The Institutional Biosafety Committee (IBCInstitutional Biosafety Committee The IBC is an instituti...) is an institutional committee created under the NIH Guidelines to review research involving recombinant DNA and synthetic nucleic acid research. The IBC also reviews all research involving biohazardous materials and has overall oversight and responsibility for the Biosafety program at BU and BMC. The IBC carries out these functions pursuant to requirements set forth by federal, state, and local agencies, as well as BU.
Below are the forms and policies you will likely need. To quickly find a form or policy in this list please use the Find Function: command+f (mac) or control+f (pc). Or view the full forms and policies libraries under Forms & Policies in the main navigation. Please download and fill out PDFs using Adobe—Acrobat Reader DC is available for free.
- WEB Biological Agents with Potential to Cause Laboratory Acquired Infection (LAI) Updated February 14, 2017
- WEB Biosafety Manual Updated July 25, 2019
- WEB Comprehensive Risk-Based Laboratory Inspection Program Updated December 1, 2014
- WEB Dual Use Research of Concern (DURC) Policy Updated September 29, 2015
- WEB Exposure Control Plan (ECP) Updated January 1, 2016
- WEB IBC Application (Biological Use Authorization) Updated November 8, 2016
- PDF IBC Protocol Closure Form Updated August 15, 2016
- WEB IBC Training and Health Clearance Requirements Updated May 17, 2016
- WEB Inactivated Biological Sample Use Updated August 15, 2016
- WEB Training Policy for IBC Updated September 29, 2016
- WEB Verification of Attenuated Biosafety Level 3 (BSL-3) Pathogens Policy Updated April 19, 2016
Biosafety Manual
The purpose of this manual is to define the biological safety policies and procedures pertaining to research operations at Boston University. These policies and procedures are designed to safeguard personnel and the environment from biologically hazardous materials and to comply with federal, state, and local regulatory requirements. All BU Principal Investigators and laboratory workers must adhere to the biological safety policies and procedures in the conduct of their research and the management of their laboratories.
For information about specific biological safety programs for operations not covered in this manual, contact the Institutional Biosafety Committee office or the Biological Safety Officer.
Table of Contents
- Chapter 1: Biological Safety Program: Purpose, Scope, and Responsibilities
- Chapter 2: Approval of Research Projects
- Chapter 3: List of Regulations and Guidelines
- Chapter 4: Biosafety Principles
- Chapter 5: Laboratory Biosafety Practices
- Chapter 6: Laboratory Training
- Chapter 7: Decontamination and Sterilization
- Chapter 8: Biohazardous Spill Response
- Chapter 9: Biohazardous and Medical Waste Disposal
- Chapter 10: Center for Disease Control /United States Department of Agriculture Select Agents
- Chapter 11: Transportation of Biological Materials
Appendices
- Appendix A: IBC Application Forms / Biological Use Authorization (BUA)
- Appendix B: Import and Export of Infectious Biological Agents
- Appendix C: Laboratory Ventilation and Containment for Biosafety
- Appendix D: Autoclave Quality Assurance Program
- Appendix E: Biosafety Level 2 (BSL-2) Requirements
- Appendix F: Biosafety Level 3 (BSL-3) Requirements and Practices
- Appendix G: Guidelines for Work with Toxins of Biological Origin
- Appendix H: List of Biological Agents with the Potential to Cause Laboratory Acquired Infection (LAI)
- Appendix I: Prion Research/Creutzfeldt-Jacob Disease (CJD) Guidelines
- Appendix J: Summary of Requirements for Biosafety Levels
- Appendix K: Summary of Requirements for Animal Biosafety Levels
- Appendix L: Bloodborne Pathogen Standard
- Appendix M: Working Safely with Animals
- Appendix N: Procedures for Working in an Animal Biosafety Level 2 (ABSL-2) Facility at BU
- Appendix O: Policy for Verifying the Identity of Attenuated Pathogens
- Appendix P: Boston Public Health Commission Requirements
- Appendix Q: ROHP Medical Surveillance Program
- Appendix R: Laboratory and Equipment Decontamination Procedures
- Appendix S: Laboratory Door Signage
- Appendix T: Boston University Research Compliance Policy on Disease Surveillance and Reporting for High-Risk Agents
- Appendix U: Institutional Biosafety Committee Oversight Program
- Appendix V:Criteria for Development of Standard Operating Procedures (SOP)
IBC Meetings
Meeting Dates and Submission Deadlines
| Submission Deadline | Meeting Date |
|---|---|
| September 24, 2019 | October 15, 2019 |
| October 22, 2019 | November 19, 2019 |
| November 26, 2019 | December 17, 2019 |
| January 6, 2020 | January 28, 2020 |
| February 3, 2020 | February 25, 2020 |
| February 25, 2020 | March 17, 2020 |
| April 6, 2020 | April 28, 2020 |
| April 28, 2020 | May 19, 2020 |
| May 26, 2020 | June 16, 2020 |
| June 29, 2020 | July 21, 2020 |
| July 28, 2020 | August 18, 2020 |
| August 24, 2020 | September 15, 2020 |
| September 28, 2020 | October 20, 2020 |
| October 26, 2020 | November 17, 2020 |
| November 19, 2020 | December 15, 2020 |
*Applications must be received before the submission deadline to allow time for a detailed and complete review.
