This presentation discusses the intersection of social media and human subjects research regulations. It provides an overview of the scope and requirements of HHS regulations for protecting human subjects. It then examines how these regulations apply to using social media for subject recruitment and as a research tool, as well as conducting research on social media. Key issues addressed include informed consent, privacy/confidentiality, risks/benefits, and challenges for IRBs in evaluating this type of research.
The document outlines the history and basic principles of the Declaration of Helsinki, which provides ethical guidelines for medical research involving human subjects. It discusses how the Declaration was first adopted in 1964 and has since undergone revisions to regulate research. The key principles outlined include protecting subjects' lives, health, dignity and privacy, ensuring proper scientific conduct and qualifications of researchers, registering clinical trials, obtaining consent, and assessing risks and benefits to populations involved in research.
The Belmont Report summarizes the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It discusses three principles that should guide research with human subjects: respect for persons, beneficence, and justice. The report was created to identify ethical standards for research and outline how risks and benefits, informed consent, and subject selection should be handled.
Declaration of helsinki powerpoint presentationPoojaGupta767
The document summarizes the history and key principles of the Declaration of Helsinki, which establishes ethical guidelines for medical research involving human subjects. It originated in 1964 and has undergone several revisions. The Declaration's goals are to protect research participants and ensure research is justified. Some key principles are that research must have scientific merit and potential benefits outweigh risks, participants must provide informed consent, and special protections apply to biomedical research combined with patient care.
The declaration of helsinki by akshdeep sharmaAkshdeep Sharma
This document summarizes the Declaration of Helsinki, which outlines ethical principles for medical research involving human subjects. It was originally adopted in 1964 and has been amended multiple times, most recently in 2013. The declaration addresses the duties of physicians to protect research participants and ensure their well-being and rights. It also discusses informed consent, risk/benefit assessments, vulnerable groups, and compensation in case of injury. The overall purpose is to promote ethical research that respects the health, dignity and self-determination of all human subjects.
The document summarizes The Belmont Report, which established ethical principles for protecting human subjects in research. It was created in 1979 by a commission in response to unethical human subject research studies. The Belmont Report outlines three basic ethical principles - respect for persons, beneficence, and justice. It also distinguishes between research and practice, and provides guidelines for informed consent, risk-benefit assessments, and subject selection to help apply these principles. While not formally adopted, The Belmont Report has become the primary framework for research ethics in the United States.
The Declaration of Helsinki was created in 1964 by the World Medical Association to establish ethical guidelines for human experimentation. It has since been revised six times to address issues like placebo use and how researchers should treat patients after trials. While not legally binding, the Declaration has significantly influenced other medical standards and guidelines. It aims to protect the rights, safety, and well-being of human subjects in medical research by requiring voluntary and informed consent as well as oversight by independent ethics committees.
This document discusses several topics related to research methodology and biostatistics including cultural concerns, truth-telling, online business practices, and control resolution. Cultural concerns involve understanding a patient's culture, language, beliefs, and removing barriers to equal participation. Truth-telling focuses on honesty with patients about diagnoses and errors while balancing autonomy and mental stability. Online business practices emphasize making medical practices mobile-friendly and directly connecting patients to providers through online booking and medical centers. Control resolution ensures ethical considerations in hospitals through effective accreditation addressing integrity, interests, research, and organ ethics.
The document outlines the history and basic principles of the Declaration of Helsinki, which provides ethical guidelines for medical research involving human subjects. It discusses how the Declaration was first adopted in 1964 and has since undergone revisions to regulate research. The key principles outlined include protecting subjects' lives, health, dignity and privacy, ensuring proper scientific conduct and qualifications of researchers, registering clinical trials, obtaining consent, and assessing risks and benefits to populations involved in research.
The Belmont Report summarizes the basic ethical principles identified by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. It discusses three principles that should guide research with human subjects: respect for persons, beneficence, and justice. The report was created to identify ethical standards for research and outline how risks and benefits, informed consent, and subject selection should be handled.
Declaration of helsinki powerpoint presentationPoojaGupta767
The document summarizes the history and key principles of the Declaration of Helsinki, which establishes ethical guidelines for medical research involving human subjects. It originated in 1964 and has undergone several revisions. The Declaration's goals are to protect research participants and ensure research is justified. Some key principles are that research must have scientific merit and potential benefits outweigh risks, participants must provide informed consent, and special protections apply to biomedical research combined with patient care.
The declaration of helsinki by akshdeep sharmaAkshdeep Sharma
This document summarizes the Declaration of Helsinki, which outlines ethical principles for medical research involving human subjects. It was originally adopted in 1964 and has been amended multiple times, most recently in 2013. The declaration addresses the duties of physicians to protect research participants and ensure their well-being and rights. It also discusses informed consent, risk/benefit assessments, vulnerable groups, and compensation in case of injury. The overall purpose is to promote ethical research that respects the health, dignity and self-determination of all human subjects.
