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Participant Informed Consent (Template):参与者的知情同意(模板).doc

Participant Informed Consent (Template):参与者的知情同意(模板).doc

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Participant Informed Consent (Template):参与者的知情同意(模板)

Participant Informed Consent Title of Study: Investigator: Sponsor: The (Name of Funded Institution or Awarded Individual) is conducting a research study called, “_______”. The study is funded by ____________________. What is the study about? (A brief explanation of why the study is being conducted (what you hope to learn), how many people will be in the study, why the participant has been chosen to participate (eligibility requirements.). How long will I be in the study? Your part in the study will last __________. What will happen in the study? (Provide an explanation of what will take place during the study and what is expected from participants. Itemize what will happen at each study visit and the expected visit length. Use bullets when appropriate. Be careful to use non-coercive language (e.g. we will ask you to versus you will fill out or you will do the following. Explain any experimental procedures.) If you are eligible and wish to join the study, you must sign this consent form. If you do not sign the consent form you cannot join the study. We will review this consent form with you at/during…… You will be given enough time to review the consent and have all your questions about the study answered. We will give you a signed copy of the consent for your records (when, in person, by mail, etc.). Study staff will not know which group or study drug/treatment you are assigned to. You should not join the study if you are not willing to take the study drug/treatment (or join the group) you are assigned to. What if I have questions? You can contact _______________ at ___________ if you have questions about the study. __________________ is in charge of the study. You may also contact _____________ at _________________ if you have questions about the study. Do I have to be in the study? (Use all statements below. White space between key statements is important.) You decide if you want to be in the study. Deciding not to take part will not affect your re

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