If you are have received information regarding the CHIP research and are therefore eligible, please find the information sheet below.
We are inviting you to participate in this research project which is being conducted by Children’s Heartbeat Trust, Belfast Health & Social Care Trust and University College Cork.
At several time points between 2001 and 2010 your family participated in the Congenital Heart disease Intervention Programme (CHIP). This research helped us better understand outcomes for infants and children with congenital heart disease (CHD), and whether a new intervention programme (CHIP) could improve outcomes. This work has been published in papers and books internationally and has helped inform service developments for children with CHD and their families. We are now interested in evaluating how those children (you) are doing in early adulthood. There is less research on how adults with CHD are faring, and also what factors predict these outcomes. Such research will be important in understanding what makes for a good -v- more challenging outcome and to inform services to help such adjustment.
You have been invited to participate because you and your family participated in previous waves of the CHIP study.
No. Participation is completely voluntary and has nothing to do with any clinical or other services you receive or will receive. You can also withdraw, without any need for explanation, at any stage during the assessment session. You also have the right to change your mind and withdraw information up to one month after participation.
Yes. All information is treated in confidence. No-one, other than the researchers named below, will know your personal results. The only exception to this is if you tell us anything which suggests you, or someone else, is at risk for harm. Then we would have to act after discussion with yourself.
After participation, hard copies of the information you provide will be stored securely in a locked cabinet in Children’s Heartbeat Trust. These copies will be destroyed after the data is transferred to a computer database after one month. After this time your summary results will be transferred to an encrypted computer. All participants will be allocated a study code at this stage and only the research team will have access to the list of codes and names, which will be held securely in Children’s Heartbeat Trust. Only anonymised codes will be apparent on the main research database and so no personally identifiable information will be apparent at this stage. The anonymised research database will be stored on the organisations servers and will be sent to University College Cork for analysis, but it will not be possible to identify you in any of the information sent.
In line with open and fair research principles, other researchers who are interested in outcomes in CHD may request access to this data held on the anonymised database. No personally identifiable information would be available for such. Occasionally research records are audited by representatives from the sponsor or regulatory authorities to ensure we have treated all information in line with your consent. The information you provide is likely to contribute to research publications and conference presentations about how young adults fare with congenital heart disease.
We will need to use information from you and from your medical records for this research study. This information will include your initials, NHS number, name and contact details. People will use this information to do the research or to check your records to make sure that the research is being done properly.
People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. We will keep all information about you safe and secure.
Some of your anonymised information will be sent to Republic of Ireland. They must follow our rules about keeping your information safe.
Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.
You can find out more about how we use your information
When the study is completed the results will be presented at scientific meetings and published in health journals. You will not be identified in any report or publication which results from this work. You will be notified when a summary of these results is published on the Children’s Heartbeat Trust website.
We do not anticipate any negative outcomes from participating in this study. No negative impacts have been apparent in our previous research in this and related areas. However, should you experience distress arising from participating in the research, you may contact Children’s Heartbeat Trust and / or your Consultant Cardiologist (contact details below), who will discuss any appropriate actions with you.
You may not experience any personal benefit from taking part in this research but will be contributing to wider understanding of what affects outcomes for young adults who have experienced congenital heart disease. Such is important in helping us develop clinical services.
If you have a concern about any aspect of this study you should contact one of the study team (see details below) and we will do our best to answer your questions. If you remain unhappy and wish to complain formally, the normal Trust complaints mechanisms are also available to you and can be contacted through:
Complaints Department
Belfast Health and Social Care Trust
7th Floor, McKinney House
Musgrave Park Hospital
Stockman’s Lane
Belfast
BT9 7JB
Tel: (028) 9504 8000
Email [email protected]
This research project is organised by researchers from the Belfast Health & Social Care Trust and Children’s Heartbeat Trust, these organisations are the sponsors of the study. This project is supported by funding from Children’s Heartbeat Trust.
All research in the NHS is looked at by an independent group of people, called a Research Ethics Committee to protect your safety, rights, wellbeing and dignity. This study has received a favourable opinion from (Insert name of REC).
Ms Joan Aiken, Research Assistant
Children’s Heartbeat Trust
Dr Christopher Lockhart, Consultant Cardiologist
Royal Victoria Hospital
Dr Chris McCusker Senior Lecturer in Clinical Psychology
University College Cork
Dr Nicola Doherty Consultant Clinical Psychologist
Western Health and Social Care Trust
Thank you for considering taking part in this study.