The document summarizes The Belmont Report, which established ethical principles for protecting human subjects in research. It was created in 1979 by a commission in response to unethical human subject research studies. The Belmont Report outlines three basic ethical principles - respect for persons, beneficence, and justice. It also distinguishes between research and practice, and provides guidelines for informed consent, risk-benefit assessments, and subject selection to help apply these principles. While not formally adopted, The Belmont Report has become the primary framework for research ethics in the United States.
The Declaration of Helsinki was created in 1964 by the World Medical Association to establish ethical guidelines for human experimentation. It has since been revised six times to address issues like placebo use and how researchers should treat patients after trials. While not legally binding, the Declaration has significantly influenced other medical standards and guidelines. It aims to protect the rights, safety, and well-being of human subjects in medical research by requiring voluntary and informed consent as well as oversight by independent ethics committees.
This document discusses several topics related to research methodology and biostatistics including cultural concerns, truth-telling, online business practices, and control resolution. Cultural concerns involve understanding a patient's culture, language, beliefs, and removing barriers to equal participation. Truth-telling focuses on honesty with patients about diagnoses and errors while balancing autonomy and mental stability. Online business practices emphasize making medical practices mobile-friendly and directly connecting patients to providers through online booking and medical centers. Control resolution ensures ethical considerations in hospitals through effective accreditation addressing integrity, interests, research, and organ ethics.
There are two types of research in terms of the nature and purpose of the study, namely, (1) basic or fundamental research and (2) applied research.
Basic and applied research are further divided into three types of research in terms of methods, namely, 1) quantitative research, 2) qualitative research, and 3) mixed research method.
Basic introduction to clinical trials and the placebo effect. Definitions, examples and cartoons illustrating the subject. Ends with short info on informed consent.
This document discusses placebos, including their definition, history, mechanisms, clinical utility, individual variation, symptoms/conditions treated, and use in research. Key points include:
- A placebo is an inert substance or procedure used in clinical research trials and practice to compare against actual medical treatments.
- The placebo effect is a therapeutic improvement in a patient from an inert substance due to psychological factors like expectations and conditioning.
- Placebos can activate areas of the brain related to expectations and the release of endorphins, helping to relieve symptoms.
- While placebo effects can last for months in some cases, their clinical significance is considered small and hard to distinguish from reporting bias alone. Placebos are not recommended
Principles of essentiality
Principles of voluntariness, informed consent and community agreement
Principles of non-exploitation
Principles of privacy and confidentiality
Principles of precaution and risk minimisation
Principles of professional competence
Principles of accountability and transparency
RESEARCH METHODOLOGY
- INTRODUCTION
- OBJECTIVE
- TYPES OF RESEARCH
- RESEARCH PROCESS
- RESEARCH PROBLEM
- BROAD LITERATURE SURVEY
- HYPOTHESIS FORMULATION
- RESEARCH DESIGN
- SAMPLING
- COLLECTION OF DATA
- ANALYSIS OF DATA
- HYPOTHESIS TESTING
- PREPARATION OF REPORT
- CRITERIA OF GOOD RESEARCH
- PROBLEM ENCOUNTERED BY RESEARCHER IN INDIA
- REFERENCES
The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed by the World Medical Association. It has undergone several revisions since its adoption in 1964 to address developments in research ethics. While not legally binding, it is considered an important document for guiding ethical medical research. The US FDA abandoned following the Declaration in favor of other guidelines, sparking debate around its continued relevance and whether differing international standards could result in ethical hypocrisy.
The Belmont Report (Three Benchmark Rules)ClinosolIndia
The Belmont Report, published in 1979, is a seminal document in the field of research ethics. It was developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in response to unethical research practices, particularly the infamous Tuskegee Syphilis Study. The report sets forth three fundamental ethical principles, often referred to as the "Three Benchmark Rules," that guide the ethical conduct of research involving human subjects. These principles are:
Respect for Persons:
The principle of respect for persons emphasizes the autonomy and dignity of individuals. It requires that individuals be treated as autonomous agents capable of making informed decisions about their participation in research. Researchers must obtain informed consent from potential subjects and provide them with all relevant information regarding the purpose, risks, benefits, and alternatives of the study. Special provisions must be made for individuals with diminished autonomy, such as children or those with cognitive impairments, to ensure their rights and welfare are protected.
Beneficence:
The principle of beneficence emphasizes the obligation to maximize benefits and minimize harm to research subjects. Researchers must ensure that the potential benefits of the study outweigh the potential risks. They should conduct a thorough risk-benefit analysis and design their studies to maximize potential benefits while minimizing any potential harm or discomfort to participants. Additionally, researchers must make ongoing assessments of the risks and benefits throughout the course of the study and take necessary steps to minimize harm and maximize benefits.
