HUMAN RESEARCH ETHICS

HUMAN RESEARCH ETHICS: BENEFICENCE

PART B:

A CASE STUDY: An opportunity to identify ethical issues related to beneficience.

Read the following case study and answer the question that follows. This is not a test of your knowledge of research ethics – it is simply to give you the opportunity to say what you think are the ethical issues that relate to beneficence and to receive feedback on what you have said.

Cholesterol, childhood and cardiovascular health.

Background
There is overwhelming evidence, from autopsies performed on children who died accidental deaths and from studies on young soldiers who died in their early 20s that atherosclerosis, a build up of plaque in the arteries, starts in childhood.

It is also known that there is a correlation between cholesterol and other blood fat levels in children and the degree of atherosclerosis in their arteries. Children and adolescents with high cholesterol levels are more likely than the general population to have high levels as adults. Recent reports have further predicted that the life expectancy of this generation of obese children is likely to be reduced by at least 5 years due to complications of cardiovascular disease.

It is not yet known if lowering a child's cholesterol levels changes their risk later in life for developing coronary disease. Studies have not been conclusive and a substantial number of children with high cholesterol levels become adults with acceptable cholesterol levels without intervention. Some studies support the use of cholesterol lowering drugs by children whose cholesterol remains high despite diet and exercise changes. One class of drugs especially, known as Z-class has been shown to significantly lower cholesterol levels in children with inherited forms of high cholesterol and not to affect their growth or progression to puberty. However, some concern remains about the effects of a life-long regime of such drugs for children.

The study
Dr. Cook, who is employed as a paediatrician by the Rural Health Service located in a small town in a rural area in Australia, has been disappointed that her patients, who attend an obesity clinic, have been unable to lose weight despite changes in diet and exercise habits. She is approached by Ozpharma, an Australian pharmaceutical manufacturer to be a co-investigator in a trial of Z100, a novel agent designed to reduce cholesterol in children and young people and, as a result, decrease their risk of cardiovascular disease in adulthood. Ozpharma has proposed a clinical trial to determine the safety and efficacy of Z100 in obese children and adolescents (ages 8-16 years) with high cholesterol.

In collaboration with Ozpharma, Dr Cook devises and presents for ethical approval the following multi-pronged study.

She will recruit participants from the children who visit her clinic and members of their families and also approach the local primary and high schools to ask their principals to distribute invitations to all enrolled children between the ages of 8 and 18. Dr. Cook is aware that some of her regular patients are from Aboriginal families and that the school population includes a significant number of Aboriginal children.

Children will be randomly allocated to one of three arms: the first will receive Z100, the Ozpharma agent, and enrol and be monitored on a diet and exercise program, the second will receive a placebo that looks exactly like the active agent and also be enrolled in the diet and exercise program and the third will receive only Z100 and, although not on a diet and exercise program, will also report on what they eat and the extent of their normal exercise.. All children, whether already regulars or not, will need to attend the clinic weekly to have their cholesterol levels tested and the diaries of their diet and exercise programs checked. Neither the children nor their families nor Dr Cook and her researcher colleagues will know to which arm individual children have been allocated.

At the time of the enrolment in the study, children who have raised cholesterol will also be asked to talk with their parents and blood relatives about all giving blood samples. It will be emphasised that it is important to include as many family members as possible and that those who agree will be asked about members of their families known to have, or if they have died, to have had high cholesterol, or who are or were obese. The blood samples will be analysed to determine which of the children have inherited forms of raised cholesterol. (Some earlier studies suggest that drug intervention is only effective in reducing cholesterol that is inherited and both Ozpharma and Dr Cook want to further test this hypothesis.) The blood samples will be sent to a laboratory in the nearest State capital for testing and return. After the test results are collated to test the inherited cholesterol hypothesis, they will be destroyed.

Dr Cook believes that the study is worth doing because it may open ways to more effectively treat high cholesterol in children and, by the engagement of families, may generate better understanding of the importance of addressing these conditions in childhood.

QUESTIONS

If you were asked to be a co-researcher in this study or a member of an ethics review body reviewing this study, and needed to be satisfied that the project met the value and principle of beneficence, what would you want to know before you agreed to be part of the team or approved the study?

The material that you have reviewed in Part A of this Module will assist you to identify the ethical matters that relate to the value of beneficence.

You may well identify other matters of research ethics that relate to one or more of the other key values of the National Statement, but the focus of this Module is on beneficence.

You are encouraged to write your answers to this question in the box below. This is not a test but rather an opportunity to see whether the issues you identify are the same, in substance, as those that can be accessed by selecting the "Show Answer" tab below the box.

Matters related to beneficence that would be likely to concern co-researchers and human research ethics committee members include:

  1. What are said to be the benefits of this study?
  2. Will the clinic patients have unrealistic expectations of benefit?
  3. To whom will those benefits accrue: participants or others?
  4. Will the Aboriginal community benefit?
  5. Will there be risks of identifiability, in a small community, as participants and therefore as having raised cholesterol and being “sick”?
  6. Will there be risks of distress in identifying relatives who are obese or, if they have died, were obese?
  7. What are the risks of taking the Ozpharma agent?
  8. What are the are risks of giving blood samples?
  9. What are the risks of being identified through the blood samples?
  10. What are the risks to the participants who are children?
  11. In relation to all of the identified risks, have they been minimized?
  12. In relation to all of the identified risks, how will they be managed?
  13. Are all of the risks justified by the intended benefits?