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Consent to Participate in Research

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Consent to Participate in Research
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TEXAS WOMAN’S UNIVERSITY
Consent to Participate in Research

A. Study Title
You are requested to participate in this research study of the Cross-cultural Adaptation, Reliability and Validity of the Arabic Version of the Fear Avoidance Beliefs Questionnaire in Patients with Low Back Pain to be conducted by………………………., in partial fulfilment for the degree in………………………….at the Texas Woman’s University. The contact details of the investigator are (email)………………………….. and (phone)……………………. Participation in this study is fully voluntary and no one should thus be forced to participate B. Purpose of the study
The study seeks to develop a measurement tool specific for the Arabic community that measures fear beliefs among patients with low back pain (LBP). This measurement tool will be an adaptation and translation from the English Fear Avoidance Belief Questionnaire (FABQ) by Waddel et al. C. Expected coverage
Overall, a total of 70 subjects will be asked to participate in this project. A questionnaire that consists of 16 questions, all allowing one to select from a pre-existing set of answers will be given, which may take up to 20 minutes to complete. 48 hours later, patients will be asked to complete the same questionnaire again. Study participants will complete the questionnaire by answering each item accordingly. D. Risks The researchers will try to prevent any problem that could happen because of this research. Loss of privacy shall be maintained in accordance to the law. In case of occurrence, this shall otherwise not be compensated. Others such as loss of time during the research shall not be catered for. You should let the researchers know at once if there is a problem and they will help you. However, TWU does not provide medical services or financial assistance for injuries that might happen because you are taking part in this research. E. Benefits Your participation in this project may benefit you by allowing you to reflect on your LBP symptoms and perceptions about pain. As a result of filling out the FABQ questionnaire, you may become more aware of links between pain and self-perceptions about pain. The participants will receive the results of the study upon request. As compensation, the participants in this study will receive $ 50. F. Confidentiality Confidentiality will be protected to the extent that is allowed by law. In accordance, FABQ questionnaires will be stored in a locked file cabinet in a designated office in the Physical Therapy department of King Khalid University Hospital. After questionnaire information is entered into the computer, the questionnaires will be shredded. Participants will be assigned unique identifiers that are anonymous in the electronic files, but trace back to the original questionnaire, as required for data analysis and other procedural steps during this study. Electronic data will be stored on a pin drive that will be securely locked in the file cabinet in the same location at the same site as the FABQ questionnaires to prevent public access. Seven years after completion of the study, the pin drive and any other electronically stored information will be deleted and the pin drive destroyed. The paper questionnaires will be shredded and the pin drive will be destroyed by safely eradicating information so data is irretrievable. In general all information provided in this research will remain confidential and will only be disclosed upon your permission. G. Publication Statement
The results of this study may be published in professional and/or scientific journals. It may also be used for educational purposes or for professional presentations. However, no individual subject will be identified. H. Study Results
Results from this study will be available to participants upon request. All data obtained for study will be in aggregated form, on the development of an adapted version of the English FABQ, either presented during conferences or published in peer-review articles or publications. I. Consent PARTICIPATION IN THIS PROJECT IS VOLUNTARY. The only alternative to this project is non-participation. You may refuse to participate or withdraw at any time without penalty or loss of benefits to which you are otherwise entitled. As an interpreter or translator, your decision to participate or not or to withdraw your participation will have no effects on your position at your place of employment.
To participate in this study, you should sign below.
I give my consent to participate in this study: Name of Research Participant Date

Signature of Participant or legally authorized representative Date

Relationship to the Participant _________________________ ________________________________________ Signature of Witness Signature of the researcher Obtaining Consent

References
Waddell G., Newton M., Henderson I., Somerville D., Main C.J. (1993). Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear- avoidance beliefs in chronic low back pain and disability. pain 52, 157-168.

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