medical ethics Dr. Rami Abo Ali

1. MEDICAL ETHICS
AND
LEGAL MEDICINE
Dr. Rami Abo Ali
Medical
Ethics
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Dr.
Rami
Abo
Ali
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2. ETHICS IN MEDICAL RESEARCH
Medical
Ethics
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Dr.
Rami
Abo
Ali
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3. WHAT IS RESEARCH?
 The term "medical research" or "clinical research," refers to
research that is done to learn more about human health.
 It aims to find better ways to prevent and treat diseases.
 Medical research is an important way to help improve the
care and treatment of people worldwide.
 The development of new medical treatments and cures
would not happen without health research and the active
role of research volunteers.
 Behind every discovery of a new medicine and treatment are
thousands of people who were involved in health research
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Medical
Ethics
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Dr.
Rami
Abo
Ali

4. RESEARCH AIMS
 To contribute to enriching health knowledge
 Improve the level of health care
 The expected benefits from scientific research outweigh the
expected harm to the patient or the community.
 That the scientific research conform to the principles of ethics
, and that the noble end be not justified by an immoral
method.
 That the research hypothesis and its outputs do not
contradict the ethical framework and principles of human
protection and the society in which they live.
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Rami
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5.  Phases of research
 Planning and designing research
 Research implementation
 Reviewing research
 Reporting research result
 Dimensions of research
 Data collection, use, and interpretation
 Relationships among researchers
 Relationships between researchers and those that will be
affected by their research
 Reporting methods
 Responding to disputes or misconduct
 Promoting ethical integrity in research 5
Medical
Ethics
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Dr.
Rami
Abo
Ali

6. CRITERIA OF “GOOD” SCIENCE RESEARCH
 Systematic:
 The research developed, implemented and reported in a
systematic manner.
 Methodological:
 Adopt & use skillfully the research methods, materials,
approaches in order to ensure reliability of the results &
findings.
 Scientific:
 The research should be scientifically sound through
utilizing scientific approaches, tools and techniques.
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Medical
Ethics
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Dr.
Rami
Abo
Ali

7. WHAT MAKES RESEARCH ETHICAL?
1) Social or Scientific Value
2) Scientific Validity
3) Good Subject Selection
4) Favorable Risk-Benefit Ratio
5) Independent Review
6) Informed Consent
7) Respect for the potential and enrolled subjects
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Medical
Ethics
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Dr.
Rami
Abo
Ali

8. DEFINITION OF HUMAN SUBJECTS RESEARCH
 A human subject is "a living individual about whom an
investigator (whether professional or student) conducting
research:
 Data through intervention or interaction with individual
 Identifiable private information
 Intervention
 Includes both physical procedures by which data are
gathered (for example, venipuncture) and manipulations
of the subject or the subject’s environment that are
performed for research purposes.
 Interaction
 Includes communication or interpersonal contact between
investigator and subject.
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Medical
Ethics
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Dr.
Rami
Abo
Ali

9. HISTORY OF RESEARCH ETHICS
 The Code of Hammurabi was one of the earliest and most
complete written legal codes and was proclaimed by the
Babylonian king Hammurabi, who reigned from 1792 to 1750
B.C.
 "an eye for an eye, a tooth for a tooth"
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Medical
Ethics
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Dr.
Rami
Abo
Ali

10. HISTORY OF RESEARCH ETHICS
 Pre-World War II:
 Research standards left up to the discretion of the individual
researcher
 18Th and 19thCenturies
 James Lind “scurvy study in sailors - Salisbury
 Edward Jenner cowpox vaccine test
 1897 Giuseppe Sanarelli yellow fever test
 1900 Walter Reed established several [first ever]
“safeguards”
 Self-experimentation
 Only adults would be enrolled in research
 Written informed consent
 Reimbursement (inducement)
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Medical
Ethics
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Dr.
Rami
Abo
Ali

11. HISTORY OF RESEARCH ETHICS
 World War II:
 Nazi Doctors’ Experimentation
 Experiments conducted on inmates of Nazi concentration
camps
 1945-1949:Trials in Nuremberg, Germany– physicians
convicted of crimes against humanity
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Medical
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Rami
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Ali

12. NUREMBERG CODE
1. Voluntary human consent is essential.
2. Experimental results should result in good for society.
3. Anticipated results should justify the experiment.
4. Avoid all necessary physical and mental suffering
5. No experiment if there is a chance of death/disability
6. Minimize risk of subjects
7. Proper preparations and facilities to protect subjects
8. Experiments conducted only by qualified persons
9. Subjects can withdraw at anytime
10. Terminate experiment if results are known or with best
judgment. 12
Medical
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Dr.
Rami
Abo
Ali

