Module 6: Genetic Change

NSWBiologySyllabus dot point

Inquiry Question 3: Does artificial manipulation of DNA have the potential to change populations forever?

Evaluate the benefits of using genetic technologies in agricultural, medical and industrial applications, and the future directions and potential impacts of genetic technologies on society

A focused answer to the HSC Biology Module 6 dot point on the future of genetic research. Germline gene editing (He Jiankui case, prime editing), gene drives for mosquito control, synthetic biology, xenotransplantation, RNA therapeutics and the regulatory and ethical questions they raise.

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What this dot point is asking

NESA wants you to evaluate where genetic technologies are heading and the social, ethical and regulatory issues that come with them. Choose two or three specific named technologies rather than listing many.

The answer

Germline gene editing

What it is. Editing DNA in eggs, sperm or embryos so the change is passed to all cells of the future person and to their descendants.

State of the art. Technically possible since 2014 (CRISPR in mouse embryos) and demonstrated in humans by He Jiankui in 2018, who edited the CCR5 gene in twin embryos in an attempt to confer HIV resistance. He was prosecuted in China and the scientific community condemned the experiment as premature and unethical.

Potential benefits. Prevention of severe inherited disease in families where preimplantation diagnosis cannot help (both parents homozygous for a recessive condition).

Issues.

  • Consent. The future person cannot consent.
  • Safety. Off-target edits and mosaicism are difficult to detect and impossible to reverse once heritable.
  • Equity. Likely accessible only to wealthy families.
  • Slippery slope to enhancement. Selection of non-medical traits.

Regulation. Banned or strictly limited in almost every jurisdiction; a global moratorium has been proposed by leading scientists.

Gene drives

What it is. A CRISPR-based element that copies itself onto the homologous chromosome in every individual, so the drive is inherited by close to 100 percent of offspring instead of 50 percent. A drive can spread through a wild population in a few dozen generations.

Applications.

  • Malaria control. Engineered Anopheles mosquitoes either crash the population (sex-linked sterility drive) or block parasite transmission. Target Malaria's work in Burkina Faso is the most advanced field programme.
  • Invasive species control. Drives against rodents on islands or against cane toads in Australia.

Issues. Irreversibility, cross-border spread, ecosystem consequences, governance gap.

Prime editing and base editing

Prime editing (2019). A "search and replace" CRISPR system that can write small new sequences into a chosen location without a double-strand break. Lower off-target rate than original CRISPR-Cas9. Approaching clinical trials for sickle cell and other monogenic diseases.

Base editing (2016). Converts one base directly to another (e.g. C to T) without cutting both strands. Verve Therapeutics has run trials for inherited hypercholesterolaemia.

These technologies extend CRISPR's reach and address some of its off-target concerns.

RNA and mRNA therapeutics

The COVID-19 mRNA vaccines (Pfizer-BioNTech, Moderna) proved the platform at scale. Future applications:

  • Cancer vaccines tailored to individual tumour neoantigens.
  • Replacement therapies for protein-deficiency diseases.
  • Treatments for rare diseases that are too small a market for traditional drug development.

Synthetic biology

The engineering of new biological systems from standardised genetic parts.

  • Engineered microbes producing pharmaceuticals (artemisinin in yeast for malaria treatment), fragrances, and meat alternatives.
  • Minimal genomes. Craig Venter's group constructed JCVI-syn3.0, a bacterium with only 473 genes, the smallest known self-replicating organism.
  • Xenobots. Programmable biological "machines" built from frog cells (Tufts and University of Vermont, 2020).

Xenotransplantation

Transplanting genetically modified animal organs into humans. Pigs engineered with CRISPR to remove pig-specific antigens and inactivate endogenous retroviruses (PERVs) have been used in two heart transplants (2022 and 2023) and several kidney transplants. The recipients all died within months but proved the technology works in principle. With ongoing organ shortages (about 1,800 Australians on the transplant waiting list at any time) the technology has significant potential.

Pharmacogenomics and personalised medicine

WGS-guided treatment is moving from research into routine care. By the late 2020s, sequencing at birth is likely to be common in high-income countries, with pharmacogenomic dosing recommendations attached to every prescription.

Artificial intelligence and protein design

DeepMind's AlphaFold (2020) solved the protein structure prediction problem. RFdiffusion and similar generative models design new proteins computationally. This accelerates drug discovery, enzyme engineering and vaccine design.

