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StaphTrav patient information engl. v1.1 ___________________________________________________________________ Replace by Responsible investigator at site Travel Clinic Address Phone Number Email StaphTrav: a multicenter study of the importation of Staphylococcus aureus through intercontinental travel Information for study participants Dear patient, You have consulted our clinic today because of problems with your skin that are timely associated with travelling. It is very likely, that this condition is an infection caused by bacteria such as Staphylococcus aureus. We, a European team of researchers in travel medicine and infectious diseases, believe that you have acquired this infection while being abroad. Definite evidence for this hypothesis, however, is missing. Such knowledge would be of great value as these bacteria are increasingly causing diseases around the globe. Through your participation in this study you could significantly contribute towards a better understanding on how these bacteria spread and enter Europe which would help us to counsel other travellers on this risk as well as on protective measures. In case you agree to participate either I or one of my colleagues will take a swab from each wound and an additional one from both openings of your nose. We will send these specimens to our research laboratory at the University of Tübingen Medical School in Germany. Alongside these swabs, you are asked to provide basic information on your last travel, the beginning and type of symptoms as well as your age and gender without mentioning your name, date of birth, address or any other identifying information. These swabs will be checked for the growth of bacteria such as Staphylococcus aureus. No other investigations, in particular none that concern parts of your body such as genetic testing will be part of Page 1 Staphtrav patient information english v.1.1 ___________________________________________________________________ this research. There will also be no follow-up visits as part of this study. We will only meet again in case this is required as part of regular care. I will receive a report of our findings from Tübingen which I can share with you upon request. However, participation in this study will not replace consultation of a microbiological laboratory near our travel clinic. Depending on the severity of your skin infection, I will decide whether this is necessary or not. The swabs taken for this study are harmless and usually not painful. As for routine specimens we will use sterile cotton swabs. The nasal swab will be taken from the lower part of both openings of your nose which can lead to a short tearing of the eyes – a natural reaction of your body. Participation in the study is voluntary. I assure that the quality of our care you will receive here at the clinic is absolutely independent from your decision to participate in this study or not. Do not hesitate to ask your doctor about further details of this study or contact the coordinator, Dr. Philipp Zanger, Institut für Tropenmedizin, Wilhelmstraße 27, 72074 Tübingen, Germany, Tel.: +49 7071 29 82365, [email protected] Dr. responsible at study site Page 2 StaphTrav, Data storage and usage, v.1.1 _______________________________________________________________________ <<Name of site investigator>> <<Name of clinic/institution>> <<Address>> <<Phone>> <<Email>> StaphTrav: a multicenter study of the importation of Staphylococcus aureus through intercontinental travel DECLARATION OF DATA PROTECTION AND USAGE The data collected as part of this research study will be kept confidential and stored in a pseudonymized form (e.g. a number code) – without mentioning the participant’s name, address or date of birth. Only this pseudonym will be used to identify my specimens at the research lab. A list that allows reassigning personal information to the pseudonym will be kept separately from the study material in a locker and is only accessible to the doctors taking care of my treatment. All data will be stored for 10 years. In case of scientific publication no personal information will be publicly accessible. In case you decide to withdraw consent it is your decision to what extent the data already collected at the local study centre may be used or has to be destroyed. Consent I hereby agree that the data collected as part of the research study „StaphTrav: a multicente study of the importation of Staphylococcus aureus through intercontinental travel“ will be used as set forth above. I know that I am allowed to view my data file kept at the local centre upon request. Place, Date Signature Name of participant in capitals Staphtrav, consent form, v.1.1 _____________________________________________________________________________________ <<Name of site investigator>> <<Name of clinic/institution>> <<Address>> <<Phone>> <<Email>> StaphTrav: a multicenter study of the importation of Staphylococcus aureus through intercontinental travel Informed patient consent I, _________________________________(Name of patient), have fully read and understood the aims, procedures, duration, risks and side effects involved in participation in this study set forth in the document “Information for study participants”. I had ample time to ask further questions and feel fully informed about all aspects the participation in this research might involve. I have been informed that participation in this study is voluntary and that I am authorized to retract this consent at any time without giving reasons for this decision and without any consequences for me and my further treatment as patient at this institution. I have been informed about all issues of data storage, analysis and publication and have signed a separate consent on the usage and protection of my data. I agree in participating in this study. I herby agree that my microbiological specimens (swabs) alongside with basic information about my disease and travel history will be analyzed for scientific purposes. ___________________, ___/___/__ __ Place, Date ____________________________________________ Name and signature of participant ___________________, ___/___/____ Place, Date ____________________________________________ Name and signature of responsible investigator