The Inhaled Steroids in ARDS (InSTAR) trial is a proposed future study we would like to perform in Intensive Care Unit (ICU) patients with Acute Respiratory Distress Syndrome (ARDS).
Patients with ARDS often require to be placed on a ventilator, so they are unable to discuss taking part in research trials and researchers have to seek consent from relatives or healthcare providers on their behalf. This process follows current legislation, but we need to be sure that the study is acceptable to the public and researchers who may be involved with the study. So, we want to hear your views.
What does the proposed trial involve?
In this trial, research nurses will approach family members of patients who have had to be put on a ventilator for presumed ARDS. The trial will involve the patient being randomly allocated to either continue with their current treatment or receive an inhaled steroid, commonly used in other breathing conditions, in addition to their current treatment. If the research team cannot identify or contact a family member, then the team will ask a doctor not connected with the trial to provide consent. If the doctor does consent on your behalf, when your relatives can be contacted, they will be asked to consent for you to continue in the trial.
For more detailed information on the study, you can read the proposed Participant Information Leaflet here which would be given to a patient’s relatives when the research nurses will ask for consent.
What are we looking for from this blog?
We would like to open a discussion regarding peoples’ thoughts about how we approach families. Although legislation allows for us to seek consent from your relatives or your doctor when you maybe not be able to provide consent, how does that feel to you? Would that be acceptable for a trial of a treatment of this type?
Also, what things could the research team do to ensure your relatives feel supported if they are being approached to ask them to consent on your behalf to take part in such a trial?
Responses will be posted below and as more people respond it would be helpful for you to read other responses to see if there are areas you agree with or not, so this can be built into your answer.
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