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Principle 2: Respect for persons

The principle of respect for persons concerns an individual’s right to autonomy or self-determination. People should be empowered to decide what is best for themselves, and be respected for their own choices.

In research involving human subjects, respect for autonomy manifests in the need to obtain consent from subjects. A valid consent should be:

(Click on each tab for further elaboration)

Fully informed

  • People should be given all the information that they would need to make the best decision for themselves.

Voluntary

  • Not coerced (i.e. forced with threats)
  • Not unduly influenced (i.e. tempted with excessive rewards, or misleading claims of benefit).

Provided by an individual who has capacity

  • Capacity should be enhanced by presenting information in a way that facilitates an individual's understanding.

When someone is unable to provide consent that satisfies all three criteria above, they are considered vulnerable to exploitation.

Test yourself: Vulnerable or not?

Based on some of the previous case examples, consider whether these subjects could have been vulnerable. 

Click on the respective links to refresh your memory about the cases.

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1. James Phipps, child who was first to be given the experimental cowpox vaccine 


2. Anonymous medical student who was used to demonstrate the effect of anaesthesia 


3. Pierre Curie, scientist who tested the effect of radium on himself 


4. Dr Nash, doctor who enrolled in dementia research due to his strong family history of Alzheimer’s 


5. David, volunteer for the TGN1412 drug trial which offered good financial incentives 


6. Prisoners who underwent experimentation in WWII concentration camps 


7. Families in Newfoundland who participated in the genetic study for heart disease

In the late 18th century, Edward Jenner, a doctor in rural England, observed that milkmaids who contracted cowpox were free from smallpox, a much deadlier infection that had claimed the lives of many children at the time. To test his hypothesis, he took his gardener’s 8-year-old son – James Phipps – and infected him with cowpox by rubbing pus from a cowpox vesicle into a wound on his arm. When Phipps recovered from the mild disease, Jenner then attempted to infect him with smallpox, but found that Phipps was now immune to it. Jenner replicated his findings on a few more children, including his own infant son. The word ‘vaccine’ was subsequently coined by Jenner, taking the Latin word for ‘cow’. (1)

In the late 19th/early 20th century, Marie Curie and Pierre Curie, both physicists at Sorbornne University in Paris, were the first to isolate the radioactive element radium while researching on the radioactivity of uranium ores under Professor Henri Becquerel. During their work, the Curies suffered from frequent poor health and raw, inflamed hands. (7) They gave little attention to the physical effects of handling radium until Becquerel himself sustained a serious skin burn from a piece of radium that he had left inside his waistcoat pocket. Intrigued by this, Pierre applied radium on his own arm for 10 hours to observe the local burn that it produced. This led Pierre to suggest the potential use of radium-induced deep skin burns in the treatment of cancer. (8,9)

Dr Nash, volunteer in dementia research

‘Every day I think about, about the Alzheimer’s. I have the memories of my mother and my father and my brother and my aunt and my grandmother (...) I wanted to get involved. I want to be monitored so that if I had a problem then I was going to quit practicing medicine.’

(Quoted from: U.S. NIH National Institute on Aging, 2012) (17)

David, healthy volunteer in phase 1 leukaemia drug trial

‘When I saw the ad I was like… two thousand pounds for three days work seemed like a good deal to me, considering I had done two previous trials and.. and it wasn’t, it wasn’t hard work.’

(Quoted from: Real stories, 2018) (18)

During the World War II (WWII) in the 1940s, thousands of prisoners in concentration camps, including women and children, were tortured and killed by Japanese and Nazi doctors in the name of ‘medical experimentation’. Examples included extreme physiological testing such as ice water immersion to induce hypothermia, and vivisection without anaesthesia.(22,23)

In 1845, Horace Wells, a dentist, conducted a public demonstration at the Massachusetts General Hospital (MGH) in Boston to prove the efficacy of nitrous oxide gas as an anaesthetic agent. However, his demonstration failed when his patient, an anonymous Harvard medical student, yelped in pain after his tooth was extracted under the influence of the anaesthetic gas, allegedly due to the gas being removed too soon. (3) 

In 1998, a team of researchers from Baylor College, Texas wanted to locate the genes for an inherited heart disease that causes sudden death in young people. They targeted a remote community in Newfoundland, Canada in which the disease has a high prevalence due to generations of genetic isolation. The local people agreed to provide their blood samples as they had been longing for a genetic test for the disease.

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Privacy and confidentiality

Also inherent in the principle of respect is the right of an individual to privacy. A person should have control over the access to his / her own body and personal information.

Private (i.e. personal / not public) information provided by research subjects should be treated in confidence (it is confidential i.e. only accessed by those who have been given permission to do so).




Principle 3: Justice