Request to Close a Study
FORM HRP-212: CONTINUING/FINAL REVIEW PROGRESS REPORT FORM –INSTRUCTION GUIDE:
Use this form to request to close a study.
If this form, and any necessary supporting documents, is not received by the date requested in the approval letter, the PI will be restricted from having new research reviewed until the form is submitted and the research has either been closed out or the IRB has received sufficient information to conduct the review to continue the research.
Section A solicits information about the enrollment status of the study. Please be sure that the numbers here (and the number of subjects withdrawn from the study) clearly add up. The most common request for clarification during the review of continuing applications is that the breakdowns (screen successes/failures/withdrawals) don’t equal the total number of subjects enrolled.
Section B has two parts: Part 1 inquires about whether all human research activity is completed. To close a study, all boxes in this section must be checked (and therefore all those conditions met). Make sure you understand what each condition means before checking it (e.g., analysis of private identifiable information is completed). If you cannot affirm each of the statements (e.g., you will still have a data set of private identifiable information that you wish to analyze), then human research activity cannot be closed and continuing review by the PPHS is necessary.
Section B, Part 2 inquires about whether the remaining research for the next period is limited to certain kinds of activities. If you have marked all the boxes in Part 1 [the human research activity is complete] continue to section C.
Section C serves as a reminder that other institution review and approval may also be necessary on a continuing or an annual basis. This is not intended to serve as an exhaustive list; it does contain some of the most common institutional entities also requiring continuing review.
Section D allows the IRB to understand what occurred in the research and whether any further action is necessary.
Program for the Protection of Human Subjects
For submissions and general inquiries send e-mail to: IRB@mssm.edu
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