History of human research ethics
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This presentations describes the history of human research ethics: from its origins in medical research to a much broader framework
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Introduction to research ethics
This document discusses the importance of ethics in medical research. It begins by defining ethics and research, and identifies human subjects. It then reviews some unethical medical experiments from history, like the Tuskegee Syphilis Study, that lacked informed consent and caused harm. This led to various codes of ethics like the Nuremberg Code, Declaration of Helsinki, and Belmont Report to protect subjects. The three main principles of research ethics are respect for persons, beneficence, and justice. Special protections are needed for vulnerable groups. Overall, ethics aim to balance scientific advancement with subject welfare and rights.
historical_background_research_ethics
This document provides a historical overview of the development of research ethics guidelines and codes. It discusses key events that shaped the field, such as the Nuremberg Code established after World War II experiments and the Declaration of Helsinki. It also outlines several international guidelines and regulations established over time to protect human subjects, including the Common Rule in the US and ICH guidelines requiring ethics review and informed consent. The document stresses that while guidelines are important, ethical conduct in research also requires vigilance and no place is immune from violations.
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The document summarizes the history of ethical guidelines for clinical trials. It discusses several key documents and events that shaped modern research ethics, including the Nuremberg Code established after World War 2 Nazi experiments, the Declaration of Helsinki, Belmont Report, ICH GCP guidelines, and India's Ethical Guidelines for Biomedical Research in Human Subjects. Overall it provides an overview of the evolution of clinical trial ethics from the 1940s to 2000 to protect human subjects and ensure scientific integrity.
Research ethics
Dr. Sarika Sawant presented on research ethics at a seminar. She discussed the definition of research ethics as regulating scientific activity to protect human participants and serve societal interests. She covered objectives like ensuring consent and oversight. Issues discussed included plagiarism, data handling, and research with humans and animals. National guidelines in India were also presented, as well as UNESCO's ethical guidelines focusing on informed consent, confidentiality, and integrity.
Research Ethics
The document discusses the background and definition of research ethics. It defines ethics as norms for conduct that distinguish acceptable from unacceptable behavior. Research ethics refers to rules that define proper conduct for researchers and are aimed at protecting human subjects. The history of modern research ethics is traced back to unethical medical experiments conducted by Nazi doctors during World War 2, which led to the Nuremberg Code establishing ethical principles for research involving human subjects. Other influential documents discussed include the Helsinki Declaration, Belmont Report, and controversies like the Tuskegee Syphilis Study.
Ethics in clinical research
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.
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Introduction to research ethics
This document discusses the importance of ethics in medical research. It begins by defining ethics and research, and identifies human subjects. It then reviews some unethical medical experiments from history, like the Tuskegee Syphilis Study, that lacked informed consent and caused harm. This led to various codes of ethics like the Nuremberg Code, Declaration of Helsinki, and Belmont Report to protect subjects. The three main principles of research ethics are respect for persons, beneficence, and justice. Special protections are needed for vulnerable groups. Overall, ethics aim to balance scientific advancement with subject welfare and rights.
historical_background_research_ethics
This document provides a historical overview of the development of research ethics guidelines and codes. It discusses key events that shaped the field, such as the Nuremberg Code established after World War II experiments and the Declaration of Helsinki. It also outlines several international guidelines and regulations established over time to protect human subjects, including the Common Rule in the US and ICH guidelines requiring ethics review and informed consent. The document stresses that while guidelines are important, ethical conduct in research also requires vigilance and no place is immune from violations.
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A lecture on clinical ethics consultations delivered to Alfarabi Medical College undergraduate medical students on 22.12.2016
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Helsinki declaration: a very important protocol to be learnt before and followed by each physiotherapist
History ethical guide lines to clinical trial
The document summarizes the history of ethical guidelines for clinical trials. It discusses several key documents and events that shaped modern research ethics, including the Nuremberg Code established after World War 2 Nazi experiments, the Declaration of Helsinki, Belmont Report, ICH GCP guidelines, and India's Ethical Guidelines for Biomedical Research in Human Subjects. Overall it provides an overview of the evolution of clinical trial ethics from the 1940s to 2000 to protect human subjects and ensure scientific integrity.