**Meetings may be cancelled if too few applications are submitted in a given month. If too many applications are submitted, those received latest will be reviewed at the next scheduled meeting.
Review Process
What does IBC review?
- Recombinant or synthetic nucleic acid molecule research for conformity with the NIH Guidlines
- Potential risk to the environment and public health
- Containment levels per NIH Guidlines
- Adequacy of facilities, procedures, practices, and training and expertise of personnel
- Adverse event report
Note:
- BU considers Human Cell Lines to be BSL-2
- E.coli K-12 strains are BSL-1 and as such do not require IBC approval
- Because the Boston Public Health Commission (BPHC) requires registration of BSL-1 rDNA projects, rDNA studies designated BSL-1 and considered “exempt” by the NIH Guidelines must be reviewed and approved by the IBC
Research involving the following may require additional requirements
- Select Agents
- Biological Agents with Potential to Cause Laboratory Acquired Infection (LAI)
Protocol Review Outcomes
Work may commence immediately upon full approval of a protocol. Approval is valid for the study as described in the protocol form for a period of three years from the approval date. PI’s must also complete an annual renewal each year.
The Boston Public Health Commission requires notification upon IBC approval of any new BSL-3 project at least 30 days before initiating any project experimentation activity requiring the IBC’s approval.
| Review Outcome | Review Criteria | Corrective Response Required | Person(s) to Review Response |
|---|---|---|---|
| Approved | Complies with all Committee policies. No additional changes needed. | None | N/A |
| Conditionally approved | Minor changes and/or clarifications (scientific or administrative)are required | Revised protocol submission | Primary and secondary reviewers (if reviewers have asked for it); otherwise IBC office |
| Deferred | Numerous and/or major changes or clarifications are required; there is insufficient time at the IBC meeting to conduct a thorough review | Entirely re-written or none (if time is the concern) | Full Committee |
| Withhold Approval | If application fails to meet one or more criteria used by the IBC for approval of research | Must re-do as new protocol submission | Full Committee |
New Applications
Complete all IBC applications online in the Research Information Management System (RIMS).
Principal Investigators (PIs) must complete a RIMS PI Account Registration in order to access the IBC application. The PI can designate others to assist in completing the application, however, only the PI can submit the application. IBC requires that all PIs be members of the BU/BMC faculty. Projects from postdoctoral scholars or other non-faculty members will require a faculty PI sponsor.
PIs seeking IBC approval for the first time also need to submit a NIH biosketch with their application. Please see this example biosketch for reference.
All personnel must complete the Lab Safety Training(s) and ROHP Clearance requirements. Additionally, PI must complete “Recombinant DNA / IBC Policies Training.” Other training will be required based on the nature of project. Personnel will need to have a RIMS Training Profile in order to complete these requirements.
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. Each application will be assigned to a primary reviewer and a secondary reviewer. Reviewer comments will be discussed at a convened IBC meeting.
IBC approval of recombinant or synthetic nucleic acid molecules and biohazardous research projects is effective for three years. However, PIs must complete an IBC Annual Renewal each year for up to three years after the initial approval to continue work. After three years, the application must be resubmitted and reviewed by the committee.