13. HISTORY OF RESEARCH ETHICS
 TUSKEGEE SYPHILIS STUDY, ALABAMA ( 1932 – 1972 )
 More than 400 AfricanAmerican men with latent syphilis were
followed for the natural course of the disease rather than
receiving treatment.
 Continued after penicillin available 1947
 By that time, 28 participants had perished from syphilis, 100
more had passed away from related complications, at least 40
spouses had been diagnosed with it and the disease had been
passed to 19 children at birth.
 In the wake of the scandal Congress passed the National
Research Act of 1974 which required more stringent oversight of
studies employing human subjects.
 In 1997, on behalf of the federal government, President Bill
Clinton issued a formal apology to the victims of the Tuskegee
Syphilis Experiment.
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Medical
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Dr.
Rami
Abo
Ali

14.  Tuskegee Syphilis Study
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Abo
Ali
Subject blood draw, c. 1953 1997 apology

15. HISTORY OF RESEARCH ETHICS
 The Belmont Report (1979)
 1972: the public became aware of the Tuskegee study
 1974: the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research was
established.
 1978: the commission submitted its report titled, The
Belmont Report: Ethical Principles and Guidelines for the
Protection of Human Subjects of Research.
 Those principles respect for persons, beneficence and justice
are accepted as the 3 fundamental principles for the ethical
conduct of research involving human participants.
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Medical
Ethics
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Dr.
Rami
Abo
Ali

16. CORE ETHICAL PRINCIPLES/ISSUES IN RESEARCH
 Respect for people’s autonomy
 the duty to respect people’s ability to make decisions on issues
related to their health and their body, if they are competent to
make such decisions; and the duty to protect individuals with
impaired or diminished autonomy
 Beneficence
 The moral duty to pursue actions that promote the well-being
of others and the ethical obligation to maximize benefit and
to minimize harm
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Medical
Ethics
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Dr.
Rami
Abo
Ali

17. CORE ETHICAL PRINCIPLES/ISSUES IN RESEARCH
 Non maleficence
 The moral duty not to cause harm to others through
interventions
 Justice
 Primarily distributive justice, which requires equitable
distribution of benefits and burdens, i.e. distribution such
that no segment of the population is unduly burdened by
the harms of research or denied the benefits of the
knowledge generated from it
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Medical
Ethics
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Dr.
Rami
Abo
Ali

18. CORE ETHICAL PRINCIPLES/ISSUES IN RESEARCH
 Vulnerability
 A status in which some people may struggle to protect
their interests or be at greater risk of being exploited.
 This situation is usually linked to specific physical,
financial, educational or social circumstances.
 Groups considered as vulnerable vary by guideline, but
children, mentally retarded and handicapped people,
prisoners, refugees, terminally ill patients and women
are often cited as the prime vulnerable groups.
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Medical
Ethics
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Dr.
Rami
Abo
Ali

19. CORE ETHICAL PRINCIPLES/ISSUES IN RESEARCH
 Informed consent
 A process whereby potential research participants decide
whether they want to participate in the proposed study
after receiving information about it.
 The requirements for consent considered to be valid vary
by guideline and regulation.
 In general, they agree that decisions must be made free
from coercion, by a competent person who can
understand the information given and appreciate the
associated risks.
 The information given to the participant should be in a
language and format suitable to the participant’s ability
to comprehend it.
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Medical
Ethics
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Dr.
Rami
Abo
Ali

20. CORE ETHICAL PRINCIPLES/ISSUES IN RESEARCH
 Privacy
 The right or expectation not to be interfered with or to be
free from surveillance or, more generally, a moral right to be
left alone.
 In practical terms, privacy is for instance concerned with the
setting in which a person’s health-related information is
acquired.
 Confidentiality
 The principle that ensures that identifiable information is
kept out of reach of others.
 All identifiable information about individuals, whether
recorded (written, computerized, visual, audio) or simply
held in the memory of health professionals, is subject to the
duty of confidentiality .
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Medical
Ethics
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Dr.
Rami
Abo
Ali

21. CORE ETHICAL PRINCIPLES/ISSUES IN RESEARCH
 Research ethics review
 A process by which a group of experts in research, ethics
and other disciplines decides whether a research protocol
fulfills the ethical standards of research before being
undertaken
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Medical
Ethics
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Dr.
Rami
Abo
Ali

