Zenovia who is a healthy volunteer in HIV vaccine research ⁽¹⁵⁾

Physical

Zenovia may receive an experimental HIV vaccine which has unknown side effects. This is on top of the side effects that come with any vaccination, ranging from local rash to life-threatening systemic anaphylaxis. If a live vaccine is used and Zenovia is pregnant, there is a theoretical risk of transmitting HIV to the unborn child. Furthermore, Zenovia may need to have blood tests for the initial enrolment screening and further blood tests to monitor her immune response to the vaccine. Although blood tests are usually considered safe, they still carry risks of pain, bruising and fainting due to vasovagal reactions. Frequent blood tests may also lead to anaemia or worsen pre-existing anaemia.  

Psychological 

As Zenovia is emotionally invested in HIV research, she may be disappointed if she is found ineligible for a study. She may be particularly sensitive to questions about her previous contact with HIV-affected individuals, due to the death of her uncle from AIDS. She could be worried about the side effects of HIV vaccines and whether she can contract HIV from it. She may also be afraid of injections and blood sampling. 

Socio-legal 

Zenovia’s family may not be supportive of her participation in HIV research. Zenovia may also be mistaken by her community as having HIV due to her frequent contact with the HIV research centre, leading to loss of reputation. If the information about her uncle having HIV/AIDS was found out by others due to her participation in HIV research, she and her family might be discriminated by others, especially if they live within a close-knit community. If Zenovia is involved in HIV research as an injecting drug user instead, she might face criminal charges if evidence of her drug use was obtained via the research notes. This could have many other repercussions including imprisonment.  

Financial / Economic 

Zenovia may need to take time off work in order to participate in research follow ups. Besides, any physical side effects that she experiences could increase her health expenditures, and may also affect her productivity at work.  Societal discrimination due to her participation in HIV research may make it more difficult for her to find a job. 

Hong Meng who had heart disease with no current effective treatment ⁽¹⁶⁾

Physical

Hong Meng may end up in the control group of the clinical trial and may not receive the potential benefits offered by the experimental intervention if it is subsequently proven to be better. Hong Meng may need to go through a multitude of tests and perhaps surgery, all of which carry risks of their own, further complicated by Hong Meng’s young age, ill health and potential interactions with the medications that he is already on. If Hong Meng’s condition improved due to an experimental drug, he may worsen if the drug is stopped at the end of a trial.

Psychological 

Hong Meng and his mother may be disappointed if the trial did not help his condition or actually worsen his condition. This would be especially so if they clung on to the belief that a clinical trial is meant to benefit them, when in fact the main purpose of research is to generate knowledge about what may or may not be beneficial. The term ‘therapeutic misconception’ describes this common misconception by patients. ⁽¹⁹⁾ Hong Meng could also suffer from extra pain and fatigue due to the additional tests that are performed for research purposes only. If he is a palliative care patient, adherence to the strict requirements of a trial can be very emotionally burdensome.   

Socio-legal 

Genetic tests may be performed as part of research, especially with the current trend towards personalised medicine. However, genetic tests may reveal findings that affect not just Hong Meng, but also his blood relatives. This may infringe other family members’ privacy, especially if they would actually prefer not to know about information such as genetic predisposition towards incurable diseases. 

Financial / Economic 

Hong Meng may be required to travel long distances to a specialist heart centre for multiple tests and follow ups. Or he may require prolonged inpatient monitoring. These can all become financial burdens to his family if his parents have to take time off work to accompany his visits. If Hong Meng gets better on a trial drug, his family may need to afford it themselves once the trial has ended, which could be very costly if not totally inaccessible (if the drug is not available in Malaysia). 

Dr Nash who volunteered for dementia research due to his strong family history ⁽¹⁷⁾

Physical

Dr Nash may be required to undergo tests such as imaging of the brain. Such tests may yield incidental physical findings such as an aneurysm. These may lead to further tests and/or treatments which may or may not be necessary. 

Psychological 

Socio-legal 

If Dr Nash’s patients and colleagues discovered that he is participating as a subject in dementia research, they may lose trust in his professional capabilities. This may even predispose him to complaints, resulting in formal inquiries into his fitness to practice by the medical council.

Financial / Economic 

Dr Nash may lose his job if he is found unfit to practice medicine. If Dr Nash’s insurance company discovers the results of his tests (e.g. brain lesions on MRI scan or presence of high-risk genes), they may increase his insurance premium even if those findings are inconclusive of dementia. 

David who is a healthy volunteer in the phase 1 leukaemia drug trial ⁽¹⁸⁾

Now that you have gone through three examples, you should be able to figure out some of the risks and burdens that David might face.

However, the exploratory nature of research always brings with it the possibility of unforeseeable risks. This can be profound in the case of phase 1 drug trials when drugs are tested on humans for the first time.

Click 'Next' to find out what actually happened in this study.