Cross-cutting issues

Issue Why it matters
Consent Future generations and ecosystems cannot consent
Equity High-cost therapies may widen health inequalities
Dual use Same techniques can build vaccines or bioweapons
Regulation lag Technology moves faster than law
Public engagement Acceptance varies widely between countries and communities
Reversibility Gene drives and germline edits are heritable; not easily undone

Worked example

You are asked which emerging technology is most likely to "change populations forever."

Argument: gene drives.

  • Spread through wild populations without further human input.
  • Could eradicate species (e.g. invasive rodents) or eliminate disease vectors (Anopheles).
  • Cross national borders; unilateral release is possible.
  • Once released, very difficult to retract.

Comparison. Somatic gene therapy is reversible at the population level (it affects only the treated individual). Germline editing is heritable but is unlikely to affect more than a small minority of the human population. Gene drives uniquely have the property of self-propagation, so they meet the "forever" criterion most clearly.

Judgement. Gene drives have the highest potential to permanently change populations, which is why their development has been accompanied by an unusual degree of self-regulation and international consultation.

Common traps

Treating "future" as "more than 10 years away." Many of these technologies are already in clinical trials or field experiments. Be specific about state of development.

Listing many technologies superficially. Pick two or three and go deep; markers reward analysis over breadth.

Forgetting the equity dimension. A million-dollar gene therapy that only the rich can access has very different implications from a public-health gene drive.

Confusing germline editing with gene therapy. Somatic gene therapy is already approved and widely accepted; germline editing is banned in almost every country.

In one sentence

The future of genetic research is dominated by heritable interventions (germline editing, gene drives), more precise editing tools (prime and base editing), mRNA therapeutics, synthetic biology, xenotransplantation and AI-driven protein design, each promising large medical or environmental benefits but raising consent, equity, dual-use and reversibility concerns that current regulation is struggling to keep pace with.

Past exam questions, worked

Real questions from past NESA papers on this dot point, with our answer explainer.

2022 HSC6 marksEvaluate the potential future impacts of one emerging genetic technology on society.
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A 6-mark evaluation needs the technology, mechanism, benefits, harms, and a justified judgement.

Named technology: gene drives for mosquito control.

Mechanism. A CRISPR-based gene drive copies itself onto the homologous chromosome in every individual, so almost all offspring inherit it (rather than 50 percent). Gene drives have been engineered in Anopheles mosquitoes to either kill females (population suppression) or block malaria transmission (population replacement).

Benefits.

  1. Public health. Malaria killed roughly 600,000 people in 2023, mostly children in sub-Saharan Africa. A successful drive could eliminate Anopheles vectors locally.
  2. Conservation. Drives could eradicate invasive species (cane toads, rodents on islands) that drive native extinctions.
  3. Equity. Unlike bed nets and drugs, drives need no ongoing individual behaviour or expense.

Harms.

  1. Ecosystem effects. Removing a species can have unpredictable knock-on effects on predators, pollination, or other ecological roles.
  2. Cross-border release. Mosquitoes do not respect borders; a drive released in one country spreads to others. International governance is unresolved.
  3. Resistance. Resistant alleles can arise and undermine the drive.
  4. Reversibility. "Daisy chain" drives are designed to fade out, but verifying this in the field is hard.

Judgement. The malaria burden is so high that a successful drive could be one of the largest single advances in global health. Risks are tractable; the technology should be developed in parallel with international governance, with phased trials beginning on islands. Benefits likely outweigh risks within the next decade if regulation keeps pace.

Markers reward (1) named technology and mechanism, (2) two or more benefits and harms, (3) examples and quantitative claims, and (4) a justified judgement.

2021 HSC4 marksDiscuss the ethical issues raised by germline gene editing in humans.
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Germline editing alters DNA in eggs, sperm or embryos. The changes are heritable.

Ethical issues.

  1. Consent. Future generations who inherit the edit cannot consent. This violates a basic principle of medical ethics.
  2. Safety. Off-target effects and mosaicism may produce unintended changes that propagate across generations. The 2018 He Jiankui case (twins edited at the CCR5 locus) demonstrated the safety gap; the off-target consequences in those children remain unknown.
  3. Equity. If germline editing becomes available, only wealthy families would access it, creating a "genetic underclass" or entrenched inequality.
  4. Eugenics. Selection of traits beyond medical necessity (height, intelligence, appearance) raises concerns about the meaning of disability and human variation.
  5. Regulation. Most countries ban germline editing for reproduction. The international research community broadly endorses a moratorium pending safety and societal consensus.

Markers reward (1) at least three distinct ethical concerns, (2) the He Jiankui example, and (3) a balanced acknowledgement of potential medical benefit (preventing severe inherited disease).

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