Podcast
Questions and Answers
Which of the following best describes the primary focus of the Declaration of Helsinki?
Which of the following best describes the primary focus of the Declaration of Helsinki?
- Ensuring voluntary participation in research.
- Prioritizing the interests of the researcher.
- Protecting the interests of the human subject. (correct)
- Guaranteeing legal protection for research institutions.
According to the provided information, which of these is NOT a typical responsibility of a Medical Research Ethics Committee (MREC)?
According to the provided information, which of these is NOT a typical responsibility of a Medical Research Ethics Committee (MREC)?
- Assessing the safety of human subjects.
- Ensuring the ethical conduct of research involving human subjects.
- Providing legal protection for researchers.
- Overseeing the financial aspects of research studies. (correct)
A study involves testing a new surgical technique on patients with a specific condition. Participants are required to undergo a detailed pre-operative examination and a strict post-operative rehabilitation plan. Based on the WMO criteria, is this considered WMO research?
A study involves testing a new surgical technique on patients with a specific condition. Participants are required to undergo a detailed pre-operative examination and a strict post-operative rehabilitation plan. Based on the WMO criteria, is this considered WMO research?
- Yes, because all medical device research is WMO by default.
- No, because surgical procedures are excluded from WMO.
- Yes, because it involves a procedure on human subjects. (correct)
- No, because it is a surgical procedure.
A researcher is conducting a retrospective study using anonymized data from a hospital database, with no patient interaction. Is this study classified as WMO or non-WMO research?
A researcher is conducting a retrospective study using anonymized data from a hospital database, with no patient interaction. Is this study classified as WMO or non-WMO research?
In the context of ethical considerations for research, what primarily constitutes the 'burden' on a participant?
In the context of ethical considerations for research, what primarily constitutes the 'burden' on a participant?
What does the term 'METC' stand for in the context of medical ethics review?
What does the term 'METC' stand for in the context of medical ethics review?
A study is testing a new custom-made prosthetic on a group of participants, where they need to undergo a set of exercises and routines. Is this classified as WMO or non-WMO research?
A study is testing a new custom-made prosthetic on a group of participants, where they need to undergo a set of exercises and routines. Is this classified as WMO or non-WMO research?
When assessing the implications of a new technology, which of the following steps is typically recommended to perform first?
When assessing the implications of a new technology, which of the following steps is typically recommended to perform first?
In the context of technology assessment, 'indirect effects' are best described as:
In the context of technology assessment, 'indirect effects' are best described as:
Which of these statements best describes the role of values in technology assessment, according to the content?
Which of these statements best describes the role of values in technology assessment, according to the content?
Which action would be most effective when trying to identify the range of values relevant to a specific technology?
Which action would be most effective when trying to identify the range of values relevant to a specific technology?
What is a key aspect of the approach to technology ethics encouraged by the various ethics codes provided?
What is a key aspect of the approach to technology ethics encouraged by the various ethics codes provided?
Within a mentor/trainee relationship, which dynamic is LEAST likely to cause conflict?
Within a mentor/trainee relationship, which dynamic is LEAST likely to cause conflict?
Which of the following best describes the initial impact of international influences on the establishment of Research Ethics Committees (RECs)?
Which of the following best describes the initial impact of international influences on the establishment of Research Ethics Committees (RECs)?
Which of these is NOT a key aspect explored in the peer review process?
Which of these is NOT a key aspect explored in the peer review process?
What does the text suggest about the development of research ethics governance in the USSR compared to Western models?
What does the text suggest about the development of research ethics governance in the USSR compared to Western models?
In collaborative science, explicit articulation of assumptions is most vital for which of the following?
In collaborative science, explicit articulation of assumptions is most vital for which of the following?
Which factor does the text indicate as having significantly shaped the evolution of institutional ethics review in the United States?
Which factor does the text indicate as having significantly shaped the evolution of institutional ethics review in the United States?
Which of the following BEST describes the European focus on research ethics, as mentioned?
Which of the following BEST describes the European focus on research ethics, as mentioned?
How did the reunification of Germany affect the development of research ethics governance there?
How did the reunification of Germany affect the development of research ethics governance there?
Which of these is a core tenet of Good Scientific Practice (GSP)?
Which of these is a core tenet of Good Scientific Practice (GSP)?
What was a significant outcome of the reported cases of scientific misconduct in Germany?
