Question 1: Define 'ethics' in the context of biological research and medical applications.

Answer: Ethics refers to moral principles that govern the conduct of research and medical practices, ensuring actions are right or wrong and considering the impact on society and individuals.

Question 2: Explain how monoclonal antibodies are produced in a laboratory setting.

Answer: Monoclonal antibodies are produced by creating identical immune cells (hybridomas) that are fused from a specific B-cell and a tumour cell, allowing large-scale, identical antibody production.

Question 3: What are the primary ethical concerns associated with the use of monoclonal antibodies in humans?

Answer: Concerns include potential side effects, informed consent, accessibility and cost, and the use of animals in production processes.

Question 1: Design a basic outline for an experiment to test the effectiveness of monoclonal antibodies against a specific virus, considering ethical constraints.

Answer: The experiment should include obtaining informed consent, ensuring minimal risk to participants, using appropriate controls, and considering animal testing ethics. It should also include steps for data collection and analysis while prioritising participant safety and ethical approval.

Question 2: Identify three variables that should be controlled in an experiment testing monoclonal antibody efficacy.

Answer: Dosage of antibodies, temperature during testing, and the strain of virus used.

Question 3: List two safety precautions that must be observed when handling monoclonal antibodies in a laboratory setting.

Answer: Wearing protective gloves and eye protection; working within a biosafety cabinet to prevent contamination.

Question 1: A new monoclonal antibody treatment has shown high efficacy in clinical trials, but it is extremely expensive and only available to wealthy patients. Discuss the ethical issues this raises.

Answer: The ethical issues include inequality of access, fairness in healthcare, the distribution of resources, and whether it is morally acceptable to restrict life-saving treatments based on ability to pay.

Question 2: In a scenario where monoclonal antibodies are produced using genetically modified animals, what ethical concerns might arise?

Answer: Concerns include animal welfare and rights, the morality of genetic modification, and potential ecological impacts.

Question 3: Describe how informed consent is important in the ethical use of monoclonal antibodies in clinical trials.

Answer: Informed consent ensures participants understand the risks, benefits, and purpose of the trial, respecting their autonomy and rights to make voluntary decisions.

Question 1: How might public opinion influence the ethical approval and commercialisation of monoclonal antibody-based therapies?

Answer: Public opinion can affect regulatory decisions, funding, and acceptance of new treatments, with ethical considerations influencing transparency, safety, and accessibility.

Question 2: Discuss the role of government regulation in addressing ethical issues associated with monoclonal antibody therapies.

Answer: Government regulation ensures safety and efficacy through approval processes, monitors ethical standards, enforces animal welfare laws, and promotes equitable access to treatments.