Justice:
The principle of justice requires the fair distribution of the burdens and benefits of research. It emphasizes the need for equal access to participation in research, regardless of factors such as race, gender, socioeconomic status, or other characteristics. Researchers must ensure that the selection of research subjects is fair and avoid exploiting vulnerable populations. Additionally, the benefits derived from research should be distributed equitably, ensuring that the burdens of research are not borne solely by disadvantaged groups while the benefits accrue to others.
These Three Benchmark Rules provided in the Belmont Report serve as the foundation for modern ethical guidelines and regulations governing research involving human subjects. They have significantly influenced the development of ethical review boards and informed consent processes, ensuring the protection of individuals' rights and well-being in research studies.
This document provides an overview of research methodology, including definitions of key terms, the need for research, research objectives, requirements, and types of research. It discusses qualitative and quantitative research approaches. Qualitative research deals with non-quantifiable conditions and is exploratory, while quantitative research defines empirical investigations using statistical techniques with large sample sizes. The document also covers reviewing literature to understand the background and avoid duplication, and identifies various sources for literature reviews.
This document discusses English semantics and propositional content. It defines a proposition as the meaning of a sentence that can be true or false. Propositions involve predicate-argument structure and can be represented notationally. Arguments refer to roles in a proposition and can be realized by referring expressions. Predicates provide specific information about the arguments. The relationship between entities as arguments and events as predicates is known as predication. Various semantic roles of arguments are identified, including agent, patient, and instrument. Propositions can be represented notationally in different ways, such as using capital letters for predicates and lowercase letters for arguments.
The Declaration of Helsinki is a set of ethical principles and guidelines for medical research involving human subjects. It was first adopted by the World Medical Association (WMA) in 1964 and has been revised multiple times, with the most recent version released in 2013. The Declaration provides a framework to protect the rights, safety, and well-being of individuals participating in research studies. Here are the key elements of the Declaration of Helsinki:
Respect for Autonomy and Informed Consent: The Declaration emphasizes the importance of respecting the autonomy of individuals and their right to make informed decisions about participating in research. It requires researchers to obtain informed consent from participants or their legally authorized representatives, ensuring they have been adequately informed about the study's purpose, procedures, potential risks and benefits, and their right to withdraw at any time.
Beneficence and Risk Assessment: Researchers have a responsibility to maximize potential benefits and minimize potential harm to research participants. The Declaration states that research protocols should be based on a thorough scientific assessment of risks and benefits and should prioritize the well-being of participants.
Ethical Review and Approval: The Declaration highlights the necessity of independent ethical review of research protocols by an appropriate research ethics committee or institutional review board (IRB). The committee should ensure that the study is scientifically valid, ethically sound, and compliant with relevant regulations and guidelines.
Privacy and Confidentiality: The Declaration emphasizes the importance of protecting the privacy and confidentiality of research participants. Researchers should ensure that participants' personal information is kept confidential, and data should be anonymized or pseudonymized whenever possible to protect participant identities.
Data and Safety Monitoring: The Declaration emphasizes the importance of ongoing data monitoring and safety assessments during the research study. Researchers should have plans in place to detect and manage any adverse events or unanticipated risks that may arise during the study.
Vulnerable Populations: Special protections are outlined for vulnerable populations, such as children, pregnant women, prisoners, and individuals with impaired decision-making capacity. Researchers should take extra precautions to ensure their well-being, and their involvement in research should be justified based on the potential benefits to their own population.
Publication and Dissemination of Results: The Declaration emphasizes the responsibility of researchers to publish and share the results of their research in a timely manner. The results should be accurately reported, and negative or inconclusive results should also be disseminated to prevent publication bias.
Hippocrates was a Greek physician born around 460 BC on the island of Cos. He is considered the father of modern medicine. The Hippocratic Oath is believed to be the earliest expression of medical ethics and is still used today by physicians. The original oath called on Apollo and other gods as witnesses and included promises to teach medicine, help the sick, avoid harming patients, keep patient information private, and more. A modern version updated the language while keeping similar ethical principles of caring for patients and doing no harm. Breaking the oath was taken seriously in ancient times and could mean losing the right to practice medicine, while today it may result in malpractice penalties.
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.
The document discusses the role of placebos in clinical trials. It defines placebos as inert substances with no therapeutic value used as dummy medicines. Placebos are used in clinical trials to compare effects to active drugs and exclude placebo responders. The placebo effect is psychological and based on expectations. Mechanisms involve neurobiological and psychological factors. Guidelines state placebos can only be used when no alternative exists and risks are justified, with informed consent and risk monitoring. A placebo washout period terminates prior drug effects to observe the trial drug's effects. Problems include imperfect placebos, impure placebos, selection bias, and overestimating placebo effects.
This document discusses euthanasia, including its history, types, legality in different places, and religious views. It defines euthanasia as intentionally ending a life to relieve suffering and outlines types like passive vs. active and voluntary vs. involuntary. The document also summarizes several notable euthanasia cases and concludes by stating that while most religions oppose euthanasia, views vary significantly in different faiths and countries have different laws regarding its legalization.
