Template information sheet for participants to read

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HEADER: Write your information sheet on headed letter paper which bears the name of the

University and the name and address of the department to which the principal researcher is attached. Use University email addresses

Participant Information Sheet

 The following is a guide to writing an information sheet.

 You can adapt this actual sheet or use your own document and formatting. However, you

1. Study title

Add Title of the study and CUREC ethics reference [which you will receive after ethics approval].

must cover each of the areas below in your finished version.

 Note there are some standard wordings to include.

2. Background and aims of the study

This section should describe the aims of the research study, and what questions it hopes to answer. It should briefly introduce the researcher providing their name and University of Oxford contact details as well as their status/role (e.g. staff, undergraduate/ postgraduate/doctoral student).

3. Why have I been invited to take part?

[Write addressing the participant as “You” throughout these sections eg “You have been invited because…”] This should explain how the participant has been identified as suitable to take part in the study (e.g. because they are residents of a particular place, users of a particular facility, speakers of a particular language). Please include information on any exclusion criteria.

4. Do I have to take part?

This section should state that potential participants can ask questions about the study before deciding whether to participate. It should say that they choose whether they participate and, if they agree, they may withdraw themselves and their data from the study without penalty at any time, and without giving a reason, by advising the researchers of this decision. (If the potential participants are students there should be particular reassurance that there is no academic penalty for non participation or withdrawal).

5. What will happen in the study?

Participants should be advised here that if they are happy to take part in the study, they will be asked to sign a consent form [do not advise participants of this if consent will be oral]. This section should then go on to talk about what participants will be required to do in the study e.g. completing a questionnaire, interviews, assignment to an experimental activity. It should list each activity and say how long each one will take. This section should also provide the location and duration of each activity.

6. Are there any potential risks in taking part?

This should explain any potential risk, any burdens imposed and any specific preparatory requirements (eg special diet, exercise). It should also cover what you, as the researcher, will do to mitigate risk (eg counselling participants for whom interviews are distressing, offering to re-schedule or abandon the interview). Also mention any benefits of taking part.

7. What happens to the research data provided?

This section should provide information on the confidentiality and anonymity of the participants.

It should cover who will have access to personal data provided, how the data will be stored; and what will happen to the data at the end of the project. Information on what constitutes personal and

SSH_IDREC reference: Template IS for participants – Version 5, 24 June 2015

HEADER: Write your information sheet on headed letter paper which bears the name of the

University and the name and address of the department to which the principal researcher is attached. Use University email addresses sensitive data is available here: http://www.admin.ox.ac.uk/councilsec/compliance/dataprotection/definitions/ . You should state here whether you will ask participants for their permission to use direct quotes. Information on data storage and retention should also be provided here. The University has published guidance on this on their

Research Data management site (see http://researchdata.ox.ac.uk/preserving-your-data/ ).

8. Will the research be published?

Comment here on whether the research will be published and in what format eg internal-only publication, peer-reviewed journal, or (in the case of some student research) online in University archives.

8.1. Note on student thesis online publication (only relevant if you are a student whose successful thesis will be deposited both in print and online in the University archives)

Where the research will be written up as a student’s thesis that will be published online, please explain how the personal data (see Glossary definition [link to Glossary]) included in that thesis will be published and stored. The following is sample text for you to adapt and include in your information sheet:

“The University of Oxford is committed to the dissemination of its research for the benefit of society and the economy and, in support of this commitment, has established an online archive of research materials. This archive includes digital copies of student theses successfully submitted as part of a University of Oxford postgraduate degree programme. Holding the archive online gives easy access for researchers to the full text of freely available theses, thereby increasing the likely impact and use of that research.

If you agree to participate in this project, the research will be written up as a thesis. On successful submission of the thesis, it will be deposited both in print and online in the University archives, to facilitate its use in future research. The thesis will be published with [insert here information on the type of access and what that means, e.g. open or restricted access (or closed or embargoed access), open access meaning available to every internet user].

9. Who has reviewed this project?

Include the standard wording here “that this project has been reviewed by, and received ethics clearance through, the University of Oxford Central University Research Ethics Committee”;

Also include any other review such as peer review or review by supervisor. Include substantial funders eg research council or industry. Explain the process for participants receiving feedback after the investigation is complete. Inform the participant if the results are to be published.

10. Who do I contact if I have a concern about the study or I wish to complain?

Please use our standard wording, making sure you populate with your contact details. And please make sure to state the correct ethics committee which reviewed your project:

10.1. For studies solely reviewed by a University research ethics committee [use only the contact details of the committee which reviewed your project]

“If you have a concern about any aspect of this project, please speak to the relevant researcher

([insert tel. no. here]) [or their supervisor ([insert tel. no. here]), where applicable,] who will do his/her best to answer your query. The researcher should acknowledge your concern within 10 working days and give you an indication of how he/she intends to deal with it. If you remain unhappy or wish to make a formal complaint, please contact the chair of the Research Ethics Committee at the University

SSH_IDREC reference: Template IS for participants – Version 5, 24 June 2015

.

HEADER: Write your information sheet on headed letter paper which bears the name of the

University and the name and address of the department to which the principal researcher is attached. Use University email addresses of Oxford (using the contact details below) who will seek to resolve the matter in a reasonably expeditious manner:

10.1.1. Chair, Medical Sciences Inter-Divisional Research Ethics Committee ; Email: ethics@medsci.ox.ac.uk

; Address: Research Services, University of Oxford, Wellington

Square, Oxford OX1 2JD

10.1.2. Chair, Social Sciences & Humanities Inter-Divisional Research Ethics

Committee ; Email: ethics@socsci.ox.ac.uk; Address: Research Services, University of

Oxford, Wellington Square, Oxford OX1 2JD

10.1.3. [For applications reviewed by the Oxford Tropical Research Ethics Committee

(OxTREC), please insert the contact details for the local ethics committee which has reviewed your project]

10.2. For studies reviewed by both a University research ethics committee and the Clinical

Trials and Research Governance team:

If a participant in University-sponsored research is ever considered to have suffered harm through their participation, the University has arrangements in place to provide for compensation. If you have a concern about any aspect of this project, please speak to the researcher [insert name and tel. no here] or the Principal Investigator [insert name] [ delete as necessary ], who will do his/her best to answer your query. The researcher should acknowledge your concern within 10 working days and give you an indication of how he/she intends to deal with it. If you remain unhappy or wish to make a formal complaint, please contact the University of Oxford Clinical Trials and Research Governance

(CTRG) office on 01865 572224, email ctrg@admin.ox.ac.uk

, who will also inform the chair of the

Research Ethics Committee at the University of Oxford .

SSH_IDREC reference: Template IS for participants – Version 5, 24 June 2015

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