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Why is scientific research regulated? - Coggle Diagram
Why is scientific research regulated?
Genetic modification and manipulation of sex cells and embryos
What
CRISPR
Clustered Regularly Interspaced Short Palindromic Repeats
enzymes = bacteria found, 'chop up' DNA invading viruses, protection
CRISPR Cas-9 = snip DNA @ particular base
attached to guide RNA targets specific complementary sequence
added to
Results
genes = spliced + inserted w/ pinpoint accuracy
used to reverse symptoms in adult mouse w/ liver disorder
alter non-human primates
natural DNA mechanisms close gap caused by gRNA brining Cas9 to site
new bases added or deleted
original gene = nonfunctional
Biotechnology
new discoveries + advancements = ^ scientific knowledge
predict future impact of biotech ind., societies, enviro
DNA splicing
molecular scissors
IVF can be used
embryos not affected by illness = implanted
Types
Germline
sex reproduc. cells make gametes
mutations passed to offspring
mutation replicated = every cell of body, divide and growth
Gene editing
direct manipulation of genome >> molecular engineering techn.
help avoid disorders
many conditions = avoided
technique: preimplantation genetic diagnosis (PGD)
embryos created through IVF screened for mutations
gene = code for protein, protein = cell
genes influence health and disease, traits, behaviour
Genetic modification
Uses
used to make medicines
insulin
vaccines
Hendra vaccine for horses
GMOs
crops
Golden Rice
Vitamin A = more (betacarotene)
for countries w/ low vitamin A richness diet
cotton
higher yield improvements
economy = $2.5 billion/year
95% cotton grown from CSIRO bred varieties
reduce pesticide 85%, herbicide 52%
livestock
Belgian Blue Cow
muscle protein manipulated
2x muscle growth > 'double muscled'
increase gain meat industry
'DESIGNER BABIES'
large volumes of protein
gene different from organism = more advantages
enables scientists = find individual genes
separate and transfer directly into cells of plant, animal, bacteria or virus
genetically modified used in research
plants
animals
bacteria
type of biotechnology
gene tech
range molecular tech = allow direct alteration genetic material
changed fucntions/performance
produce new or modified substances
Gene therapy HUMANS
attempted since 1990s
gene therapy = difficult for complex diseases
heart disease
diabetes
camcer
used AFTER birth to treat >>> cells/tissues relevant
modification
germline > all cells subsequent generations = inherit modification
Regulation
Why is regulation needed?
Australia
Gene Technology Regulator
appointed by Governor General of Australia
regulates everything , legislation, ethics, regulations
Research Involving Human Embryos Act 2002 (RIHE)
prohibits use of embryos for research w/o a license
establishes licensing system for creation + use
Prohibition of Human Cloning for Reproduction Act 2002
prohibits certain practices >> create embryos unless license = obtained
completely prohibit other practices involve. embryos
Section 15
prohibits a person from altering the genome of a human embryo in such a way that the alteration is heritable by descendants and the person intended
IVF clinics = grow embryo to blastocyst (70-100 cells)
assessed for appropriateness of implantation
modified embryos not implanted into womant
not allowed to develop for more than 14 days
Gene Technology Act 2000
collab btwn AUS gov, state, territory gov
lays out comprehensive and rigorous process
scientific identification, assessment and management of risks posed by gene tech
QLD gov
est. regulations/codes ethics ensure research state = carried out w/in transparent/ethical enviro
includes use in animal research + biotech, gene tech, GMOs
AUS + QLD gov = collab
Cmmonwealth Gene Tech Act 2000
Gene Tech (Queensland) Act 2016
Sex cells and embryos
germline editing = no-no
banned in 40 countries, prohibited
international treat Council of Europe
Social and ethical issues
Equality
big advances engineering = available to people $
regardless of age, ethnic background, cultural group, gender, religion
Designer Babies
immune to all viruses
prettier, smarter, faster
manipulation DNA humans
contentious issue
what values at stake?
unpredictable effects
eugenics
Consideration
Medical and health benefits
Financial and social justice issues
Animal and human rights
Effects on environment
Basic principles
Benefit and non-harm >>>> WELLBEING
Individual rights and autonomy >>>> CHOICE
Privacy and Societal perception >>> RESPECT
Equity and justice >>>> FAIRNESS
Ethical issues
based on individual, group, societal answers to questions about what is good/right thing to do
Case Study
1
He Jiankui and twin girls
Outline
engineered mutations - human embryos >> use produce babies
Disabled gene CCR5 > encodes protein allows HIV enter cells
aimed to mimic gene 10% Europeans > protection HIV infection
CCR5 = aid fight off other infection e.g. West Nile Virus
girls = vulnerable
cause mutation in other parts of genome
unpredicted health consequences
GERMLINE!
HIV resistance
uses CRISPR-Cas 9 system
Ethics
Jiankui = neglected adequate safety testing
Jiankui failed to follow standard procedures > get participants
breach of various guidelines
Ethical Guiding Principles on Human Embryonic Stem Cell Research
Guidelines on Human Assisted Reproductive Technologies
'prohibits manipulation of genes in human gametes, zygotes or embryos for the purpose of reproduction'
Backlash/conflict
'The negative focus is, of course, not good'
- Fredrik Lanner (stem-cell scientists from Stockholm)
editing genes in human embryos > see how stem cells regulate
Timeline
Mar 2015
Chinese researchers = first edit genes in human embryo
June 2016
Jiankui = project to edit genes human embryos, goal = live birth
March 2017
Jiankui = recruit couples, HIV positive father
Early Nov 2018
twin girls, gene edit = born
secondary pregnant w/ third-gene edited embryo = established
25-26 Nov, 2018
MITT Technology Review = reveals existence of research programme
associated press = public w/ twin girl story
Privacy ethics and regulations?????
carefully balance right patient against wider world but need to be consistent w/ legal obligation
Respect > breach privacy
28 Nov 2018
offers details about work, criticised
Nov-Dec 2018
China's National Health Commission = investigation into his work
Jan 2019
censured by Guandong health ministry + fired from uni
18 March 2019
World Health Organisation = meet set guidelines for human gene editing
August 2019
third gene-edited baby expected
He Jiankui
Professor He Jiankui, Uni of Science and Tech
Lulu and Nana = twins