ARTS AND SCIENCES INSTITUTIONAL REVIEW BOARD



Social, Humanist, and Behavioral IRB Annual Continuation Approval Form

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Federal regulations require that continuing reviews of non-exempt activities be conducted at least annually. Therefore, this form must be completed and returned prior to the current IRB expiration date (about 45 days prior is preferable). If your project has closed or was never initiated, it is still important that you return this form so that we can update our records.

|Protocol Number:       |Current Approval Expires:       |

|Principal Investigator:       |Today’s Date:       |

|Faculty Advisor/Sponsor (if applicable):       |

|Department:       |

|Campus Address:       |

|Phone Number:       |Email Address:       |

|Title of Project:       |

| |

|1. |Project Status: | Active | Closed on date:       (Skip to study summary, #5 below) |

| | | | |

|2. |Current status of human subject use: |

| | Total number of subjects approved by IRB (give number)       |

| |Do you want to increase this number? Yes No |

| |If yes, what is the number of subjects you would like to enroll:       |

| |Still enrolling subjects or reviewing charts/data on new subjects. |

| |Total number enrolled/reviewed in past approval period:       |

| |Total number enrolled/reviewed to date:       |

| | No subjects enrolled/data reviewed to date |

| | Enrollment ended on       (date), human subjects data collection complete, working on data analysis only. |

| |Total number enrolled:       |

| | Enrollment ended on       (date), but continuing human subjects research activities or continuing subject follow-up (describe |

| |specific activities in #5 below) |

| | |

| | |

|3. |If a funded study, please indicate: |

| | Agency or Sponsor:       |

| | Project period:       |

| | Agency award number (if applicable):       |

| | |

|4. |Number of subjects who withdrew from the project in the past approval period:       |

| |Please provide reasons for each subject’s withdrawal from study:       |

| | |

|5. |Write a brief report describing the progress of your study thus far. Include a description of any adverse events or unanticipated |

| |problems involving risks to subjects or others as well as a summary of any recent literature, findings, or other relevant information|

| |associated with your study. If enrollment is closed, please describe what human subjects research activities are still ongoing, if |

| |any. |

| |      |

| | |

|6. |Are you requesting changes to your research or consent form(s) at this time? |

| | Yes No |

| |If yes, please describe the nature of the changes:       |

| | |

|7. |If written consent is still required, attach an unsigned, unstamped copy of your currently approved informed consent(s) with this |

| |application. |

| | |

| |Number of different consent/assent forms used:       |

| | |

| |Current version date(s) of approved consent form(s):       |

| | |

|8. |Would you like to request a change in study personnel at this time, or update contact information for the PI? |

| |Yes (Please attach list) No |

| | | | | |

|____________________________ | |___________________________ | |___________ |

|Typed/Printed Name | |Signature | |Date |

| | | | | |

|____________________________________________________________ | |___________ |

|Faculty Advisor/Sponsor Signature (if applicable) | |Date |

| | | |

IRB Determination

The Continuing review of this protocol has been reviewed and approved by the IRB full Committee or a designated reviewer. The re-approval date is _______________________ and is valid for _____________________ (period) from this date.

The Continuing review of this protocol has been reviewed and changes are required by the IRB full Committee or designated reviewer (describe required changes below).

Expedited Review ___________________________________

Full Board Review IRB Designated Reviewer

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