Chief Investigator: Nicola Heslehurst

1. I confirm that I have read the information sheet dated 09/06/2023 (version 3.1) for the above study. I have had the opportunity to consider the information, ask questions and have had these answered satisfactorily.
   

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2. I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason, without my medical care or legal rights being affected.
   

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3. I understand that relevant sections of my medical notes and data collected during this study may be looked at by individuals from the Newcastle upon Tyne Hospitals NHS Foundation Trust or relevant regulatory bodies where relevant to my taking part in this research (for example, for the purpose of audit of this research project). I give permission for these individuals to have access to my records.
   

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4. I agree for my information, gathered for this study, to be stored on a secure database for analysis on a Newcastle University server anonymously.
   

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5. I agree to take part in the above study.

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Name of participant: _______________     Date: ________________    Signature: ________________

Name of person
receiving consent: ________________      Date: ________________     Signature: ________________

Please tick the relevant box and provide contact details below if you would like to:

1. take part in the prize draw □

2. receive a summary of results for the SHAPES study □

    

E-mail: _____________________________ Telephone number: _____________________________

Address: _________________________________________________________________________

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 SHAPES Study Interviews:

 
A. I agree that my contact details can be shared with the research team at Newcastle University so they can contact me at a later date about the SHAPES Interview Study. I understand that this agreement is not consent to take part in the interview study, and that I might not be contacted.

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If you have consented to optional extra A for SHAPES interviews, please provide your contact details below (if not already provided on page 1):

E-mail: _____________________________ Telephone number: _____________________________

Address: _________________________________________________________________________

  ________________________________________________________________________________

Future research about long-term health and well-being of women and their
children:

A. I agree to the research team storing my NHS number, name and date of birth linked to my SHAPES research ID number.

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B. I agree to the research team storing my baby’s NHS number and date of birth linked to my SHAPES research ID number.

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C. I understand that these data are being stored so that the SHAPES study data can be linked with routine databases in the future to explore long-term health and well-being of women and children. I understand that these data will be held securely on a Newcastle University server in line with current data protection regulations, and that the data will not be shared with anyone else or used for any other purposes than described here. I understand that future studies will need to have the appropriate research approvals in place before the research team can access this data.

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D. I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason, without my medical care or legal rights being affected.

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 Future research with blood samples:

A. I agree that any leftover routine blood samples that are collected during my dating scan appointment and not used as part of my routine care can be linked with my SHAPES research ID number and stored in freezers at the Newcastle upon Tyne Hospitals NHS Foundation Trust until they are needed for future research.

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B. I understand that these samples will be used for future research exploring whether blood tests can be used instead of, or alongside, SHAPES measurements to help identify which women and babies would benefit most from extra care in pregnancy.

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C. I understand that this future research is subject to the research team getting additional funding and if there is no funding awarded then my blood samples will be destroyed by the Newcastle NHS Trust.

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D. I understand that if the funding is awarded, then my blood samples will be transferred to a university laboratory for analysis, and will be destroyed by incineration after the research is complete.

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E. I understand that my participation is voluntary and that I am free to withdraw at any time until 31 st July 2025 without giving any reason, without my medical care or legal rights being affected.

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Name of participant: _______________     Date: ________________    Signature: ________________

Name of person
receiving consent: ________________      Date: ________________     Signature: ________________

 SHAPES Consent Forms