Professor & Head of Forensic Medicine &Clinical Toxicology
Department, FOM - - SCU, Egypt
Certified Trainer of Research Ethics, Maryland University, USA
Some Difficulties& Challenges of Health Some Difficulties& Challenges of Health
Research in Developing Countries
• Small national budget which is devoted to health
research
• In Egypt : the national fund of research is nearly 0.9% of
the total national income
• TheUNESCO has determined indicators of nation’s
research and development ( R & D status). The level set
for R&D expenditure is 1.5% of Gross National Product
(GNP) in newly industrialized countries (NICs)
1 - Community Partnership
To be ethical clinical research must involve the
community in which it occurs
2 - Social Value
It is important to show that setting a health health
research agenda research agenda will lead to action even
though, at the beginning, it may only be
possible to implement part part of total agenda
“ Investment in research to
ensure advances in health &
policy decisions”
“We have to understand how
priority setting in research
for health can best
contribute to health,
equity& development at
country level”
Social value is mandatory mandatory because of :
*responsible use of finite resources
*avoidance of exploitation
3 - Scientific Validity:
Ethical research must be conducted in a
methodologically rigorous rigorous manner
4 - Fair Subject Selection:
• The scientific objectives of the study should guide
inclusion criteria
• Groups cannot be excluded without scientific
reasons
• Vulnerable groups should not be targeted
• It is important that the results of the research be
generalizable to the populations that will use the
intervention
5 - Favorable Risk - - Benefit Ratio:
• Potential benefits are enhanced
• Risks are identified and minimized
• The potential benefits to individual subjects
& society are proportionate to or outweigh
the risks
6 - Independent Review
Investigators have multiple interests:
1. interests to conduct high quality research
2. Complete the research expeditiously
3. Protect research subjects
4. Obtain funding
5. Advance their career
7 - Informed Consent Process
• Who will conduct the informed consent
• Quality of the informed consent
– Content
– Understandability
– Documentation
8 - Respect for Enrolled Subjects
The ethics of clinical research do not end with
the signing of a consent signing of a consent document but
encompass:
• the actual implementation
• Analysis
• Dissemination of research
Impact of Applying Research Ethics
• Enhance protection protection of rights and welfare
of human research subjects
• Play a pivotal role in prioritize prioritize the health
research
• Strengthen the culture culture of research
• Create a favorable environment to
stimulate Research & Development (R &D)
• Enhance trust trust between research
endeavor with society
• Researchers more likely to get funding funding
• More likely to get published in
international journals international journals
• Publication trends are one measure of
research productivity research productivity
How to start?
• Established awareness campaign
• Example: HRETIE Program
– see: www.hretie.com www.hretie.com
– research ethics workshops workshops in many Egyptian
universities and scientific institutes
– training of many individuals many individuals in research
ethics
– “training of the trainers” (TOT) aspect of the
program that ensures sustainability of
research ethics capacity
Trainers can:
Carry out workshops workshops of research ethics
to their colleagues
Help establish institutional RECs RECs
Work together to prepare courses courses in
research ethics
postgraduate courses in faculties
medicine, pharmacy, nursing, dentistry, etc
• We can group research ethics as
educational domains with set of learning learning
objectives objectives to be demonstrated by the
students students of the medical schools
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Animal Research Ethics
Proper animal environment, housing and
management
• In recent years, the use of animals in research has
become one of the most important questions in
research ethics.
• On one hand, experiments using animals are
important when, for example, testing medicine to
ensure that it will not harm people.
• On the other hand, many feel that we have an
obligation to these animals and that we cannot let
them suffer for our sake.
Guidelines and regulations for ethics of
animal research
• Declaration of Helsinki, 1964
• WHO, 2000
• The European Science Foundation
• Australian code of practice for the care
and use of animals for scientific purposes, 2004
Guidelines for animal research
Marshall Hall ( 1830 )
– Experiments should be absolutely necessary and all
alternatives explored
– Clear and attainable objectives
– Avoid repetition
– Least possible pain should be inflicted
– Use of “lower” animals such as frogs and fish
– Witnesses to certify results and lessen need for
repetition
Three “Rs”
• R eduction
– Numbers
– Pain
• R eplacement
– Use non-animal models whenever possible
– e.g., in vitro, cell cultures, etc.
• R efinement
– Choose the appropriate animal
– Use of lower rather than higher vertebrates
Russell and Burch (1959)
Remember
Trust can take years to build and a moment to
break
Trust can take years to build and a moment to
break
