Table 2

Summary of ethical amendments

ProtocolDateSummary of changes
V216 October 2018Re-formatting of consent forms to fit within one A4 page (minor).
V2.129 March 2019Amendment to letters informing/seeking guidance from participants’ general practitioner regarding potential contraindications for nicotine replacement therapy and requesting varenicline prescriptions.
Minor amendments to interview topic guides.
Change to incentive amounts.
Audio recording of a sample of initial consultation interactions (substantial).
V2.203 June 2019Change timing of consent to YESS trial—not implemented.
V2.126 July 2019Submission of YESS subsection 1 and 2 participant information sheet (V.1 17 05 2019) as they were omitted from the original application (substantial).
V2.211 November 2019Reduction in recruitment target from 2019 to 1040 to reflect the number of smokers enrolling in YLST (substantial).
  • YESS, Yorkshire Enhanced Stop Smoking; YLST, Yorkshire Lung Screening Trial.