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