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How many parents would say ‘yes of course!’ if asked to consent to their child being involved in a research study – perhaps involving extra blood tests or additional scans as well as the planned treatment? Many of us would hesitate, or refuse outright, concerned either about any associated risks, or about the additional and unnecessary (from this child’s perspective) discomfort or distress. And yet all of us hope and expect that, when our children are ill, they will receive treatment based on the best possible evidence as to its effectiveness – evidence that cannot be straightforwardly derived from adult studies because children are not simply ‘small adults’, and their bodies deal with medicines differently. Similarly, data from older children cannot simply be extrapolated to toddlers or newborns. So, research with children is crucial if children themselves are to benefit from the best possible treatment when they are ill. But ethical problems abound – from the question of whether parents should or ought to allow their young children to participate in research that involves even minor discomfort or distress to, at the other extreme, the question of whether parents or children should have a right to participate in research – a right, for example, that may be claimed where a child is very seriously ill and a new, as yet-unlicensed, treatment is seen as being their ‘only hope’. And that’s before we start looking at the question of children’s own participation in these decisions: what part should a 6, 8 or 10 year-old child play in deciding whether or not to take part in research? Should we be encouraging our children to act altruistically, even at the cost of some temporary discomfort? Or should we be protecting them from any procedure that does not directly benefit their own health now? And how about the cases where research and treatment are inextricably combined, as in later-stage trials of new medicines – how much do we defer to the wishes of older children to participate or not in such research, when the decision may also have an impact on the child’s own health? The UK-based Nuffield Council on Bioethics has set up a Working Party to develop a report on Children and research: ethical issues, to be published in early 2015. One remit of the Working Party is to consult as widely as possible with groups of people who may be affected by the report in future, including children and young people, parents, researchers, health professionals and a wider public. The Working Party is now seeking additional input to the report from stakeholders in low and middle income countries. If you are interested in getting involved and contributing to this report please view/download the consultation information document via the link below: Nuffield Council on Bioethics - Children and clinical research: consultation on the ethical issues Once you have compiled your responses please upload them to our survey collection system by selecting the link below: Survey - Children and clinical research: consultation on the ethical issues
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Hilarious de Jesus
29 May 2014
Interesting perspectives from you morenike. It does bring into light the variations of ethical issues surrounding paediatric consent with other external factors that contribute to the whole dynamics.
I can only speak to the practice in the UK. There is a Competency Framework Assessment that we can use when consenting adolescents when consenting/assenting adolescents or sometimes referred to as young persons. It is referred to as the Fraser Guidelines which includes the Gillick competency. See link (http://www.nspcc.org.uk/Inform/research/briefings/gillick_wda101615.html#application). The proposition to eliminate the parents entirely in the consenting process of adolescents is a very delicate issue. Admittedly, there are certain situations when adolescents made contact with healthcare professionals and involving parents into the discussion can be an ethical minefield.
However, in our practice, we are guided by the said guidelineswhich is also applied into consenting for other purposes not just research. Admittedly, I have not had the opportunity to do this yet in practice but in my opinion the guideline is an invaluable resource when making decisions as a clinician. Also, our practice culture involves accessing support from other colleagues in discussing similar "ethically dubious" issues, where perspectives from other clinicians can help make a consensual decision with the aim of fulfilling "best interest of the patient" principle while keeping in balance with other pertinent principles such as rights of patient to self-determination and nonmalefeasance.
Again, thank you for your insight and it brings light to a different perspective in another part of the globe. -
morenike Ukpong
23 May 2014
Just to further add to the discussion
I attach a draft paper we are working on publishing that also looks and discuss other ethical issues beyond the informed consent remits that are of important consideration in SRH research for adolescents.
We argue that adolescents’ voluntary participation in research has been limited due to their perceived potential to be coerced into participation, and concerns that they may not fully comprehend the issues related to research risks. Many of the regulations for engaging research participants have been defined by age, rather than due consideration of psychological development.
Other ethical issues when considering engaging adolescents in research include minimizing therapeutic misconception, considerations in recruitment and retention, reimbursement types and amounts, and engagement of communities of adolescents on advisory boards of studies involving their population.
The attached manuscript discusses the potential challenges associated with recruitment of adolescents including those who are in early child marriages yet may be considered as autonomous to give informed consent by the Nigeria legislation.
I do look forward to reading a lot more discussions on this forum
Attached files: Folayan_ethics_manuscript_3.doc -
morenike Ukpong
23 May 2014
The need to develop guidelines for children is important
First, I think it is essential to separate adolescents from children as this is important. The issues that relate with adolescents do differ significantly than issues that relate with children. One of such is the need to engage adolescents in sexual and reproductive health research. The issue of autonomy is trickier with adolescents. I would want to argue that consenting for children (0-10years) is easier and the dilemma lies with adolescent - the very reason to differential between the two groups
I recently wrote a paper on this topic (accepted for publication with DWB and attached with this mail) that argues for the feasibility of reducing the age of consent of adolescents to 14 from the current 16 highlighted in the Child Right Acts. However, there are provisos to this argument.
As the document highlights, we do have a number of examples we can learn from in the field. There are lots of debates and discussions about engaging adolescents in research that can very well inform the Nuffield guideline. I also would advice that the Working Group wait for the outcome of the discussion on the same subject by the planned for Kenya on the 5th and 6th of June as well as one planned for Nigeria at the end of June. These discussions would be rich and can indeed influence the field.
I look forward to reading more on this discussion
Attached files: Ethics_adolescents_SRH.pdf -
AUGUSTINE ONYEAGHALA - Senior Contributor
15 May 2014
The idea to develop a good guideline to protect the children is a welcome development and as researchers, it is our responsibility to use all means available to protect these vulnerable ones.
Although I have not conducted any clinical research work using children, yet one of my major concerns in conducting clinical research among children has always been the subject of consent. Various versions of DoH have recommended that in situations where consent cannot be received from the under aged, such consent should be given by the child's authorized representative. In the developing world, this can be very tight, legal and could have relative interpretations. who is the child's authorized representative? Should this have a legal definition? Is it right for another person to take a consent for a child, while allowing the child to bear the pain and discomfort associated with the research? When the child grows and he gets to know about this how will he fill? Betrayed or protected?
Another issue here is that of Justice or fair share from the study outcome. Will the parents of the child be able to afford the drug when finally approved ? How about other children living in the LMIC?. We must do it right!!. -
Hilarious de Jesus
14 May 2014
Having worked with kids for quite some time now, I can say that consenting the parents and the kids is a matter of putting the study into context. In my experience, a trained research nurse makes a whole new difference into consenting minors in studies which may appear to be "asking quite a lot". Normally, the delivery of information, emphasis on equipoise, clear and simple explanation of randomisation, reassurances in terms of safety and monitoring are the information that when given in the right context can make the huge difference between a yes and a no.
In my opinion, the Nuffield Council is doing a fantastic job by releasing an ethical guideline into this issue. Kids deserved to be in clinical trials and its down to us research nurses to innovate that perception that trials does not mean "using kids as guinea pigs".
On another note though, it is quite important to be culturally and ethically sensitive. My dilemma at work is when working with people with difficulty communicating in English. We use translators as is the norm here in the UK, but in my experience, there has been a high rate of rejection and I am worried that this is a case of "getting lost in translation". I am quite interested if context in consent is being lost in translation when using this services.