Research ethics
Dr. Sarika Sawant presented on research ethics at a seminar. She discussed the definition of research ethics as regulating scientific activity to protect human participants and serve societal interests. She covered objectives like ensuring consent and oversight. Issues discussed included plagiarism, data handling, and research with humans and animals. National guidelines in India were also presented, as well as UNESCO's ethical guidelines focusing on informed consent, confidentiality, and integrity.
Research Ethics
The document discusses the background and definition of research ethics. It defines ethics as norms for conduct that distinguish acceptable from unacceptable behavior. Research ethics refers to rules that define proper conduct for researchers and are aimed at protecting human subjects. The history of modern research ethics is traced back to unethical medical experiments conducted by Nazi doctors during World War 2, which led to the Nuremberg Code establishing ethical principles for research involving human subjects. Other influential documents discussed include the Helsinki Declaration, Belmont Report, and controversies like the Tuskegee Syphilis Study.
Ethics in clinical research
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.
Icmr ethical guidelines for biomedical research on human subject
This document outlines ethical guidelines for biomedical research involving human subjects presented by Suraj P.S. It discusses the ICMR Code established in 1949 and covers several topics including general principles of biomedical research, informed consent, composition and responsibilities of ethics committees, training requirements, and the review process. The key principles are that research must be directed to increasing knowledge, conducted in a way that respects human dignity, and subjected to evaluation at all stages.
Declaration of-helsinki presantation
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 dignity, rights, and welfare. It addresses issues like informed consent, risk/benefit ratio of research, and special protection of vulnerable groups. The Declaration has undergone several revisions over time to update and clarify its guidelines for ethical medical practice and research involving human subjects.
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Declaration of-helsinki presantation
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.
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This document discusses ethics in medical research. It begins by outlining the lesson objectives which are to explain ethics, describe important historical events related to research ethics, list important guidelines, describe informed consent, and describe the role of institutional ethics committees. It then discusses the definition of ethics, important historical incidents like the Nuremberg trials, Thalidomide tragedy, and Tuskegee syphilis experiment. It also describes key documents that outline research ethics guidelines like the Nuremberg Code, Helsinki Declaration, ICH Guidelines, and ICMR Guidelines. It concludes by explaining informed consent and the responsibilities of institutional ethics committees in research.
ICH GCP
The document provides an overview of ICH GCP (International Council for Harmonisation Good Clinical Practice) guidelines. ICH GCP guidelines were developed to harmonize clinical trial standards and processes across regions. They establish international ethical and scientific quality standards for designing, conducting, and reporting clinical research involving human subjects. Adherence to ICH GCP provides public assurance that the rights, safety, and well-being of clinical trial subjects are protected.
Ethical Guidelines.pptx
This document summarizes the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants released by the Indian Council of Medical Research (ICMR) in 2017. The guidelines cover 12 sections that establish general ethical principles, review procedures, informed consent processes, and regulations for research involving vulnerable groups or children. Key points include requirements for ethics committee review and clinical trial registration, guidelines for informed consent depending on the situation, ownership of biological materials and data, and conducting research during emergencies or with vulnerable populations.
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The document summarizes key ethical principles for conducting clinical trials including: obtaining informed consent, minimizing risks and ensuring a favorable risk-benefit ratio for participants, selecting participants equitably, respecting privacy and confidentiality, having trials approved and monitored by an IRB, stopping trials if risks are found to outweigh benefits, and disseminating results. It also discusses ethical issues around placebos, randomization, choice of controls, recruitment, monitoring safety, authorship, and conflicts of interest.
The Declaration of Helsinki
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.
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This document discusses ethics in health research. It provides an overview of the origins and principles of ethics, including teleological and deontological perspectives. It then discusses ethics specifically in the context of health research, including how research must be useful and avoid harm. The document outlines several historical examples of unethical human experimentation, such as the Nazi experiments and Unit 731 tests during WWII. It also discusses international efforts to establish ethical guidelines, including the Nuremberg Code, Declaration of Helsinki, and Belmont Report. The core ethical principles of autonomy, beneficence, justice, and respect for the environment are covered. Elements of informed consent and protections for vulnerable populations are also summarized.