What was a significant outcome of the reported cases of scientific misconduct in Germany?
What is the main point that the authors make regarding the geographical coverage in their special issue?
What is the main point that the authors make regarding the geographical coverage in their special issue?
How does the European perspective on research ethics differ from that of the United States, based on the text?
How does the European perspective on research ethics differ from that of the United States, based on the text?
Which aspect of REC establishment does the text emphasize as a point of national divergence?
Which aspect of REC establishment does the text emphasize as a point of national divergence?
What does the text suggest is a result of the tensions regarding the functions of RECs?
What does the text suggest is a result of the tensions regarding the functions of RECs?
According to the content, which nation was the first in Europe to establish a national entity to oversee scientific dishonesty?
According to the content, which nation was the first in Europe to establish a national entity to oversee scientific dishonesty?
What is the primary purpose of the focus on both collaboration and competition in the research context?
What is the primary purpose of the focus on both collaboration and competition in the research context?
What was the primary catalyst for the establishment of RECs in Switzerland and Canada during the 1960s and 1970s?
What was the primary catalyst for the establishment of RECs in Switzerland and Canada during the 1960s and 1970s?
How did the ideological principles of the USSR affect its approach to research ethics governance, according to the text?
How did the ideological principles of the USSR affect its approach to research ethics governance, according to the text?
Besides geographical representation, what other aspect of the research does the text indicate as needing further exploration for new insights?
Besides geographical representation, what other aspect of the research does the text indicate as needing further exploration for new insights?
How does the concept of 'ethics as guidance' differ from the traditional 'ethical assessment' model?
How does the concept of 'ethics as guidance' differ from the traditional 'ethical assessment' model?
What is a key characteristic of 'ethics from within' as it relates to technology?
What is a key characteristic of 'ethics from within' as it relates to technology?
What’s the primary question should 'guidance ethics' address when dealing with technology?
What’s the primary question should 'guidance ethics' address when dealing with technology?
What aspect does guidance ethics consider most important when examining the impact of technology?
What aspect does guidance ethics consider most important when examining the impact of technology?
In the context of guidance ethics, what does a thorough inventory of a technology's effects involve?
In the context of guidance ethics, what does a thorough inventory of a technology's effects involve?
When is the consideration of societal implications most important when evaluating new technologies?
When is the consideration of societal implications most important when evaluating new technologies?
How does the text describe the relationship between ethics and technology in the 'ethics from within' perspective?
How does the text describe the relationship between ethics and technology in the 'ethics from within' perspective?
What is the central focus of the deliberative process within guidance ethics?
What is the central focus of the deliberative process within guidance ethics?
Which statement best reflects the evolving nature of ethical frameworks in relation to technology, as discussed in the text?
Which statement best reflects the evolving nature of ethical frameworks in relation to technology, as discussed in the text?
When applying ethics guidance on technology, what should the analysis focus on?
When applying ethics guidance on technology, what should the analysis focus on?
Flashcards
Medical Research Ethics Committee (MREC)
Medical Research Ethics Committee (MREC)
An ethics committee that reviews research involving human subjects to ensure ethical conduct and protect participant safety.
WMO Research
WMO Research
A type of research protocol that involves procedures or rules of behavior imposed on participants, often involving interventions or testing.
nonWMO Research
nonWMO Research
A research protocol that does not involve invasive procedures or rules of behavior imposed on participants. It may involve data collection, surveys, or retrospective analysis.
