for
human subjects set forth in this
declaration.
49. 49
B. BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH
10. It is the duty of the physician in medical
research to protect the life, health, privacy, and
dignity of the human subject.
11. Medical research involving human subjects
must conform to generally accepted scientific
principles, be based on a thorough knowledge of
the scientific literature, other relevant sources of
information, and on adequate laboratory and,
where appropriate, animal experimentation.
50. 50
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
12. Appropriate caution must be exercised in
the conduct of research which may affect
the environment, and the welfare of
animals used for research must be
respected.
51. 51
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
13. The design and performance of each experimental procedure
involving human subjects should be clearly formulated in an
experimental protocol. This protocol should be submitted for
consideration, comment, guidance, and where appropriate, approval
to a specially appointed ethical review committee, which must be
independent of the investigator, the sponsor or any other kind of
undue influence. This independent committee should be in
conformity with the laws and regulations of the country in which the
research experiment is performed. The committee has the right to
monitor ongoing trials. The researcher has the obligation to provide
monitoring information to the committee, especially any serious
adverse events. The researcher should also submit to the
committee, for review, information regarding funding, sponsors,
institutional affiliations, other potential conflicts of interest and
incentives for subjects.
52. 52
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
14. The research protocol should always contain a
statement of the ethical considerations involved and
should indicate that there is compliance with the
principles enunciated in this Declaration.
15. Medical research involving human subjects should be
conducted only by scientifically qualified persons and
under the supervision of a clinically competent medical
person. The responsibility for the human subject must
always rest with a medically qualified person and never
rest on the subject of the research, even though the
subject has given consent.
53. 53
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
16. Every medical research project involving
human subjects should be preceded by
careful assessment of predictable risks
and burdens in comparison with
foreseeable benefits to the subject or to
others. This does not preclude the
participation of healthy volunteers in
medical research. The design of all studies
should be publicly available.
54. 54
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
17. Physicians should abstain from
engaging in research projects involving
human subjects unless they are confident
that the risks involved have been
adequately assessed and can be
satisfactorily managed. Physicians should
cease any investigation if the risks are
found to outweigh the potential benefits or
if there is conclusive proof of positive and
beneficial results.
55. 55
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
18. Medical research involving human subjects
should only be conducted if the importance of
the objective outweighs the inherent risks and
burdens to the subject. This is especially
important when the human subjects are healthy
volunteers.
19. Medical research is only justified if there is a
reasonable likelihood that the populations in
which the research is carried out stand to benefit
from the results of the research.
56. 56
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
20. The subjects must be volunteers and informed
participants in the research project.
21. The right of research subjects to safeguard
their integrity must always be respected. Every
precaution should be taken to respect the
privacy of the subject, the confidentiality of the
patient’s information and to minimize the impact
of the study on the subject’s physical and mental
integrity and on the personality of the subject.
57. 57
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
22. In any research on human beings, each potential
subject must be adequately informed of the aims,
methods, sources of funding, any possible conflicts of
interest, institutional affiliations of the researcher, the
anticipated benefits and potential risks of the study and
the discomfort it may entail. The subject should be
informed of the right to abstain from participation in the
study or to withdraw consent to participate at any time
without reprisal. After ensuring that the subject has
understood the information, the physician should then
obtain the subject’s freely-given informed consent,
preferably in writing. If the consent can not be obtained in
writing, the non-written consent must be formally
documented and witnessed.
58. 58
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
23. When obtaining informed consent for
the research project the physician should
be particularly cautious if the subject is in
a dependent relationship with the
physician or may consent under duress. In
that case the informed consent should be
obtained by a well-informed physician who
is not engaged in the investigation and
who is completely independent of this
relationship.
59. 59
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
24. For a research subject who is legally
incompetent, physically or mentally incapable of
giving consent or is a legally incompetent minor,
the investigator must obtain informed consent
from the legally authorized representative in
accordance with applicable law. These groups
should not be included in research unless the
research is necessary to promote the health of
the population represented and this research
cannot instead be performed on legally
competent persons.
