To be completed by Wofford College IRB member: Date Received _______Department___________________________________ Representative________________________________________________________ *Protocol Number_______________________________________________________ *(To be assigned by the Office of Grants & Contracts) Protocol Qualifies for: Full Review____ Expedited Review____ Exemption____
Instructions: In order to comply with federal regulations as well as to conform with guidelines of the College's Institutional Review Board (IRB), the principal investigator is required to complete all of the following items contained in the Submission Form and the IRB Protocol. Upon completion of all information, the principal investigator must submit the original Submission Form and one copy of the IRB Protocol, including all consent forms and research instruments (questionnaires, interviews, etc.) to the IRB Chair for review and action. If the Chair determines that full review by the IRB is warranted, the Chair will notify the principal investigator to supply the Chair with copies of the Submission Form, IRB Protocol, and consent forms for distribution to the IRB members and files. Incomplete forms may delay review by the IRB. For further information, refer to the Policy and Procedure Manual for Research with Human Subjects.
I. General Information
A. Project Title_______________________________________________________ New_____ Continuation/Renewal_____ Revision_____ Proposed Start Date________________________________________________ Proposed Duration of Research______________________________________ Performance Site(s)________________________________________________ B. Principal Investigator______________________________________________ Faculty _____ Staff _____ Student _____ Department ________________________________________________________ Mailing Address____________________________________________________ Phone Number ______________________________________________________ Co-Investigator(s) ________________________________________________ Principal Investigator's Signature________________________Date__________ II. Funding Information If this protocol is part of an application to an outside agency, please provide: A. Source of Funding _____________________________________________________________ B. Project Title (if different from above)________________________________________ C. Principal Investigator (if different from above)_______________________________ D. Type of Application: Grant_____ Subcontract_____ Contract_____ Fellowship______ E. Date of Submission _______________________________________
III. Cooperative Research
Cooperative research projects are those that involve more than one institution and can be designed to be both multi-site and multi-protocol in nature. Each participating institution is responsible for safeguarding the rights and welfare of human subjects and for complying with all regulations. If this proposal has been submitted to another Institutional Review Board please provide:
Name of Institution _________________________________________ Date of Review ___________ Contact Person __________________ IRB Recommendation __________________________________________ IV. Subject/patient Information A. Types of Subjects/Patients (check all that apply) Fetus in Utero/non-viable fetues/abortuses Newborns/Infants Children (aged 2-12) Adolescents (aged 13-18) Adults (over 18) Pregnant Women Special populations (e.g., prisoners, mentally disabled) Specify ____________ B. Other (Check all that apply) Use of investigational drugs or devices Information to be collected may require special sensitivity (e.g. substance abuse, sexual behavior) C. Number of Subjects/Patients __________ D. Approximate time commitment for each subject/patient ___________ E. Compensation to subjects/patients : Yes_____ No_____ Form (e.g. cash, taxi fare, meals) _____ Amount_____ V. Continuation or Renewals A. Attach a copy of the original IRB protocol B. Indicate all proposed changes in the IRB protocol affecting subjects C. Progress Report
D. Attach consent form(s) to be used and indicate if any changes have been made.