Clinical studies can be either observational studies or interventional studies (clinical trials). Observational studies assess outcomes without assigning interventions, while interventional studies compare interventions. Common study designs include cohort studies (longitudinal studies following groups over time), case-control studies (comparing cases and controls), and randomized controlled trials (RCTs; experimental studies randomly assigning interventions). RCTs can be single, double, or triple blind to reduce bias.
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.
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.
Presentation exploring the development of clinical trial registries and clinical trial results databases and their impact on the clinical study industry, including their challenges and the potential for creating new forms of liability.
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.
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 outlines a plan for urban renewal and integrated transportation in Fort Collins, Colorado. The plan aims to reduce sprawl, increase density, improve environmental quality, and enhance community. Key elements include re-zoning areas for mixed-use development, establishing urban renewal districts, and integrating public school buses with the city transit system. The goals are to concentrate development, preserve open space, and provide more efficient transportation options. Benefits cited include reduced emissions, improved mobility, economic development, and enhanced quality of life. Challenges include restrictions on growth and potential increases in population density.
As a real estate developer in Israel, the main focus of GlobaLinks Urban Renewal is based on developing and executing projects under ‘Tama 38’, a government-supported national real estate program.
There are two types of research in terms of the nature and purpose of the study, namely, (1) basic or fundamental research and (2) applied research.
Basic and applied research are further divided into three types of research in terms of methods, namely, 1) quantitative research, 2) qualitative research, and 3) mixed research method.
Basic introduction to clinical trials and the placebo effect. Definitions, examples and cartoons illustrating the subject. Ends with short info on informed consent.
This document discusses placebos, including their definition, history, mechanisms, clinical utility, individual variation, symptoms/conditions treated, and use in research. Key points include:
- A placebo is an inert substance or procedure used in clinical research trials and practice to compare against actual medical treatments.
- The placebo effect is a therapeutic improvement in a patient from an inert substance due to psychological factors like expectations and conditioning.
- Placebos can activate areas of the brain related to expectations and the release of endorphins, helping to relieve symptoms.
- While placebo effects can last for months in some cases, their clinical significance is considered small and hard to distinguish from reporting bias alone. Placebos are not recommended
Principles of essentiality
Principles of voluntariness, informed consent and community agreement
Principles of non-exploitation
Principles of privacy and confidentiality
Principles of precaution and risk minimisation
Principles of professional competence
Principles of accountability and transparency
RESEARCH METHODOLOGY
- INTRODUCTION
- OBJECTIVE
- TYPES OF RESEARCH
- RESEARCH PROCESS
- RESEARCH PROBLEM
- BROAD LITERATURE SURVEY
- HYPOTHESIS FORMULATION
- RESEARCH DESIGN
- SAMPLING
- COLLECTION OF DATA
- ANALYSIS OF DATA
- HYPOTHESIS TESTING
- PREPARATION OF REPORT
- CRITERIA OF GOOD RESEARCH
- PROBLEM ENCOUNTERED BY RESEARCHER IN INDIA
- REFERENCES
The Declaration of Helsinki is a set of ethical principles regarding human experimentation developed by the World Medical Association. It has undergone several revisions since its adoption in 1964 to address developments in research ethics. While not legally binding, it is considered an important document for guiding ethical medical research. The US FDA abandoned following the Declaration in favor of other guidelines, sparking debate around its continued relevance and whether differing international standards could result in ethical hypocrisy.
The Belmont Report (Three Benchmark Rules)ClinosolIndia
The Belmont Report, published in 1979, is a seminal document in the field of research ethics. It was developed by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in response to unethical research practices, particularly the infamous Tuskegee Syphilis Study. The report sets forth three fundamental ethical principles, often referred to as the "Three Benchmark Rules," that guide the ethical conduct of research involving human subjects. These principles are:
Respect for Persons:
The principle of respect for persons emphasizes the autonomy and dignity of individuals. It requires that individuals be treated as autonomous agents capable of making informed decisions about their participation in research. Researchers must obtain informed consent from potential subjects and provide them with all relevant information regarding the purpose, risks, benefits, and alternatives of the study. Special provisions must be made for individuals with diminished autonomy, such as children or those with cognitive impairments, to ensure their rights and welfare are protected.
Beneficence:
The principle of beneficence emphasizes the obligation to maximize benefits and minimize harm to research subjects. Researchers must ensure that the potential benefits of the study outweigh the potential risks. They should conduct a thorough risk-benefit analysis and design their studies to maximize potential benefits while minimizing any potential harm or discomfort to participants. Additionally, researchers must make ongoing assessments of the risks and benefits throughout the course of the study and take necessary steps to minimize harm and maximize benefits.