Three Year Renewals
General IBC Three-Year Resubmission Instructions
After three years, the application must be resubmitted and reviewed by the committee.
- For all expiring IBC Protocols, complete a Three-Year Resubmission in RIMS and click “confirm the submission” to send it to the IBC Office for review.
- Make sure the PI and all lab staff complete the annual EHS Lab Safety Training requirement , the annual Research Occupational Health Program (ROHP) clearance update (contact ROHP at ; 617-414-7647), and any other applicable training requirements.
- The IBC Office will notify you when your Three Year Resubmission has been processed and approved.
De novo IBC Approval is required for the continuation of the work beyond the previous protocol expiration date.
Instructions for the Three-Year Resubmission in RIMS
- Log in to 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 due for three-year resubmission.
- In the left menu, click the blue links in sequence up to the Grant Funding Information page.
- Check the radio button for Three-Year Resubmission.
- Note: Make sure any old amendments listed in the amendment summary box are deleted, as the entire project should be described in completion and is subject to de novo review.
- On the bottom of the Grant Funding Information page, click Save Changes.
- 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 original IBC approval.
- After all updates are complete and saved, select Confirm the Submission to send the Three-Year Resubmission to the IBC Office.
Updates to Lab Personnel
On the Personnel page, delete and add personnel as appropriate.
To delete a person
- Select that person by clicking the “+” next to their name in the table at the top of the page.
- Click the “Delete” button at the bottom of the page to remove them from the protocol.
To add a person
- Click the “Add Personnel” button at the bottom of the page.
- 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.
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
- Select the location by clicking the “+” next to its name in the table at the top of the page.
- Click the “Delete” button at the bottom of the page to remove it from the protocol.
To add a location
- Click the “Add Research Laboratory Location” at the bottom of the page.
- Complete all subsequent questions.
- Be sure to update the Biological Safety Cabinet information/certification on the Personal Protective Equipment/Safety Equipment page, if applicable.
Updates to Experimental Agents, Vectors, and Procedures
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.
Update changes in...
- Biohazardous agents on the Hazardous Biological Agent page
- rDNA host-vector-donor components on the Recombinant DNA page
- Human and NHP materials on the Potentially Infectious Material page
- Details of any other changes should be updated on the other relevant pages
Annual Renewals
An email notice of Annual Renewal will be sent to the PIs at the first and second years after initial approval of a protocol. Complete the Annual Renewal in RIMS.
Overview
To complete the renewal, PIs should list all proposed modifications from the protocol as initially approved (or since the last renewal notice), including:
- any changes in laboratory location or equipment
- changes in laboratory staff working on the project
- any project titles to be added
- any agent or experimental changes
If there are significant modification from the protocol, especially those that affect the containment level (i.e., new study on organisms, a new host-vector-donor system, or any other modifications that may affect the containment level), the IBC will send the protocol for committee review and approval.
When a project is renewed, the PI and all lab staff must complete the Lab Safety Annual Refresher Training requirement, the annual Research Occupational Health Program (ROHP) clearance (contact ROHP at rohp@bu.edu; 617-414-7647), and any other training requirements applicable to the project.
For changes in PI, the new PI must attach two-page NIH biosketch to the renewal form. This must be reviewed by the full committee.
The IBC Office will notify you when your Annual Renewal has been processed and approved. IBC approval is required before any changes in the work can commence.
General IBC Annual Renewal Instructions
- Complete the IBC annual renewal in RIMS (see instructions below) and click “confirm the submission” to send it to the IBC Office for renewal evaluation.
- Make sure the PI and all lab staff complete the annual EHS Lab Safety Training requirement , the annual Research Occupational Health Program (ROHP) clearance update (contact ROHP at 617-414-7647), and any other applicable training requirements.The exact training required for a particular person will depend on the hazards to which he or she is exposed.
- The IBC Office will notify you when your annual renewal has been processed and approved. IBC Approval is required before any changes in the work can commence.
Instructions for Annual Renewal in RIMS
- Log in to 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 due for annual renewal.
- In the left menu, click the blue links in sequence up to the Grant Funding Information page.
- Check the radio button for Annual Renewal. Summarize any updates/changes to your protocol in 1-2 sentences in the text box.
- 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.
- Click to the Dual Use Research of Concern page to review the questions and confirm your answers. If you make any changes, click Save Changes at the bottom of the page.
