Task: Watch the videos below.
Task: Answer the following questions.
- What does genetic modification or genetic engineering mean?
- What is a ‘frankenfish’
- Why was Dolly the sheep different to other sheep?
- Should humans be allowed to be cloned? Explain your view.
The progression from animal testing to human testing or human trials occurs with most new medications. Human subject research is often necessary to get drugs to the final phase of regulatory approval. It serves as the final check of how a given medicine or chemical will interact with the human system. Yet, time and time again it has hurt, maimed, or killed individuals.
In 1947, it was discovered that German physicians conducted deadly experiments on concentration camp prisoners during WWII. Some were prosecuted as war criminals in the Nuremberg Trials, after which the Allies then established the Nuremberg Code, being the first international document for voluntary human consent for research.
In today’s human testing, all patients must consent to the study. However, as long as human trials are conducted, there are people who are coerced to participate. For this reason, the ethics of the entire situation are still be hotly debated.
Task: Watch this video to understand how medicines are developed and how humans are used as part of the development.
Task: Read the article to understand what happened when the Northwick Park Drug Trials went wrong.
The following is information from the World Health Organisation:
Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to take part in clinical trials to test medical interventions including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioural treatments and preventive care.
Clinical trials are carefully designed, reviewed and completed, and need to be approved before they can start. People of all ages can take part in clinical trials, including children.
There are 4 phases of biomedical clinical trials:
- Phase I studies usually test new drugs for the first time in a small group of people to evaluate a safe dosage range and identify side effects.
- Phase II studies test treatments that have been found to be safe in phase I but now need a larger group of human subjects to monitor for any adverse effects.
- Phase III studies are conducted on larger populations and in different regions and countries, and are often the step right before a new treatment is approved.
- Phase IV studies take place after country approval and there is a need for further testing in a wide population over a longer timeframe.
Although in the UK, participants in drug trials must give their consent and show that they understand the risks, they still often receive a payment.
Task: Explain whether you believe that humans should be paid for human trials of new medicines. Do you think there should be additional regulations on who can take part in trials?