Justice:
The principle of justice requires the fair distribution of the burdens and benefits of research. It emphasizes the need for equal access to participation in research, regardless of factors such as race, gender, socioeconomic status, or other characteristics. Researchers must ensure that the selection of research subjects is fair and avoid exploiting vulnerable populations. Additionally, the benefits derived from research should be distributed equitably, ensuring that the burdens of research are not borne solely by disadvantaged groups while the benefits accrue to others.
These Three Benchmark Rules provided in the Belmont Report serve as the foundation for modern ethical guidelines and regulations governing research involving human subjects. They have significantly influenced the development of ethical review boards and informed consent processes, ensuring the protection of individuals' rights and well-being in research studies.
This document provides an overview of research methodology, including definitions of key terms, the need for research, research objectives, requirements, and types of research. It discusses qualitative and quantitative research approaches. Qualitative research deals with non-quantifiable conditions and is exploratory, while quantitative research defines empirical investigations using statistical techniques with large sample sizes. The document also covers reviewing literature to understand the background and avoid duplication, and identifies various sources for literature reviews.
This document discusses English semantics and propositional content. It defines a proposition as the meaning of a sentence that can be true or false. Propositions involve predicate-argument structure and can be represented notationally. Arguments refer to roles in a proposition and can be realized by referring expressions. Predicates provide specific information about the arguments. The relationship between entities as arguments and events as predicates is known as predication. Various semantic roles of arguments are identified, including agent, patient, and instrument. Propositions can be represented notationally in different ways, such as using capital letters for predicates and lowercase letters for arguments.
The Declaration of Helsinki is a set of ethical principles and guidelines for medical research involving human subjects. It was first adopted by the World Medical Association (WMA) in 1964 and has been revised multiple times, with the most recent version released in 2013. The Declaration provides a framework to protect the rights, safety, and well-being of individuals participating in research studies. Here are the key elements of the Declaration of Helsinki:
Respect for Autonomy and Informed Consent: The Declaration emphasizes the importance of respecting the autonomy of individuals and their right to make informed decisions about participating in research. It requires researchers to obtain informed consent from participants or their legally authorized representatives, ensuring they have been adequately informed about the study's purpose, procedures, potential risks and benefits, and their right to withdraw at any time.
Beneficence and Risk Assessment: Researchers have a responsibility to maximize potential benefits and minimize potential harm to research participants. The Declaration states that research protocols should be based on a thorough scientific assessment of risks and benefits and should prioritize the well-being of participants.
Ethical Review and Approval: The Declaration highlights the necessity of independent ethical review of research protocols by an appropriate research ethics committee or institutional review board (IRB). The committee should ensure that the study is scientifically valid, ethically sound, and compliant with relevant regulations and guidelines.
Privacy and Confidentiality: The Declaration emphasizes the importance of protecting the privacy and confidentiality of research participants. Researchers should ensure that participants' personal information is kept confidential, and data should be anonymized or pseudonymized whenever possible to protect participant identities.
Data and Safety Monitoring: The Declaration emphasizes the importance of ongoing data monitoring and safety assessments during the research study. Researchers should have plans in place to detect and manage any adverse events or unanticipated risks that may arise during the study.
Vulnerable Populations: Special protections are outlined for vulnerable populations, such as children, pregnant women, prisoners, and individuals with impaired decision-making capacity. Researchers should take extra precautions to ensure their well-being, and their involvement in research should be justified based on the potential benefits to their own population.
Publication and Dissemination of Results: The Declaration emphasizes the responsibility of researchers to publish and share the results of their research in a timely manner. The results should be accurately reported, and negative or inconclusive results should also be disseminated to prevent publication bias.
Hippocrates was a Greek physician born around 460 BC on the island of Cos. He is considered the father of modern medicine. The Hippocratic Oath is believed to be the earliest expression of medical ethics and is still used today by physicians. The original oath called on Apollo and other gods as witnesses and included promises to teach medicine, help the sick, avoid harming patients, keep patient information private, and more. A modern version updated the language while keeping similar ethical principles of caring for patients and doing no harm. Breaking the oath was taken seriously in ancient times and could mean losing the right to practice medicine, while today it may result in malpractice penalties.
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.
The document discusses the role of placebos in clinical trials. It defines placebos as inert substances with no therapeutic value used as dummy medicines. Placebos are used in clinical trials to compare effects to active drugs and exclude placebo responders. The placebo effect is psychological and based on expectations. Mechanisms involve neurobiological and psychological factors. Guidelines state placebos can only be used when no alternative exists and risks are justified, with informed consent and risk monitoring. A placebo washout period terminates prior drug effects to observe the trial drug's effects. Problems include imperfect placebos, impure placebos, selection bias, and overestimating placebo effects.
This document discusses euthanasia, including its history, types, legality in different places, and religious views. It defines euthanasia as intentionally ending a life to relieve suffering and outlines types like passive vs. active and voluntary vs. involuntary. The document also summarizes several notable euthanasia cases and concludes by stating that while most religions oppose euthanasia, views vary significantly in different faiths and countries have different laws regarding its legalization.
