Helsinki Declaration: Ethical Principles in Biomedical Research
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Questions and Answers

What was the primary motivation behind the birth of modern research ethics?

  • To advance the field of biomedical research
  • To ensure a high ethical standard in biomedical research
  • To promote the use of animal experimentation in research
  • To protect human subjects involved in research projects (correct)

    • What is the primary purpose of Institutional Review Boards (IRBs) in research ethics?

  • To enforce confidentiality and anonymity in research data
  • To approve research projects that involve animal experimentation
  • To monitor and ensure compliance with research protocols (correct)
  • To educate researchers on ethical standards

    • What is the fundamental principle of informed consent in research ethics?

  • The researcher's duty to obtain written consent from participants
  • The researcher's right to conduct research without interference
  • The participant's right to remain anonymous throughout the study
  • The participant's right to withdraw from the study at any time (correct)

    • What is the primary concern of research ethics in regards to animal experimentation?

    <p>The reduction of animal suffering and distress</p> Signup and view all the answers

    What is the primary role of Research Ethics in biomedical research?

    <p>To provide guidelines for the responsible conduct of research</p> Signup and view all the answers

    What is the primary consequence of violating Ethical Principles in research?

    <p>Harm to human subjects or animal participants</p> Signup and view all the answers

    What is the primary purpose of confidentiality and anonymity in research ethics?

    <p>To ensure the privacy of research participants</p> Signup and view all the answers

    What is the primary difference between Ethics and Morality in the context of research ethics?

    <p>Ethics are governed by professional guidelines, while Morality is based on personal values</p> Signup and view all the answers

    What is the primary responsibility of researchers in regards to research participant rights?

    <p>To ensure the safety and well-being of participants</p> Signup and view all the answers

    What is the primary goal of Research Ethics in promoting the responsible conduct of research?

    <p>To protect human subjects and animal participants</p> Signup and view all the answers

    Study Notes

    Helsinki Declaration

    • Lays out basic ethical principles for conducting biomedical research and specifies guidelines for research conducted by a physician or within a clinical setting.
    • Unique principles include:
      • Necessity of using an independent investigator to review potential research projects.
      • Employing a medically qualified person to supervise research and assume responsibility for human subjects' health and welfare.
      • Importance of preserving the accuracy of research results.
      • Guidelines for obtaining informed consent from research participants.
      • Rules for research with children and mentally incompetent persons.
      • Evaluating and using experimental treatments on patients.
      • Determining which medical situations and conditions are appropriate and safe for research.

    Encouraging Participation Ethically

    • Anonymity: promise and keep promises of anonymity, and reassure people that personal information will not be shared with the media.
    • Confidentiality: guarantee that no individual will be identifiable in research reports, publications, and tables.
    • Informed Consent: provide participants with information about the research purpose, procedures, potential risks, benefits, and confidentiality.

    Institutional Review Board (IRB)

    • A board consisting of professionals and lay people review research proposals to ensure ethical standards.
    • Researcher must submit a research protocol to the IRB for review.
    • Three main categories of review: exempt studies, expedited review, and full board review.
    • Educational research often falls into the exempt category, but it is still essential to follow ethical guidelines.

    Imperatives for Animal Use

    • Nuremberg Code (1947): experiments on humans should be based on results of animal experimentation.
    • Declaration of Helsinki (1964): medical research on humans should be based on adequately performed laboratory and animal experimentation.
    • Animal rights: theorists equate animal lives with human lives, and believe humans do not have the right to use animals.
    • Animal welfare: believe animals have a right not to suffer needlessly.
    • Animal Welfare Act (1966): provides guidelines and regulations for research with animals.

    Ethics and Morality

    • Ethics: governed by professional and legal guidelines within a particular time and place.
    • Morality: transcends cultural norms and may be guided by a higher covenant.
    • Origin: ethics comes from the Greek word "ethos" meaning "character", and morality comes from the Latin word "mos" meaning "custom".

    Research Ethics

    • Provides guidelines for responsible conduct of biomedical research.
    • Educates and monitors scientists to ensure high ethical standards.
    • Originated from a desire to protect human subjects involved in research projects.
    • The birth of modern research ethics began with the Doctors Trial of 1946-1947.

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    Description

    Learn about the Helsinki Declaration, a set of ethical principles guiding biomedical research, including the role of independent investigators and medically qualified supervisors. Understand the guidelines for physician-conducted research and clinical settings.

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