FDA-regulated clinical trials, Note: For all data collected up to the time of subject withdrawal must be retained in the database. Thus, the consent document should inform participants that their data will be retained for analysis even if they withdraw. If you have any questions please the rights of research subjects or research-related injury, contact the IRB Administrator, (515) 294-4566, , or Director, (515) 294-3115, Office for Responsible Research, Iowa State University, Ames, Iowa 50011. (This statement MUST be What if I am injured as a result of participating in this study? included if there is greater than minimal risk to the subject.) Omit if not applicable. Please tell the researchers if you believe you have any injuries caused by your participation in the study. The researchers may be able to assist you with locating emergency treatment, if appropriate, but you or your insurance company will be responsible for the cost. [When applicable, add: Eligible Iowa State University students may obtain treatment from the Thielen By agreeing to participate in the study, you do not give up your right to Student Health Center.] seek payment if you are harmed as a result of being in this study. However, claims for payment sought from the University will only be paid to the extent permitted by Iowa law, including the Iowa Tort Claims Act (Iowa Code Chapter 669). Whom can I call if I have questions about the study? You are encouraged to ask questions at any time during this study. For further information about contact [principal investigator name and contact information; the the study, for a student project, supervising investigator’s name and contact information MUST be included]. Your Consent If signed consent will be obtained, use verbiage similar to the following: By signing this document, you are agreeing to participate in this study. Make sure you understand what the study involves before you sign. If you have any questions about the study after you agree to participate, you can contact the research team using the information provided above. I agree to take part in this study. If the study involves obtaining identifiable data about participants from private student records (e.g., grades, coursework, data from the Registrar or other offices, etc.), add: I also agree that the research team may obtain information from my educational records, as described in this document, for the study. Participant’s Name (printed) Participant’s Signature Date
Note: For FDA-regulated clinical trials, all data collected up to the time of subject withdrawal must be retained in the database. Thus, the consent document should inform participants that their data will be retained for analysis even if they withdraw. If you have any questions the rights of research subjects or research-related injury, please contact the IRB Administrator, (515) 294-4566, , or Director, (515) 294-3115, Office for Responsible Research, Iowa State University, Ames, Iowa 50011. What if I am injured as a result of participating in this study? (This statement MUST be included if there is greater than minimal risk to the subject.) Omit if not applicable. Please tell the researchers if you believe you have any injuries caused by your participation in the study. The researchers may be able to assist you with locating emergency treatment, if appropriate, but you or your insurance company will be responsible for the cost. [When applicable, add: Eligible Iowa State University students may obtain treatment from the Thielen Student Health Center.] By agreeing to participate in the study, you do not give up your right to seek payment if you are harmed as a result of being in this study. However, claims for payment sought from the University will only be paid to the extent permitted by Iowa law, including the Iowa Tort Claims Act (Iowa Code Chapter 669). Whom can I call if I have questions about the study? You are encouraged to ask questions at any time during this study. For further information about the study, contact [principal investigator name and contact information; for a student project, the supervising investigator’s name and contact information MUST be included]. Your Consent If signed consent will be obtained, use verbiage similar to the following: By signing this document, you are agreeing to participate in this study. Make sure you understand what the study involves before you sign. If you have any questions about the study after you agree to participate, you can contact the research team using the information provided above. I agree to take part in this study. If the study involves obtaining identifiable data about participants from private student records (e.g., grades, coursework, data from the Registrar or other offices, etc.), add: I also agree that the research team may obtain information from my educational records, as described in this document, for the study. Participant’s Name (printed) Participant’s Signature Date
Informed-consent-template-QA_1.23.2018-FINAL.docx