Clinical studies can be either observational studies or interventional studies (clinical trials). Observational studies assess outcomes without assigning interventions, while interventional studies compare interventions. Common study designs include cohort studies (longitudinal studies following groups over time), case-control studies (comparing cases and controls), and randomized controlled trials (RCTs; experimental studies randomly assigning interventions). RCTs can be single, double, or triple blind to reduce bias.
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.
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.
Presentation exploring the development of clinical trial registries and clinical trial results databases and their impact on the clinical study industry, including their challenges and the potential for creating new forms of liability.
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.
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 outlines a plan for urban renewal and integrated transportation in Fort Collins, Colorado. The plan aims to reduce sprawl, increase density, improve environmental quality, and enhance community. Key elements include re-zoning areas for mixed-use development, establishing urban renewal districts, and integrating public school buses with the city transit system. The goals are to concentrate development, preserve open space, and provide more efficient transportation options. Benefits cited include reduced emissions, improved mobility, economic development, and enhanced quality of life. Challenges include restrictions on growth and potential increases in population density.
As a real estate developer in Israel, the main focus of GlobaLinks Urban Renewal is based on developing and executing projects under ‘Tama 38’, a government-supported national real estate program.
How to Develop your Career In Project Management - Strategies, Tactics and To...Nicos Kourounakis
How to Develop your Career In Project Management - Strategies, Tactics and Tools.
Is becoming better at what you do bringing you any closer to what you want to be?
What do I want to be? What do I want to do? Where do I start and what's next?
How do I get there? What's the process? What tools can I use to help me?
Why would anyone want a Career?
One should formulate their own honest definition of success based on their own beliefs, values, wants, capabilities and capacity. A space we would like to live in. An internal perspective and a “reflected” perspective. The value of this space (of success) is subjective. The defined space of success is multidimensional: professional, spiritual, social, financial, and dimensions related to health, family, physical appearance, etc.
Use your Effective Intelligence: Your ability to use your natural and developed capabilities effectively in order to achieve "success".
Effective Intelligence is demonstrated by:
Defining (and continuously refining and evolving) your own honest definition of success.
Acknowledging the multidimensionality of success and the need for trade-offs and productive compromises.
Exhibiting productive self-awareness.
Understanding your constraints and capacity limitations.
Understanding the physics (laws) of the systems you interact with.
Defining a plan on how to achieve success (translate your honest definition of success into goals and actions).
Optimizing (continuously) your plan - finding your Personal Efficient Frontier.
Developing and aligning values, beliefs, mindsets, attitudes, capabilities and goals.
Managing effectively the dynamic nature of life.
Balancing the contribution of both goals and journey.
Learning from the challenges while enjoying the journey.
The more you achieve or the more capable you are, the more is expected from you.
Urban Renewal in Lyon Confluence How to transform an unused industrial area to the new eco-quarter? Zoltán Gábor Virányi VIA University College 2010 November
Urban conservation provides cultural and economic benefits. Culturally, it preserves historic architecture, streetscapes, and sites that give cities a unique identity and sense of place. Economically, conserving urban heritage increases income opportunities from tourism as well as making cities more livable and competitive. Improving conservation and management of historic assets in cities generates civic pride while attracting investment and spending from tourists, thereby boosting local economies.
This document identifies a site in Matara, Sri Lanka for urban regeneration. The site consists of a shopping complex owned by the Matara Municipal Council with 129 shops, but only 28 are currently functioning. It also includes the Star Fort, which has lost its original context, and a general hospital. These three separate functions currently disturb and fail each other, leading to an overall failure of the site area. Urban decline in the area is evidenced by out migration, a drop in economic activities and land values, and increased unemployment and social unrest. The document performs an analysis of the context and current issues of the site to determine why regeneration is needed.
The document discusses urban regeneration as a tool for housing delivery in Nigeria. It outlines the concepts and types of regeneration, challenges of housing delivery in Nigeria including issues with land, finance, and previous housing policies. It provides examples of urban renewal programs in Lagos, challenges they face, and examples of regeneration programs in other countries. Regeneration can help address poverty, unemployment, infrastructure issues, and improve communities when implemented as a coordinated long-term economic, social and environmental intervention.
We find urban renewal projects to be both fascinating and inspirational. They showcase amazing creativity and reviltalise neglected neighbourhoods, underused waterfronts or even entire cities. Here’s a list of 20, about half of which are just getting started.
The document discusses examples of urban planning projects in Curitiba, Brazil, Martin Place in Sydney, Australia, and Cheonggyecheon Stream in Seoul, South Korea before and after redevelopment. It notes that Cheonggyecheon Stream was once heavily polluted and traffic-clogged but was transformed by removing an elevated highway, restoring the stream, adding pedestrian and cycling infrastructure, and creating new public green spaces. Criteria for great streets are also listed, emphasizing accessibility, safety, participation, memorability, and representation of community identity.
