Medical Research Ethics Quiz

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Questions and Answers

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)?

  • 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?

  • 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?

<p>Non-WMO research (C)</p> Signup and view all the answers

In the context of ethical considerations for research, what primarily constitutes the 'burden' on a participant?

<p>Both the physical and emotional/mental risks and implications (D)</p> Signup and view all the answers

What does the term 'METC' stand for in the context of medical ethics review?

<p>Medisch Ethische Toetsingscommissie (C)</p> Signup and view all the answers

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?

<p>WMO research, as it involves procedures and rules of behavior. (D)</p> Signup and view all the answers

When assessing the implications of a new technology, which of the following steps is typically recommended to perform first?

<p>Creating a list of both negative and positive impacts without any initial filtering. (B)</p> Signup and view all the answers

In the context of technology assessment, 'indirect effects' are best described as:

<p>Outcomes that are not immediately apparent, resulting from a chain of events. (A)</p> Signup and view all the answers

Which of these statements best describes the role of values in technology assessment, according to the content?

<p>Values are implicit, often only surfacing during critiques of technology applications. (C)</p> Signup and view all the answers

Which action would be most effective when trying to identify the range of values relevant to a specific technology?

<p>Conducting an open inventory of all values before prioritizing them. (B)</p> Signup and view all the answers

What is a key aspect of the approach to technology ethics encouraged by the various ethics codes provided?

<p>An ongoing process of reflection and deliberation on values within a specific context. (B)</p> Signup and view all the answers

Within a mentor/trainee relationship, which dynamic is LEAST likely to cause conflict?

<p>Clarity regarding power dynamics. (C)</p> Signup and view all the answers

Which of the following best describes the initial impact of international influences on the establishment of Research Ethics Committees (RECs)?

<p>They provided a foundational framework, but the specific implementations varied. (D)</p> Signup and view all the answers

Which of these is NOT a key aspect explored in the peer review process?

<p>The procedures for submitting grant proposals. (D)</p> Signup and view all the answers

What does the text suggest about the development of research ethics governance in the USSR compared to Western models?

<p>It adopted a centralized approach as an alternative to Western RECs. (C)</p> Signup and view all the answers

In collaborative science, explicit articulation of assumptions is most vital for which of the following?

<p>To prevent disputes over intellectual property rights. (C)</p> Signup and view all the answers

Which factor does the text indicate as having significantly shaped the evolution of institutional ethics review in the United States?

<p>The overbearing influence of the market logic. (A)</p> Signup and view all the answers

Which of the following BEST describes the European focus on research ethics, as mentioned?

<p>Emphasis on broad general principles along with avoiding negative behaviors. (A)</p> Signup and view all the answers

How did the reunification of Germany affect the development of research ethics governance there?

<p>It revealed significant differences between West and East Germany's approaches. (C)</p> Signup and view all the answers

Which of these is a core tenet of Good Scientific Practice (GSP)?

<p>Ensuring honesty in all forms of scientific communication. (C)</p> Signup and view all the answers

What was a significant outcome of the reported cases of scientific misconduct in Germany?

<p>The creation of an international commission focused on scientific self-regulation. (A)</p> Signup and view all the answers

What is the main point that the authors make regarding the geographical coverage in their special issue?

<p>It includes different countries but some still need research. (B)</p> Signup and view all the answers

How does the European perspective on research ethics differ from that of the United States, based on the text?

<p>Europe focuses more on the social impact of science. (B)</p> Signup and view all the answers

Which aspect of REC establishment does the text emphasize as a point of national divergence?

<p>Their role and political functions in each society. (C)</p> Signup and view all the answers

What does the text suggest is a result of the tensions regarding the functions of RECs?

<p>The emergence of various solutions in different national settings. (D)</p> Signup and view all the answers

According to the content, which nation was the first in Europe to establish a national entity to oversee scientific dishonesty?

<p>Denmark (C)</p> Signup and view all the answers

What is the primary purpose of the focus on both collaboration and competition in the research context?

