Potential respondents must be given all the information that might reasonably be expected to influence their willingness to participate. The information must be presented in simple language so as to be easily understood by persons unfamiliar with research or the specific research topic. A sample letter written at the 8th grade level is attached. “Implicit consent” may be approved for studies in which the researcher asks participants to complete a questionnaire that involves no more than minimal risk. Implicit consent means that completion and return of the questionnaire may be taken to document consent. The cover letter may contain wording that says that something to the effect that “by completing and returning the survey you have shown your agreement to participate in the study”. Address the person you are writing to in the second person. If oral consent is to be obtained the PI should provide the IRB with a “script” of how the project will be described to the participant. Where oral consent is obtained participants should still be provided with a written document describing the study and providing the name and contact information for the PI and IRB. The letter template attached is a starting point that you can tailor to your study and subjects. You must ensure that your informed consent materials contain the following elements:
A statement that the study involves research
A simple descriptive title of the project
Name and phone number of the Principal Investigator (students must have a faculty advisor sponsor them as the PI). A clear statement of the research purpose(s)
A clear explanation of the procedures to be followed
A statement about the risks or benefits, including the...