Development and Engagement in the Age of Social Media Paul Brown
Originally presented to the professional staff at the University of Dayton in January of 2016. Reviews aspects of college student development online and how to engage college students.
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April Heyward Research Methods Class Session - 7-22-2021
The Intersection of Social Media and Human Subjects Research
1. The Intersection of Social Media
and Human Subjects Research
Laura Odwazny
Department of Health and Human Services
Office of the General Counsel
May 4, 2010
This presentation does not constitute legal advice. The views expressed are the presenter’s
own, and do not bind the U.S. Department of Health and Human Services or its
components.
2. Topics
Scope of HHS protection of human subjects
regulations
Application of regulations to the use of social
media in human subjects research
Application of regulations to human subjects
research on social media
4. HHS protection of human subjects
regulations
45
CFR part 46 – HHS Protection of
Human Research Subjects
Subpart A is the Federal Policy for the Protection
of Human Subjects – “Common Rule” (1991)
Applies to 17 Federal Departments and
Agencies
Subparts B (pregnant women, fetuses and
neonates), C (prisoners), D (children), E (IRB
registration)
5. Regulatory requirements
3 basic requirements:
Assurance of compliance
Federalwide Assurance (FWA)
Institutional review board (IRB) review of
research
Informed consent
6. Scope of regulations
HHS-conducted or -supported human
subjects research
Human subjects research covered by an
applicable assurance of compliance (FWA)
If research institution chooses to extend FWA to
all research regardless of funding source, includes
privately funded research
7. Criteria for IRB approval of research
Determinations at 45 CFR 46.111
risks minimized
risk/benefit ratio reasonable
subject selection equitable
informed consent
data monitored
privacy and confidentiality
Determinations under subparts
If research involves pregnant women/fetuses, children,
prisoners
9. Subject recruitment
OHRP considers subject recruitment part of
informed consent
Recruitment plan must receive IRB review/
approval prior to initiation
10. Social media as recruitment tool
Twitter app from TrialX (3/20/09)
Sample tweet: @trialx CT studies for
diabetes male 45 in new york
Stated benefits:
use of Twitter
tweets are public -- others can learn
about research by looking at searches,
which could potentially increase
awareness of trials and participation.
11. Social media as recruitment tool (2)
Blog post from founder of Inspire.com (3/11/09):
I'm writing today to let you know about some new features we're
introducing related to clinical trials…This community was founded with
the promise that you are in control of your own privacy. We will never
provide personal information about you to another party without your
express permission.
What's new is that from time to time we'll tell you about clinical trials in
which you may be interested in participating. If you're not interested in
participating, simply do nothing. If you do think you might be interested,
we'll provide a link where you'll be able to read about a trial, decide if you
are interested in participating, and fill out a short survey to see if you
may qualify. If it appears that you may qualify, we'll put you in touch with
the physicians conducting the trial so that you can learn more and find
out if you do qualify.
12. Subject recruitment (2)
OHRP guidance on IRB review of clinical trial
websites http://www.hhs.gov/ohrp/policy/
clinicaltrials.html
No IRB review needed for descriptive information:
study title
purpose of the study
protocol summary
basic eligibility criteria
study site location(s), and
how to contact the study site for further information.
13. Subject recruitment (3)
IRB review needed if additional information is
provided
Description of research risks/potential benefits
Solicitation of identifiable private information (e.g.
eligibility survey)
Incentives – monetary and non-monetary
What needs to be reviewed:
Recruitment plan, not the actual webpage
14. Use of social media vs. traditional
recruitment tools
Uncontrolled following discussion among
viewers/bloggers
Interactive, not static
Subsequent posts may in effect modify
posted information
Must PI/IRB actively monitor social media
sites used for recruitment?
15. Subject networking
A PI for a longitudinal study of a chronic
disease wants to establish a Facebook page
for study subjects to facilitate communication
between participating families.
Confidentiality of participation?
Privacy settings for FB?
IRB understanding of FB operations?
Monitoring? Regulatory considerations?
Impact on subject retention or validity of data?
16. Social media as a research tool
Using social media to evaluate effective
methods of communication regarding
consent, participation, and return of results
May be new research study that needs IRB
review/approval if private identifiable information is
obtained for research purposes
Same considerations as research involving mining
social media for information (see slides below)
17. Return of study results
Return of study results to subjects through
social media vs. through publishing data
analysis in peer-reviewed journal
Validity of conclusions – eliminates extra layer of
protection peer review provides
19. Research on social media
Research studying the impact of social media
on x
Research mining information from social
media sites/archived posts
Research using social media to interact with
subjects
20. Data mining of social media sites:
is it “human subjects” research?
