HUMAN SUBJECTS PROTOCOL CORRECTION FORM Dear __________________________:

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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
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