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Why Ethics In Medical
Research?
Tamer Hifnawy. MD. Dr (PH)
Associate Professor of Public health
Faculty of Medicine, Beni Suef University, Egypt
College of Dentistry, Taibah University, KSA
Vice Dean for Quality and Development
Certified Trainer in International Research Ethics
Points Covered Today
 Define ethics
 Define Research
 Identify Human Subjects in research
 Overview of history of research ethics
 Identify evolution of codes of ethics
 Identify three fundamental principals of
research ethics
WHAT IS ETHICS ?
WHAT IS: ETHICS ?
The word is derived form the Greek
word “ethos” meaning;
“the set of moral principles”
What do we mean by ethics?
 Morality or ethics represents a code of
conduct that governs how people treat each
other.
 In essence, it is concerned with the way
people act or behave.
 The term ‘ethics’ usually refers to the moral
principles, guiding conduct, which are held
by a group or even a profession”
(Wellington, 2000: 54)
WHAT IS: ETHICS ?
 Ethics are ways of understanding and
examining the moral life, or of right and wrong
human conduct.
 Bioethics is a way of understanding and
examining the moral aspects of biomedical
research and practice
WHY WORRY ABOUT
RESEARCH ETHICS ?
 The science itself
 Other scientists
 The research participant
 The public
 The future
 Ourselves
WHY WORRY ABOUT
ETHICS ?
 The science itself
 Other scientists
 The research participant
 The public
 The future
 Ourselves
WHO IS THE RESEARCH
PARTICIPANT ?
WHO IS A HUMAN SUBJECT?
“a living individual about whom an
investigator (professional or student)
conducting research obtains;
1. Data or
2. Identifiable private information
Through intervention or interaction
with the individual.”
45 CFR 46.102(f)
WHAT IS RESEARCH ?
It is important at this point to
draw the line between
“research” and “practice”.
WHAT IS RESEARCH ?
Research is defined as;
“a systematic investigation,
including research
development, testing and
evaluation, designed to
develop or contribute to
GENERALIZABLE knowledge.”
45 CFR 46.102(d)
HUMAN SUBJECT RESEARCH
A research Involving living
individuals about whom the
researcher obtains:
Data through
intervention
or interaction
Identifiable
Human Material
+/Private
Information
AND
OR
BALANCING TWO GOALS
Advancement
of Science
Protection of
Subject Welfare/Rights
HISTORICAL
BACKGROUND
During The Islamic
Era
 Islamic Rules included all the basic
ethical principles known in modern
history which include:
 Respect for persons
 Non-maleficence
 Beneficence
 Justice
History of Research Ethics
Codes, guidelines & regulations
developed to guide research
involving human participants.
Guidelines were created in response to:
1. An ethical lapses in research.
2. Provide answers to new problems and
challenges in research.
 By 1833 William Beaumont records
what some consider to be the oldest
American document dealing with
research ethics. Which identified key
issues which may be summarized as
follows:
 Experimentation is needed;
 Investigator must be
conscientious and responsible;
 Investigations must have good
methodological approach and there should
be no random studies;
 Voluntary consent is necessary;
 Discontinuation of experiment when it causes
distress to the subject or the subject objects
or becomes dissatisfied
HISTORY OF RESEARCH
ETHICS
 Before 20th century
 Small scale, involving few individuals
 Edward Jenner -- Small pox vaccine
 Beginning of 20th century
 Larger scale clinical trials
 Collect Systematic data
 Groups of individuals
 Vulnerable groups
Prisoners
Orphans
Mentally ill
No Formal Codes of Research
Ethics
RESEARCH HISTORY
TRAGEDIES
 Albert Neisser, discoverer of the
gonococcus
 In order to find a method of syphilis
prevention he injected cell free serum from
patients with syphilis into patients who
were admitted for other medical conditions.
 Most of these patients were commercial
sex workers, who were neither informed
about the experiment nor asked for their
consent.
Neisser Case Cont.
 When some of them contracted syphilis
Neisser concluded that the
“vaccination did not work”.
 However, he argued that the women did
not contract syphilis as a result of his
serum injections but contracted the
disease because they were commercial
sex workers.
Neisser Case Cont.
 Most academic physicians at the time
supported Neisser.
 In 1898 the public prosecutor investigated
the case.
 The court ruled that, though Neisser as a
well known medical authority may have
been convinced that the trials were
harmless, he should have sought the
patients' consent.
 Not questionable science but lack of
patients' consent was the main principle
for the legal judgment.
