power point presentation of Clinical evaluation of strabismus
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
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
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
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
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