Over the course of submission and review, it may be appropriate to copy the elements of one study into a new submission which then can be edited and submitted for review by the IRB. For example, it is appropriate to copy a study if:
- There are basic elements of a study (such as the list of study team members) that are similar to a new project that will be proposed;
- A study was discarded in error;
- A member of the IRB office requests that you copy the study; or
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A study received one of the following determinations from the IRB, and the mode of IRB review must now change:
- Not Human Subjects Research/Not Research,
- Human Research, Not Engaged, or
- Determination under 45 CFR 46.118, proposals lacking definite plans for the involvement of human subjects.
Copying a submission will replicate all information on a study (including documents) into a new submission. A study can be copied at any time. However, note that:
- The status of the copy is completely independent of the status and management of the original study
- Only a Main/Initial Study (or Reportable New Information) can be copied. Other submissions, for example: Modification/Update or Continuing review cannot be copied
- Only the PI can copy a study
- The new copy must be further edited and submitted by the PI for review by the IRB
- If the copy was created in error, it can be discarded
Important! Do not copy a study to propose changes to an active project or to request continued review. See Creating a Follow-On after Study Approval for instructions to create a modification, continuing review or study closure for an active project.
To copy a study:
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Log in to irb.harvard.edu
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Navigate to a study (see Accessing a Submission for more instructions)
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Click Copy Submission from the Next Steps list on the left. A new window opens.
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Write in the name of the new submission (this can also be edited after the submission is created).
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Click OK
The copy activity will appear under the History tab of the study workspace. While the system is creating the copy, a progress note will appear.
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Navigate to the new study by either:
Refreshing the page to view and click on a link to the new copy, or
Clicking My Inbox in the top navigator bar and click on the new submission.
- Complete steps to edit the submission and submit it to the IRB for review. (see Editing a Submission for more instructions).