World War II
Nazi Experiments
Hypothermia Experiments
The goal of this type
of experiments was
to determine how
long German pilots
would survive after
parachuting into the
cold north sea.
A prisoner is submerged in a
tank filled with cold water.
High Altitude Experiments
• High altitude experiments were performed to test how long
pilots would survive after being ejected from their planes.
Prisoners were put into low-pressure tanks with little oxygen.
• Many of those who did not die immediately were put under
water until they died.
Tuskegee Syphilis Study
(1932 - 1972)
 Tuskegee, Alabama
High prevalence of syphilis
Although treatment existed, blacks in the rural
southern town were not receiving treatment
Lack of funds/Lack of doctors
 Study natural course of syphilis
Enrolled 400 black males infected with
syphilis
Not an experiment but rather a “study in
nature”
Tuskegee Syphilis Study
(1932 - 1972)
Ethical Issues  Inadequate disclosure of
information
 Subjects believed they were
getting free treatment
 Told that spinal taps was therapy
 US Gov’t actively prevented
men from receiving penicillin
 1972 press reports caused the
U.S. Gov’t to stop the study
Ethical issues in Tuskegee
study:
 Inadequate disclosure of
information
 Subjects believed they
were getting free treatment
 Told that spinal taps was
therapy
 US Gov’t actively
prevented men from
receiving penicillin
 1972 press reports caused
the U.S. Gov’t to stop the
study
Problems with research include;
 Lack of informed consent
 Use of vulnerable population
 Exploitation of vulnerable population
 Withholding information and / or treatment
 Putting subjects at risk
 Risks outweigh benefits
 Deception and violation of rights
The Willowbrook Study
(1963-1966)
 Research done at a state school of mentally
handicapped children
 Deliberate infection with live Hepatitis virus
 Institution could only take in those accepting
to participate in the study
 Poor public had no other institutional choice
 Parents were not completely told what study
involved
The Willowbrook Study cont.
 Researchers defended the
deliberate injection of these
children by pointing out that
the vast majority of them
would acquire the infection
anyway while at
Willowbrook, given the
crowded and unsanitary
conditions, and
 Only children whose
parents had given consent
were included
Nuremburg Nazi Doctors’ Trial
(1947)
Nazi doctors & scientists
put on trial for the murder
of concentration camp
inmates who were used
as research subjects
15 of 23 guilty, 7 hanged, 5 life sentences
How Could This Happen?
German physicians had sworn to
“DO NO HARM” by the Hippocratic Oath
Science corrupted by politics?
Relevance of Hippocratic Ethics to Human
Experimentation
 Medical Practice
 Ethics: guided by Hippocratic Oath
 Doctor’s primary obligation is patient’s welfare
 Doctor acts in the patients’ best interest
 Research
 Lies outside of the context of the physician-patient
relationship
 Two Interests
 Test a hypothesis
 Subject welfare
Two different types of practices
Ends, means, subjects and
objects
There is a danger of reducing
research subjects
to
research objects
Balancing Two Goals
Without an Adequate Framework of Research Ethics
Advancement
of Science
Protection of
Subject Welfare/Rights
>>>
In the context of research
Could not protect human welfare
Could not respect human rights
Hippocratic Oath
Expand on Hippocratic Ethics to
Protect Research Subjects
+ Concept of
Human Rights
Nuremberg Code
Nuremberg Code (1947)
First Codification of Research Guidelines
Human Rights + Welfare of Subjects
The first and longest
principle
Article (9)
Subjects have the right to
withdraw at any time
“The voluntary consent
of the human subject is
absolutely essential.”
The Declaration of Helsinki
Developed by the World Medical
Association in Finland in 1964.
Provide guidance for physicians and
participants in medical research.
Many updates were introduced in
1975, 1983, 1989, 1996, 2000 and in
2008.
The Declaration of Helsinki
It indicates:
o The well-being of the subject should
take precedence over the interests of
science and society.
o Physician should obtain the subject’s
freely given informed consent in
writing.
o Ethical review committee approval is a
must.
The Belmont Report
• In 1974, the National Commission for the
Protection of Human Subjects of
Biomedical and Behavioral Research was
established.
• In 1978, it submitted The Belmont Report
that sets the fundamental ethical principles
1. Respect for persons
2. Beneficence
3. Justice
The first step in the evolution of ethics is a
sense of solidarity with other human beings.
