Elfghi, M. http://orcid.org/0000-0003-1383-5683
Jordan, F.
Dunne, D.
Gibson, I.
Jones, J.
Flaherty, G.
Sultan, S.
Tawfick, W.
Funding for this research was provided by:
Ministry of Higher Education and Scientific Research, Libyan Embassy (IA8-368-45817)
Article History
Received: 1 December 2019
Accepted: 1 February 2021
First Online: 13 February 2021
Ethics approval and consent to participate
: Ethical approval has been obtained from the Merlin Park Hospital, Clinical Research Ethics Committee (approval number: C.A. 1912).The procedures detailed in this protocol are designed to ensure that investigators abide by the principles of the Good Clinical Practice guidelines of the International Conference on Harmonisation (ICH). The trial will adhere to the guidelines of the World Medical Association Declaration of Helsinki in its revised edition (Fortaleza 2013) [CitationRef removed], as well as the demands of national drug and data protection laws and other applicable regulatory requirements.The investigator is responsible for ensuring that no patient is subject to any trial related examination or activity before that patient has given informed consent. Written consent must be given by the patient after the receipt of detailed information. The verbal explanation will cover all the elements specified in the written information provided for the patient.The investigator will inform the patient of the aims, methods, anticipated benefits and potential hazards of the study including any discomfort it may entail. The patient must be given every opportunity to clarify any points he/she does not understand and if necessary, as for more information.Patients will be required to sign and date the informed consent form. Participants will also be asked for permission for the research team to share relevant data with people from the Universities taking part in the research or from regulatory authorities, where relevant. This trial does not involve collecting biological specimens for storage. After completion, informed consent forms will be kept and archived by the investigator in the investigator’s trial master file. We are conducting a study within the trial Study within a Trial “Same-day Consent vs Delayed Consent in a Randomised Trial: A Study within a Trial”, to ensure of the rigorousness of the consent process [CitationRef removed].It should be emphasised that the patient is at liberty to withdraw their consent to participate at any time, without penalty or loss of benefits to which the patient is otherwise entitled. Patients who refuse to give, or who withdraw written informed consent will not be included or continued in the trial; however, they will be assured of continued appropriate medical care.
: Not applicable.
: The authors declare that they have no competing interests.