Information

Ethical Clearance Reference Number: HR/DP-22/23-36797
Invitation Paragraph
I would like to invite you to participate in this research project which forms part of our female-specific psychedelic use research. Before you decide whether you want to take part, it is important for you to understand why the research is being done and what your participation will involve. Please take time to read the following information carefully and discuss it with others if you wish. Ask me if there is anything that is not clear or if you would like more information.

What is the purpose of the study?
The purpose of the study is to understand the complexities and changes women experience throughout their lives. As psychedelic medicines move toward clinical use, it is of paramount importance to explore their interactions with female-specific biology, symptoms, and conditions to ensure the safety and effectiveness of these therapies for women.

Why have I been invited to take part?
You are being invited to participate in this study because you are a female person over the age of 18 who has used psychedelic substances at one point in your life.

What will happen if I take part?
If you agree to take part you will complete a survey anonymously. The survey will ask you questions about your personal experience with your menstrual cycle and past use of psychedelic substances, e.g. “Did your menstrual cycle's length change after the psychedelic experience?” and “If you are on birth control currently, which option most closely describes your situation?”. The survey will take you approximately 10-15 minutes to complete.  

Do I have to take part?
Participation is completely voluntary. You should only take part if you want to and choosing not to take part will not disadvantage you in any way. If you choose to take part you will be asked to provide your consent. To do this you will be asked to indicate that you have read and understand the information provided and that you consent to your anonymous data being used for the purposes explained.

You are free to withdraw at any point during the completion of the survey, without having to give a reason by closing the window in your browser. Withdrawing from the study will not affect you in any way. Once you submit the survey, it will no longer be possible to withdraw from the study because the data will be fully anonymous. Please do not include any personal identifiable information in your responses.

Incentives
By participating in and completing this survey, you will be given the opportunity to enter into a prize draw in order to win a £50 Amazon gift voucher.

What are the possible risks of taking part?
The participation in this survey might involve being confronted with uncomfortable questions about your own body and menstrual cycle. The survey will also pertain to menopause, which can be a difficult topic for some as it can be a challenging time in a woman’s life. Furthermore, you will be asked to disclose previous diagnoses, which might bring up painful memories. You will be provided with mental health resources and helplines before starting the survey, which you should feel free to contact at any point during the process of participating should it feel needed. You are also free to stop participating in the survey at any point by closing the window in your browser and not returning to the questionnaire after. There is also a risk of disclosing illegal activity, such as substance intake.
What are the possible benefits of taking part?
If you wish to enter the prize draw for the Amazon gift voucher and receive results from the study at hand you may provide your personal details independently from your anonymous survey data by following the link given to you at the end of the survey which will take you to a separate questionnaire with further instructions. Your personal details will be deleted once the prize draw has been completed. This ensures that your answers to the survey questions are truly anonymous.

Data handling and confidentiality
Although the research is anonymous, there will be a separate survey asking for you to share your contact details to be included in the prize draw as explained above. These personal details will be completely separate from the research outputs and impossible to link to other information provided. This means that nobody, including the researchers, will be aware of your identity, and that nobody will be able to connect you to the answers you provide, even indirectly. Your answers will nevertheless be treated confidentially and the information you provide will not allow you to be identified in any research outputs/publications. Your data will be held securely on a verified database and will be retained until analyses have been conducted, after which the data will be deleted.

Any personal data collected independently of the anonymous survey as described elsewhere in this information sheet will be processed under the terms of UK data protection law (including the UK General Data Protection Regulation (UK GDPR) and the Data Protection Act 2018). If you would like more information about how your data will be processed under the terms of UK data protection laws please visit the links below:

https://www.surveymonkey.co.uk/mp/privacy/
https://www.kcl.ac.uk/research/support/research-ethics/kings-college-london-statement-on-use-of-personal-data-in-research

King’s College London has a responsibility to keep information collected about you safe and secure, and to ensure the integrity of research data. Specialist teams within King’s College London continually assess and ensure that data is held in the most appropriate and secure way.

How is the project being funded?
This study is being funded by the researchers conducting the study.

What will happen to the results of the study?
The results of the project will be summarised in a published research article. You will be able to obtain a copy of the published research by opting into receiving further results at the end of the study, in a separate survey which will in no way link back to the information you provide in the study at hand. The data itself will not be made publically available, only the summary of the data analysis and the results found.

Who should I contact for further information?
If you have any questions or require more information about this project, please contact the researcher using the following contact details:

Name: Ingeborg Lykke Monsen
Email: ingeborg.monsen@kcl.ac.uk
What if I have further questions, or if something goes wrong?
If this project has harmed you in any way or if you wish to make a complaint about the conduct of the project you can contact King's College London using the details below for further advice and information:

Name: Dr Grace Blest-Hopley
Email: grace.blest-hopley@kcl.ac.uk

Or, you can contact:
The Chair
Health Faculties RESC
rec@kcl.ac.uk

Thank you for reading this information sheet and for considering taking part in this research.

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