<p>To encourage a balance between individual achievement and shared progress. (C)</p> Signup and view all the answers

What was the primary catalyst for the establishment of RECs in Switzerland and Canada during the 1960s and 1970s?

<p>Concerns voiced by the international medical community (D)</p> Signup and view all the answers

How did the ideological principles of the USSR affect its approach to research ethics governance, according to the text?

<p>They shaped an alternative, centralized system, different to Western models (A)</p> Signup and view all the answers

Besides geographical representation, what other aspect of the research does the text indicate as needing further exploration for new insights?

<p>The cultural context of these national research ethics programs. (C)</p> Signup and view all the answers

How does the concept of 'ethics as guidance' differ from the traditional 'ethical assessment' model?

<p>Ethical assessment sees ethics as an external assessor of technology, while guidance ethics places ethics within the technological development process. (D)</p> Signup and view all the answers

What is a key characteristic of 'ethics from within' as it relates to technology?

<p>It acknowledges that ethical frameworks evolve alongside technological developments. (C)</p> Signup and view all the answers

What’s the primary question should 'guidance ethics' address when dealing with technology?

<p>How can this technology be responsibly integrated into society? (D)</p> Signup and view all the answers

What aspect does guidance ethics consider most important when examining the impact of technology?

<p>The concrete effects and consequences of specific technology applications within a societal domain. (B)</p> Signup and view all the answers

In the context of guidance ethics, what does a thorough inventory of a technology's effects involve?

<p>Considering impacts across various societal structures, such as education and law enforcement. (A)</p> Signup and view all the answers

When is the consideration of societal implications most important when evaluating new technologies?

<p>As a crucial part of the ethics from within approach, even before design. (D)</p> Signup and view all the answers

How does the text describe the relationship between ethics and technology in the 'ethics from within' perspective?

<p>Ethics is interwoven with technology, influencing its development and societal interactions. (B)</p> Signup and view all the answers

What is the central focus of the deliberative process within guidance ethics?

<p>Identifying the potential societal implications and the values at stake when implementing a technology. (D)</p> Signup and view all the answers

Which statement best reflects the evolving nature of ethical frameworks in relation to technology, as discussed in the text?

<p>Ethical frameworks develop and interact with new technologies. (C)</p> Signup and view all the answers

When applying ethics guidance on technology, what should the analysis focus on?

<p>Specific technological applications and their impacts within a particular industry. (D)</p> Signup and view all the answers

Flashcards

Medical Research Ethics Committee (MREC)

An ethics committee that reviews research involving human subjects to ensure ethical conduct and protect participant safety.

WMO Research

A type of research protocol that involves procedures or rules of behavior imposed on participants, often involving interventions or testing.

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

The principle stating that the well-being and interests of research participants should take precedence over any other considerations.

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Nuremberg Code

A set of ethical guidelines for human experimentation established after the Nuremberg Trials. It emphasizes voluntary participation, informed consent, and the right to withdraw from research.

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Safety in Research

Potential risks to participants' physical or emotional well-being during research. This includes the potential for physical harm, discomfort, psychological stress, or emotional distress.

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Assessment of Research Protocols

The process of reviewing research protocols to assess potential risks and benefits to human participants, ensuring ethical conduct, and protecting their well-being.

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Research Ethics Review

The process of reviewing research proposals to ensure ethical conduct and protect the well-being of participants.

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Technology Effect Analysis

Analyzing how a technology impacts various aspects, taking into account its positive and negative sides, direct and indirect consequences, and effects on different individuals and groups.

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Research Ethics Committee (REC)

A committee responsible for reviewing research proposals and ensuring ethical conduct in research involving human subjects.

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Technology Value Identification

Identifying the core values that are at play when evaluating a technology, for example, justice, autonomy, or privacy.

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Research Ethics Governance

The principles and guidelines that govern the ethical conduct of research involving human subjects.