Albert Schweitzer
VULNERABLE POPULATIONS
 Pregnant women / fetuses
 Children
 Elderly
 Mentally disabled
 Sick persons
 Unconscious persons
 Prisoners
 Persons with little/ no education
 Poor persons
CIOMS 2002
 Council for International Organizations of
Medical Sciences: International Ethical
Guidelines for Biomedical Research
Involving Human Subjects
 Dealt with issues involving international
clinical trials
CIOMS Guideline 10:
Research in populations and communities with
limited resources
 “…the sponsor and the investigator must
make every effort to ensure that:
The research is responsive to the health
needs and priorities of the population or
community; and
Any intervention or product developed,
or knowledge generated, will be made
reasonably available for the benefit of
that population or community.
CONCLUSIONS
 All ethical codes and principals
advocate three fundamental principals;
Respect for persons
Beneficence
Justice
 Research is a privilege, not a right
 The well-being of participant is a priority
CASE
STUDIES
First Questions to Ask:
Is the project considered
research?
Second Questions to Ask:
Does the study involve
Human Subjects?
Case 1: Research with autopsy
specimens
 An application describes the following
proposed activities:
 An investigator receives autopsy
specimens from a pathologist at the
same institution.
 The investigator will receive and
record identifiable private information
about the individuals from medical
records
Case 1: Is the investigator conducting
human subjects research?
 No:
 Research involving only specimens and
data from dead individuals is not human
subjects research
 Investigator is neither interacting nor
intervening with living individuals for
research
Definition of “human
subject” is not met
Case 2: Discarded Tumor Specimens
 An application describes the following
proposed activities:
 Investigators will obtain human specimens
for basic research from a pathologist who
has previously collected tumor specimens
from cancer patients.
 The pathologist will de-identify the data so
that he/she and the investigators will not
know the identities of the samples.
Case 2: Are the recipient investigators
conducting human subjects research?
 The recipient investigators are not
conducting human subjects
research, because
 They have received existing de-
identified data
 There is no way they can ever
access the identities of the samples
 Data has been anonymized
What is meant by existing
data?
Data has already been collected at the
time the proposal was conceived
Existing data had been collected for
purposes other than the proposed research
Applies to retrospective studies involving
already collected data where data must be
“on the shelf” when the protocol is
initiated.
THANK YOU
Tamer Hifnawy MD. Dr PH.
Associate Professor of Public Health & Community Medicine
Faculty of Medicine, Beni Suef University, Egypt
College of Dentistry, Taibah University, KSA
Vice Dean for Quality and Development
Certified Trainer in International Research Ethics
Email: tamer.hifnawy@bsu.edu.eg
thifnawy@yahoo.com
Mobile: +201114130107 Egypt
+966564356123 KSA

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Introduction to research ethics

  • 1. Why Ethics In Medical Research? Tamer Hifnawy. MD. Dr (PH) Associate Professor of Public health Faculty of Medicine, Beni Suef University, Egypt College of Dentistry, Taibah University, KSA Vice Dean for Quality and Development Certified Trainer in International Research Ethics
  • 2. Points Covered Today  Define ethics  Define Research  Identify Human Subjects in research  Overview of history of research ethics  Identify evolution of codes of ethics  Identify three fundamental principals of research ethics
  • 4. WHAT IS: ETHICS ? The word is derived form the Greek word “ethos” meaning; “the set of moral principles”
  • 5. What do we mean by ethics?  Morality or ethics represents a code of conduct that governs how people treat each other.  In essence, it is concerned with the way people act or behave.  The term ‘ethics’ usually refers to the moral principles, guiding conduct, which are held by a group or even a profession” (Wellington, 2000: 54)
  • 6. WHAT IS: ETHICS ?  Ethics are ways of understanding and examining the moral life, or of right and wrong human conduct.  Bioethics is a way of understanding and examining the moral aspects of biomedical research and practice
  • 7. WHY WORRY ABOUT RESEARCH ETHICS ?  The science itself  Other scientists  The research participant  The public  The future  Ourselves
  • 8. WHY WORRY ABOUT ETHICS ?  The science itself  Other scientists  The research participant  The public  The future  Ourselves
  • 9. WHO IS THE RESEARCH PARTICIPANT ?
  • 10. WHO IS A HUMAN SUBJECT? “a living individual about whom an investigator (professional or student) conducting research obtains; 1. Data or 2. Identifiable private information Through intervention or interaction with the individual.” 45 CFR 46.102(f)
  • 12. It is important at this point to draw the line between “research” and “practice”.