Declaration of Helsinki
Declaration of Helsinki
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Nuremberg Code
Nuremberg Code
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Safety in Research
Safety in Research
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Assessment of Research Protocols
Assessment of Research Protocols
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Research Ethics Review
Research Ethics Review
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Technology Effect Analysis
Technology Effect Analysis
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Research Ethics Committee (REC)
Research Ethics Committee (REC)
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Technology Value Identification
Technology Value Identification
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Research Ethics Governance
Research Ethics Governance
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Technology Effect Types
Technology Effect Types
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International Influences on Research Ethics
International Influences on Research Ethics
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Technology Effect Levels
Technology Effect Levels
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National Tensions in Research Ethics
National Tensions in Research Ethics
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Making Values Explicit
Making Values Explicit
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Political and Societal Influences on Research Ethics
Political and Societal Influences on Research Ethics
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Centralized State Model of Research Ethics
Centralized State Model of Research Ethics
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Market-Driven Model of Research Ethics
Market-Driven Model of Research Ethics
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Dynamic Nature of Research Ethics
Dynamic Nature of Research Ethics
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Multicultural Research Ethics
Multicultural Research Ethics
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Mentor/Trainee Relationship
Mentor/Trainee Relationship
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Collaboration vs. Competition in Research
Collaboration vs. Competition in Research
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Peer Review Process
Peer Review Process
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Research Conduct and Ethics (RCR)
Research Conduct and Ethics (RCR)
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Good Scientific Practice (GSP)
Good Scientific Practice (GSP)
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Openness and Accessibility in Research
Openness and Accessibility in Research
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Scientific Dishonesty
Scientific Dishonesty
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Danish Committee on Scientific Dishonesty
Danish Committee on Scientific Dishonesty
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International Commission on Professional Self-Regulation in Science
International Commission on Professional Self-Regulation in Science
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Guidance Ethics
Guidance Ethics
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Social Implications of Technology
Social Implications of Technology
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Deliberative Process
Deliberative Process
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Evolving Ethical Frameworks
Evolving Ethical Frameworks
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Concrete Technology Focus
Concrete Technology Focus
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How? Question in Guidance Ethics
How? Question in Guidance Ethics
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Inventory of Social Impacts
Inventory of Social Impacts
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Central Values in Guidance Ethics
Central Values in Guidance Ethics
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Evolving Definition of Privacy
Evolving Definition of Privacy
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Ethics From Within
Ethics From Within
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Study Notes
Ethics Exam - Lecture 1
- Ethics is different from tradition, social rules, religion, law, and etiquette, though it can relate to them
- Morality is used in different ways, both scholarly and outside of academia (particular vs. universal)
What is Ethics?
- Theoretical considerations about right and wrong
- Justifying actions or inaction by giving and considering reasons
- A systematic philosophical discipline
- Reflecting on a specific morality by assessing it
Is-Ought Problem
- Normative claims cannot be derived solely from factual claims
- Committing the naturalistic fallacy is assuming facts are automatically good or right
- A problem in Western ethics, highlighted by philosophers like David Hume and Immanuel Kant
Relation of Facts and Values
- Examples relevant to ethics; e.g., meat-eating
- Empirical facts' role in moral judgments and ethical reasoning
- Science and ethics relationship; e.g., medical science and biomedical engineering
Three Domains of Ethics in science and Engineering
- Research Ethics (RE): Focuses on ethical considerations of research with humans and animals
- Research Integrity (RI): Concerns researcher behavior that impacts research validity and trustworthiness. Fabrication, falsification, and plagiarism (FFP) are major concerns.
- Responsible Research and Innovation (RRI): Examines the societal and environmental effects of research. The term is mostly used in the EU.
Lecture 2
- Research Ethics Committees (RECs) / Institutional Review Boards (IRBs): Committees review research protocols involving human or animal subjects
- History of RECs: RECs have developed globally as a response to ethical concerns in research.
- RECs are increasingly part of ethical governance.
- Medical Device Regulation (MDR) / In Vitro Diagnostic Device Regulation (IVDR): Regulatory codes to ensure medical device quality and safety.
Lecture 3
- Research Misconduct: Fabrication, falsification, and plagiarism (FFP) are major forms of research misconduct.
- Plagiarism: Falsely claiming ideas, arguments, or text as someone else's.
- Different types of plagiarism: Literal copying, improper paraphrasing, and self-plagiarism
Various Regulations
- Medical Devices: MDR and IVDR regulate devices, emphasizing health protection.
- Regulations and directives regarding medical devices.
Ethical considerations of various research subjects and applications
- Genetic material: Nagoya protocol adherence is vital
- Ionizing radiation: Specific regulations about use
- Gametes and embryos: Embryo act guidelines.
Lecture 5
- WMO (Medical Research Involving Human Subjects Act): Dutch regulation for research with human participants.
- Monitoring of WMO-governed research: The sponsor is responsible for this.
- Review by ethical committee: Mandatory for approval of research involving specific entities.
- Handling Laboratory Animals: (Replacement, Reduction, Refinement) and permits required.
Guidance Ethics Approach
- Technology and ethics are intertwined, not opposing forces
- Technology is always in a context, with social implications for interpretation and action
- Using 'how' questions to avoid simple 'yes/no' determinations
- Considering the technology's social context, values, and effects on all parties.
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