60. 60
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
25. When a subject deemed legally
incompetent, such as a minor child, is
able to give assent to decisions about
participation in research, the investigator
must obtain that assent in addition to the
consent of the legally authorized
representative.
61. 61
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
26. Research on individuals from who it is not possible to
obtain consent, including proxy or advance consent,
should be done only if the physical/mental condition that
prevents obtaining informed consent is a necessary
characteristic of the research population. The specific
reasons for involving research subjects with a condition
that renders them unable to give informed consent
should be stated in the experimental protocol for
consideration and approval of the review committee. The
protocol should state that consent to remain in the
research should be obtained as soon as possible from
the individual or a legally authorized surrogate.
62. 62
BASIC PRINCIPLES FOR ALL
MEDICAL RESEARCH cont…
27. Both authors and publishers have ethical
obligations. In publication of the results of
research, the investigators are obliged to
preserve the accuracy of the results. Negative
as well as positive results should be published
or otherwise publicly available. Sources of
funding, institutional affiliations and any possible
conflicts of interest should be declared in the
publication. Reports of experimentation not in
accordance with the principles laid down in this
Declaration should not be accepted for
publication.
63. 63
C. ADDITIONAL PRINCIPLES FOR
MEDICAL RESEARCH
COMBINED WITH MEDICAL CARE
28. The physician may combine medical
research with medical care, only to the
extent that the research is justified by its
potential prophylactic, diagnostic or
therapeutic value. When medical research
is combined with medical care, additional
standards apply to protect the patients
who are research subjects.
64. 64
ADDITIONAL PRINCIPLES FOR MEDICAL
RESEARCH
COMBINED WITH MEDICAL CARE
cont…
29. The benefits, risks, burdens and
effectiveness of a new method should be
tested against those of the best current
prophylactic, diagnostic, and therapeutic
methods. This does not exclude the use of
placebo, or no treatment, in studies where
no proven prophylactic, diagnostic or
therapeutic method exists. (See footnote*)
65. 65
ADDITIONAL PRINCIPLES FOR MEDICAL
RESEARCH
COMBINED WITH MEDICAL CARE cont…
30. At the conclusion of the study, every patient
entered into the study should be assured of
access to the best proven prophylactic,
diagnostic and therapeutic methods identified by
the study.
31. The physician should fully inform the patient
which aspects of the care are related to the
research. The refusal of a patient to participate
in a study must never interfere with the patient-
physician relationship.
66. 66
C. ADDITIONAL PRINCIPLES FOR MEDICAL
RESEARCH
COMBINED WITH MEDICAL CARE cont…
32. In the treatment of a patient, where proven
prophylactic, diagnostic and therapeutic methods do not
exist or have been ineffective, the physician, with
informed consent from the patient, must be free to use
unproven or new prophylactic, diagnostic and
therapeutic measures, if in the physician’s judgement it
offers hope of saving life, re-establishing health or
alleviating suffering. Where possible, these measures
should be made the object of research, designed to
evaluate their safety and efficacy. In all cases, new
information should be recorded and, where appropriate,
published. The other relevant guidelines of this
Declaration should be followed.
67. 67
ADDITIONAL PRINCIPLES FOR
MEDICAL RESEARCH
COMBINED WITH MEDICAL
CARE cont…
*FOOTNOTE:
Note of Clarification on Paragraph 29 of the WMA Declaration of
Helsinki
• The WMA hereby reaffirms its position that extreme care must be
taken in making use of a placebo-controlled trial and that in general
this methodology should only be used in the absence of existing
proven therapy. However, a placebo-controlled trial may be ethically
acceptable, even if proven therapy is available, under the following
circumstances:
• Where for compelling and scientifically sound methodological
reasons its use is necessary to determine the efficacy or safety of a
prophylactic, diagnostic or therapeutic method; or
• Where a prophylactic, diagnostic or therapeutic method is being
investigated for a minor conditions and the patients who receive
placebo will not be subject to any additional risk of serious or
irreversible harm
• All other provisions of the Declaration of Helsinki must be adhered to,
especially the need for appropriate ethical and scientific review.