Submitting modifications to currently approved protocols
Federal regulations require that all modifications to approved research, during the period for which approval has already been given, may not be initiated without prior IRB review and approval except where necessary to eliminate apparent immediate hazards to human participants. Modifications to any protocol, procedure, personnel or related study document should be submitted to receive IRB approval prior to implementation. Some Modification submissions may not technically be changing any aspect of the study but are still required. Such as providing DSMB reports, notes to file, Memos from the sponsor, letters from the FDA or other oversight organization. Submitting these things in real time throughout the year will help to reduce the number of documents you need to coordinate and include at the time of Continuing Review and will improve regulatory compliance.
Directions for Submitting Modifications: Start by downloading the modification form (required after June 1,2016)
Paper Studies: After completing the submission form, please print and send to the IRB office with one copy of each required supporting document.PI signature is required for all paper submissions.
HSERA Studies: Follow these steps for creating a Modification in HSERA:
1. After completing the submission form, save it to your computer. PI signature on the form is NOT required when submitting in HSERA
2. Go to HSERA.
3. In the blue menu on the left side of your screen look for "Create" under "My Submissions".
4. After clicking "Create" you will be brought to a new screen where the various electronic application types are available. Click "Modification"
5. After clicking "Modification" you will be brought to a screen with a list of all HSERA studies for which you are listed as either PI, Co-PI or Study Contact (note that Key Personnel cannot create submissions). Check to make sure your filter is clear. Then enter the protocol # you wish to make a Modification for and click "Filter".
6. After clicking "Filter" with the specific protocol number entered, you should see one entry with columns showing the PI name, Submission date, Title, and a Select column - click the white and yellow "Select" button.
7. After clicking the "Select" button you will be taken to the first page of the Modification Application
- Page 1 requires that users answer questions similar to those questions in the downloaded form that you already completed. The IRB will refer to you your attached form – NOT the electronic answers on page 1 of the modification application. Currently the system requires responses to all questions on page 1. You should fill in any text boxes with “NA” or “0” or “See attached” to get through this section quickly (In the future the system will be updated to remove these questions and provide an area to attach your completed form). All the relevant information that the IRB requires will be provided in your attached form. When you get to the end of page 1, click “Next”
- Page 2 of the Modification application is actually the first page of the most recent version of the 10 page HSERA application that was submitted for IRB review when the project began. You must make the necessary changes to the content on each page (aka Basic Info, Personnel, Bio, Protocol, Procedures, ETC..) so that your HSERA application is always up to date and reflects the changes being submitted with the modification
- Sometimes changes to the HSERA application are not necessary when submitting a modification. In this case you should just keep clicking “Next” on every page until you come to the “Confirmation” Page
- The Confirmation page is the final page of the application. Here you will attach the completed Modification form (from step 1) as well as the appropriate documents related to the Modification. Please be mindful to upload documents under the appropriate header to facilitate the IRB's review of these documents. After attaching all your documents, go to the bottom of the page and click “I accept” – your Modification submission is now complete.
If a modification for a study stored in HSERA is being planned for submission around the time of continuing review, there are 2 important pieces of information to be aware of:
1. The changes should NOT be included in a continuing review submission. An entirely separate modification submission should be created and submitted. If anything that was not previously approved is included in a continuing review submission it will be returned.
2. The modification should always be created and approved by the PI prior to the creation of the continuing review whenever possible. This is to ensure that any revisions to the content of your actual HSERA application as part of the modification will be reflected in the version of the continuing review that will be submitted. Failure to complete the steps this way will potentially lead to issues down the road. This is because the researcher’s editable version of an HSERA application is based on the last version that is approved by the IRB.