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Technology Effect Types

Understanding the potential positive and negative consequences of using a technology.

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International Influences on Research Ethics

The influence of international actors and organizations on the development of research ethics governance in various countries.

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Technology Effect Levels

The impact of technology on different levels: individual, social, and societal.

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National Tensions in Research Ethics

The tensions and conflicts that arise when implementing research ethics governance in specific national contexts.

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Making Values Explicit

Explicitly acknowledging the values that guide technological development and use, ensuring ethical considerations are prioritized.

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Political and Societal Influences on Research Ethics

The impact of political and societal factors on the interpretation and implementation of research ethics regulations.

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Centralized State Model of Research Ethics

A model of research ethics governance that emphasizes centralized control by the state rather than independent ethical review committees.

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Market-Driven Model of Research Ethics

A model of research ethics governance primarily driven by market logic and commercial interests.

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Dynamic Nature of Research Ethics

The ongoing evolution and adaptation of research ethics governance in response to changing societal and technological landscapes.

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Multicultural Research Ethics

The need for a broader and more inclusive representation of diverse geographical contexts in the study of research ethics.

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Mentor/Trainee Relationship

A structured relationship where one individual provides guidance, support, and knowledge to another who is seeking to develop their skills and expertise.

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Collaboration vs. Competition in Research

The tension that exists between collaborating with others and competing for recognition and resources in scientific research. It is particularly relevant in peer review processes where researchers evaluate each other's work.

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Peer Review Process

A process used to evaluate the quality and originality of research papers and grant proposals. Researchers assess each other's work, ensuring scientific rigor and upholding ethical standards.

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Research Conduct and Ethics (RCR)

A set of ethical principles and practices that guide researchers in conducting their work with integrity and responsibility. It emphasizes honesty, accuracy, transparency, and adherence to scientific methods.

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Good Scientific Practice (GSP)

A type of research ethics framework that focuses on broad principles and positive research behaviors. It emphasizes integrity, reliability, objectivity, fairness, and responsibility in scientific practice.

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Openness and Accessibility in Research

A principle in research ethics that emphasizes openness, transparency, and collaboration in sharing research findings and data. It encourages researchers to make their results accessible to others to promote scientific advancement.

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Scientific Dishonesty

A type of scientific misconduct that involves intentionally falsifying, fabricating, or plagiarizing research data or findings. It undermines the integrity of scientific research and erodes public trust.

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Danish Committee on Scientific Dishonesty

A national body established in Denmark to investigate and handle cases of scientific misconduct. It aims to promote good scientific practices and ensure accountability in research.

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International Commission on Professional Self-Regulation in Science

An international commission formed by the German Research Council to address issues related to professional self-regulation in science. It focuses on maintaining ethical standards and promoting responsible research practices.

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Guidance Ethics

A new approach to ethics that focuses on guiding the responsible integration of technology into society, rather than simply judging its acceptability.

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Social Implications of Technology

Ethics that considers the potential consequences of technology for various aspects of society, such as education, healthcare, and law enforcement.

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Deliberative Process

A process where stakeholders engage in discussion and deliberation to understand and address the ethical implications of technology.

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Evolving Ethical Frameworks

The idea that ethical frameworks themselves evolve in response to technological advancements.

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Concrete Technology Focus

An ethical approach that emphasizes the need to start with concrete technologies and their specific effects on society, rather than making generalizations about technology as a whole.

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How? Question in Guidance Ethics

The central question in guidance ethics, focusing on how a technology can be responsibly integrated into society instead of simply accepting or rejecting it.

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Inventory of Social Impacts

The process of examining the possible effects and consequences of a technology, considering its potential benefits and risks.

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Central Values in Guidance Ethics

The core values that are at stake when considering the ethical implications of technology.

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Evolving Definition of Privacy

The understanding of privacy evolves in relation to changing technologies and the shifting boundaries between private and public spaces.

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Ethics From Within

Ethics that stems from within the technological context itself, rather than being imposed from outside.

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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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