CONSENT FORM FOR FEMALE ADULTS IN RESEARCH STUDIES
Please complete this form after you have read the Participant Information Sheet and/or listened to an explanation about the research.
Title of Study: Investigation into the Association Between Hormones Levels, Vitamin D, Dietary Intake and Sarcopenia in Peri and Post-Menopausal Women
Department: Division of Medicine
Name and Contact Details of the Researcher(s):
Esra’a Alrabi, Rachel Chataway-Green (esra’a.alrabi.23@ucl.ac.uk), (rachel.chataway-green.23@ucl.ac.uk)
Dr Nicky Keay (n.keay@ucl.ac.uk)
Name and Contact Details of the Principal Researcher: Dr Adrian Slee (a.slee@ucl.ac.uk)
Name and Contact Details of the UCL Data Protection Officer: data-protection@ucl.ac.uk
This study has been approved by the UCL Research Ethics Committee: Project ID number: 15505/005
Thank you for considering taking part in this research. The person organizing the research must explain the project to you before you agree to take part. If you have any questions arising from the Information Sheet or explanation already given to you, please ask the researcher before you decide whether to join in. You will be given a copy of this Consent Form to keep and refer to at any time.
I confirm that I understand that by ticking/initialling each box below, I am consenting to this element of the study. I understand that it will be assumed that unticked/initialled boxes means that I DO NOT consent to that part of the study. I understand that by not giving consent for any one element that I may be deemed ineligible for the study.
| Tick Box | ||
| 1. | *I confirm that I have read and understood the Participant Information Sheet for the above study. I have had an opportunity to consider the information and what will be expected of me. I have also had the opportunity to ask questions which have been answered to my satisfaction |
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| 2. | *I understand that I will be able to withdraw my data up to 4 weeks after questionnaire. | |
| 3. | *I can confirm that I do NOT have a cardiac pacemaker or similar medical electronic fitted
Device (for Bioelectrical Impedance Assessment of Body Composition). |
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| 4. | *I consent to the processing of my personal information (name, age, date of birth, phone number, email address, medical history and hormonal profile) will be used for the purposes explained to me. I understand that according to data protection legislation, “public task” will be the lawful basis for processing personal data and “research” will be the lawful basis for processing special category data. | |
| 5. | Use of the information for this project only
*I understand that all personal information will remain confidential and that all efforts will be made to ensure I cannot be identified. I understand that my data gathered in this study will be stored securely in a pseudo-anonymized coded fashion. It will not be possible to identify me in any publications. |
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| 6. | *I understand that my information may be subject to review by responsible individuals from the University for monitoring and audit purposes. | |
| 7. | *I understand that my participation is voluntary and that I am free to withdraw at any time without giving a reason. | |
| 8. | I understand the potential risks of participating and the support that will be available to me should I become distressed during the course of the research. | |
| 9. | I understand the direct/indirect benefits of participating. | |
| 10. | I understand that the data will not be made available to any commercial organisations but is solely the responsibility of the researcher(s) undertaking this study. | |
| 11. | I understand that I will not benefit financially from this study or from any possible outcome it may result in in the future. | |
| 12. | I agree that my anonymised research data may be used by others for future research. [No one will be able to identify you when this data is shared.] | |
| 13. | I understand that the information I have submitted will be published after anonymisation as a report and I wish to receive a copy of it. Yes/No | |
| 14. | I hereby confirm that I understand the inclusion criteria as detailed in the Information Sheet and explained to me by the researcher. | |
| 15. | I hereby confirm that:
(a) I understand the exclusion criteria as detailed in the Information Sheet and explained to me by the researcher; and, (b) I do not fall under the exclusion criteria. |
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| 16. | I agree that my GP may be contacted if any unexpected results are found in relation to my health. | |
| 17. | I have informed the researcher of any other research in which I am currently involved or have been involved in during the past 12 months. | |
| 18. | I am aware of who I should contact if I wish to lodge a complaint. | |
| 19. | I voluntarily agree to take part in this study. | |
| 20. | Use of information for this project and beyond:
I would be happy for the data I provide to be archived within the Division of Medicine. I understand that other authenticated researchers will have access to my anonymised data. |
If you would like your contact details to be retained so that you can be contacted in the future by UCL researchers who would like to invite you to participate in follow up studies to this project, or in future studies of a similar nature, please tick the appropriate box below.
| Yes, I would be happy to be contacted in this way | ||
| No, I would not like to be contacted |
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Name of participant Date Signature
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Researcher Date Signature