- Analyse the influence of ethical frameworks on scientific research over time, including but not limited to:
- human experimentation
- experimentation on animals
- use of research data
Ethics relate to what society deems to be right or wrong. Where as, morals are what an individual deems to be right or wrong. As a scientist, you must consider whether your experimentation is ethical.
These considerations are required to uphold the trust society places in today’s scientists – to push the boundaries of human knowledge in an ethical manner.
It is important to note, science requires experimentation on humans and animals. These experiments, however, must be reported to and approved by regulatory authorities with a range of specialists on the team.
When a new treatment is brought to the market, it usually has undergone over 10 years of testing and at least a $ 1 billion investment.
The first tests for a new drug often require biobanks. These are repositories of biological ‘stuff’, which is stored for a range of uses. The biological ‘stuff’ can be tissue of different cancers, plant seeds, healthy human cells from different people, … The drug of interest will then be tested, in vitro (meaning inside a test tube and not a living entity), to determine whether it does what it is intended to do.
These biobanks ethical considerations include, safe and secure storage, appropriate procedures to maintain the biological entities stored and correct identification of what is in storage.
The therapeutic will then be tested in vivo, meaning in living tissue. This is when animal research ethics are required. In Australia, the Animal research review panel is required to approve research with animals, where the experiment is justified in front of the Animal Ethics Committee (AEC). Animal research requires the 3 R’s to be followed.
- Reduce: Reduce the number of animals required for the experiment
- Refine: Refine the experimental technique to minimize any pain and suffering of the animal
- Replace: Where possible, use other models rather then animal models
Once this has been approved the next step is phase I clinical trials which requires human ethics considerations. In 1945, the Nuremberg code was released which outlined the experimental human ethical considerations which must always be followed by any researcher. These were to uphold respect and dignity for human life – so any research on humans had a greater effect then the cost of the research. It also required that human participants give consent to be in the study. This code was later adjusted by the Declaration of Helsinki, which meant that the outlines of the study were written in language people could understand and that those unable to consent to a study could have a guardian do it for them.
In Australia, the human research ethics committee must approve a study before it can be carried out. This also requires national ethics approval and site-specific assessments to determine whether the planned experiment is ethical and in an appropriate area.
The data generated in all of these studies must also be ethically used and refined. This requires that data is not just deleted because it isn’t what you wanted to see and it is stored safely and securely. When publishing, the identity of the participants should remain anonymous and people should be allowed to remove their data from the study at any point.