22. CONTROLS AND CONDITIONS FOR CONDUCTING RESEARCH:
Regarding the research team:
 The researcher should be qualified, with a high degree of
competence and specialization to carry out health research,
and should adhere to the scientific and methodological
foundations in all stages of scientific research.
 That the researcher respect the rights of subjects and not
waste their dignity
 Not to take advantage of the financial needs of the subjects
of the research to conduct the research.
 Make sure that the research can be conducted for all its
stages after it has been tried on the animal in terms of
clinical research.
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Medical
Ethics
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Dr.
Rami
Abo
Ali

23. CONTROLS AND CONDITIONS FOR CONDUCTING RESEARCH:
Regarding the research team cont ..
 The researcher should have a full study of the risks which the
individual or group is exposed and compare them with the
benefits expected from the research.
 The research team should adhere to all ethics such as honesty,
truthfulness, transparency and fairness.
 That the research team should preserve the right of the
subjects in their intellectual rights when publishing research or
their financial compensation for their contributions.
 The researcher is obligated to maintain the safety of the
individuals in the research (who are subject to the research)
and to ensure their comfort, security, physical and
psychological integrity and their privacy in all stages of the
research 23
Medical
Ethics
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Dr.
Rami
Abo
Ali

24. CONTROLS AND CONDITIONS FOR CONDUCTING RESEARCH:
Regarding the health institution:
 That the health institution has a monitoring research apparatus that
verifies the researchers ’commitment to the terms of the research and
approves its stages, and reviews the research from a scientific and
ethical point of view.
 The institution should protect the rights of patients and to provide
health care even after the end of the research.
 The health institution should ensure that there are no financial burdens
on the subjects subject to the research.
 Ensure that the appropriate environment is provided for efficient and
effective research.
 Ensure the integrity of funding sources and their distance from
suspicions.
 The institution should maintain confidentiality and security of
information
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Medical
Ethics
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Dr.
Rami
Abo
Ali

25. CONTROLS AND CONDITIONS FOR CONDUCTING RESEARCH:
Research quality
 To achieve the objectives of the research, to develop means
of prevention, diagnosis and treatment
 That the intent of the researcher not be merely a scientific
curiosity.
 To benefit for the individual or society, and not only to satisfy
academic curiosity.
 To achieve a balance between basic, clinical and social
researches
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Medical
Ethics
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Dr.
Rami
Abo
Ali

26. CONTROLS AND CONDITIONS FOR CONDUCTING RESEARCH:
Person subject to research
 To be competent , if not , the research will be conducted after
obtaining the approval and permission of the guardians
 To be fully informed of the quality of the research, its various
stages and goals , expected benefits, potential risks, or any
side effects.
 To be informed that he has complete freedom to participate
in the research, as he is entitled to withdraw at any time
without giving reasons and without affecting his full rights to
medical care
 The primary motive for the research should not be material
gain.
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Medical
Ethics
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Dr.
Rami
Abo
Ali

27. WHAT ARE THE CHARACTERISTICS OF THE RESEARCHER AND
HIS ASSISTANTS?
1. Honesty: It is simply not taking other people's ideas or
claiming that they are from him, and we must mention the
source that we relied on.
2. Not to steal the thoughts of a particular person
3. Not include people who have not contributed to the
research
4. List the results as they appeared and do not alter them
5. Accuracy of work and honesty in mentioning the details,
limitations and confusion of work
6. Refraining from selfishness , jealousy
7. Follow objectivity and seriousness, without fanaticism
8. Be grateful to those who contributed and participated in the
research
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Medical
Ethics
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Dr.
Rami
Abo
Ali

28. WHAT ARE THE RIGHTS OF A RESEARCH SAMPLE?
 To have enough time to decide whether or not to be in the
research study and to make that decision without any pressure
from the people who are conducting the research.
 To refuse to be in the study at all, and to stop participating at
any time after you begin the study.
 To be told what the study is trying to find out, what will happen
to you, and what you will be asked to do if you are in the study.
 To be told about the reasonably foreseeable risks of being in the
study.
 To be told about the possible benefits of being in the study.
 To be told whether there are any costs associated with being in
the study and whether you will be compensated for
participating in the study 28
Medical
Ethics
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Dr.
Rami
Abo
Ali

