ISRCTN60243484
PATIENT INFORMATION SHEET: DATA USE
1. Invitation paragraph
From time to time we need to undertake research studies involving the medical records of patients admitted to this ward. In order for us to be able to do this we need your consent to access your records. Before you decide it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with relatives, friends or your GP if you wish. Ask us if there is anything that is not clear or if you would like more information. Take time to decide whether or not you wish to take part.
Consumers for Ethics in Research (CERES) publish a leaflet entitled ‘Medical Research and You’. This leaflet gives more information about medical research and looks at some questions you may want to ask. A copy may be obtained from CERES, PO Box 1365, London N16 0BW.
Thank you for reading this.
2. What is the purpose of the study?
We are interested in the prescribing of anti-sickness medicine. Sections of your medical notes may be looked at by responsible individuals from North West Wales NHS Trust where it is relevant to the research study. Any data that is used from your medical notes will be made anonymous and patient confidentiality maintained at all times. The research study will run for one year and the outcomes of this study will inform the development of a much larger Wales-wide study and contribute to the on-going improvement of patient care.
3. Why have I been chosen?
The research methods being used for this study ask that consent to use data from medical records be sought from the patient when they are admitted to the ward.
4. Do I have to take part?
It is up to you to decide whether or not to agree to take part in the study. If you do decide to take part you will be given this information sheet to keep and be asked to sign a patient consent form for data use. If you decide you are taking part and grant access to use your medical records you are still free to withdraw at any time and without giving a reason. This will not affect the standard of care you receive.
5. Will the notes of patients taking part in this study be kept confidential?
All information, which is collected, about you during the course of the research will be kept strictly confidential. Any information about you which leaves the hospital will have names and addresses removed so that you cannot be recognised from it. The only people who will have sight of the original notes will be the research nurse assigned to the study.
6. What will happen to the results of the research study?
At the end of the study period a report will be written up detailing the outcomes of the study. A copy of the report will be made available to the healthcare professionals participating in the study. A copy of the report will also be made available to the North West Wales NHS Trust. It is intended that the outcomes of this study will be published in peer reviewed journals. Individual patients or hospital sites will not be identified in any way. It is expected that the outcomes of this study will inform the development of a Wales-wide trial.
7. Who is organising and funding the research?
The study is funded by a North West Wales NHS Trust Research Grant and supported by the North West Wales NHS Trust. Your doctor will be not be paid any extra fees for including patients in this study.
8. Who has reviewed the study?
North Wales Health Authority Research Committee (West, Central & East sub-committees)
19. Contact for Further Information
Dr A. Fowell
Macmillan Consultant
Palliative Care Department
Bodfan
Eryri Hospital
Caernarfon
Gwynedd
LL55 2YE
Tel: 01286 662 775
Thank You for Reading this Information Sheet.
The Patient will be given a copy of the 'Patient Information Sheet Data Use' and a signed 'Patient Consent Form Data Use' to keep for their records.
ISRCTN60243484
Centre Number:
Study Number:
Patient Identification Number for this trial:
Patient Consent Form : Data Use
Title of Project:
" Conducting Research in Palliative Care: Finding the Best Way Forward"
Name of Researcher:
Dr A Fowell
Macmillan Consultant
01286 662775
Please initial Box
1. I confirm that I have read and understand the information sheet dated………………
(version……………) for the above study and have had the opportunity to ask questions.
2. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected.
3.I understand that sections of my medical notes maybe looked at by responsible individuals from North West Wales NHS Trust where it is relevant to taking part in research. I give my permission for these individuals to have access to my records.
4. I agree to take part in the above study.
Name of patientDateSignature
Name of Person taking Consent
(If different from researcher)Date Signature
Researcher Date Signature
1 for patient; 1 for researcher; 1 to be kept with hospital notes