Human subject – living individual about whom
investigator obtains (1) data through intervention or
interaction, or (2) identifiable private information (45
CFR 46.102(f))
Private information – includes information about behavior
that occurs in a context in which individual can reasonably
expect that no observation or recording is occurring, and
information provided for specific purposes which the
individual can reasonably expect will not be made public
Is information on a Facebook page private? How
about a tweet? How about chat room discussions?
21. Research using social media to
interact with subjects
Initial question: does it involve ‘human
subjects’?
May be exempt, under 45 CFR 46.102(b)(2),
as survey or interview research, unless:
information is recorded in a manner whereby
subjects can be identified AND disclosure of
the responses could reasonably place them
at risk of criminal or civil liability or be
damaging to the subjects’ financial standing,
employability, or reputation.
22. IRB approval of research -- again
Determinations at 45 CFR 46.111
risks minimized
risk/benefit ratio reasonable
subject selection equitable
informed consent
data monitored
privacy and confidentiality
23. Challenges for IRBs in applying
criteria to research involving social media
Maximize benefits and minimize harm
Data sampling techniques
Validity and reliability of data collected
How to debrief and follow up to assess benefits or
harms?
Fair, equitable and appropriate treatment… how do you
know?
Anonymity and use of pseudonyms in cyberspace
Constant flux of identities and number of members
Economic and social disparity in internet access and
usage
24. Challenges for IRBs in applying
criteria to research involving social media (2)
Informed Consent- how do you get it,
ensure it, validate it?
Privacy/Confidentiality- how to secure data
and identity?
Minors- how do you know?
Vulnerable Populations- assessment of
understanding/capacity? Additional
protections?
25. Research involving social media
Research involving social media presents
new considerations vis a vis the traditional
IRB issues of:
Risk/Benefit
Consent
Research With Children
Security Issues
26. Research involving social media (2)
Risks-- Two main sources of harm:
participation in the research
No direct contact with subjects
Can’t deal with individual reactions
(intervention or debriefing)
breach of confidentiality
Primary source of harm in most internet
research
27. Research involving social media (3)
Benefits (?):
Conducting research on the Internet raises concerns
about the reliability and validity of the data
skewed subject populations
ease with which subjects can mislead investigators
difficulty in preventing multiple submissions
Invalid research can have no benefit
inappropriate when there is risk to subjects
28. Informed consent
Informed consent:
IRBs can waive the requirement for consent where
appropriate [45 CFR 46.116(d)]
Waiver of documentation of informed consent:
If consent is required, IRBs can waive the
requirement for documentation of consent where
appropriate [45 CFR 46.117(c)]
29. Informed consent (2)
Points to Consider:
Where consent required but documentation is
waived, a “portal” can be used to provide consent
information.
e.g., subjects must click on consent page to get to
next page.
Where documentation required – consider
alternatives to traditional documentation
--e.g., electronic signature
30. Children
Research With Children:
Consider waiver of parental permission
Where parental permission required,
consider previous options for consent
flexibilities
31. Children (2)
Research With Children
Points to consider in “screening out” children:
use internet monitoring software or adult check
systems
none of these is foolproof.
Since it may be difficult to guarantee that
children won’t access research, some research
may not be appropriate for social media.
32. Security
Security Issues:
Two potential sources of breach of confidentiality
inadvertent disclosure
Investigator who sent out research database
to entire listserve
Investigator whose computer was stolen
deliberate attempts to gain access
Hacking into research data
Technology can provide reasonable security but
cannot guarantee absolute security
33. Security (2)
Security Issues:
Data transmitted via e-mail is not anonymous
without the use of additional steps. Almost all forms
of e-mail contain the sender's e-mail address.
use an "anonymizer" - a third party site that strips off the
sender's e-mail address
Web servers automatically store a great deal of
personal information about visitors to a web site and
that information can be accessed by others.
34. Security (3)
Security Issues:
Web sites can leave “cookies”, a small file left on the
user’s hard drive that is sent back to the web site
each time the browser requests a page from that
site. Cookies can record which computer the user is
coming from, what software and hardware is being
used, details of the links clicked on, and possibly
even email addresses, if provided by the user.
35. Security (4)
Security Issues:
Degree of concern over confidentiality
depends on sensitivity of the information
Since it is impossible to guarantee absolute
data security over the internet, some
extremely sensitive research may not be
appropriate for the internet
36. Care and feeding of IRB
Investigator and IRB Responsibilities:
Investigators are going to have to provide technical
information on how they will deal with considerations
particular to the use of social media
IRBs need to have sufficient expertise on the
technical aspects of social media in order to ask the
right questions and appropriately evaluate the
information provided
37. Resources
AAAS Report on Internet Research
http://www.aaas.org/spp/dspp/sfrl/projects/
intres/main.htm
Papers from “Research Ethics in the
Facebook Era” workshop http://
www.cc.gatech.edu/~yardi/ethics-
cscw2010_files/AcceptedPapers.htm