29. WHAT ARE THE RIGHTS OF A RESEARCH SAMPLE?
 To be told who will have access to information collected
about you, and how your confidentiality will be protected.
 To be told whom to contact with questions about the
research, about research-related injury, and about your rights
as a research subject. If the study involves treatment or
therapy:
 To be told about the other non-research treatment choices
you have.
 To be told where treatment is available should you have a
research-related injury, and who will pay for research-
related treatment.
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Medical
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Rami
Abo
Ali

30. ROLES FOR CONDUCTING RESEARCH ON MINORS SUCH AS
PEOPLE WITH MENTAL RETARDATION OR BEHAVIORAL DISORDER
 Health research is not carried out on minors, handicapped, or
incapacitated if it is possible to do on healthy people.
 Research is carried out on minors, the handicapped, or the
incompetent after obtaining written infomed consent from the
official guardian or proxy .
 The nature of the clinical research on minors, handicapped or
incapacitated people must be subjected to assist them, and
this research should be specific to their condition, with no
harm.
 When research is necessary on minors, the handicapped, or
people with incompetence, the proxy is informed of the
dimensions of the research, its importance, its complications,
and all aspects of the research. 30
Medical
Ethics
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Dr.
Rami
Abo
Ali

31. ROLES FOR CONDUCTING RESEARCH ON CHILDREN
 Research should not be conducted on children if it can be
conducted on adults to give the same results.
 The research should be conducted to enrich knowledge
regarding the needs of children and develop the services
provided to them.
 The approval of the child should be obtained according to the
degree of maturity and competence .
 If that is not possible, parents informed permission should
be taken
 Research should not cause any harm to the child, and the
benefits should be more than the risk .
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Abo
Ali

32. ROLES FOR CONDUCTING RESEARCH ON PREGNANT AND
LACTATING WOMEN
1. All conditions for conducting the research mentioned above
apply to them, in addition to:
a) Woman and her husband should have full knowledge
about the research and if there is any risk to the fetus , an
informed consent should be taken .
b) The research must not have complications to the fetus or
the newborn , or leads to deformities, any disabilities, lack
of growth, or death according to documented scientific
facts.
2. It is not permissible at all to conduct research on pregnant
or lactating women if they can be conducted on others.
3. Research is carried out on pregnant women if there is a
desired or benefit to the mother or the fetus, or to obtain
new information.
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Medical
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Rami
Abo
Ali

33. ROLES FOR CONDUCTING RESEARCH ON THOSE WHOSE
LIBERTY IS RESTRICTED (PRISONERS, CAPTIVE PERSONS)
 Follow medical ethics principles , and give prisoners the
opportunity to take benefit from any therapeutic procedure
that may be of curative or preventive benefit
 Providing all health care
 The research team is cautioned not to carry out any immoral
or unethical acts or behavior with prisoners .
 Informed consent
 Do not put prisoners under pressure to do research .
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Rami
Abo
Ali

34. RESEARCH MISCONDUCT
 Research misconduct is defined as fabrication, falsification, or
plagiarism in proposing, performing, or reviewing research, or in
reporting research results.
 Fabrication is making up data or results and recording or
reporting them.
 Falsification is manipulating research materials, equipment, or
processes, or changing or omitting data or results.
 Plagiarism is the appropriation of another person’s ideas,
processes, results, or words without giving appropriate credit.
 Research misconduct does not include honest error or
differences of opinion.
 Research misconduct includes the destruction of, absence of, or
accused person's failure to provide research records accurately
documenting the questioned research.
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Medical
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Dr.
Rami
Abo
Ali

35. FORMS OF MISCONDUCT
 Falsification
 Obfuscation
 Fabrication
 Plagiarism
 Self-plagiarism
 Bare assertions
 Improper authorship
 Misappropriation
 Violation of ethical standards regarding human and animal
experiments
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Medical
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Rami
Abo
Ali

36. HOW TO MAINTAIN RESEARCH ETHICS
AND AVOID SCIENTIFIC MISCONDUCT?
 Before conduct of research
 Develop clear research plan (who will do ,what, when, and
how)
 Submit protocol to ethical review
 Prepare (communicate) well with your research
community
 Agree on authorship
 During conduct of research
 Follow the approved protocol
 Gain consent
 Involve the community
 Protect yourself, your team, & your participants
 Regularly check your data 36
Medical
Ethics
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Dr.
Rami
Abo
Ali

37. HOW TO MAINTAIN RESEARCH ETHICS
AND AVOID SCIENTIFIC MISCONDUCT?
 Share your study report(s) with
 Return ‘something’ back to the researched community
 Publish following publication ethics
 Use Reference Management Software
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Medical
Ethics
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Dr.
Rami
Abo
Ali