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
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 study SmartForm: Basic Information Page question 7 will copy as read only (and cannot be edited in the copy)
- 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:
Log in to irb.harvard.edu
Navigate to a study (see Accessing a Submission for more instructions)
Click Copy Submission from the Next Steps list on the left. A new window opens.
Write in the name of the new submission (this can also be edited after the submission is created).
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.
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).