# 2 Research integrity

Below is a case study on Edward Jenner, who conducted an early medical trial on a living human subject. The results of his experiment are an example of a great scientific advance, but today the ethics would be very questionable.

## Edward Jenner - a case study

Edward Jenner (1749–1823) was a doctor and in 1796 he carried out an experiment which led to him becoming known as ‘the father of immunology’. The experiment involved inoculating an eight-year-old boy, James Phipps, with pus from a cowpox pustule taken from an infected milkmaid. When James recovered he was then later infected with smallpox pus in the same manner.

Figure 2 Edward Jenner inoculating a child.

Jenner was testing a hypothesis that followed his observation of local folklore, which said that milkmaids who suffered from cowpox did not suffer from smallpox. Smallpox infection was a big killer, especially in children, in the 1790s, but cowpox was a mild disease. Jenner’s hypothesis was that people who suffered from cowpox would not then suffer from smallpox. This hypothesis was confirmed (albeit in a sample of one).

There is a great deal of difference between unknowingly and knowingly practising what could be termed ‘bad science’. Under today’s strict legislation James Lind and Edward Jenner would not have been able to conduct their experiments.

In 2006 the UK Research Integrity Office (UKRIO) was established. According to its website, UKRIO is:

> an organisation that offers support to the public, researchers and organisations to further good practice in academic, scientific and medical research. The UKRIO promotes integrity and high ethical standards in research, as well as robust and fair methods to address poor practice and misconduct.

In the following activity you will learn more about the role of UKRIO.

## Activity 2 UK Research Integrity Office

You should allow about 30 minutes for this activity.

While the UKRIO is relevant to the UK, there are similar organisations in other countries of the world. Spend some time researching the website of the UKRIO. While you are researching think about finding the answers to the following questions:

What sort of organisation is UKRIO?

### Answer

UKRIO is a charity and an ‘advisory’ body, not a regulatory body.

What are the aims of the UKRIO?

### Answer

The aims of the UKRIO are to:

- promote the good governance, management and conduct of academic, scientific and medical research
- share good practice on how to address poor practice, misconduct and unethical behaviour
- give confidential, independent and expert advice on specific research projects, cases, problems and issues.

What are the principles of the UKRIO?

### Answer

The principles of the UKRIO are: excellence, honesty, integrity, cooperation, accountability, training and skills, safety.

What should researchers do to ensure they follow good practice?

### Answer

Researchers should:

- recognise their responsibility to conduct research of high ethical standards
- be aware of their organisation’s policies and procedures on good practice in research
- make sure that their research complies with these policies and procedures, and seek guidance from their organisation when necessary
- work with their organisation to ensure that they have the necessary training, resources and support to carry out their research; and
- suggest to their organisation how guidance on good practice in research might be developed or revised.

Poor practice, fraud and other forms of misconduct can cause significant harm to the public perception and, indeed, the reputation of scientific research.

Scientific research is undertaken through funding from charities, taxes and commercial companies. Any breach of trust with the public due to misconduct and poor practice can cause considerable financial and reputational damage to research institutions and jeopardise further funding opportunities. Most importantly, participants, patients and the public can be put at risk or even caused actual harm.

In the UK in 2006 there was a clinical trial that went seriously wrong. The clinical trial became known in the popular press as the ‘elephant man drug trial’ and it was the first phase of the trial of the drug known as TGN1412 in humans. It was hoped that the drug might be used in the treatment of cancer and rheumatoid arthritis. The trial involved eight healthy men aged 19–34 years. Six men received TGN1412 and two men received a placebo ( a placebo is a substance with no therapeutic effect).

- Why do you think it is important to use a placebo in a clinical trial?

- The placebo acts as the ‘control’ in the experiment. This means that any differences noted between people given a drug and people given a placebo in a clinical trial can be attributed to the drug and not to the way the drug was administered.

The people involved in the clinical trial were not aware of whether they were given the placebo or the test drug. The six men who received TGN1412 all complained of severe pain within two hours of being infused with the drug and all were in intensive care within 12 hours of the infusion. One volunteer was described as having a ‘ballooned head’, hence the ‘elephant man drug trial’ label; another volunteer lost his fingers and toes.

It is important to view the ‘elephant man drug trial’ in context. It was one drug trial out of thousands conducted every year and fortunately none of the volunteers died. The fact that the trial received such broad press coverage at the time was precisely because it was unusual and horrific for those involved. It is important that scientific research is open to scrutiny as this promotes good practice because of the wider consequences.

It is vital to promote integrity in our scientific research. The experiments undertaken by Lind and Jenner would be considered unethical by today’s standards. But they did undertake their experiments with the best intentions; that is, to provide a cure for scurvy and prevention for smallpox.

However, there are other scientists that do act unethically either for their own glory or for money or for some other reason. These scientists are few and far between, but it is important that they are exposed for bringing science into disrepute.

OpenLearn - Ethics in science?
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