# Please take part in my research



## 13781 (Dec 13, 2005)

If any body would like to take part in my research i would greatly appreciate it as I am in need of participants, the information sheet is below:Version 2 â€“ 9/06/05 PIS for IBS Participants taking part in the Postal ConditionCarly JacobsBSc (Hons) MScUniversity of SurreyGuildfordSurrey GU2 7XH UKTel: +44 (0)1483 686883Fax: +44 (0)1483 689553Email: c.jacobs###surrey.ac.uk Department of Psychology13 December 2005Patient Information Sheet For IBS Participants1. Study TitleSelf Regulatory Model based intervention in IBS2. Invitation ParagraphYou are being invited to take part in a research study. Before you decide if you would like to take part it is important for you to understand why the research is being done and what it will involve. Please take time to read the following information carefully and discuss it with others if you wish. Contact me if there is anything that is unclear to you, or if you would like more information. Take time to decide whether or not you wish to take part.Thank you for reading this.3. What is the purpose of the study?Thank you for your interest in participating in this study. This study will investigate whether an intervention based on a psychological model relating to how you think and behave relating to your IBS affects the frequency of your IBS symptoms and quality of life. Research of this type is necessary to gain a better understanding of how to improve illness outcomes for sufferers. It will take up to four hours of your time spread over a period of five months (proposed duration of the study one year). 4. Why have I been chosen?You have been chosen because you sufferer from IBS, with a confirmed diagnosis from a medical professional. You are one of approximately 100 patients participating in this study.5. Do I have to take part?It is up to you to decide whether or not to take part. If you do decide to take part you will be given this information sheet to keep and be asked to sign a consent form, which you will have a copy of. If you decide to take part you are still free to withdraw at any time and without giving a reason. A decision to withdraw at any time, or a decision not to take part, will not affect the care you receive from the NHS. 6. What will happen to me if I take part?Your involvement in this research will be for a total of four hours spread over a period of five months. There are a number of stages to this research which will be numbered below:1. Stage 1. You will be sent two envelopes through the post one marked pre-intervention pack, and one marked post-intervention pack. You will also receive an intervention booklet. Firstly you need to fill in the pre-intervention pack. This needs to be completed in the order it is presented to you and prior to starting the â€˜IBS intervention bookletâ€™. If you have taken part in my research previously you may recognise the style of questionnaires and the diary. Despite having filled them in previously they need to be filled in again this time to see if the intervention is successful. Once you have completed the pre-intervention pack it needs to be returned to the envelope and posted back to me. Once you have completed the pre-intervention pack you can then start the intervention. The first page of the booklet contains instructions for filling in the booklet, which you need to read before taking part. Once you have completed the booklet it is yours to keep, although if you would like to send me a photocopy with any comments you have you are very welcome. Once you have completed the booklet you need to fill in the questionnaires contained in the envelope marked post- intervention questionnaires. Once completed you need to return them to the envelope and post back to me. Postage is free post therefore please do not put stamps on the envelope.2. Stage 2. Two months after I have received your completed pre and post intervention packs you will receive a pack containing questionnaires similar to those in the pre-intervention pack. This is necessary to assess the success of the intervention. 7. What do I have to do?The research is designed to involve minimal disruption to your routine, and can be completed at a location convenient to you. There are no lifestyle restrictions and you can therefore continue to undertake all normal activities.8. What is the procedure that is being tested?The research is testing the usefulness of an intervention based on how you think and feel about issues relating to your illness.9. What are the alternatives for treatment?There are a number of alternative treatments available for IBS however, none so far have been found to have long-term success. For the purposes of this study you are not required to alter any other treatments you are currently receiving including medical care or any alternative treatments you are having. This intervention is designed to be administered in conjunction with you current treatments10. What are the possible disadvantages and risks of taking part?There are no disadvantages or risks from participating in this study.11. What are the possible benefits of taking part?The results of this study may help future treatments of IBS, in addition you may experience some benefit. The first is that hopefully the intervention will improve your IBS, however this cannot be guaranteed. Secondly the information from this study may help in the future treatment of IBS, this is important as many sufferers report frustration at the current lack of knowledge concerning this illness. No previous research has investigated the usefulness of an intervention of this type and therefore it is important to establish its usefulness in order to see if it improves illness outcomes.12. What if new information becomes available?In the event of further contact being necessary, inclusion of your address on the consent form will allow for you to be contacted.13. What happens when the research study stops?When the research study stops you are not required to have any further involvement.14. What if something goes wrong?In the unlikely event you are harmed by taking part in this research, there are no special compensation arrangements, but standard university insurance cover is in place. If you are harmed due to someoneâ€™s negligence, then you may have grounds for a legal action, but you may have to pay for it. Regardless of this if you wish to complain, or have any concerns about any aspect of the way you have been approached or treated during the course of this study, the standard university complaints mechanisms should be available to you.15. Will my taking part in this study be kept confidential?Your doctor will not be informed of your participation in this study. All personal data will be anonymous and processed in the strictest of confidence and in accordance with the Data Protection Act (1988). By consenting to participate in this study you are indicating your agreement not to restrict the results of the study on the understanding that your anonymity is preserved. It is necessary for you to sign the consent form to indicate your consent, but this is the only place where your name will appear, all other data will be identified by coding only. It is essential that you include an identifying code word on the consent form, and the same word on the questionnaires and the diary, this will allow for all of your data to be matched together. If you would like to be contacted in the event of any further information regarding this research becoming available, then please include a contact address on the consent form. 16. What happens to the results of the research study?It is anticipated that the results of this study will be published. Participants should note that they will not be able to be identified in any publication. Publication may be in academic journals, in the journal of the IBS NETWORK, and on the IBS NETWORKâ€™s website. The findings may also be presented at academic conferences. The IBS NETWORKâ€™s website has no access restrictions and can therefore be accessed by the general public. Requests can also be made to myself the chief investigator for a summary of the research findings.17. Who is organising and funding the research?The research is funded by the University of Surrey.18. Who has reviewed the study?This study has been reviewed by the Berkshire Research Ethics Committee who raised no objections on ethical grounds.17. Contact for further informationIf you have any questions regarding any aspects of the study, or would like further information and advice please do not hesitate to contact me prior to the start of the study. The signing of the consent form indicates that you fully understand the study, and therefore if this is not the case please contact me prior to indicating your consent.Carly Jacobs Psychology DepartmentSchool of Human SciencesUniversity of SurreyGU2 7XHE-mail â€“ c.jacobs###surrey.ac.ukTel: (University) +44 (01438) 686883 (Mob) 07931 565820


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