2. • The application of moral rules and professional codes of
conduct to the collection, analysis, reporting, and
publication of information about research subjects, in
particular active acceptance of subjects' right to privacy,
confidentiality, and informed consent
• A paramount issue in those experiments which involve
human subjects
2
3. • Birth of modern research ethics: Nuremberg (1946- 1947)
Nuremberg Code (1947):
• 23 Nazi physicians were trialed
• Arose out of post-WWII trial of Nazi doctors for crimes
against humanity
• Deals with medical research on human subjects
3
4. 1. Research participants must voluntarily consent to
research participation
2. Research aims should contribute to the good of society
3. Research must be based on sound theory and prior
animal testing
4. Research must avoid unnecessary physical and mental
suffering
4
5. 5. No research projects can go forward where serious
injury and/or death are potential outcomes
6. The degree of risk taken with research participants
cannot exceed anticipated benefits of results
7. Proper environment and protection for participants
is necessary
5
6. 8. Experiments can be conducted only by scientifically
qualified persons
9. Human subjects must be allowed to discontinue their
participation at any time
10. Scientists must be prepared to terminate the
experiment if there is cause to believe that continuation
will be harmful or result in injury or death
7. • Ethical principles
– Respect for the Dignity of Person
– Beneficence & Non-maleficence
– Justice
– Respect for the Environment
7
8. Principles
• Do good (known as beneficence)
• Do no harm (known as non-malfeasance)
– Informed consent
– Minimize risk of harm to participants
• Protect their anonymity and confidentiality
• Avoid using deceptive practices; and
• Right to withdraw from research
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9. PRINCIPLE ONE-Minimizing the risk of
harm
• Physical harm to participants.
• Psychological distress and discomfort.
• Social disadvantage.
• Harm to participants? financial status.
• An invasion of participants? privacy and anonymity
9
10. • Obtaining informed consent from participants.
• Protecting the anonymity and confidentiality of
participants.
• Avoiding deceptive practices when designing your
research.
• Providing participants with the right to withdraw from
your research at any time.
10
11. PRINCIPLE TWO-Obtaining informed
consent
• Informed consent-principle that participants should
be volunteers, taking part without having
been coerced and deceived
• Informed consent is not necessarily needed
certain educational, organizational and naturalistic
research settings
11
12. • Participants should understand that
– They are taking part in research and
– What the research requires of them
– Purpose of the research,
– The methods being used,
– The possible outcomes of the research
– Associated demands, discomforts, inconveniences and
risks that the participants may face
12
13. PRINCIPLE THREE-Protecting
anonymity and confidentiality
• Information of a private or sensitive nature
• Data collected from research participants needs to
be kept confidential or anonymous
• Permissions should be sought before such
confidential information is disclosed
13
15. PRINCIPLE FIVE-Providing the right to
withdraw
• Research participants should always have the right to
withdraw from the research process
• Right to withdraw at any stage in the research process.
• When a participant chooses to withdraw from the research
process, they should not be pressured or coerced in any way
to try and stop them from withdrawing
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16. Respect for the Dignity of Persons
• Respect for the autonomy of persons,
• The active protection of persons
• No research should prevail over for human rights,
fundamental freedoms and human dignity.
16
17. Beneficence & Non-maleficence
• Beneficence: Do Good
• Non-maleficence: Safeguarding against possible
harms and abuses (Do no harm)
17
18. Justice
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• It requires that persons in similar circumstances be
treated alike
• It also requires the equitable distribution of the
burdens and benefits of research
19. Respect for Environment
• Proper and safe disposal of biologically hazardous waste from
research
• Safeguard the cultural, including religious and linguistic,
heritage of communities and persons
• Treat with respect domestic and wild animals in the context of
research
19
20. Informed Consent
• At first inform what we are going to do with
research participants, then take their consent.
• Intent of the study
• Possible benefits and risk
• Chance of withdrawn during the research
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21. Institutional Review Board
• Independent ethics committee/ Ethical review board
• Designated to approve, monitor, and review
biomedical and behavioural research involving
humans
• Attempts to ensure protection of subjects by
reviewing research protocols and related materials
21
22. 22
• Established in Institute of medicine: 2004
• Objective: To do an ethical review of the proposals
submitted by the faculties and the students within
the institute
23. • Defines the fabrication, falsification, or plagiarism in
proposing, performing, or reviewing research, or in
reporting research results.
• Research misconduct does not include honest error
or differences of opinion
(Office of Scientific and Technology Policy:OSTP, 2000)
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24. • Fabrication: Making up data or results and recording
or reporting them
• Falsification: Manipulating research materials,
equipment, or processes, or changing or omitting
data or results such that the research is not
accurately represented in the research record
24
25. • Plagiarism:
– Appropriation of another person’s ideas,
processes, results, or words without giving
appropriate credit.
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Editor's Notes
moral principles that govern a person's behaviour or the conducting of an activity……………….. the branch of knowledge that deals with moral principles
Nuremberg code: Ethical principles
The atrocities committed by Nazi physicians on Jewish prisoners during World War II prompted an international tribunal, convened in the city of Nuremberg, Germany between 1945-1946, to elaborate 10 principles, called the Nuremberg Code, by which research involving human subjects should be governed. Publication of the Nuremburg Code in 1947 ushered in the modern era of research ethics,
1. 1. decision making right remains in patient…………….active protection regarding confidentility, physixally and mentally……….
Obligation to maximize possible benefits and to minimize possible harms and wrongs
) i.e. protecting the health of the participants and their communities
1.and that differences between persons due to circumstances be acknowledged and addressed
Informed Consent is a voluntary agreement to participate in research. It is not merely a form that is signed but is a process, in which the subject has an understanding of the research and its risks
