Amendments
Amendments must be submitted to the IBC for approval of changes within an approved project. All changes should be described in detail, and these must be reviewed and approved by the IBC according to the table below. IBC approval is required before any changes in the work can commence.
For all IBC Protocols, complete the Amendment in RIMS and “confirm the submission” to send it to the IBC Office for amendment evaluation. Detailed instructions on completing the Amendment in RIMS are found below.
Amendment Instructions
General IBC Amendment Instructions:
- For all IBC Protocols, complete the Amendment in RIMS (see instructions below) and click “confirm the submission” to send it to the IBC Office for amendment evaluation (as either an expedited or a reviewable amendment).
- Make sure any lab staff complete the annual EHS Lab Safety Training requirement, contact the Research Occupational Health Program (ROHP) for medical clearance (at 617-414-7647), and complete any other applicable training requirements.
- The IBC Office will notify you when your AMENDMENT has been processed and approved. IBC Approval is required before any changes in the work can commence.
Instructions for the AMENDMENT in RIMS:
- Log in to RIMS at www.bu.edu/rims.
- Under “Activities and Authorizations” in the left menu, click on “Biological Use Authorization – IBC Application.”
- Click on the blue-underlined PROJECT TITLE of your IBC Protocol that you wish to amend.
- In the left menu, click the blue links in sequence up to the GRANT FUNDING INFORMATION page.
- Check the radio button for “Amendment,” and in the text box summarize any updates/changes to
your protocol in 1-2 sentences.Example: “Addition of graduate student John Doe; removal of departing visiting scientist; move of laboratory space (coordinated with EHS); change in host-vector-donor system; addition of virus strains”
- On the bottom of the GRANT FUNDING INFORMATION page, click on “Save Changes.”
- Update any of the other application pages/sections with the relevant information regarding changes/updates in your IBC protocol.
- For updates to lab personnel: On the PERSONNEL page, delete and add personnel as appropriate.
To delete a person, first select that person by clicking the “+” next to their name in the table at the top of the page, and then click the “Delete” button at the bottom of the page to remove them from the protocol.
To add a person, first click the “Add Personnel” button at the bottom of the page and then complete questions on training and experience. If a person has been entered into the PI Profile when you first log in to RIMS (highly recommended), you may click the “Select personnel from your PI list” button to add that person.
- For updates to laboratory space: On the RESEARCH LABORATORY FACILITY INFORMATION page, delete and add research spaces as appropriate, including all facilities used for the project.
To delete a location, first select the location by clicking the “+” next to its name in the table at the top of the page, and then click the “Delete” button at the bottom of the page to remove it from the protocol.
To add a location, first click the “Add Research Laboratory Location” at the bottom of the page and then complete all subsequent questions. Also, be sure to update the Biological Safety Cabinet information/certification on the PERSONAL PROTECTIVE EQUIPMENT/SAFETY EQUIPMENT page if that applies.
- For changes in experimental agents/vectors/procedures, etc.: On the RESEARCH PROJECT DESCRIPTION page, add details of your experimental change at the bottom of the 2nd question (regarding lab procedures); start by writing “Amendment” and the date, and then describe the changes. Make any other edits or changes within your project description as appropriate. Additionally, changes in biohazardous agents need to be updated on the HAZARDOUS BIOLOGICAL AGENT page, changes in rDNA host-vector-donor components need to be updated on the RECOMBINANT DNA page, changes in human and NHP materials need to be updated on the POTENTIALLY INFECTIOUS MATERIAL page, and details of any other changes should be updated on the other relevant pages.
- After all changes are complete and saved, click on “Confirm the Submission” to send the Amendment to the IBC Office.
The IBC Office will notify you when your Amendment has been processed and approved. IBC approval is required before any changes in the work can commence.
Amendment | Review Type | Considerations |
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Title Additions | Expedited | Approvals may be applied to several different granting agencies, but all grant titles must be registered with the IBC. |
Lab Space additions | Expedited | IBC approval applies only to work performed in registered lab space. |
Non-PI personnel change | Expedited | Individuals must complete the “Initial Laboratory Safety Training” and “ROHP clearance” requirements. |
Technical Changes | Full committee | If changes are extensive, the IBC may require that a completely new application be submitted by the PI. Change in PI (full committee review) New PI’s must attach curriculum vitae (2 page National Institute of Health (NIH) format) |