TO BE PRINTED ON LOCAL TRUST HEADED PAPER Version 2.0,31st July, 2014
CONFIDENTIAL WHEN COMPLETED
TheBASIL-2 Trial:Bypass vs. Angioplasty in Severe Ischaemia of the Leg
CONSENT FORM
Chief Investigator: ProfessorAndrewBradbury
Participant Trial Number: 2iiI iiI iiI ii(to be added after randomisation)
1 / I have read and understood the Participant Information Sheet,Version……….. dated…………………..for the above trial and I confirm that the trial procedures and information have been explained to me. I have had the opportunity to ask questions and I am satisfied with the answers and explanations provided. /
2 / I understand that my participation in this trial is voluntary and that I am free to withdraw at any time, without giving a reason and without my medical care or legal rights being affected. I understand that data collected up to my time of withdrawal may be used for trial purposes. /
3 / I understand that sections of my medical notes or information related directly to my participation in this trial may be looked at by responsible individuals from the trial sponsor and research personnel at the NHS Trust where it is relevant to my taking part in the research. I give permission for these individuals to have access to my records. /
4 / I understand that my doctors will provide a copy of my signed consent form and personal information about my progress, in confidence, to the central organisers at the University of Birmingham Clinical Trials Unit (BCTU) for use in the BASIL-2 trial. /
5 / I understand that the trial researchers may contact me by telephone, post or email to remind me to complete the questionnaires or to ask me the questions over the telephone and that my address and relevant contact details will be passed to the Birmingham Clinical Trials Unit (BCTU) to assist with this. /
6 / I agree to my GP being informed of my participation in the BASIL-2 trial and agree that they may be contacted to provide information about my progress, in confidence, to the BCTU. /
7 / I agree to the information held and maintained by The Health and Social Care Information Centre and other current and future NHS bodies being used in the future to provide information about my long-term health status and health care. For this purpose, I agree to BCTU holding my name, gender, date of birth, postcode and NHS number. This information will be shared with these central bodies. /
8 / I agree to participate in the BASIL-2 Trial. /
Name of participant:…………………………………Signature:………………………....Date:…..…………..…..…
Name of person receiving consent:………………………………………………....Signature:…………………………Date:………………….…..
1 copy for the participant, original for the Investigator Site File, 1 copy to be retained in the hospital notes and 1 copy faxed to BCTU