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    Ethics in Human Medical Research - v1.1

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    Olivia
    This document discusses the history and development of ethical principles for medical research involving human subjects. It outlines the key ethical principles defined by Hippocrates and how they are still followed today. While early medical researchers like Jenner and Pasteur made advances, their work did not fully respect human rights. It was not until after World War II and the Nuremberg Code that informed consent became a requirement. Since then, various declarations and regulations have been put in place to protect research participants, though new topics require continuous reevaluation of ethics standards.

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    Ethics in Human Medical Research - v1.1

    Uploaded by

    Olivia
    10 views10 pages
    This document discusses the history and development of ethical principles for medical research involving human subjects. It outlines the key ethical principles defined by Hippocrates and how they are still followed today. While early medical researchers like Jenner and Pasteur made advances, their work did not fully respect human rights. It was not until after World War II and the Nuremberg Code that informed consent became a requirement. Since then, various declarations and regulations have been put in place to protect research participants, though new topics require continuous reevaluation of ethics standards.

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    Ethics-in-Human-Medical-Research_v1.1

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    This document discusses the history and development of ethical principles for medical research involving human subjects. It outlines the key ethical principles defined by Hippocrates and how they are still followed today. While early medical researchers like Jenner and Pasteur made advances, their work did not fully respect human rights. It was not until after World War II and the Nuremberg Code that informed consent became a requirement. Since then, various declarations and regulations have been put in place to protect research participants, though new topics require continuous reevaluation of ethics standards.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    10 views10 pages

    Ethics in Human Medical Research - v1.1

    Uploaded by

    Olivia
    This document discusses the history and development of ethical principles for medical research involving human subjects. It outlines the key ethical principles defined by Hippocrates and how they are still followed today. While early medical researchers like Jenner and Pasteur made advances, their work did not fully respect human rights. It was not until after World War II and the Nuremberg Code that informed consent became a requirement. Since then, various declarations and regulations have been put in place to protect research participants, though new topics require continuous reevaluation of ethics standards.

    Copyright:

    © All Rights Reserved
    Download as PPTX, PDF, TXT or read online from Scribd
    Download as pptx, pdf, or txt
    of 10

    European Patients’ Academy

    on Therapeutic Innovation

    Ethics in Human Medical Research


    Ethical Principles of Research
    European Patients’ Academy
    on Therapeutic Innovation

    Hippocrates was the first physician to define the ethical


    principles of research in humans. These principles are still
    valid today:
     Autonomy – to respect the autonomy of the participant or
    of their representative;
     Beneficence – to act always in the best interest of the
    participant;
     Non-maleficence – to do as little harm as possible to the
    participant;
     Justice – to act fairly to all.

    2
    History of ethics in medical research
    European Patients’ Academy
    on Therapeutic Innovation

     In the 18th century Edward Jenner was the pioneer of


    vaccination against infectious diseases, however, his
    research did not respect the principal rights of humans in
    research because these had not yet been defined.
     Louis Pasteur understood the need for comprehensive
    information generated by research in animals before
    exposing a human being to an experiment. Urgent
    patient need was the reason for his first medical
    administration to humans in 1885.

    3
    History of ethics in medical research
    European Patients’ Academy
    on Therapeutic Innovation

     In the 20th century, medical research experienced rapidly


    developing methodology, precision measurements, and
    quick development of new scientific disciplines.
     However, unethical experiments with human beings were
    still being performed in many countries, such as the
    Tuskegee Syphilis Study, conducted between 1932 and
    1972 by the U.S. Public Health Service.
     Some unethical studies were carried out in concentration
    camps during World War II.

    4
    Post-WWII definition of principles of
    ethical research in humans European Patients’ Academy
    on Therapeutic Innovation

     Beginning with the Nuremberg trials in 1947, the


    principles of ethical research in human beings were
    defined based on the voluntary informed consent of
    research participants.
     The United Nations (UN) and World Health Organization
    (WHO) followed with a focus on the priority of the
    wellbeing of the individual over the interests of the
    patients at large.

    5
    Declaration of Helsinki
    European Patients’ Academy
    on Therapeutic Innovation

     In 1961, public opinion around the world was shocked by


    the Thalidomide scandal. 2,000 children died and
    10,000 children were seriously disabled.
     Government Authorities were then required to take
    action and make regulatory arrangements to oversee the
    testing of new medicines.
     In 1964, the World Medical Association (WMA)
    developed and indeed continues to review and adapt
    the Declaration of Helsinki as a guide for performing
    research in human beings.

    6
    Regulation and Autonomy
    European Patients’ Academy
    on Therapeutic Innovation

     During the last sixty years, there has been rapid


    emergence of different codes, regulations, and Acts to
    govern ethical research in humans.
     As medical experimentation moved into the public
    domain, decisions previously left to the conscience of
    individual doctors came under collective surveillance.
     A new balance of authority and an increase in autonomy
    began to be observed between researcher and research
    participant.

    7
    New Research Topics
    European Patients’ Academy
    on Therapeutic Innovation

    The progress of science and technology has led to


    continued development of ethical principles and guidelines
    as a variety of different new research topics continues to
    expand, for example,
     assisted reproduction,
     stem-cell research,
     prenatal diagnostics.

    8
    Safety and Protection of Clinical Trial
    Participants European Patients’ Academy
    on Therapeutic Innovation

     The assessment of trial applications by research ethics


    committees and National Competent Authorities helps to
    ensure the well-being, safety, and protection of persons
    who participate in clinical trials.
     It is in the best interest of all stakeholders (including
    patient representatives) to cooperate to improve the
    ethical conduct of clinical trials.

    9
    References
    European Patients’ Academy
    on Therapeutic Innovation

    World Medical Association (2013) WMA Declaration of


    Helsinki – Ethical principles for medical research involving
    human subjects. Online. Retrieved 28 July, 2015,
    from: http://www.wma.net/en/30publications/10policies/b3/

    10

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