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    Principles of Human Research Ethics

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    Exjack Reinter
    This document summarizes several key guidelines and principles of human research ethics: 1) The Belmont Report outlines three basic ethical principles - respect for persons, beneficence, and justice. It also discusses informed consent and risk/benefit assessments. 2) International guidelines like the CIOMS/WHO and ICH GCP guidelines provide standards for ethical review and informed consent in clinical trials to protect research participants. 3) Regulations like the Common Rule and European Clinical Trials Directive establish policies for obtaining consent from vulnerable populations and assessing risks and benefits of research.

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    Principles of Human Research Ethics

    Uploaded by

    Exjack Reinter
    30 views13 pages
    This document summarizes several key guidelines and principles of human research ethics: 1) The Belmont Report outlines three basic ethical principles - respect for persons, beneficence, and justice. It also discusses informed consent and risk/benefit assessments. 2) International guidelines like the CIOMS/WHO and ICH GCP guidelines provide standards for ethical review and informed consent in clinical trials to protect research participants. 3) Regulations like the Common Rule and European Clinical Trials Directive establish policies for obtaining consent from vulnerable populations and assessing risks and benefits of research.

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    This document summarizes several key guidelines and principles of human research ethics: 1) The Belmont Report outlines three basic ethical principles - respect for persons, beneficence, and justice. It also discusses informed consent and risk/benefit assessments. 2) International guidelines like the CIOMS/WHO and ICH GCP guidelines provide standards for ethical review and informed consent in clinical trials to protect research participants. 3) Regulations like the Common Rule and European Clinical Trials Directive establish policies for obtaining consent from vulnerable populations and assessing risks and benefits of research.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    30 views13 pages

    Principles of Human Research Ethics

    Uploaded by

    Exjack Reinter
    This document summarizes several key guidelines and principles of human research ethics: 1) The Belmont Report outlines three basic ethical principles - respect for persons, beneficence, and justice. It also discusses informed consent and risk/benefit assessments. 2) International guidelines like the CIOMS/WHO and ICH GCP guidelines provide standards for ethical review and informed consent in clinical trials to protect research participants. 3) Regulations like the Common Rule and European Clinical Trials Directive establish policies for obtaining consent from vulnerable populations and assessing risks and benefits of research.

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    Principles

    of Human Research
    Ethics
    Dr. Jonathan D. Moreno
    Coursera: Neuroethics
    THE BELMONT REPORT
    National Commission for the Protection of
    Human Subjects of Biomedical and
    Behavioral Research 1979

    A. Boundaries between research and practice


    B. Ethical principles underlying the conduct of
    research:
    Respect for persons
    Beneficence
    Justice
    Respect for Persons
    Individuals should be treated as autonomous
    agents (capable of self-determination)
    Persons with diminished autonomy deserve
    protection
    Application: Informed consent

    Benecence
    Do no harm
    Maximize possible benefits and minimize
    possible harms
    Application: Risk/Benefit assessment
    Jus>ce
    Fairness in the distribution of the benefits and
    burdens of research (distributive justice)
    Application:
    Fair procedures and outcomes in the selection of
    subjects
    Protection of vulnerable subjects
    Equitable health care system?
    45CFR.46 Protec>on of Human
    Subjects
    PHS policy (1966)
    National Research Act (1974)
    DHEW regulations (1981)
    Part A is the Common Rule for 17 Federal
    agencies (1991)
    Parts B,C,D for vulnerable populations
    International Ethical Guidelines for Biomedical
    Research Involving Human Subjects

    CIOMS/ WHO 2002
    Effective application of the Helsinki principles
    to developing countries
    Proposed guidelines 1982, Guidelines for
    ethical review of epidemiological studies 1991,
    and revised International guidelines 1993,
    currently undergoing revision
    International Ethical Guidelines for Biomedical
    Research Involving Human Subjects

    15 Guidelines with extensive commentary
    Informed consent
    Research involving children, persons with
    mental or behavioral disorders, prisoners,
    subjects in underdeveloped communities,
    pregnant women
    Externally sponsored research
    International Ethical Guidelines for Biomedical
    Research Involving Human Subjects

    Responsiveness to the health needs and
    priorities of the community
    Reasonable availability
    Rights of subjects to compensation for
    research injury
    ICH Harmonised Tripar>te Guideline-
    GCP, 1996
    Objective: to provide a unified standard for the
    European Union, Japan, and the U.S.for
    mutual acceptance of clinical data by
    regulatory authorities
    GCPan international ethical and scientific
    quality standard for designing, conducting,
    recording, and reporting trials that involve the
    participation of human subjects
    ICH-Guideline for Good Clinical
    Prac>ce

    Compliance with this standard provides


    public assurance that the rights, safety, and
    well-being of trial subjects are protected,
    consistent with the principles that have their
    origin in the Declaration of Helsinki, and that
    the clinical data are credible
    European Union Clinical Trials
    Direc>ve, 2001
    Risk assessment, ethics committee review,
    protection of personal data
    Persons incapable of giving legal consent only
    included when grounds for expecting direct
    benefit, outweighing the risks
    Children should be protected but medicinal
    products likely to be of value should be tested
    European Union Clinical Trials
    Direc>ve, 2001
    Others incapable of giving consent should only
    be involved when grounds for assuming that
    direct benefits outweigh risks
    Written consent by legal representative in
    cooperation with treating doctor
    Participant must consent to scrutiny of
    personal information

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