basic principles of research ethics dr. milind y nadkar professor of medicine seth gs medical...
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Basic Principles ofResearch Ethics
Dr. Milind Y NadkarProfessor of Medicine
Seth GS Medical College &KEM Hospital, Mumbai
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The Belmont Report April 18, 1979
• National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
• To identify the basic ethical principles
• To develop guidelines
• Directed to consider – Boundaries between research and the accepted and
routine practice
– Assessment of risk-benefit criteria
– Guidelines for the selection of human participants
– Nature and definition of informed consent
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National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research
• Boundaries Between Practice and Research
• Basic Ethical Principles– Respect for Persons – Beneficence – Justice
• Applications– Informed Consent – Assessment of Risk and Benefits – Selection of Subjects
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Boundaries Between Practice & Research
• Distinction between research and practice is blurred – Both often occur together – Notable departures from standard practice are
often called ‘experimental’
• When the terms ‘experimental’ and "research" are not carefully defined
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• ‘Practice’
– Interventions that are designed solely to enhance the well-being of an individual patient
– Reasonable expectation of success
– Purpose is to provide diagnosis, preventive treatment or therapy
• ‘Research’
– When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research
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• ‘Research’
– Activity designed to test a hypothesis, permit
conclusions to be drawn, and thereby to develop
or contribute to generalizable knowledge
– Described in a formal protocol that sets forth an
objective and a set of procedures
– Radically new procedures be made the object of
formal research in order to determine whether
they are safe and effective
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Basic Ethical Principles
• Respect for Persons
• Beneficence
• Justice
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Respect for Persons
• Two ethical convictions
– Individuals should be treated as autonomous agents
– Persons with diminished autonomy are entitled to protection
• Two separate moral requirements
– Acknowledge autonomy
– Protect those with diminished autonomy
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Autonomous Person
• Capable of deliberation about personal goals and of acting under the direction of such deliberation
• To respect autonomy – Give weight to autonomous persons' considered opinions
and choices – Refraining from obstructing their actions
• Lack of respect for an autonomoy– Repudiate that person's considered judgments– Deny an individual the freedom to act on those
considered judgments– Withhold information necessary to make a considered
judgment
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Capable of Self-determination ?
• Capacity for self-determination– Matures during an individual's life
– Lose this capacity wholly or in part because of illness, mental disability, or circumstances that severely restrict liberty
• Subjects enter into the research voluntarily and with adequate information
• Not be deprived of the opportunity to volunteer for research
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Beneficence
• Often understood to cover acts of kindness or charity that go beyond strict obligation
• Beneficence is understood in a stronger sense, as an obligation
• General rules
– Do not harm
– Maximize possible benefits and minimize possible harms
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• One should not injure a person regardless of the benefits that might come to others
• Avoiding harm requires learning what is harmful
• Learning what will in fact benefit may require exposing persons to risk
• When it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks
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Justice
• Benefits vs. Burdens of research
• ‘Fairness in distribution’
• Some classes are systematically selected simply because of – Easy availability
– Compromised position
– Manipulability
• Research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research
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ICMR Code
• International Covenant on Civil and Political Rights specifically stated ……
• 'No one shall be subjected to torture or to cruel, inhuman or degrading treatment or punishment. In particular, no one shall be subjected without his consent to medical or scientific treatment.'
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General Statement
• Purpose
– Directed towards the increase of knowledge
– For the betterment of all, especially the least advantaged
• Conducted
– Not mere means for the betterment of others
– Dignity and well being
– Professional fair treatment and transparency
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General Statement contd…
• Evaluation– At all stages of the proposal– Anticipated benefits and dangers– Saving and ensuring the safety of each human
life
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ICMR:Statement of General Principles
• Principles of essentiality– Absolutely essential after a due consideration of
all alternatives
– Considered by an appropriate and responsible body of persons who are external to the particular research
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• Principles of voluntariness, informed consent and community agreement– Participants are fully apprised of the research
and the impact and risk
– Right to abstain from further participation irrespective of any legal or other obligation
– Subject to only minimal restitutive obligations
– A person incompetent to give consent, someone who is empowered and under a duty to act on their behalf
– Continually kept informed of any and all developments
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• Principles of non-exploitation
– In-built mechanism for compensation
– Either through insurance cover or any other
appropriate means to cover all foreseeable and
unforeseeable risks
– Remedial action and comprehensive aftercare
• Principles of privacy and confidentiality
– Does not suffer from any form of hardship,
discrimination or stigmatisation as a
consequence of having participated
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• Principles of precaution and risk minimisation
– Due care and caution is taken at all stages
• Principles of professional competence
– Research is conducted at all times by competent and qualified persons who act with total integrity and impartiality
• Principles of accountability and transparency
– Conducted in a fair, honest, impartial and transparent manner
– Data and notes are retained for such reasonable period
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• Principles of the maximisation of the public
interest and of distributive justice
– Benefit all human kind
– Not just those who are socially better off
– But also the least advantaged
– In particular, the research participants
themselves and or the community from which
they are drawn
• Principles of institutional arrangements
– All the procedures required to be complied with
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• Principles of public domain – brought into the public domain – results are generally made known through
scientific and other publications
• Principles of totality of responsibility – due observance of all the principles, guidelines
or prescriptions laid down generally or in respect of the research
– the researchers, those responsible for funding, and the institution
• Principles of compliance – both the letter and the spirit of these guidelines
are scrupulously observed and duly complied with
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Thank You