- Update any of the other application pages/sections with the relevant information regarding any changes or updates in your IBC protocol.
- After all changes are complete and saved, click on “Confirm the Submission” to send the Annual Renewal update to the IBC Office.
Updates to Lab Personnel
On the Personnel page, delete and add personnel as appropriate.
To delete a person
- Select that person by clicking the “+” next to their name in the table at the top of the page.
- Click the “Delete” button at the bottom of the page to remove them from the protocol.
To add a person
- Click the “Add Personnel” button at the bottom of the page.
- 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.
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
- Select the location by clicking the “+” next to its name in the table at the top of the page.
- Click the “Delete” button at the bottom of the page to remove it from the protocol.
To add a location
- Click the “Add Research Laboratory Location” at the bottom of the page.
- Complete all subsequent questions.
- Be sure to update the Biological Safety Cabinet information/certification on the Personal Protective Equipment/Safety Equipment page, if applicable.
Changes in experimental agents/vectors/procedures, etc.
On the Research Project Description page:
- Add details of your experimental change at the bottom of the second question (regarding lab procedures)
- Start by writing “Annual Renewal” and the date
- Describe the changes.
- Make any other edits or changes within your project description as appropriate
Update changes in ...
- Biohazardous agents on the Hazardous Biological Agent page
- rDNA host-vector-donor components on the Recombinant DNA page
- Human and NHP materials on the Potenitally Infectious Material page
- Details of any other changes should be updated on the other relevant pages
Amendments
Overview
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.
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 |
|---|---|---|
| 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) |
General IBC Amendment Instructions
- For all IBC Protocols, complete the Amendment in RIMS 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 lab staff complete the annual EHS Lab Safety Training requirement.
- Contact the Research Occupational Health Program (ROHP) for medical clearance (617-414-7647).
- 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 Amendments in RIMS
- Log in to 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 summarize any updates or 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 Save Changes.
- Update any of the other application pages and sections with the relevant information regarding changes or updates in your IBC protocol.
- After all changes are complete and saved, click Confirm the Submission to send the Amendment to the IBC Office.
Updates to Lab Personnel
On the Personnel page, delete and add personnel as appropriate.
To delete a person
- Select that person by clicking the “+” next to their name in the table at the top of the page.
- Click the “Delete” button at the bottom of the page to remove them from the protocol.
To add a person
- Click the “Add Personnel” button at the bottom of the page.
- 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.
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
- Select the location by clicking the “+” next to its name in the table at the top of the page.
- Click the “Delete” button at the bottom of the page to remove it from the protocol.
To add a location
- Click the “Add Research Laboratory Location” at the bottom of the page.
- Complete all subsequent questions.
- Be sure to update the Biological Safety Cabinet information/certification on the Personal Protective Equipment/Safety Equipment page, if applicable.
Changes in Experimental Agents, Vectors, or Procedures
On the Research Project Description page, add details of your experimental change at the bottom of the second question (regarding lab procedures)
- Write “Amendment” and the date.
- Describe the changes.
- Make any other edits or changes within your project description, as appropriate.
Update changes in ...
- Biohazardous agents on the Hazardous Biological Agent page
- rDNA host-vector-donor components on the Recombinant DNA page
- Human and NHP materials on the Potentially Infectious Material page
- Details of any other changes should be updated on the other relevant pages
Printing and Saving IBC Approval Letters
- Log in to your RIMS Account.
- Click ‘Biological Use Authorization’ on the middle-left of your screen. 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 (example shown below).
- You cannot download a pdf of an application that you have modified and saved but not submitted in RIMS yet. You may click the title of the protocol in the second column and go to individual pages of your unsubmitted protocol.
If you have questions or need help, please contact one of the specialists. You can email them directly or feel free to call. Office information can be found below.
Primary Contacts
Additional Contacts
-
MA
Michelle Auerbach
Executive Director, Research Integrity
617-358-7891 (BUMC); 617-358-3867 (CRC)
Email Me -
SG
Sajal K. Ghosh
Senior Compliance Specialist, Safety Committees Program
617-358-7910
Email Me -
SJ
Serena Jao
Compliance Specialist, Animal Welfare Program/Safety Committees Program
(617) 358-7889
Email Me