All IBC applications (or “BUAs”) are submitted electronically to the Research Information Management System (RIMS). The IBC office is available for any questions on how to prepare for the submission of an IBC application, what to write in individual sections, and any other related questions.
Setting up an PI account in RIMS
A principal investigator account is necessary to begin submission of IBC application via RIMS. A request for this account may be submitted by completing the “PI Profile Registration” in the RIMS webpage or by asking the IBC office.
Eligibility for becoming a PI in RIMS
Any faculty member (i.e., Professor, Associate Professor, Assistant Professor, Instructor Adjunct Professors) may have a RIMS PI account. Projects from postdoctoral scholars or other non-faculty members will require a faculty PI sponsor. Any scientific or administrative members designated by the department to run a Core Facility are eligible to have PI account in RIMS. Details of eligibility can be found here.
Delegation options for access to RIMS
A PI can designate a member of their lab to become a primary user of a PI’s RIMS account. A PI can do this in RIMS by going to the ‘Add Primary User’ section of their profile or they can ask the IBC office for help in giving this access. A primary user is able to perform the same functions as a PI with this access, however, only a PI can submit an application to RIMS.
General Instruction for completing IBC applications
IBC applications may be submitted in four different formats:
New Application
This applies when submitting an application for the first time
Choose Biological Use Authorization link in the “Submissions” box after you login to RIMS. Then choose “start a new IBC application”.
For all new protocol submission PIs need to submit a biosketch (NIH format is recommended) with their application. This needs to be done using the upload buttons in the Overview and Grant Funding.
All personnel must complete the biosafety trainings (Lab Safety, BSL1/2, Blood Borne Pathogen [BBP] training(s) and Chemical Safety) in BioRAFT/Scishield as well as ROHP medical clearance through the ROHP website. Additionally, PI must complete “Recombinant DNA / IBC Policies Training.” These trainings and other agent specific trainings will be required based on the nature of project.
Multiple projects may be listed in the title section, although a unified broader descriptive title that provides a better understanding of all your research work, is preferred. However, if the projects involve different biosafety risks and unrelated work, submission of separate specific IBC applications is recommended.
Complete each individual sections of the application as appropriate and save each page before moving on to another page of the application.
All personnel working in the project must be included in the personnel list, including undergraduates or temporary fellows. Each person must be added separately and all associated questions must be addressed. To add a person click the “Additional III. IBC personnel” link at the very bottom of the page (scroll to the bottom) and complete all requested information, import training information and save. To add another person, do it all over again. Personnel Information provided in Scichield does not automatically get carried over to IBC applications in RIMS.
To add Research laboratory Facility room, scroll to the bottom and add a room and provide all requested information including room number, BSL/ABSL information. If room locations are not obvious, one can search for them.
In the “Materials Used in Research” choose which of the activities apply to your research, complete highest biosafety or animal biosafety levels, BMC clinical space use information and save. Separate specific forms based on your selection will appear, which you must complete.
In the Hazardous Biological Agent list (Section A), list all agents as a separate entry. Make sure to provide their BSL status and specific source information and then complete all the requested information, again one item at a time. Save before adding a second agent. One have to scroll to the bottom of the page (like other pages) to find the “Add Hazardous Biological Agent” button.
For deleting any personnel, room or hazardous biological agent, first click on the left-most name of the item on the table of items at the top of page, then scroll to the bottom and click delete. Say “yes” on the next screen and then SAVE before deleting a second item.
All applications must be received by the deadline to allow time for review by the committee members and a Biological Use Authorization Site Assessment by EHS. Upcoming deadlines can be found under Meeting Dates & Deadlines.
3-year Renewals
These renewals are required for all protocols at every 3-yr anniversary of the original approval. RIMS will send automatic reminders for these renewals
Under the Submissions box, click on Biological Use Authorization – IBC Application.
Click on the blue-underlined Project Title of your IBC Protocol due for three-year resubmission.
Click the Overview and Grant Funding Information page and check the radio button for “Three-Year Resubmittal”.
Complete the mandatory “Protocol Update Information”.
