INFORMED CONSENT STATEMENT - The North Carolina …知情同意的声明-北卡罗莱纳州….doc

Guidance on Developing an Informed Consent Statement Elements of an Informed Consent Statement (ICS) See 45 CFR 46.116 (1998) 1- That the study involves research; 2- The purposes of the research; 3- The expected length of time of research participation; 4- The procedures to be performed and which, if any, are experimental; 5- Reasonably foreseeable risks and discomforts; 6- Reasonably expected benefits to subjects or others; 7- Alternatives, including treatment, that could benefit the individual more than research participation; 8- The level of confidentiality protecting any identifiable information recorded on the subject; 9- Whether compensation and medical treatment will be available for injuries resulting from research; 10- The identity of the person(s) to notify if the subject has questions or suspects research-related injury; and 11- That participation is voluntary, refusal will not be penalized, and participation may cease at any time without penalty. SAMPLE INFORMED CONSENT STATEMENT You are being asked to take part in a research project called [The project title goes here] conducted by [Investigator’s name, degree, and affiliation]. The purpose of this study is [to learn more about whatever the topic is]. The expected length of time of your participation is [fill this in]. During the course of this study, the following will occur: [using lay language, describe step-by-step what will be required of, or done to, the research subject. State what information will be gathered and whether by interviews, record extraction, etc.] The possible risks to you as you take part in this study may be thoughts and feelings of sadness as you think about your past, your family, and what you did to get here [Replace our example with a complete description of the risks]. You have been told that, should you want to, you can be referred to staff at [the DTC Office] to talk about this experience afterwards [if this is necessary]. You will not benefit directly from tak