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This document discusses research ethics. It defines ethics and research ethics, and explains the importance of ethics in promoting valid research, building trust, and accountability. Key stakeholders in research like participants, researchers, funding agencies are discussed. Important ethical issues related to participants include informed consent, privacy and preventing harm. Ethical issues for researchers include honesty, objectivity, and appropriate methodology. Ethical issues for funders include restricting research and potential misuse of findings. The conclusion emphasizes balancing these issues, following guidelines, and acting ethically despite challenges to uphold scientific integrity.
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The Presentation will take the reader through various ethical issues in biomedical research. It covers topics like The Nuremberg Code, Declaration of Helsinki, Declaration of Geneva, selected code and regulations that guide research with human subjects, etc.
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This document discusses ethics in research. It covers key principles like voluntary participation, informed consent, avoiding harm, and maintaining privacy, anonymity and confidentiality. It discusses proper data gathering and storage procedures. It also addresses issues like plagiarism, fabrication, misleading authorship, and non-publication of data. The document provides guidelines from organizations like ESRC on ensuring research integrity and quality, informing participants, respecting confidentiality, avoiding coercion, and minimizing harm to participants. It discusses balancing risks and benefits in research.
Ethics in health research (history)
Concept of ethics
Importance of ethics in health research,
Brief overview on history of ethics in public health
Informed consent process
Informed consent process a prerequisite in any clinical trial study as an understanding between the participant and the study team.
Declaration of helsinki
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.
Belmont report
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.
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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.
ICMR ethical guidelines for biomedical research .pptx
The ICMR first issued ethical guidelines in 1980 and has since revised them in 2002, 2006, and 2017. The current guidelines, called the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, provide guidance on topics like informed consent, vulnerability of participants, ethical review procedures, and the responsible conduct of research. The guidelines apply to all biomedical, social, and behavioral research conducted in India. They are intended to enhance knowledge about human health while respecting cultural and ethical values.
Ethics in research
Ethics in research are integral to protect participants and ensure research is conducted for legitimate purposes. The summary discusses key ethical standards including informed consent, confidentiality, and treating participants according to principles of autonomy, beneficence and justice. Research ethics committees review proposals to evaluate risks and benefits before research begins. Historical documents like the Nuremberg Code and Declaration of Helsinki established ethical guidelines which research ethics boards now use to review proposed studies.
ETHICAL ISSUES IN BIOMEDICAL RESEARCH
Principles of essentiality
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Principles of non-exploitation
Principles of privacy and confidentiality
Principles of precaution and risk minimisation
Principles of professional competence
Principles of accountability and transparency
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Declaration of-helsinki presantation
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 dignity, rights, and welfare. It addresses issues like informed consent, risk/benefit ratio of research, and special protection of vulnerable groups. The Declaration has undergone several revisions over time to update and clarify its guidelines for ethical medical practice and research involving human subjects.
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This document discusses ethical considerations in nursing research. It outlines various codes of ethics that were developed in response to past human rights violations in medical experiments, including the Nuremberg Code and Helsinki Declaration. Ethical review boards were established to review research proposals and ensure the protection of human subjects. The document then details the ethical principles and guidelines set forth by the Indian Council of Medical Research for biomedical research involving human subjects, including principles of informed consent, non-exploitation, privacy/confidentiality, and risk minimization. Institutional ethics committees are responsible for reviewing all research proposals involving human participants.
Declaration of-helsinki presantation
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.
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This document discusses ethics in medical research. It begins by outlining the lesson objectives which are to explain ethics, describe important historical events related to research ethics, list important guidelines, describe informed consent, and describe the role of institutional ethics committees. It then discusses the definition of ethics, important historical incidents like the Nuremberg trials, Thalidomide tragedy, and Tuskegee syphilis experiment. It also describes key documents that outline research ethics guidelines like the Nuremberg Code, Helsinki Declaration, ICH Guidelines, and ICMR Guidelines. It concludes by explaining informed consent and the responsibilities of institutional ethics committees in research.
