HUMAN SUBJECTS PROTOCOL CORRECTION FORM Dear __________________________: Date: __________________ The IRB Chair reviewed your protocol and needs additional information before the protocol can be approved. Please correct the checked items and follow the instructions on page 2 of this form. PART A: Proposed start date has already passed, please update No training documentation on file/the required course was not completed Name(s) missing training:__________________________________________________ There is no alternate contact listed Sponsored Research is indicated but copy of proposal was not attached Other ________________________________________________________________ PART B: The choice selected at PART B #1 does not match the choice selected in PART I #1 PART B #5g indicates there will be video or voice recordings, but this is not explained on the consent form and/or in the Research Methods and Procedures section of the protocol form Other ________________________________________________________________ PART C: This section was left blank: __________________________ Other _______________________________________________ PART D: The proposed location requires a site letter of support, but no letter was attached to the protocol. Other ________________________________________________________________ PART E: The time per session (PART E, #1) exceeds the total time (PART E, #2) Other ________________________________________________________________ PART F: The protocol indicates that surveys/interviews/questionnaires will be used, but they are not described in this section Office of Research Services Page 1 of 3 Revised 6/22/10 HUMAN SUBJECTS PROTOCOL CORRECTION FORM Copies of the surveys/interviews/questionnaires described in this section were not attached to the protocol Other ________________________________________________________________ PART G: This section was left blank Other ________________________________________________________________ PART H: There is no recruitment method indicated in #1 The Research Methods and Procedures section was left blank The Research Methods and Procedures section needs a more detailed description of the activities. It appears deceptive techniques will be used, but nothing is indicated at #3 Other ________________________________________________________________ PART I: The choice selected at PART B #1 does not match the choice selected in PART I #1 There is no information in #2 regarding where the research records will be kept Other ________________________________________________________________ PART J: The protocol indicates that the standard consent procedure will be used, but no consent form was attached to the protocol The protocol indicates that minors will be used but there is no assent-permission form attached to the protocol The personnel listed to obtain informed consent do not have training documentation A waiver of the standard process has been requested in #3, but the proper wording to include at the top of the anonymous survey is missing. Other ________________________________________________________________ PART K: This section was left blank Other ________________________________________________________________ PART L: Office of Research Services Page 2 of 3 Revised 6/22/10 HUMAN SUBJECTS PROTOCOL CORRECTION FORM This section was left blank Other ________________________________________________________________ PART M: The PI did not sign the protocol form The student researcher did not sign the protocol form Other ________________________________________________________________ PART N: There were attachments checked, but none were submitted with the protocol form Other ________________________________________________________________ Consent Form Comments: Comments on Other Attachments: Instructions: Please revise as noted above and resubmit the entire package Please revise and resubmit this document: ___________________________________ The IRB chair will hold the other documents until the package is complete. Other ________________________________________________________________ Contact Information: IRB Chair – Dr. Candace Gauthier, 962-3558, gauthierc@uncw.edu Office of Research Services Page 3 of 3 Revised 6/22/10