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    Bioethics

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    rajx2shekhar
    Bioethics is the study of ethics related to biology and medicine. It deals with moral issues arising from new discoveries and technologies in fields like genetics and drug development. The principles of ethical research include ensuring social and scientific value of research, independent review, fair subject selection, favorable risk-benefit ratio, informed consent, and respect for subjects. Bioethics aims to guide controversial areas like stem cell research, gene therapy, and clinical trials to protect patients and public health.

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    Bioethics

    Uploaded by

    rajx2shekhar
    3 views19 pages
    Bioethics is the study of ethics related to biology and medicine. It deals with moral issues arising from new discoveries and technologies in fields like genetics and drug development. The principles of ethical research include ensuring social and scientific value of research, independent review, fair subject selection, favorable risk-benefit ratio, informed consent, and respect for subjects. Bioethics aims to guide controversial areas like stem cell research, gene therapy, and clinical trials to protect patients and public health.

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    Bioethics is the study of ethics related to biology and medicine. It deals with moral issues arising from new discoveries and technologies in fields like genetics and drug development. The principles of ethical research include ensuring social and scientific value of research, independent review, fair subject selection, favorable risk-benefit ratio, informed consent, and respect for subjects. Bioethics aims to guide controversial areas like stem cell research, gene therapy, and clinical trials to protect patients and public health.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    3 views19 pages

    Bioethics

    Uploaded by

    rajx2shekhar
    Bioethics is the study of ethics related to biology and medicine. It deals with moral issues arising from new discoveries and technologies in fields like genetics and drug development. The principles of ethical research include ensuring social and scientific value of research, independent review, fair subject selection, favorable risk-benefit ratio, informed consent, and respect for subjects. Bioethics aims to guide controversial areas like stem cell research, gene therapy, and clinical trials to protect patients and public health.

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    © All Rights Reserved
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    Download as pdf or txt
    of 19

    01

    BIOETHICS
    02

    WHAT IS ETHICS?

    Justified principles and values.


    Convincing argument.
    Character and virtues that produce trust.
    03

    WHY ETHICS
    MATTERS?
    Ethics leads the law.
    Ethics is what people care about
    when it comes to medicine and
    biotechnology!
    Duty to protect patients and public
    health.
    Those who pursue health have a
    higher moral standard to meet.
    04

    Bioethics is the study of typically


    controversial ethics brought
    about by advances in biology and
    WHAT IS medicine.
    BIOETHICS? Bioethics are moral and ethical
    choices faced in medical research
    and in the treatment of patients.
    Bioethics are largely involved with
    advanced technology
    05
    DEALS WITH THE:

    Exploration of moral and ethical questions surrounding life,


    health, science, medicine and the environment
    study and consideration of what is right and wrong in biological
    advances and activities such as genetic engineering, the
    transplantation of organs and the care of the terminally ill.
    06

    The study of the ethical and moral implications of new


    biological discoveries and biomedical advances — as in
    the fields of genetic engineering and drug research
    07

    THE 21ST CENTURY WILL BE THE CENTURY


    OF BIOLOGY AND THE LIFE SCIENCES.

    BUT WE ARE NOT READY TO RESPOND TO


    THE ETHICAL CONCERNS PEOPLE
    WORLDWIDE HAVE ABOUT THIS FACT!
    08
    ETHICAL FAILURE CAN KILL
    BIOTECH:

    Fetal tissue research


    Gene therapy
    Stem cell research
    GMO foods
    Research in the third world
    09

    MODELS FOR MANAGING


    PROACTIVE PRODUCT
    MANAGEMENT IN BIOETHICS:
    Hacking
    Fire fighting (smoke jumpers)
    Audit and educate
    Policy/Code formulation
    10

    EXAMPLES OF
    INFLUENTIAL CODES OF Nuremberg Code (1947)
    ETHICS AND Declaration of Helsinki
    REGULATIONS THAT (2000)
    GUIDE ETHICAL Belmont Report (1979)
    CLINICAL RESEARCH: CIOMS (2002)
    U.S. Common Rule (1991)
    WHAT MUST INVESTORS, 11

    CEOS, BOARDS AND


    AUDITORS DO?

    Due Diligence
    Understand bioethics
    Prepare clients to cope
    Enter public policy debates over ethics
    12

    PRINCIPLES OF ETHICAL RESEARCH:

    Using these sources of guidance and others, seven main principles


    have been described as guiding the conduct of ethical research:-

    1. Social and clinical value:


    Every research study is designed to answer a specific question.
    2. Scientific validity: 13

    This includes considering whether the question researchers are


    asking is answerable, whether the research methods are valid
    and feasible.

    3. Fair subject selection


    The primary basis for recruiting and enrolling groups and
    individuals should be the scientific goals of the study — not
    vulnerability, privilege, or other factors unrelated to the purposes
    of the study.
    14

    4. Independent Review:
    To minimize potential conflicts of interest and make sure a study is
    ethically acceptable before it even starts, an independent review panel
    with no vested interest in the particular study should review the
    proposal and ask important questions, including: Are those conducting
    the trial sufficiently free of bias? Is the study doing all it can to protect
    research volunteers?
    15

    6. Informed consent:
    For research to be ethical, most agree that individuals should make
    their own decision about whether they want to participate or continue
    participating in research.
    This is done through a process of informed consent in which
    individuals-
    Are accurately informed of the purpose, methods, risks, benefits,
    and alternatives to the research,
    Understand this information and how it relates to their own clinical
    situation or interests, and
    Make a voluntary decision about whether to participate.
    16

    7. Respect for potential and enrolled subjects:


    Individuals should be treated with respect from the time they are
    approached for possible participation—even if they refuse enrollment
    in a study—throughout their participation and after their participation
    ends.
    Bioethics provides reasoned and defensible solutions that
    incorporate ethical principles for actual or anticipated moral
    dilemmas facing clinicians in medicine and biology.
    THANK YOU!

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