Participant Information Sheet


Title of the project

The measurement and analysis of salivary hormones and their association with wellbeing and performance.

Summary

Mint Diagnostics Ltd (MDL) develops innovative diagnostic solutions to help support an individual’s wellbeing and performance. MDL has developed and continues to further develop a digital health laboratory service for the regular monitoring of salivary hormones. In addition, MDL is developing a unique point-of-care diagnostic system for the monitoring of salivary hormones in real-time.As part of its activities, MDL carries out research studies with voluntary participants, which includes the testing of saliva samples in laboratory conditions and the collection of subjective health data, These data will help increase the understanding of the relationship between hormone profiles, wellbeing and performance. We are therefore requesting that you participate in this research by providing us with samples of your saliva for testing and by tracking your symptoms using the Hormonix mobile application.

Some frequently asked questions in relation to the study are answered below but if you have any additional questions please contact Dr. Stefano Borini at Mint Diagnostics Ltd (e-mail: stefano@mintdiagnostics.com).

Frequently Asked Questions

What is the purpose of this research?
It has been suggested that a relationship exists between fluctuating hormone levels in the body and an individual’s wellbeing and performance. While scientific research exists in this area, more is required to increase our understanding of the relationship. By increasing our knowledge about the influence of hormone levels, we will be able to support individuals to optimise their wellbeing more than ever before. This research will measure levels of oestradiol (the most potent oestrogen), progesterone, cortisol and/or testosterone which are hormones associated with stress, fatigue, menstrual function among many other physiological characteristics and conditions. The levels of these hormones can then be tracked over time and compared with markers of physical condition and performance levels.

The insight gained during this research will contribute to the general scientific understanding and we will disseminate this research in the form of scientific publications where applicable. Additionally we will look to incorporate this research into improved products and services so that we can bring the benefits to users.

What do I need to do?
Before collecting saliva, you will be required to download and install the Hormonix mobile application from the App Store or from Google Play Store depending on your mobile’s operating system. MDL will provide a saliva collection kit and the Hormonix mobile application which helps to guide you in the collection of saliva according to agreed protocols. You will need to regularly take samples of your saliva, record the collection of each sample by scanning the unique barcode using the Hormonix app and store all samples in a freezer during the collection period. After you have collected all the necessary saliva samples during the collection period, you will be be required to return frozen samples to an MDL laboratory or an affiliated laboratory either by courier collection or by post.

During the collection period, you may be asked to complete a questionnaire within Hormonix app in order to track how you’re feeling, some physicological symptoms and other supporting information to help in providing context to your hormone measurements.

Do I have to take part?
No, you do not have to take part. If you do not wish your samples and data to be passed to Mint Diagnostics as part of this research study, then you do not need to sign this form. You will also be able to withdraw your consent at any time by contacting hormonix@mintdiagnostics.com.

What are the potential health risks?
There are no known health risks related to taking part in this research project.

What will happen to my samples?
Samples will be shipped to an MDL laboratory or an affiliated laboratory for analysis. Upon receipt of your samples, we will either analyse the samples immediately or we will remove all cellular material from the samples in accordance with the Human Tissue Act and store the samples in a freezer for analysis at a later date. During analysis, hormone concentrations will be measured with CE-marked diagnostic kits and the data will be stored securely. After analysis, saliva samples may be kept for up to six months, after which samples and residues will be disposed of as biohazard waste. If you choose to withdraw your consent during the storage period then samples will be disposed of accordingly.
What is the lawful basis for handling my personal data?

By your participation in this project we will need to collect and further process personal data (including special category data) about you, and we do this on the basis of Mint Diagnostics’ legitimate interests and for scientific research purposes.

While participation in the study is optional, the processing of personal data is not based on the GDPR lawful basis of ‘consent’ (which is different from seeking consent to participate in research for ethical purposes). Instead, the processing of data from participants involved in this study is considered necessary for the legitimate interests and research purposes as detailed in the Mint Diagnostics Privacy Policy for Study Participants and App Users, available on the Hormonix app (a copy can also be requested via email to privacy@mintdiagnostics.com). All data provided as part of this research is handled as sensitive and confidentially.

Main investigator and contact details:
Dr. Stefano Borini, CEO, Mint Diagnostics Ltd, Unit 190 Carver Drive, Kent Science Park, Sittingbourne, ME9 8NP, United Kingdon. Email: stefano@mintdiagnostics.com

Member of the research team:
Dr Richard Burden, Head of Human Science, Mint Diagnostics Ltd, Unit 190 Carver Drive, Kent Science Park, Sittingbourne, ME9 8NP, United Kingdom. Email: richard.burden@mintdiagnostics.com