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Biosafety and Bioethics Dr. Sarah bukhari
Ass.Prof. pharmaceutical microbiology
Ancient GreekChimeraThe Chimera was a hybridmonster of ancient Greeklegend that was thoughtto live in southwestAnatolia (present-dayTurkey).
OUTLINENew limits to the interference with life?
How do we know what is acceptable?
What are the concerns of the public?
What will be considered ethically acceptable?
NEW LIMITS TO THE INTERFERENCE WITH LIFE?
NEW LIMITS TO THE INTERFERENCE WITH LIFE? (1/2)
During the last century scientists have made genuine progress in explaining and usefully modifying the processes of life
Until recently, the main limits to interference with life were of a technical kind: what is possible to do?
Increasingly scientists and industry are faced with ethical limits: what is acceptable to do?
NEW LIMITS TO THE INTERFERENCE WITH LIFE? (2/2)
Breeding has changed domestic animals over thousands of years
However, genetic changes were poorly understood until recently
Modern genetics, scientific breeding schemes and others forms of biotechnology have increased our control
With greater control comes greater responsibility
HOW DO WE KNOW WHAT IS ETHICALLY ACCEPTABLE?
Bioethics Decision-Making Model
Basic ethical principles
Major Ethical Principles.secondary Ethical Principles.
Major Ethical Principles
Non-maleficence
Beneficence
Autonomy
Justice
Secondary Ethical Principles
truth telling
fidelity and promise keeping
confidentiality
how much harm can be justifiably risked to effect good
Attempt to avoid undesirable exceptions
Medical ethics
Medical ethics is the study of moral values and judgments as they apply to medicine.
Medical issues
ABORTIONVaccine controversyCloningGene therapy
WHAT ARE THE CONCERNS OF THE PUBLIC?
EUROPEAN ATTITUDES TO BIOTECHNOLOGY
Since 1991 the Eurobarometer surveys have examined the
attitudes of the European public
In general the surveys show that members of the European
public
• Differentiate between medical and agricultural applications
• Do not become more positive towards biotechnology the more they know
about it
• Are most sceptical towards biotechnology when it is applied to animals or
food-production
SHOULD BIOTECHNOLOGY BE ENCOURAGED?
APPLICATION score
Genetic testing 0,85
Medicines and vaccines 0,77
Crop plants 0,28
Research animals - 0,10
Food production - 0,15
Xeno transplants - 0,27
Eurobarometer 1996: Mean score in the EURange from - 2 to + 2
WHAT WILL BE CONSIDERED ETHICALLY ACCEPTABLE?
THREE GROUPS OF CONCERNS
• Concern for animals– Animal welfare– Animal integrity
• Concern for environment/nature– Biodiversity
• Concerns for humans– Biosafety– Slippery slope concerns– Need for ”nature”
FEATHERLESS CHICKEN
BLIND HENS
BRINGING IN SCIENTIFIC UNCERTAINTY
Some of the consequences for animal welfare of biotechnology can be foreseen
However, many consequences are unforeseen; and researchers clearly tend to be much too optimistic
A good example is cloning
WHAT WILL BE CONSIDERED ETHICALLY ACCEPTABLE?
The debate must allow all concerns to be heard and discussed
Given the widely shared sceptical views presented in this talk it will only be considered acceptable to use biotechnology if important benefits are at stake
What can we do with rDNA?
“Pharming”: modify organisms to produce drugs or other usable materials (also xeno-technology)
Research: designing model organisms
GM agriculture: modify crops or animals for human consumption
Gene therapy: modify genetic disease
“Designer babies”: modify offspring
Bio-weapons: modify biological agents
What can we do with rDNA?
‘Biosafety’ means the need to protect human and animal health and environment from the possible adverse effects of the products of modern biotechnology
BIOSAFETY
The Cartagena Protocol on Biosafety (CPB) Entered into force on 29th December
1993 Seeks to lay down an internationally
acceptable framework to provide for an adequate level of protection against the possible adverse effects on biodiversity and human health.
Basic Premises of CPB “Advance Informed Agreement”
between Parties (AIA)
Decision on the basis of scientific risk assessment
Precautionary Principle
Lab safety
Lab safety: Each laboratory should adopt Standard
operational procedures from guidelines of the WHO according to the type of work being carried out in their lab by:
identifying potential hazards, and specifies practices and procedures to eliminate or minimize such hazards.
Such operational procedures should be logged and
made available in form of Laboratory manual to protect workers, products, co-workers, lab support personnel and environment.
Safety practices should be applied throughout the testing process and this met by three
main steps:
Pre-analytical
Analytical
Post- analytical
1. Pre- Analytical
which include Specimen collection, Specimen preparation and Specimen transport.
The accuracy of test results depends greatly on the quality of the specimen. Therefore, proper specimen collection, preparation and handling is essential for samples submitted to the laboratory for testing.
2. Analytical
which include testing: follow the safety rules when performing any test in the lab.
3. Post- Analytical
disposal: After testing, clean up working area and properly dispose of contaminated waste.
Also known as BMBL 5—Describes the Centers for DiseaseControl and Prevention/National Institutes of Health (CDC/NIH) guidelines for each BSL
• Appropriate work for each BSL is described with combinationsof the following :
• Laboratory Practices and Techniques• Standard Practices• Special Practices• Safety Equipment (Primary Barriers)• Laboratory Facilities (SecondaryBarriers)
Biosafety in the Microbiology andBiomedical Laboratory
Thank you