IRB Progress Report

I. Purpose for Submission of Report

Select ONE box in ONE of the following five categories:

1. I have been informed that my study is due for annual review:

No revisions are proposed to my study.

I am proposing revisions.
(Describe your revisions below in Section II, Question 3. Submit revised protocols, consent documents, survey instruments, etc., to irb@kennesaw.edu for review.)

2. Revisions when annual review is not due or when a study has been classified as exempt:

I am proposing revisions to my study.
(Describe your revisions below in Section II, Question 3. Submit revised protocols, consent documents, survey instruments, etc., to irb@kennesaw.edu for review.)

3. Close my study:

My study expired or was administratively closed by the IRB. This is my official closure report for your records.

I'm completely finished with my research study (including analysis of collected data). Research activities were completed on (enter mm/dd/yy).

I'm finished enrolling participants and collecting data, but I would like to continue analyzing de-identified data. (Interaction or intervention with human subjects to collect data is over, but you still want to use, study and analyze data that you can never link back to your participants. If you used a code system that could link back to participants, you are considered to still be engaged in human subject research and your study must remain open.) .

4. Withdraw my study

Research has not begun and the study will not be conducted at this time.

5. Reopen my study: (Complete all questions within Section II below.)

My study was officially closed, but I want to collect additional data. (If it has been more than one year since the closure of your study, or if you wish to make major revisions to your study, you must resubmit your protocol, consent documents, and survey instruments to irb@kennesaw.edu.)

My study expired and was administratively closed by the IRB, but I wish to once again enroll participants and collect data.

II. Study Information

  • Study #:
  • Study Title:
  • Investigator/Researcher:
  • Email:
  • Faculty Advisor (if applicable):
  • Total Number of Subjects who have Participated in this Study:
  • Study Summary:

    Summarize participants' experience, including benefits, number and reasons for withdrawal of participants, or complaints about the research in the space below:


    If study is continuing, answer questions 1-3 below:

    1. Summarize study results so far including current risk-benefit analysis assessment based on study results:

    2. Summarize any new literature, findings, or other relevant information, especially information about risks and adverse events or unanticipated problems associated with the research or which relate to subjects' willingness to continue participation, since the last review:

    3. Are any changes planned?

    Yes

    No

    If yes, describe here:
  • If you are requesting to reopen an expired or administratively closed study, answer questions 4 & 5 below:

    4. Were human subjects enrolled in the study at the time of expiration?

    Yes

    No

    5. Were any research related activities conducted during the period in which study approval lapsed; e.g., new subjects enrolled, surveys or interviews conducted, identifiable data analyzed, etc.?

    Yes

    No

    If yes, describe here:
  • If you have further information you would like to share regarding this study, please contact the IRB at irb@kennesaw.edu and remember to include your study number.