Remove all checkboxes from the “For amendments and annual renewals” table. Remove any old statement mentioned during previous amendment submission as the entire project will be subject to de novo
Make changes in the protocol title, funding information, if applicable.
On the bottom of the Grant Funding Information page, click Save Changes.
To add personnel, room or hazardous biological agent, follow the direction stated for New Application.
For deleting any personnel, room or hazardous biological agent, first click on the left-most name of the item on the table of items at the top of page, then scroll to the bottom and click delete. Say “yes” on the next screen and then SAVE before deleting a second item.
Click to the “Dual Use Research of Concern” page to review the questions and confirm your answers. If you make any changes, click on Save Changes at the bottom of the page.
Click on all other pages to review the questions and confirm your answers. Update any of these application pages/sections with the relevant information regarding your IBC protocol, describing procedures as if you were seeking the IBC approval for the first time.
If a previously approved amendments has been described as a separate paragraph at the end of the application, please consolidate it the main body of the laboratory procedure section in the 3-year renewal submission.
On the Research Project Description page review the details of your experiments, with special focus on the second question (regarding lab procedures). Make sure this reflects a complete description of your biohazardous and recombinant DNA work. Make any other edits or changes within your project description, as appropriate.
Also update changes in the Hazardous Biological Agent page, rDNA host-vector-donor components on the Recombinant DNA page and on any primary human and NHP materials on the Potentially Infectious Material page.
Details of any other changes should be updated on the other relevant pages.
Add a cover sheet (use the second green button at the top of any of the RIMS pages) if you have any specific issues about the application that you want IBC to consider.
After all updates are complete and saved, select “Submit your Forms” orange button at the top of any of the RIMS pages to send the Three-Year Resubmission to the IBC Office.
Amendments
Amendments to an IBC application are submitted for any personnel changes, room changes, minor procedural changes or addition of new biological agents, PI changes, etc.
How to submit Amendments
Submission of an IBC amendment is appropriate and needed when there is a need for update on protocol title, update of laboratory location, changes in listed personnel or minor changes in protocol activities.
Under the Submissions box, click on Biological Use Authorization – IBC Application.
Click on the blue-underlined Project Title of your IBC Protocol that you want to amend.
Click the Overview and Grant Funding Information page and check the radio button Amendment.
Check specific boxes that applies for your amendment submission (personnel, lab space, biological agents or procedures.
In the summary of changes box, state in a line or two what the amendment is for. Save the page.
To add personnel, room or hazardous biological agent, follow the direction stated for New Application.
To remove any personnel, room or hazardous biological agent, follow the direction stated in the New Application or 3-year renewal section.
On the Research Project Description page, on the second question (Section VII.2) add a brief statement on the purpose of this amendment.
In the laboratory procedure section (Section VII.3) provide details of your experimental change at the bottom of the section writing “Amendment: Date”.
Make any other edits or changes within your project description, as appropriate.
Submit the amendment like any other submissions using the “Submit your forms” button.
Annual Renewals
BSL3 and BSL4 protocols must submit annual renewals
How to submit Annual Renewals
Annual renewals are required only for BSL3 and BSL4 application.
Click the Overview and Grant Funding Information page and check the radio button “Annual Renewals”
Follow rest of the procedures as described in the “Amendments” tab.
Click ‘Biological Use Authorization’ link on the middle box. A list of all your IBC protocols will appear on the next screen.
The sixth column in the list is the source of documents for your specific IBC protocol. Clicking any of those links will generate a pdf file of the document (this include approved IBC protocol and official IBC approval letter).
You cannot download a pdf of an application that you have modified and saved but not submitted in RIMS yet. To view your locally saved but yet unapproved protocol click the title of the protocol in the second column and go to individual pages of your unsubmitted protocol.
How to Navigate RIMS pages
Use following expandable links to find out how to complete individual sections
Protocol Submission Type
How to choose Protocol Submission Type
To choose submission type, go to the “Overview and Grant Funding” section and select appropriate radio button as shown below. Note that the text below the radio buttons will change depending on which button is selected and you have to respond accordingly.