ICH GCP
The document provides an overview of ICH GCP (International Council for Harmonisation Good Clinical Practice) guidelines. ICH GCP guidelines were developed to harmonize clinical trial standards and processes across regions. They establish international ethical and scientific quality standards for designing, conducting, and reporting clinical research involving human subjects. Adherence to ICH GCP provides public assurance that the rights, safety, and well-being of clinical trial subjects are protected.
Ethical Guidelines.pptx
This document summarizes the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants released by the Indian Council of Medical Research (ICMR) in 2017. The guidelines cover 12 sections that establish general ethical principles, review procedures, informed consent processes, and regulations for research involving vulnerable groups or children. Key points include requirements for ethics committee review and clinical trial registration, guidelines for informed consent depending on the situation, ownership of biological materials and data, and conducting research during emergencies or with vulnerable populations.
Ethics of clinical trials
The document summarizes key ethical principles for conducting clinical trials including: obtaining informed consent, minimizing risks and ensuring a favorable risk-benefit ratio for participants, selecting participants equitably, respecting privacy and confidentiality, having trials approved and monitored by an IRB, stopping trials if risks are found to outweigh benefits, and disseminating results. It also discusses ethical issues around placebos, randomization, choice of controls, recruitment, monitoring safety, authorship, and conflicts of interest.
The Declaration of Helsinki
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.
Ethics in health research
This document discusses ethics in health research. It provides an overview of the origins and principles of ethics, including teleological and deontological perspectives. It then discusses ethics specifically in the context of health research, including how research must be useful and avoid harm. The document outlines several historical examples of unethical human experimentation, such as the Nazi experiments and Unit 731 tests during WWII. It also discusses international efforts to establish ethical guidelines, including the Nuremberg Code, Declaration of Helsinki, and Belmont Report. The core ethical principles of autonomy, beneficence, justice, and respect for the environment are covered. Elements of informed consent and protections for vulnerable populations are also summarized.
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This document discusses research ethics. It defines ethics and research ethics, and explains the importance of ethics in promoting valid research, building trust, and accountability. Key stakeholders in research like participants, researchers, funding agencies are discussed. Important ethical issues related to participants include informed consent, privacy and preventing harm. Ethical issues for researchers include honesty, objectivity, and appropriate methodology. Ethical issues for funders include restricting research and potential misuse of findings. The conclusion emphasizes balancing these issues, following guidelines, and acting ethically despite challenges to uphold scientific integrity.
Ethical issues in biomedical research
The Presentation will take the reader through various ethical issues in biomedical research. It covers topics like The Nuremberg Code, Declaration of Helsinki, Declaration of Geneva, selected code and regulations that guide research with human subjects, etc.
Ethics in research
This document discusses ethics in research. It covers key principles like voluntary participation, informed consent, avoiding harm, and maintaining privacy, anonymity and confidentiality. It discusses proper data gathering and storage procedures. It also addresses issues like plagiarism, fabrication, misleading authorship, and non-publication of data. The document provides guidelines from organizations like ESRC on ensuring research integrity and quality, informing participants, respecting confidentiality, avoiding coercion, and minimizing harm to participants. It discusses balancing risks and benefits in research.
Ethics in health research (history)
Concept of ethics
Importance of ethics in health research,
Brief overview on history of ethics in public health
Informed consent process
Informed consent process a prerequisite in any clinical trial study as an understanding between the participant and the study team.
Declaration of helsinki
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.
Belmont report
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.
RESEARCH METHODOLOGY
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.
ICMR ethical guidelines for biomedical research .pptx
The ICMR first issued ethical guidelines in 1980 and has since revised them in 2002, 2006, and 2017. The current guidelines, called the National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, provide guidance on topics like informed consent, vulnerability of participants, ethical review procedures, and the responsible conduct of research. The guidelines apply to all biomedical, social, and behavioral research conducted in India. They are intended to enhance knowledge about human health while respecting cultural and ethical values.
