Protocol # Application for Research Involving Human Subjects (admin use only) EM from PI HS Research Protocol: All research projects, involving human subjects, regardless of funding source EM from FA must submit an application for review and approval by the Institutional Review Board (IRB) or the Psychology Departmental Human Subjects Review Board (DRB) prior to the initiation of the research. Completed applications must be emailed as attachments to [email protected]. If you have questions, contact the Office for the Advancement of Research and Scholarship: (513) 529-3600. A. Personnel Information: Primary Investigator(s): Faculty Staff PRIMARY INVESTIGATOR: Name, Department, UniqueID (ex: smithja), Graduate Undergraduate CITI online training date, MU Application Training Date Name Email address: [email protected] Campus or Postal Address(es): enter address Phone: (513) 529 - Other project personnel who will interact with subjects or data (CO-PI’s, research assistants, etc.) List Names, UniqueID, and Date completed CITI online training (add lines as necessary) Names, training information FACULTY ADVISOR (for student PI’s): Name , Department, UniqueID, CITI online training date, MU Training Date Enter faculty advisor information Faculty Advisor email address: [email protected] B. PROJECT INFORMATION: Project Title: Enter Project Title Human Subjects Research Dates: Funding Source: Projected beginning date: mm dd yy (e.g. Jan 01 09) Projected ending date: mm dd yy (and after IRB approval) If externally funded, enter OARS eSPA ID eSPA ID number: C. Does this project make use of any of the following special types of subjects and/or locations? (check all that apply) Children International Research Elementary and Secondary Schools Prisoners Pregnant Women and Fetuses in Utero Research in VA Hospitals Research Conducted with Clinical Populations in which HIPPA Applies (e.g. medical, psychiatric) *In the online CITI Training Program there are training modules associated with each of the above special cases. You will need to complete any of the checked associated modules, if not listed in the required modules. 1 D. Answer these six true-false questions to the best of your ability (or leave blank if unsure) : (The answers to these questions will aid the reviewers in determining the type of review conducted) T F Subjects are over 18 years old. T F Research does not focus on subjects that are pregnant, prisoners, or economically or educationally disadvantaged. T F Risk of harm is not reasonably greater than normal everyday life. Note: risk categories include physical, emotional, psychological, social, economic, legal etc. T F The data was collected by someone other than the personnel listed above before the research was planned and identifiers were removed or were never recorded before Miami personnel had access to the data. T F The research uses normal educational practices in a normal setting: e.g. evaluating established educational techniques, curricula, or classroom management T F The research is initiated by program leadership to evaluate a public benefit program where evaluation or improvement of service quality is the objective and methods to gauge this do not include interviews/surveys that pose a risk greater than normal to those interviewed or completing surveys. E. INVESTIGATOR’S ASSURANCE STATEMENT I have read Miami University's policy concerning research involving human subjects and by signing below: 1. I agree to accept responsibility for the ethical conduct of research conducted in this project; 2. I agree to obtain approval from the Institutional Review Board or Departmental Review Board prior to modifying any of the procedures; 3. I agree to submit an Application for Approval of Continuing Projects describing the current status of the project as specified in the approval letter; 4. I attest that the information submitted in this application is true to the best of my knowledge. Students: send your application to your faculty advisor. Faculty: submission by attachment using your MU email address to [email protected] serves as your signature and pledge to abide by the conditions stated above. This cover page document should be sent in its current format (not scanned), no original signatures are required Primary Investigator Signature _____(Submitting by MU email serves as your signature) _____ Date: mmm dd yy Faculty Advisor Signature _____(Submitting by MU email serves as your signature) _____ Date: mmm dd yy Notes: (for administrative use only): 2
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