This document summarizes the use of microorganisms, animals, plants, and humans in experimentation. It discusses how microbes can be used to produce treatments for various diseases and conditions. When using human subjects, strict ethical guidelines and informed consent are required. The three R's rule of replacement, reduction and refinement must be followed when using animal models in research. Plants can also be engineered through biotechnology to have enhanced traits like disease resistance. The document closes by noting some environmental and biosafety issues that may arise from increased genetic engineering of plants.

1. USE OF
MICRORGANISMS,
ANIMALS, PLANTS AND
HUMANS IN
EXPERIMENTATION
Presented by
Ghalia Nawal
(LCWU-PHDF20-2025338005 )
Session: 2020-2025
Course Instructor: Dr. Saima Sharif

2. as source of as treatment for
• Single cell proteins
• Bacteriocins as biopreservatives
• Anti-tumor drugs
• Enzyme inhibitors
• Immuno-suppresants
• Hypocholestolemic drugs
• Anti-fungal drugs
• Anti-oxidants
• Natural Colors
• Obesity
• Anemia
• Irritable Bowl Syndrome (IBS)
• Atomic dermatitis
• Crohn's disease
• Diabetes
• Allergies
Use of Microbes (bacteria, yeast, mold and
algae)

3. ETHICAL
CONCERN
S
• Code of Ethics (American Society For Microbiology)
• Nuffield Council on Bioethics (Infectious Disease)
• WHO Operational Guidelines for Ethics Committees that
Review Biomedical Research
• ICMR Ethical Guidelines for Biomedical Research on
Human Participants
• ICMR Guidelines for Good Clinical Laboratory Practices

4. USE OF HUMAN SUBJECTS
17 federal agencies have regulations governing the conduct of research involving
human subjects. Examples of agencies with human subject requirements include
 The Department of Health and Human Services (DHHS)
 The Food and Drug Administration (FDA)
Principles
1. Respect for Person
2. Beneficence
3. Justice

5. Guidelines
Research that involves humans is subject to regulation. No procedure or study
should be performed that is not explicitly exempted or a part of an approved
protocol. Applicable regulations include requirements for adherence to IRB
approved research protocols like:
Maintenance of documentation and records
Obtaining approval prior to initiation of changes
Reporting of adverse events
Investigators are responsible for compliance

6. Think about issues like
Responsible
Conduct
Use of human
subjects is
Justifiable &
Necessary
Informed
Consent

7. 8 BASIC ELEMENTS OF
CONSENT
1. Statement that the study involves
research
2. Description of risks or
discomforts
3. Description of benefits
4. Disclosure of alternatives
5. Confidentiality of records
6. Description of compensation
7.Contacts for concerned questions
8. A statement that participation is

8. USE OF ANIMAL MODEL IN RESEARCH
Longstanding practice in biological research
Often debated because of animal rights but done in compliance with the
regulatory provisions like:
 Inspection and licensing of animal premises
 The training and competence of all personal designing projects
 Performing animal procedures and taking care of animals
 The mandatory authorization of every project after ethical evaluation by an
Animal Ethics Committee.
Three R's Rule
Replacement Reduction Refinement

9. THE MEDICAL RESEARCH COUNCIL (MRC)
The MRC considers the use of animals to be essential in biomedical research for:
• Better understanding the living body
• What goes wrong in disease, and to develop safe and effective treatment
In accordance with the law research using animals is only undertaken when
• There is no alternative research technique
• The expected benefits outweigh any adverse effects
Access to all guidelines, policy documents and publications on the animal use are
available at the official website.

10. USE OF PLANTS IN RESEARCH
Gave rise to Agricultural Biotechnology or Green Biotechnology
Benefits
• Plants with enhanced nutritional content
• Desired texture, color, flavor, growing season and yield
• Imparts disease resistance
• Improve other properties of production crops
• Currently focused on producing genetically engineered plants (transgenic
plants)
• Transgenic Bt corn is an outstanding example, It produces its own insecticide
and contains a gene from the bacterium Bacillus thuringiensis.
• Production of edible vaccines

11. ENVIRONMENT AND BIOSAFETY ISSUES
The various environmental and bio safety issues which arise as a result of the
increasing plant biotechnological research and the wide adoption of GM crops are:
A) genetic erosion and biodiversity loss
B) potential introgression
C) contamination
D) resistance emergence
E) harm to other organisms
F) resistance to antibiotics

12. THE END
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