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Ethics in research are integral to protect participants and ensure research is conducted for legitimate purposes. The summary discusses key ethical standards including informed consent, confidentiality, and treating participants according to principles of autonomy, beneficence and justice. Research ethics committees review proposals to evaluate risks and benefits before research begins. Historical documents like the Nuremberg Code and Declaration of Helsinki established ethical guidelines which research ethics boards now use to review proposed studies.
ETHICAL ISSUES IN BIOMEDICAL RESEARCH
Principles of essentiality
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1. The Nuremberg Code established ethical guidelines for human experimentation after Nazi doctors were tried for war crimes for medical experiments without consent. It included requirements for voluntary and informed consent.
2. The Declaration of Helsinki expanded on informed consent and emphasized that subjects' welfare takes precedence over scientific interests.
3. The Belmont Report summarized ethical principles of respect for persons, beneficence, and justice in research involving human subjects. It addressed informed consent, risk-benefit assessment, and fair subject selection.
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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.
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This short presentation explains resilience of infrastructures in more detail and also discusses the difference with sustainability.
Research Integrity TU Delft, CESAER, Paris
Workshop for CESAER about the policies of the TU Delft regarding Research Integrity, Human Research Ethics and Responsible Innovation.Includes questions for pondering and references to readings.
Policy input open_online_education
This is a presentation for an international delegation from universities in Uganda, Nepal and India.
Human Research Ethics: guidelines for students
Human Research Ethics: guidelines for students TU Delft, Faculty of Technology, Policy and Management
This presentation provides more details about the human research ethics regulations (i.e. for students) at TU Delft including the implications of the GDPR. Iczm project starting-with_open_education. may 2016
Iczm project starting-with_open_education. may 2016TU Delft, Faculty of Technology, Policy and Management
This document provides an overview of open educational resources (OER) and open education. It discusses current developments in the field and considerations for institutions looking to incorporate OER and open education. Some of the key points covered include:
1) A quick tour of global developments in OER and open education, including the rise of MOOCs and open courseware.
2) Motivations for institutions to engage with OER and open education, such as improving quality, increasing access, and furthering educational innovation.
3) Practical considerations for starting OER initiatives, including developing a vision, selecting content, establishing technical infrastructure and workflows, supporting instructors, and addressing costs.
4) AdditionalIczm project blended_education 13.09.2016
This presentation forms part of the Integrated Coastal Zone Management (ICZM)-project. This projects concerns a cooperation between ITS, ITB (both Indonesia) and TU Delft focusing on joint curriculum development
This project includes the use of open, online and blended education to support this process.
The presentation sketches the issues – for further discussions- to be taken into consideration when it comes to blended education (policy development, approach /priorities and planning) .
Online education in the field of Responsible Education
Online education in the field of Responsible EducationTU Delft, Faculty of Technology, Policy and Management
he project ‘From campus students to professional learners: Flexible learning paths in Responsible Innovation' is one of the projects funded by the Ministry of OC&W in order to promote online education.This presentation gives and update on the progress.Human Research Ethics Commitee TU Delft: procedures and criteria
Human Research Ethics Commitee TU Delft: procedures and criteriaTU Delft, Faculty of Technology, Policy and Management
The document summarizes the role and functions of the Human Research Ethics Committee (HREC) at Delft University of Technology. The HREC was established in 2012 to review all university research involving human subjects for ethical issues like informed consent and data privacy. It is chaired by Sabine Roeser and has seven members from various faculties. While ethics review is now common internationally, most European technical universities do not have such a committee. The HREC process involves submitting an application for either chair approval if minimal risk, or committee review. Applications have steadily increased and cover a range of research areas. The HREC checks for issues like safety certification, data collection methods, and informed consent forms. It aims to improve awareness and developOpen education TU Delft in the field of Responsible Innovation
Open education TU Delft in the field of Responsible InnovationTU Delft, Faculty of Technology, Policy and Management
The project ‘From campus students to professional learners: Flexible learning paths in Responsible Innovation' is one of the projects funded by the Dutch Ministry of OC&W in order to promote online education.
