Begh, Rachna http://orcid.org/0000-0003-0822-9689
Coleman, Tim
Yardley, Lucy
Barnes, Rebecca
Naughton, Felix
Gilbert, Hazel
Ferrey, Anne
Madigan, Claire
Williams, Nicola
Hamilton, Louisa
Warren, Yolanda
Grabey, Jenna
Clark, Miranda
Dickinson, Anne
Aveyard, Paul
Funding for this research was provided by:
National Institute for Health Research (PDF-2016-09-043)
NIHR School for Primary Care Research (Project Reference 333)
Article History
Received: 30 April 2019
Accepted: 25 October 2019
First Online: 28 November 2019
Ethics approval and consent to participate
: The study gained approval from the National Research Ethics Committee Wales REC 4 (REC reference: CitationRef removed/WA/0352) and Health Research Authority (HRA). The CI will submit and, where necessary, obtain approval from the above parties for all substantial amendments to the original approved documents. The CI will ensure that this study is conducted in accordance with relevant regulations and with Good Clinical Practice.Written versions of the participant information and informed consent forms will be re-presented to participants at the baseline visit by the study researcher, detailing no less than: the nature of the study; what it will involve for the participant; the implications and constraints of the protocol; the known side effects and any risks involved in taking part. It will be clearly stated that the participant is free to withdraw from the study at any time for any reason without prejudice to future care, without affecting their legal rights, and with no obligation to give the reason for withdrawal.The participant will be allowed as much time as wished to consider the information, and the opportunity to question the Investigator, their GP or other independent parties to decide whether they will participate in the study. Written informed consent will then be obtained by means of participant dated signature and dated signature of the person who presented and obtained the informed consent. The person who obtained the consent must be suitably qualified and experienced, and have been authorised to do so by the chief investigator. A copy of the signed informed consent will be given to the participant, a copy will be retained at the study site and the original signed form will be stored securely at the University of Oxford.Verbal consent will be obtained for interviews conducted over the telephone with practitioners and members of the vape team and recorded on an audio consent script. The PIS will be sent to participants in advance of the interview when they are invited to take part. A copy of the audio consent form will be sent to participants.As the true nature of the study is disguised from participants, the study team will post a letter to or email participants to explain the true nature and scope of the study after they have completed their 8-month follow up. Participants will be given the option to withdraw their data by notifying the study team within 7 days of receiving the letter/email.
: Not applicable.
: The authors declare that they have no competing interests.