Presentation 1: Developing Presentation 1: Developing information for participants information for participants in your research – getting in your 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 results The results might includemight 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 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, social 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 decision they can base their decision to take partto 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/applications/guidance/consent-guidance-and- forms/?1311929_entryid62=67013 Make sure that you have the most up to date edition.

Information Sheets & Consent Forms Information Sheets & Consent Forms Guidance for Researchers & ReviewersGuidance 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.

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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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See also the Department of Health pages on consent at http://www.dh.gov.uk/health/search/?searchTerms=consent

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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 about 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 study

or

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

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