This study (which is called CONNECT) will look at people’s experiences and views of being invited to consent for their children to take part in medical research studies (also known as trials) when these are conducted in different situations. The two situations we want to compare are: a) medical trials in emergency care and b) medical trials outside emergency care. We have therefore decided to look at how families are approached about studies of medicines for children and their views on the experience in order to improve how consent is sought in the future.
In this study we want to include parents with different experiences. We are therefore inviting parents and children who have taken part in medical trials, as well as parents whose children have not taken part in medical trials.
We are asking parents to complete a consent form and a few additional questions (attached) and then take part in an interview or focus group. Participation is optional for everyone.
In all, we will hope to involve around 350 parents and 15-20 children from a range of different treatment centres and parent groups around the UK and from different backgrounds to take part in CONNECT.
A key person in the parent group you attend or research nurse in a trial your child has taken part in will send you an invitation to take part in a focus group or individual interview. If you would like to take part please fill in a consent form (attached) with your contact details and answers to some brief questions (e.g. has your child taken part in a medical trial?). This includes a question about whether your child has passed away. This is to help place parents with similar circumstances into focus groups (if applicable). If you do not wish to answer these questions but do wish to take part in the focus group please just answer questions 1-9.
You will also be asked if you would prefer to take part in a focus group or individual interview. Please return the consent form in the stamped addressed envelope provided or email to K.Woolfall@liverpool.ac.uk . These information sheets are yours to keep. The lead researcher Kerry Woolfall will then contact you to make arrangements for interviews or focus groups. We will be interviewing a maximum of 80 parents so unfortunately we may not be able to include everybody who would like to take part. We will write to you and let you know if this is the case.
Each interview or focus groups will take about 60-90 minutes and will be conducted in a private room in the hospital, at your home, on the telephone or your parent group meeting place; whichever you prefer. Kerry Woolfall will ask you about your views on different types of consent (e.g. deferred consent, which is consent after treatment). She will also ask you questions about your reasons for taking part in the trial (if applicable) and what factors influenced your decision (e.g. a belief that people should take part in research to help others). She will also ask you about your overall thoughts about trials of medicines for children. If there are any questions you do not want to answer just tell Kerry and she will move to the next topic. You can stop the interview at any point or leave the focus group. You can also ask for the recorder to be switched off at any point. If you take part in a focus group we will be using a voting system like the one used in the TV show ‘Who wants to be a millionaire’. This system will allow you to answer sensitive or personal questions privately in the group.
We will also be interviewing some of the doctors, nurses and researchers involved in approaching families to consent to research in order to explore their views on consent processes and how they handle parental concerns. With your permission, each interview and focus group will be audio-recorded and then typed out.
No – it is your decision entirely. If you decide to take part, you will be given this information sheet to keep and you will be asked to sign the consent form attached including a few questions about your involvement in a trial and whether you would like to take part in an interview or focus group. You are still free to withdraw from the study at any time and without giving a reason (details at the bottom of the sheet). All information we have collected from you will be destroyed if you wish.
This study is completely separate from any clinical trial. Any decisions you make about this study at any time will not affect the care given to you or your child.
All information collected during this study will be kept confidential. This means that apart from the interviewer (Kerry), no one, including your child’s doctors and nurses, will know what you have said. Although names will be used during interviews, they will not be included when the recordings are typed out. We may include brief quotations from some interviews in our reports, but we will always change details such as names and places so nobody can be identified. We will not be looking at your child’s medical records for this study.
We do not anticipate any major risks, though sometimes interviews can cover upsetting topics. Should you feel upset after an interview and want to talk things over, you can contact Kerry Woolfall (her telephone number is at the end of this sheet) to discuss whether you feel any additional support would help you.
We hope this study will benefit future families who are approached to take part in medical trials for children. We cannot promise that your family will benefit directly from the study, but many people find that taking part in studies of this sort is useful because they have a chance to air their views and to reflect on things.
Any complaint about the way you have been dealt with during this study or any possible harm you might suffer will be addressed. Further information on this is given in part 2.
The Wellcome Trust has provided funds to carry out this study and the University of Liverpool is the study sponsor. The University of Liverpool is organising the study.
This study was given a favourable ethical opinion for conduct in the NHS by the North West East Ethics Committee.
Thank you very much for taking time to read this information sheet.
If you have any questions at all, at any time, please contact:
Dr Kerry Woolfall Tel: 0151 494 4634, Email: K.Woolfall@liverpool.ac.uk,Institute of Psychology 2nd Floor Waterhouse Building University of Liverpool Liverpool L69 3GB