Study Title: The accidental consumption of aspartame in phenylketonuria (PKU): The experiences of patients and their caregivers.

PARTICIPANT INFORMATION 

You are being invited to take part in a research study. Before you decide if you would like to take part, please take your time to read through the participant information sheet below, this should take about 10 minutes.  Please contact us with any questions if there is anything that is not clear.

What is the purpose of the study?

The research is being undertaken with patients that have phenylketonuria (PKU) and those who are a caregiver of a person with PKU on their behalf. The study wishes to understand how often aspartame is accidentally consumed by patients with PKU and the effect aspartame consumption has on patients with PKU and their families.

Why have I been invited to take part?

You have been invited to take part, as you have indicated that you are a UK resident aged 18 or over that has PKU, or you are a caregiver of a person with PKU that is willing to complete this questionnaire on behalf of the person with PKU.

Do I have to take part?

It is up to you to decide to whether you wish to take part in the study, participation is voluntary. You can withdraw from the study up until the 31st July without giving a reason. If you wish to withdraw from the study after completing the questionnaire, we will require the date and time that you completed the study questionnaire in order to identify you. We will then destroy any information provided to us.

What will happen if I take part and what is expected of me?

The survey will take approximately 15 minutes to complete. It should be completed once for each person with PKU (this applies if there is more than one family member with PKU). 

All information you provide will be anonymous. You will be expected to complete the online survey answering all questions in full. Please ensure you click “finish” once you have completed the final question. The study will then be complete.

An analysis of the information will form part of a report at the end of the study. The results of this study will be shared with interested parties such as The National Society for PKU (NSPKU) and are likely to be published in a health professional journal. All information presented in reports will be anonymous and unidentifiable.

Will my taking part in the study be kept confidential?

Your data will be processed in accordance with General Data Protection Regulation 2016 (GDPR). All information collected during the study is anonymous and will be stored on a password-protected computer file on a university database which is only accessible to the researcher. This information will be stored for 10 years before being destroyed.

What are the possible disadvantages and risks of taking part?

There are minimal ethical issues with this type of research project. The questions do not require you to disclose any identifiable information. There are no physical measurements taken from the participants and there is no psychological or physical harm to participants during the recruitment process, data collection or data analysis. However, should you require further support following the completion of this questionnaire, please contact your GP, local dietetic service or the NSPKU helpline on 0303 040 1090.

What are the possible benefits of taking part?

We cannot promise that this study will provide any benefits. However, the results from this study will enhance our understanding of the difficulties associated with the presence of aspartame, for patients with PKU and their parents and carers. We hope this research will inform future government policies regarding food and drink manufacturing to improve health outcomes for patients with PKU.

What if there is a problem?

If you wish to complain or have any concerns about the way you have been approached and treated during this study, please contact the study supervisor, Kiri Pointon-Bell kiri.pointon-bell@bcu.ac.uk and the Birmingham City University ethics team HELS_ethics@bcu.ac.uk

Who is organising the research?

This research is conducted as part of an MSc in Dietetics within the department of Health, Education and Life sciences at Birmingham City University. The study is organised with supervision from the department, by Ella Newbould an MSc Dietetic student. The research will be carried out in conjunction with the NSPKU. If you are interested in the results of this study, please contact the researcher. 

Further information and contact details.

If you would like more information about the research before you decide whether or not you would like to take part, please contact:

Researcher- Ella Newbould ella.newbould@mail.bcu.ac.uk

Supervisor: Kiri Pointon- Bell kiri.pointon-bell@bcu.ac.uk