How is the study funded?
The Santé-AF feasibility study is supported by a grant of £10,000 from the British Acupuncture Council, of which the researcher is a registered member. The study is also supported in kind by the Northern College of Acupuncture in York, UK.
In addition, Santé-AF is a portfolio-adopted study of the National Institute for Health Research’s Clinical Research Network (Yorkshire & Humber). This means that the CRN supports the study’s treatment costs and assists with recruitment and the management of the study.
Is the study registered with a trials registry?
Yes! Santé-AF can be found on the ISRCTN trial registry with the number 13671984. Please click here to see the record.
Who is providing indemnity for the study?
The University of York will provide indemnity and compensation in the event of a claim by, or on behalf of participants, for negligent harm as a result of the management of the trial.
University of York will also provide indemnity and compensation in the event of a claim by, or on behalf of participants for negligent harm as a result of the trial design.
Indemnity for medical malpractice, public and products liability will be met by practitioners’ own professional insurance.
Indemnity covering activities of staff in primary care practices will be standard NHS indemnity arrangements.
Who has given ethical approval for the study?
The Health Research Authority (HRA)’s London (Surrey) Research Ethics Committee (REC) gave full ethical approval to Santé-AF on 3 November 2020, and has since issued a favourable opinion of a substantial amendment on 7 May 2021 (reference 20/LO/0598).
Santé-AF has also been scrutinised by the University of York’s Health Sciences Research Governance Committee (decision letter HSRGC/2019/346/H).
If you would like to see copies of the study’s ethical approvals, please click here to contact the researcher.
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