  • 13. WHAT IS RESEARCH ? Research is defined as; “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to GENERALIZABLE knowledge.” 45 CFR 46.102(d)
  • 14. HUMAN SUBJECT RESEARCH A research Involving living individuals about whom the researcher obtains: Data through intervention or interaction Identifiable Human Material +/Private Information AND OR
  • 15. BALANCING TWO GOALS Advancement of Science Protection of Subject Welfare/Rights
  • 17. During The Islamic Era  Islamic Rules included all the basic ethical principles known in modern history which include:  Respect for persons  Non-maleficence  Beneficence  Justice
  • 18. History of Research Ethics Codes, guidelines & regulations developed to guide research involving human participants. Guidelines were created in response to: 1. An ethical lapses in research. 2. Provide answers to new problems and challenges in research.
  • 19.  By 1833 William Beaumont records what some consider to be the oldest American document dealing with research ethics. Which identified key issues which may be summarized as follows:  Experimentation is needed;  Investigator must be conscientious and responsible;
  • 20.  Investigations must have good methodological approach and there should be no random studies;  Voluntary consent is necessary;  Discontinuation of experiment when it causes distress to the subject or the subject objects or becomes dissatisfied
  • 21. HISTORY OF RESEARCH ETHICS  Before 20th century  Small scale, involving few individuals  Edward Jenner -- Small pox vaccine  Beginning of 20th century  Larger scale clinical trials  Collect Systematic data  Groups of individuals  Vulnerable groups Prisoners Orphans Mentally ill No Formal Codes of Research Ethics
  • 22. RESEARCH HISTORY TRAGEDIES  Albert Neisser, discoverer of the gonococcus  In order to find a method of syphilis prevention he injected cell free serum from patients with syphilis into patients who were admitted for other medical conditions.  Most of these patients were commercial sex workers, who were neither informed about the experiment nor asked for their consent.
  • 23. Neisser Case Cont.  When some of them contracted syphilis Neisser concluded that the “vaccination did not work”.  However, he argued that the women did not contract syphilis as a result of his serum injections but contracted the disease because they were commercial sex workers.
  • 24. Neisser Case Cont.  Most academic physicians at the time supported Neisser.  In 1898 the public prosecutor investigated the case.
  • 25.  The court ruled that, though Neisser as a well known medical authority may have been convinced that the trials were harmless, he should have sought the patients' consent.  Not questionable science but lack of patients' consent was the main principle for the legal judgment.
  • 27. Nazi Experiments Hypothermia Experiments The goal of this type of experiments was to determine how long German pilots would survive after parachuting into the cold north sea. A prisoner is submerged in a tank filled with cold water.
  • 28. High Altitude Experiments • High altitude experiments were performed to test how long pilots would survive after being ejected from their planes. Prisoners were put into low-pressure tanks with little oxygen. • Many of those who did not die immediately were put under water until they died.
  • 29. Tuskegee Syphilis Study (1932 - 1972)  Tuskegee, Alabama High prevalence of syphilis Although treatment existed, blacks in the rural southern town were not receiving treatment Lack of funds/Lack of doctors  Study natural course of syphilis Enrolled 400 black males infected with syphilis Not an experiment but rather a “study in nature”
  • 30. Tuskegee Syphilis Study (1932 - 1972) Ethical Issues  Inadequate disclosure of information  Subjects believed they were getting free treatment  Told that spinal taps was therapy  US Gov’t actively prevented men from receiving penicillin  1972 press reports caused the U.S. Gov’t to stop the study
  • 31. Ethical issues in Tuskegee study:  Inadequate disclosure of information  Subjects believed they were getting free treatment  Told that spinal taps was therapy  US Gov’t actively prevented men from receiving penicillin  1972 press reports caused the U.S. Gov’t to stop the study
  • 32. Problems with research include;  Lack of informed consent  Use of vulnerable population  Exploitation of vulnerable population  Withholding information and / or treatment  Putting subjects at risk  Risks outweigh benefits  Deception and violation of rights
  • 33. The Willowbrook Study (1963-1966)  Research done at a state school of mentally handicapped children  Deliberate infection with live Hepatitis virus  Institution could only take in those accepting to participate in the study  Poor public had no other institutional choice  Parents were not completely told what study involved
  • 34. The Willowbrook Study cont.  Researchers defended the deliberate injection of these children by pointing out that the vast majority of them would acquire the infection anyway while at Willowbrook, given the crowded and unsanitary conditions, and  Only children whose parents had given consent were included
  • 35. Nuremburg Nazi Doctors’ Trial (1947) Nazi doctors & scientists put on trial for the murder of concentration camp inmates who were used as research subjects 15 of 23 guilty, 7 hanged, 5 life sentences
  • 36. How Could This Happen? German physicians had sworn to “DO NO HARM” by the Hippocratic Oath Science corrupted by politics?
