ETHICS COMMITTEE AND REGULATORY APPROVALS
The study will not be initiated before the protocol, informed consent forms and the participant information sheets have received approval / favourable opinion from the Research Ethics Committee (REC), the respective National Health Service (NHS) or other healthcare provider’s Research & Development (R&D) department, and the Health Research Authority (HRA) if required.
Should a protocol amendment be made that requires REC approval, the changes in the protocol will not be instituted until the amendment and revised informed consent forms and participant information sheets (if appropriate) have been reviewed and received approval / favourable opinion from the REC and R&D departments. A protocol amendment intended to eliminate an apparent immediate hazard to participants may be implemented immediately providing that the REC are notified as soon as possible and an approval is requested. Minor protocol amendments only for logistical or administrative changes may be implemented immediately; and the REC will be informed.
The study will be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, 1996; the principles of Good Clinical Practice, and the UK Department of Health Policy Framework for Health and Social Care, 2017.
INFORMED CONSENT AND PARTICIPANT INFORMATION
The process for obtaining participant informed consent will be in accordance with the REC guidance, and Good Clinical Practice (GCP) and any other regulatory requirements that might be introduced.
For the qualitative element: participants will provide online informed consent before the person can participate in the study. The decision regarding participation in the study is entirely voluntary. The investigator or their nominee shall emphasise to them that consent regarding study participation may be withdrawn at any time without penalty or affecting any benefits to which the participant is otherwise entitled. If the Informed Consent Form is amended during the study, the investigator shall follow all applicable regulatory requirements pertaining to approval of the amended Informed Consent Form by the REC and use of the amended form (including for ongoing participants).
RECORDS
Transcripts of Audio Recordings. Transcripts will be treated as confidential documents and held securely in accordance with regulations. The investigator will make a separate confidential record of the participant’s names to permit identification of all participants enrolled in the study, in accordance with regulatory requirements and for follow-up as required. Transcripts shall be restricted to those personnel approved by the Chief Investigator and recorded on the ‘Study Delegation Log.’
DATA PROTECTION
All study staff and investigators will endeavour to protect the rights of the study’s participants to privacy and informed consent, and will adhere to the Data Protection Act, 2018. Computer held recordings and transcripts will be held securely and password protected. All data will be stored on a secure dedicated web server. Access will be restricted by user identifiers and passwords (encrypted using a one-way encryption method). Electronic data will be backed up every 24 hours to both local and remote media in encrypted format.
INSURANCE AND INDEMNITY
The University of Nottingham as research Sponsor indemnifies its staff, research participants and research protocols with both public liability insurance and clinical trials insurance. These policies include provision for indemnity in the event of a successful litigious claim for proven non-negligent harm.
STUDY CONDUCT
The Study Coordinator/Academic Supervisor, or where required, a nominated designee of the Sponsor, shall carry out a site systems audit at least yearly and an audit report shall be made to the Study management group.
STUDY DATA
The Principal Investigator, or where required, a nominated designee of the Sponsor, shall carry out monitoring of study data as an ongoing activity.
RECORD RETENTION AND ARCHIVING
In compliance with the ICH/GCP guidelines, regulations and in accordance with the University of Nottingham Research Code of Conduct and Research Ethics, the Chief or local Principal Investigator will maintain all records and documents regarding the conduct of the study. These will be retained for at least 7 years or for longer if required. If the responsible investigator is no longer able to maintain the study records, a second person will be nominated to take over this responsibility. The Study Master File and study documents held by the Chief Investigator on behalf of the Sponsor shall be finally archived at secure archive facilities at the University of Nottingham.This archive shall include all study databases and associated meta-data encryption codes.
DISCONTINUATION OF THE STUDY BY THE SPONSOR
The Sponsor reserves the right to discontinue this study at any time for failure to meet expected enrolment goals, for safety or any other administrative reasons.
STATEMENT OF CONFIDENTIALITY
Individual participant medical information obtained as a result of this study are considered confidential and disclosure to third parties is prohibited with the exceptions noted above. If information is disclosed during the study that could pose a risk of harm to the participant or others, the researcher will discuss this with the CI and where appropriate report accordingly. Data generated as a result of this study will be available for inspection on request by University of Nottingham representatives, the REC, local R&D Departments and the regulatory authorities.