MRF members help study on ethical standards in research
11 May 2012
MRF members have taken part in a study of the ethics of research involving critically ill children.
When a child is hospitalised in an emergency, parents need reassurance that their child is in the best possible hands and receiving the right treatment. However, many emergency treatments have crept into common use and are routinely administered to critically ill children without a strong evidence base for their use.
To improve patient outcome in sudden, lethal illnesses, clinical research is crucial, but there is no time to ask for consent before starting emergency treatment in a child with life-threatening illness. Deferred consent is legally permitted if informed consent is obtained as soon as possible. This study aimed to find ways to minimise anxiety and distress parents may feel in this intensely emotional situation.
The study was a collaboration between the University of Liverpool, Imperial College at St Mary’s Hospital in London, Meningitis Research Foundation, and London School of Tropical Medicine and was published in the Public Library of Science Medicine journal (PLOS) One this week.
The researchers investigated the views of parents with first-hand experience: all MRF members whose child had been treated for severe meningitis or septicaemia within the past 5 years. A survey was sent to parents, along with a description of an emergency resuscitation trial comparing two treatments in widespread use and considered safe. Parents answered questions about deferred consent, timing of requesting consent, and telling the family about the trial after a child’s death.
The majority of bereaved parents said they would want to be told about the trial. Most non-bereaved families thought it was better not to tell the bereaved family about the trial at any time. Bereaved parents’ responses stressed the importance of individualised management of disclosure about a trial following a child’s death.
Dr Carrol Gamble, Deputy Director of the Clinical Trials Centre at the Medicines for Children Research Network, Liverpool and lead author said “This is the first survey to explore parents’ views on the difficult issue of deferred consent in trials and whether and how parents should be approached for consent if the child dies during the study. Results showed that deferred consent is acceptable to the majority of respondents. ”
Dr Simon Nadel, Reader in Paediatric Intensive Care at St Mary’s Hospital London, a co-author on the study said: “Seeking consent for research must not delay patient treatment, but we have to make the process as acceptable as possible to parents. Parents value their relationship with the expert care team and doctors with training and experience can ensure that telling parents about trials is part of the process of individualised care."
Linda Glennie, Head of Research and Medical Information at Meningitis Research Foundation, another co-author said: “Few clinicians or parents would disagree that clinical research in emergency, life- threatening illness is essential to identify the best treatments and improve the chances of survival. However this sort of research raises difficult ethical issues. Our members have shown us that communication about the research is important and should be tailored to the needs of individual parents. We are very grateful to all MRF members who took part in this study.”