developing information for participants in your research – getting started this presentation...

Developing information Developing information for participants in your for participants in your research – getting research – getting startedstarted

This presentation contains some exercises to help you

get started. You can do these alone or in a group

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You have been asked to You have been asked to take part in a research take part in a research projectproject

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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 Group ideas together under mustmust,, shouldshould and and couldcould. . The The results might includeresults might include

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MustsConfidentiality

Why is this research being done?

Are there any risks? Who is doing the

research?What will I have to

do?

ShouldsWhy me?

Will I be paid?Will I get to hear the

outcome?How long will data

be kept and where?

CouldsWhere 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.

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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.

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Like you, potential Like you, potential participants need participants need information upon which information upon which they can base their they can base their decision to take partdecision to take part

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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.

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Where do I start? 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 nowhttp://www.nres.npsa.nhs.uk Make sure that you have the most up to date edition.

Information Sheets & Consent Forms Information Sheets & Consent Forms Guidance for Researchers & Guidance for Researchers & ReviewersReviewers

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.

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Essential readingEssential 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)

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• Guidance related to the particular group you want to recruit

• Adults with capacity• Adults without

capacity• Children and young

people

Additional Additional reading;reading;You may also need to consult later sections on specific issues such as genetics, pregnancy, payment of participants and emergency situations.

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Normally, information for participants is in two parts.

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Part 1Part 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.

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Part 2Part 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.

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But rememberBut remember

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One size will not fit all 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.

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if appropriate if appropriate

produce a single section information sheet for a short studyor for a simple questionnaire study, insert sufficient information at the front of the questionnaire.

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What next?What next?Go to presentation 2 which

will explain how to set about writing your information for

participants.

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End of this presentati

on