Developing information for participants in your research – getting started This presentation contains some exercises to help you get started. You can do these alone or in a group PMM/FEB/10

You have been asked to take part in a research project PMM/FEB/10 What information do you think the researcher must give you? What information do you think the researcher should give you? What information do you think the researcher could give you? Write each of your ideas on a post it note

Group ideas together under must, should and could. The results might include PMM/FEB/10 Musts Confidentiality Why is this research being done? Are there any risks? Who is doing the research? What will I have to do? Shoulds Why me? Will I be paid? Will I get to hear the outcome? How long will data be kept and where? Coulds Where will it be? How long will it take? Is the researcher experienced?

All these points and more are important in trying to decide whether or not to take part. You may have concerns about whether any information or opinions you give will remain confidential, whether data will be anonymised, who will have access to it and under what conditions. PMM/FEB/10

You may also be concerned about what taking part will involve and whether this involves any physical or psychological risk, either now or in the future. PMM/FEB/10

Like you, potential participants need information upon which they can base their decision to take part PMM/FEB/10

Providing information is just one part of seeking the consent of participants and the Research Ethics Committee (REC) will wish to consider the whole process. PMM/FEB/10

Where do I start? Make sure that your information for participants conforms to the guidelines issued by NRES. Title: Information Sheets & Consent Forms Guidance for Researchers & Reviewers Access this document now Make sure that you have the most up to date edition.

Information Sheets & Consent Forms Guidance for Researchers & Reviewers Some parts of this document need to be read in detail; the rest depends on the nature of your project. The next few slides will help you to decide which sections to concentrate on. PMM/FEB/10

Essential reading Why participant information is needed (section 4); General comments (section 5) Good clinical practice elements of informed consent (section 16). Mental capacity and competence (section 37) Consent issues (section 14 and 15) PMM/FEB/10

Guidance related to the particular group you want to recruit Adults with capacity Adults without capacity Children and young people Additional reading; Additional reading; You may also need to consult later sections on specific issues such as genetics, pregnancy, payment of participants and emergency situations. PMM/FEB/10

Normally, information for participants is in two parts. PMM/FEB/10

Part 1 provides information on the main elements of the study, the voluntary nature of participation, what will happen during and after the study, what treatment may be withheld, what participants will be asked to do, the potential risks, inconvenience or restrictions balanced against any possible benefits and the alternative(s). This should allow the potential participant to decide whether the study is of interest and whether they wish to read and discuss it further. PMM/FEB/10

Part 2 should contain additional information on factors such as confidentiality and data protection, communication with the GP, indemnity and compensation, publication, etc. which should, of course, be read and understood before potential participants decide whether they want to take part. PMM/FEB/10

But remember PMM/FEB/10

One size will not fit all The level of detail should be appropriate to the nature and detail of the study. Match the length to the complexity and risk of your study. NRES recommends that, where possible, the sequence of questions set out in the guidance is used as subheadings, omitting those that are not appropriate to the particular study. PMM/FEB/10

if appropriate produce a single section information sheet for a short study or for a simple questionnaire study, insert sufficient information at the front of the questionnaire. PMM/FEB/10

What next? Go to presentation 2 which will explain how to set about writing your information for participants. PMM/FEB/10 End of this presentation