Participant Information Sheet for Adults
Project Title: <insert>
Chief Investigator: <insert>
Research Coordinator / Assistant: <insert>
Sponsor: <insert>
We would like to invite you to take part in a research study. Before deciding if you will give permission to take part in this study, you need to understand why the research is being done and what it will involve for you. Please take time to read the following information carefully. Talk to others about the study if you wish.
You are being asked to take part in this study because you …………………………..
Why have I been invited?
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Do I have to take part?
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What will happen to me if I take part?
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What will I have to do?
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What are the possible disadvantages and risks of taking part?
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What are the side effects of any treatment received when taking part?
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What are the possible benefits of taking part?
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What happens when the research study stops?
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Part 2
What if relevant new information becomes available?
Should write something along these lines:
Sometimes we get new information about the treatment being studied. If this happens, your research doctor will tell you and discuss whether you should continue in the study. If you decide not to carry on, your research doctor will make arrangements for your care to continue. If you decide to continue in the study he may ask you to sign an agreement outlining the discussion.
What will happen if I don’t want to carry on with the study?
Should write something along these lines:
You can withdraw from treatment but keep in contact with us to let us know your progress. Information collected may still be used. Any stored blood or tissue samples that can still be identified as yours will be destroyed if you wish.
What if there is a problem?
Should write something along these lines:
If you have a concern about any aspect of this study, you should ask to speak to the researchers who will do their best to answer your questions [contact number]. If you remain unhappy and wish to complain formally, you can do this [insert details eg NHS Complaints Procedure ]
In the event that something does go wrong and you are harmed during the research and this is due to someone‘s negligence then you may have grounds for a legal action for compensation against [name of Sponsor Organisation, NHS Trust, Private Clinic] but you may have to pay your legal costs. The normal National Health Service complaints mechanisms will still be available to you (if appropriate).
Will my taking part in this study be kept confidential?
Should write something along these lines:
If you join the study, some parts of your medical records and the data collected for the study will be looked at by authorised persons from the company sponsoring and/or the company organising the research. They may also be looked at by authorised people to check that the study is being carried out correctly. All will have a duty of confidentiality to you as a research participant and we will do our best to meet this duty.
Or for other research:
All information which is collected about you during the course of the research will be kept strictly confidential, and any information about you which leaves the hospital/surgery will have your name and address removed so that you cannot be recognised (if it is applicable to your research).
Or
Data collected during the study may be sent to associated researchers to countries where the laws don‘t protect your privacy to the same extent as the law in the UK but the company will take all reasonable steps to protect your privacy.
Involvement of the General Practitioner/Family doctor (GP)
Should write something along these lines:
You should explain if the participant’s GP (or other health care practitioner) needs to be notified of their participation, and seek consent for this. You should explain what information will be exchanged. There may be circumstances in which informing the GP may not be necessary, acceptable or possible
What will happen to any samples I give?
It should be clear to the participant, in the description of study procedures whether:
New samples will be taken (e.g. blood, tissue, specifically for this study); samples excess to a clinical procedure will be asked for; access to existing stored samples will be asked for; the secure procedures for collecting, using and storing samples; any possible intended use in the future for research that cannot yet be specified. A separated or two part consent form is recommended if future use is intended, and it should be clear if further REC approval will be sought; Whether samples will be transferred outside the UK, provision for destruction; the level of identifiability (for this study and for storage for future studies),
who will have access;
If there is any possibility that samples may be used in future research, we strongly advise prospective consent is obtained.
What will happen to the results of the research study?
You should tell the patients what will happen to the results of the research, whether it is intended to publish the results and how the results will be made available to participants. You should add that they will not be identified in any report/publication unless they have given their consent. The results could be separated into „broad scientific results of a trial‟ and „results with relevance to the individual‟. Consider both as appropriate but they may need different management.
Who is organising and funding the research?
The answer should include the organisation or company sponsoring the research and funding the research if these are different (e.g. Medical Research Charity, Pharmaceutical Company or academic institution).
Who has reviewed the study?
All research in the NHS is looked at by independent group of people, called a Research Ethics Committee, to protect your interests. This study has been reviewed and given favourable opinion by ______Research Ethics Committee.
Who do I contact for general information about research?
You can contact the R&D office via or 02089095529
Who do I contact for specific information about this research project?
This should be the study team, provide contact number or email address.
Who they should approach if unhappy with the study?
Patient Advice and Liaison Service via or 020 8909 5439/5717
Study Investigator: <insert PI’s name>
Study Coordinator: <insert name>