  • 37. Relevance of Hippocratic Ethics to Human Experimentation  Medical Practice  Ethics: guided by Hippocratic Oath  Doctor’s primary obligation is patient’s welfare  Doctor acts in the patients’ best interest  Research  Lies outside of the context of the physician-patient relationship  Two Interests  Test a hypothesis  Subject welfare Two different types of practices
  • 38. Ends, means, subjects and objects There is a danger of reducing research subjects to research objects
  • 39. Balancing Two Goals Without an Adequate Framework of Research Ethics Advancement of Science Protection of Subject Welfare/Rights >>>
  • 40. In the context of research Could not protect human welfare Could not respect human rights Hippocratic Oath Expand on Hippocratic Ethics to Protect Research Subjects
  • 41. + Concept of Human Rights Nuremberg Code
  • 42. Nuremberg Code (1947) First Codification of Research Guidelines Human Rights + Welfare of Subjects The first and longest principle Article (9) Subjects have the right to withdraw at any time “The voluntary consent of the human subject is absolutely essential.”
  • 43. The Declaration of Helsinki Developed by the World Medical Association in Finland in 1964. Provide guidance for physicians and participants in medical research. Many updates were introduced in 1975, 1983, 1989, 1996, 2000 and in 2008.
  • 44. The Declaration of Helsinki It indicates: o The well-being of the subject should take precedence over the interests of science and society. o Physician should obtain the subject’s freely given informed consent in writing. o Ethical review committee approval is a must.
  • 45. The Belmont Report • In 1974, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established. • In 1978, it submitted The Belmont Report that sets the fundamental ethical principles 1. Respect for persons 2. Beneficence 3. Justice
  • 46. The first step in the evolution of ethics is a sense of solidarity with other human beings. Albert Schweitzer
  • 47. VULNERABLE POPULATIONS  Pregnant women / fetuses  Children  Elderly  Mentally disabled  Sick persons  Unconscious persons  Prisoners  Persons with little/ no education  Poor persons
  • 48. CIOMS 2002  Council for International Organizations of Medical Sciences: International Ethical Guidelines for Biomedical Research Involving Human Subjects  Dealt with issues involving international clinical trials
  • 49. CIOMS Guideline 10: Research in populations and communities with limited resources  “…the sponsor and the investigator must make every effort to ensure that: The research is responsive to the health needs and priorities of the population or community; and Any intervention or product developed, or knowledge generated, will be made reasonably available for the benefit of that population or community.
  • 50. CONCLUSIONS  All ethical codes and principals advocate three fundamental principals; Respect for persons Beneficence Justice  Research is a privilege, not a right  The well-being of participant is a priority
  • 52. First Questions to Ask: Is the project considered research?
  • 53. Second Questions to Ask: Does the study involve Human Subjects?
  • 54. Case 1: Research with autopsy specimens  An application describes the following proposed activities:  An investigator receives autopsy specimens from a pathologist at the same institution.  The investigator will receive and record identifiable private information about the individuals from medical records
  • 55. Case 1: Is the investigator conducting human subjects research?  No:  Research involving only specimens and data from dead individuals is not human subjects research  Investigator is neither interacting nor intervening with living individuals for research Definition of “human subject” is not met
  • 56. Case 2: Discarded Tumor Specimens  An application describes the following proposed activities:  Investigators will obtain human specimens for basic research from a pathologist who has previously collected tumor specimens from cancer patients.  The pathologist will de-identify the data so that he/she and the investigators will not know the identities of the samples.
  • 57. Case 2: Are the recipient investigators conducting human subjects research?  The recipient investigators are not conducting human subjects research, because  They have received existing de- identified data  There is no way they can ever access the identities of the samples  Data has been anonymized
  • 58. What is meant by existing data? Data has already been collected at the time the proposal was conceived Existing data had been collected for purposes other than the proposed research Applies to retrospective studies involving already collected data where data must be “on the shelf” when the protocol is initiated.
  • 59. THANK YOU Tamer Hifnawy MD. Dr PH. Associate Professor of Public Health & Community Medicine Faculty of Medicine, Beni Suef University, Egypt College of Dentistry, Taibah University, KSA Vice Dean for Quality and Development Certified Trainer in International Research Ethics Email: tamer.hifnawy@bsu.edu.eg thifnawy@yahoo.com Mobile: +201114130107 Egypt +966564356123 KSA