Ethical Issues in Genetics Flashcards
Animal experiments
*Genetic crosses
*Transgenic organisms
* “Knockout” gene
* Gene editing using CRISPR
* Introduction of foreign
genes
Animal experiments (cont.)
*Growth of other organisms
* Viruses
* Parasites
* Human/animal surrogate mother
*Testing compounds / drugs / vaccines
Animal experiments (cont.)
*Embryology research
*Cloning
Animals (Scientific Procedures) act
1986
*Legislation underpinning animal
experimentation
* Amendments in 1993 and 2013 to bring into line
with EU Directives
*Managed by the Home Office
*Built around 3 principles – 3Rs:
* replacement – bacterial tests, cell culture,
computer modelling/simulation
* refinement – better animal housing (“red
houses”), data collection implants
* Reduction – overall reduction in animal use,
inbred lines to reduce variability
*Legislation underpinning animal
experimentation – key requirements:
*Certificate of Designation (place)
*Project License
*Personal License
Overall principle – only use animals if no other
means
Human experimentation
*Human subject research is systematic,
scientific investigation that can be:
*either interventional (a “trial”)
*or observational (no “test article”)
and involves human beings as research subjects, commonly known as test subjects
*Use of human tissue
*Studying embryos
*Studying behaviour
*Conducting questionnaires
*Testing drugs or vaccines
Human experimentation
*Legislation underpinning human
experimentation:
*Human Fertilisation and Embryology Act
(HFEA) (2008)
*Human Tissue Act (HTA) 2004 (Human Tissue
Authority)
*HTA revision 2019 – Organ donor “opt out’’
Human Fertilisation and Embryology Act (2008)
*Covers the use of embryonic tissue
*Particularly complex
Human Tissue Act (HTA) 2004
*Collection of human tissue
*Storage of human tissue
*Use of human tissue
*Protection of data associated with human tissue
Human experimentation
*Ethics
*Declaration of Helsinki (DoH) 2013
*World Medical Association started this in 1964 and has updated regularly since
*Integrated Research Application System (IRAS)
*Main UK system, based on the DoH principles
*Legal requirement for all human research to
go through IRAS approval in the UK.
Ethical Approval
Principles
1. Informed consent
2. Anonymity
3. Duty of care
4. Information and sample security
5. Restricting activity
6. Protocol management
7. Protection of the vulnerable
Case study
Measurement of transmission of the parasite
Toxoplasma gondii from mother to baby requires collection of umbilical cords from babies
- Parasite of cats
- Secondary hosts including humans
- All warm blooded animals and birds
- Prevalence 30 – 40%
- Mostly asymptomatic
- Miscarriage in humans
- Abortion in sheep and other animals
- Foetal abnormalities
- Retinochoroiditis
- Serious for immunocompromised hosts
Tachyzoite stage
(replicating stage)
Toxoplasma cyst
Containing the dormant bradyzoite
stage – often found in the brain
Background to the human study – mice and sheep
- 200 mice were trapped from
an urban location - Analysis of infection rates
Analysis of transmission in
pregnant mice
Result and Conclusion of the study
Results
* 59% of mice infected with
Toxoplasma
* 16 mice pregnant
* 12 of the pregnant mothers were
positive
Conclusions
* High frequency of congenital
transmission (100% from
infected mothers)
* 74.6% of foetuses
* Congenital transmission
important
Is congenital/vertical
transmission important in
natural populations of sheep?
Sampled umbilical cord tissue from
newborn lambs
Sampled internal tissues from
aborted lambs
Conclusions
69%
*High levels of congenital
transmission in sheep
Case Study Research
requires collection of umbilical cords from
babies
…need about 100 – 400 samples
…ideally an unbiased sample
Ethical Approval
- Recruitment
Payment – bias, force subjects
Information - stress
Timing – needs to be considered
Vulnerable people
Random<——-> Selective - Informed consent
Anonymity
Information – process, link information to
samples, define uses (exclude DNA
fingerprinting)
Consent – record, anonymous, link consent to samples - Samples and Data
Defined use
Security
Withdrawal protocol - Results
Do you tell the subject?
Ethics of the human genome project
2003 – Human genome sequenced
Now – the 100,000 genomes project
-Huge amount of knowledge
-Provides some ethical challenges…
Ethics of the human genome project
*Genes from an individual (Parents, siblings
and offspring) – issues with consent
*Predictive use (diseases)
*Insurance
*patenting genes
*Accurately identifying genetic traits
*Designer babies (e.g. Use of gene editing techniques like CRISPR)
Genetic testing and counselling
*prior to conception
*risk of genetic diseases
*Cystic fibrosis (Cc X Cc)
CC = Healthy
Cc = Healthy
cc = Cystic Fibrosis- 25% chance
Risk of CF
Decisions need to be made
During pregnancy
*Amniocentesis
*Testing for genetic diseases using tissues taken
directly from the womb
*Ethical issues associated with providing advice
and guidance
Working with embryos
*Why do we need to do this?
Important for research
*Embryonic stem cells can differentiate into
any other cell type
*Research into replacement organs such as kidneys
*Fertility treatment
*This raises the question as to when does an embryo become a person?
Development of the embryo
Fertilised Zygote—–>Embryonic Stem Cells—–>@32 Cells : Cells multiply
and differentiate (specialise)——-> at 5 Days in the human (BLASTOCYST STAGE) ——>Inner cells – forms the embryo and Outer cells – forms the placenta——> Future embryo and Endoderm——–>9 days in humans Wall of the uterus (womb) implantation occurs———>15 days in humans (Primitive streak)——>3 weeks in humans (Gastrulation)—-> 5 weeks in humans- Hind limb
bud and Head formation
When does an embryo become a person?
Human Fertilisation and Embryology Act (2008)
(1A) No person shall keep or use an embryo
except—
(a) in pursuance of a licence….
(3) A licence cannot authorise—
(a) keeping or using an embryo after the
appearance of the primitive streak
