some concepts. Key concepts, such as voluntary participation, withdrawal, data handling and insurance should all be covered in the information sheet (see this template). of view, length and language level Consistent with the objective of the PIS: write from the point of view of the study subject (not the investigator). Make sure that the information sheet is concise and easy to read. This may require specialist input from e.g. a professional editor, instructor or communication specialist. Ask a lay person preferably educated to no more than basic secondary education level to proofread your text. The subject information sheet must not be longer than 1500/2500 words. This word count does not include the consent form(s) and the following appendices: contact details, insurance text, schematic overview of study procedures and, for example, more information about side effects or mechanism of action of the product or treatment under investigation. The appendices, like the rest of the PIS, should be concise and easy to read. The language level of the information sheet should be no higher than basic secondary education level. The standard and example passages in this template meet this requirement (tested by Readability Foundation [Stichting Makkelijk Lezen]). Exceptions include a target audience very different from the ordinary Dutch population (e.g. children under 12, students in further education). This template was supported by and developed in collaboration with Nefarma, NFU, STZ, V&VN Research Professionals, ACRON, de Hart&Vaatgroep, Insurance Alliance, NVMETC and the Ministry of Health, Welfare and Sport. Please use the feedback form on the DCTF website to report any inconsistencies or give other feedback. The general brochure on medical research can be found on the CCMO website or you can order one free of charge from the government, call 1400 or visit . Subject information for participation in medical scientific research [Title of the study] Official title: Introduction Dear <Always>You are asked to take part in a medical-scientific study. Participation is voluntary. Participation requires your written consent. <if the patient was invited because of a specific disease or procedure or recent diagnosis>You have received this letter because you have [disorder]/have been diagnosed with [syndrome]/you will shortly undergo [procedure].
The following will take place: We will do a physical examination - at two visits We will make a heart tracing (ECG) - at one visit We will draw - at each visit, two tubes each time + what it is for (do not list all analyses, but, for example. This is to see how well […] is absorbed in your blood/We will measure […]/to check for [side effects/…]). We will ask you to complete a questionnaire about […] - at each visit Appendix C describes what will take place during each visit. OR You will be telephoned at home [X] times. You will then be asked about […]. A telephone call will take [...]. OR You will be sent a questionnaire [X] times. The questions are about […]. Completing the questionnaire will take you about [X minutes]. END OF EXAMPLE PASSAGE EXAMPLE PASSAGE Other than standard care Usually you may perhaps only visit your doctor for follow-up for [disorder] once every two months. Your doctor [will then take 1 tube of blood/will examine your … /will make …]. The study-related visits will replace these regular visits to your doctor/are additional. END OF EXAMPLE PASSAGE What is expected of you In order to carry out the study properly [<if applicable> and for your own safety], it is important that you follow the study instructions. The instructions require that you: <delete or supplement as appropriate, see guidance in the comment>: [take the study product/do the exercises] as directed. do not participate in another medical study. keep appointments for visits. carry your participant card for the study with you. This card states that you are participating in this study. It also states whom to contact in the event of an emergency. Show this card if you visit any [other] doctor. It is important that you contact the investigator: <delete as appropriate> before you start using other medicines. Even if they are homeopathic or natural remedies, vitamins and/or over-the-counter medicines. if you are admitted to hospital or are for treatment there. if you suddenly develop any health problems. if you no longer want to participate in the study. if your contact details change. EXAMPLE PASSAGE Pregnancy<Include as appropriate - split into text for women and text for men if appropriate> Your or your partner’s pregnancy
End of the study Your participation in the study stops when you have completed all the visits [according to the schedule/as described under point 4] you choose to stop you become pregnant <if applicable> <and if applicable:> the end of the entire study has been reached <if applicable; if the study continues until an endpoint has been reached, this should be explained here, for example, a specific number of cases of X> the investigator considers it best for you to stop [name of company], the government or Medical Research Ethics Committee, decides to stop the study. The study is concluded once all the participants have completed the study. <if the participants are patients and this concerns a medicinal product medication you have used during the study [will/will not] be available once the study has ended. The investigator will discuss the options for further medical care with you. After processing the data, the investigator will inform you about the most important results of the study. <if known, and it can be indicated in general> This will happen about [timeframe] after your participation. The investigator will also tell you treatment you had/which group you were in, <if applicable>]. If you do not want this to happen, please tell the investigator. He/she will then not be permitted to tell you. and storage of your data [and bodily material] For this study it is necessary to collect and use your [bodily material and] your medical and personal data. Each study subject will receive a code that will be marked on [the bodily material and] the data. Your name and other personal data will be deleted. Your data All your data will remain confidential. The investigator [and …] [is/are] the only [person/people] who will know which code you have. <if applicable> We will share your data with the sponsor of the study, but only using that code, never using your name. The key to the code will stay with the investigator. In the reports about the study only use this code will be used. Some people may access your medical and personal data. This is to check whether the study has been conducted in a good and reliable manner. General information about this can be found in the general brochure on medical research. People who may access your data are <give a full list, select as appropriate>: the study