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What are the possible disadvantages and risks of taking part?

The child assessment, equipment and materials themselves are safe and carry no risk. Over 8000 children in 13 countries have been assessed using the INTER-NDA, including 600 at the John Radcliffe Hospital, Oxford. Almost all parents and children have reported the tests to be quick and enjoyable. However, toddlers do, extremely rarely, become upset during assessments. In the unlikely event that your child becomes distressed for any reason then we would stop straight away. https://www.wrh.ox.ac.uk/team/josephine-agyeman-duah We anticipate that a proportion of children taking part in the study may be identified as having some potential disturbances in neurodevelopment. We understand this may cause concern and distress for parents. However, we feel that it is in the best interest of the child that such potential disturbances are identified as it enables access to early referral and interventions that may mitigate the risks of problems in the future. In such cases, the child will be referred to the community paediatrician via the Neonatal Team. 

 


What are the possible benefits of taking part? 

Taking part in this study would not usually benefit you or your child directly. The only situation where there might be direct benefit would be if we detected potential developmental problems, which might allow earlier referral of your child to doctors for further investigation and/or intervention. Taking developmental measures from your child would help us to determine what proportion of children born between 32 and 37 weeks of pregnancy, and who are not currently followed up at 2 years of age on developmental assessments, have developmental disturbances. This is important as it would help us present evidence to the Health Authorities to support an extension of the current preterm screening strategy from children born at less than 32 weeks of pregnancy to all children born at less than 37 weeks of pregnancy.

 


Expenses and payments 

You may claim back travel expenses for the INTER-NDA neurodevelopmental appointment. There is no payment for participating in the study.

 


Will my taking part in the study be kept confidential? 

Yes. We follow ethical and legal practice and all information and data collected are handled in complete confidence. The details are included in [insert link to webpage above].

 

What will happen if I don’t want to carry on with the study?

You may withdraw from the study at any time. It would not affect the care you or your child receives in any way. If you withdraw from the study, any stored data that identifies you or your child would be destroyed from computer hard drives, Project servers and Project email inboxes according to Research Data Oxford governance, and the policies of the RDM Delivery Group, University of Oxford. Printed materials and paper forms containing your and your child’s data will be disposed of according to the University’s policy for destroying Confidential Waste. 

 


What if there is a problem?

If you have concerns about the way you have been approached or treated during the course of the study, you can contact the the University of Oxford Clinical Trials and Research Governance office on 01865 616480 or email ctrg@admin.ox.ac.uk. You can also contact the Patient Advice and Liaison Service (PALS) on telephone number 01865 221473 or email PALS@ouh.nhs.uk. If you remain unhappy and wish to complain formally, you may also follow the normal NHS complaints procedure. Please see: www.nhsdirect.nhs.uk/articles/article.aspx?articleId=569 for more information.

 


Will my taking part in this study be kept confidential?

Any information that is collected about you and your child during the course of the research will be kept strictly confidential. Our research team – Chief Investigator, CoInvestigators, Neonatal Consultant, Data Manager, Statistician and Research Assistants, who have a duty of confidentiality to you and your child as research participants, are the only persons able to identify you and your child. If you choose to continue with the study, your and your child’s data will be held de-identiably in a secure database to which only the research team will have access.

Authorised representatives of the University of Oxford and/or the Oxford University Hospitals NHS Foundation Trust may look at the de-identified results to check that the study is being performed correctly. No individual participants will be identified when the results of the study are published. Any information that leaves the hospital will have your name removed so that you cannot be identified.

If you choose to continue with the study, your and your child’s electronic data and results will be held de-identifiably on a secure database on a secure University of Oxford server, and any hard copies of the data will be stored in a locked office, in a securely locked cabinet which only the research team has access to.

The data will be retained for 17 years after the end of the study (until the youngest child participating in the study reaches 21 years of age) in the event that future discussions about outcomes in children born preterm require the data to be reanalysed. After 17 years, the data will be disposed of securely from computer hard drives, Project servers and Project email inboxes according to Research Data Oxford governance, and the policies of the RDM Delivery Group, University of Oxford. Printed materials and paper forms will be disposed of according to the University’s policy for destroying Confidential Waste. You have the right to check the accuracy of data held about you and your child, and to correct any errors.

We would like your permission to share your child’s de-identified data, which include reports of your child’s clinical assessment and your socio-demographic data, with academic collaborators around the world. At no point will these collaborators be able to identify or contact you or your child.

 


What will happen to the results of the research study?

The results will be prepared for publication in scientific journals and presentation at international meetings. We can provide you with a copy of the papers after publication if you wish; please contact the study team to request this. Some of the data from the study may be included in the PhD thesis of one or more of the researchers. Your identity will be protected at all times.

 


Who is organizing and funding the research?

The research is being carried out by the Nuffield Department of Women’s & Reproductive Health at the University of Oxford. It is being funded by a donation to the University. The doctors and researchers involved in the research are not being paid to include you in the study and have no conflicts of interest with regards to the study.

 


Who has reviewed the study?

The research has been reviewed by an independent group of people called a Research Ethics Committee to protect your interests, safety, rights, well-being and dignity. This study has been reviewed and given a favourable opinion by XXX Research Ethics Committee -

 

Can you give me a record of my child’s results? 

As this is a research project we will not be carrying out analysis from each individual child. Rather we will be combining the data we obtain from all the children participating in the study and analyzing this based on the extent of their prematurity. However, if we do notice any significant cause for concern in your child, we will refer these concerns to your child’s GP, paediatrician or neonatologist as the case may be.

 

How long will the analysis take?

The analysis can take up to 3 years following the completion of the study. How will the results of this study be shared with its participants? The results of this study will be published in peer reviewed Journals and presented at scientific and clinical meetings. We will also share a summary of the results of this study here, on this website. We will also share the results of this study with a number of Neonatal charities that have been involved with our work.