Overview and Grant Funding page
What information is required in the Overview and Grant Funding page
The field below the submission type radio buttons will look different depending on the submission type chosen for the submission.
For a 3-year resubmittal, a ‘Protocol Update’ field will appear. PIs will have to state in that box what significant changes have been made in the submission.
For all other submissions the page will look as below:
For a new submission, no response is required for the fields asking for nature or description of changes.
But for all Amendment submission and for Annual Renewal submission (only BSL3 and BSL4 applications require Annual Renewal), please complete the sections marked with an arrow.
Attachments
How to upload Biosketch or any other document
External documents can be easily uploaded in different sections of the IBC application, such as 1) Overview & Grant Funding; 2) Core Facilities; 3) Hazardous Biological Agent; 4) Recombinant DNA; and in 5) Inactivated Biological Samples section.
Screenshot below shows how it is done in the Overview and Grant Funding page, but the procedure is same wherever attachment is allowed.
First, scroll all the way to the bottom of the page to see “Upload” button for biosketch and 3 additional upload buttons.
Biosketch of the PI must be uploaded with each IBC application from the PI.
If you already have a document uploaded on a specific upload button, the button will instead display as “Open”.
To upload, just click the “Upload” button. A new window will open which will allow you to choose the file that you want to upload from your local PC. Then choose ‘upload’ in this new window followed by closing this new window. Then click the “Save Changes” button at the bottom of the screen. The button where you just uploaded a document will now show as “Open”.
You can remove any incorrectly attached file the same way.
Adding new personnel
How to add new personnel in an IBC application
Personnel list in an IBC application must be managed via “Personnel Information” section in RIMS. Updating personnel list in Scishield will have NO effect in IBC application. Also, DO NOT use ‘Identify your personnel’ in the PI Profile box in RIMS to change personnel list in IBC application.
PI must be added to the personnel list.
To add a new person, go to the Personnel Information section in RIMS. Scroll to the bottom of the page and click “Additional III. IBC Personnel” as shown below:
The page will refresh with all the fields blank right below the PI’s name and ID number.
Identify the new person by adding email alias and search.
Complete all the questions asked on the page.
Make sure to type in ‘Title’ and ‘Descriptive Role’ of the new person (use ‘Examples’ if needed).
Choose level of experience with rDNA, infectious agents and select agents questions using the dropdown menu as shown by arrows in the screenshot below.
Click if the person is experienced with the procedures described in the IBC application.
If it is ‘No’, indicate if PI or someone else in the lab will train the person.
If it is ‘Yes’, carefully respond to each of the three experience related questions as shown in the screenshot.
Application with blank or incomplete response will not be reviewed and will be returned to the PI to make correction.
Based on the nature of the proposed work, the new personnel will be required to complete multiple biosafety trainings via Scishield.
To know if the person already is current with required training or needs update, click the ‘Yes’ button under the Training Dates section of the page. Then click “Import Training” button. This action will automatically populate with dates when the person last time took all required trainings and if the person has current medical clearance.
All trainings and medical clearance are valid for one year, except shipping training (valid for two years) and rDNA/IBC Policy training (valid for 3 years).
Removing Personnel
How to remove a person from Personnel list in an IBC application
Personnel list in an IBC application must be managed via “Personnel Information” section in RIMS. Updating personnel list in Scishield will have no effect in IBC application. Also, do not use ‘Identify your personnel’ in the PI Profile box in RIMS to change personnel list in IBC application.
To remove a listed personnel from a particular IBC application, go to the IBC Personnel section for that application in RIMS.
Click on the last name of the person whose name needs to be removed from the list from the table at the top of the page as shown below.
Make sure the page now shows personal information for that specific person.
Scroll down all the way to the bottom of the page.
Click the ‘Delete’ button. A new window will appear alerting that the form will be permanently deleted. Do not worry, this will only delete the person you opted to remove. Other listed personnel will not be affected.
Click OK on this new window.
Then click ‘Save Changes’ before removing another person or moving on to a different section of the application.