Until 31.12.2016 this project will develop multipurpose online content and create flexible learning paths in Responsible Innovation (RI) for different target groups:
- Our on-campus engineering students.
- Professionals (engineers/designers/architects and decision makers/executives).
This presentation gives an update on the progress so far. MOOC Next Generation Infrastructures, Presentation innovative aspects
MOOC Next Generation Infrastructures, Presentation innovative aspectsTU Delft, Faculty of Technology, Policy and Management
This document discusses plans for developing MOOCs at Delft University of Technology. It provides details on current and upcoming MOOCs, including courses on complex problems, cybersecurity, and Next Generation Infrastructures (NGI). Developing MOOCs is time-consuming, particularly recording web lectures and grading student assignments. For the NGI MOOC, students submitted case studies but data analysis was problematic. Peer review through the edX platform needs improvement. Lessons learned include rethinking collaboration between students and whether there were too many teachers involved.OpenCourseWare/Open Educational Resources & potential for higher education in...
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This document discusses examples of how open educational resources (OER) and open courseware (OCW) have been used in higher education in developing countries. It provides several examples including initiatives in India, Vietnam, Teacher Education in Sub-Saharan Africa (TESSA), and OER Health Africa. It also describes projects between the Delft University of Technology and universities in Indonesia and Bandung focused on water management education using OCW and study visits. The document raises challenges and opportunities for using OCW and OER to build educational capacity through projects supported by Nuffic, and discusses whether Dutch institutions are ready to support this approach through voluntary learning services linked to partnerships.More from TU Delft, Faculty of Technology, Policy and Management (12)
Resilient infrastuctures: brief explanation of the concept
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Online education in the field of Responsible Education
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Human Research Ethics Commitee TU Delft: procedures and criteria
Human Research Ethics Commitee TU Delft: procedures and criteria
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Open education TU Delft in the field of Responsible Innovation
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History of human research ethics
- 1. History of human research ethics: ‘Human subjects in research must be protected’: Joost Groot Kormelink, secretary HREC March 2018
- 2. Human research ethics has developed in both theory and practice from experiences in medical research
- 4. Nuremburg tribunal: medical research The voluntary consent of the human subject is absolutely essential, making it clear that subjects should give consent and that the benefits of the research must outweigh the risks
- 5. Helsinki declaration 1964 The subject's welfare must always take precedence over the interests of science and society and ethical considerations must always take precedence over laws and regulations
- 6. Principles Helsinki Declaration • Protect the life, health, privacy, and dignity of the human subject. • The right of research subjects to safeguard their integrity must always be respected. Informed consent by research participants is necessary. Risks should not exceed benefits. Vulnerable groups: special procedures. • Research protocols should be reviewed by an independent committee prior to the research. Committees oversee most governmentally-funded medical research around the world.
- 8. From medical human research to general adaptation for all experiments ‘Basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects (also non- medical)’ . Always ensure approval by IRB
- 9. Belmont report: fundamental principles for human research • Respect for persons • Beneficence • Justice.
- 11. Over the last decades… Increasing awareness that all human research needs institutional review, also because of regulations from sponsors and journals.
- 12. Since 2012 the TU Delft has its own independent human research ethics committee.
- 13. Key references • WHO/Helsinki declaration and updates: https://www.wma.net/policies-post/wma-declaration-of- helsinki-ethical-principles-for-medical-research-involving-human-subjects/ • Belmont report 1978 : https://www.hhs.gov/ohrp/regulations-and-policy/belmont- report/index.html • Applying Ethical Principles to Information and Communication Technology Research: A Companion to the Department of Homeland Security Menlo Report (2012): https://www.dhs.gov/sites/default/files/publications/CSD-MenloPrinciplesCOMPANION-20120103- r731.pdf • Human Participants in Engineering Research: Notes from a Fledgling Ethics Committee, 2014 ( David Koepsell, Willem-Paul Brinkman Sylvia Pont - HREC TU Delft): https://www.ncbi.nlm.nih.gov/pubmed/24938695 Questions: Hrec@tudelft.nl
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