The Institutional Biosafety Committee (IBCInstitutional Biosafety Committee The IBC is an instituti...) is an institutional committee created under the NIHNational Institutes of Health 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 by National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), Occupational Safety and Health Administration (OSHA), the City of Boston Public Health Commission (BPHC), the Massachusetts Department of Public Health (DPH), and Boston University.
IBC Charter
Approved May 17, 2022
Scope of Committee Oversight
The Institutional Biosafety Committee’s (IBC) scope extends to BU and Boston Medical Center (BMC) and to all laboratories affiliated with, served by, owned, or controlled by BU.
Committee Responsibilities
The IBC is an institutional committee created under the National Institutes of Health (NIH) Guidelines to review research involving recombinant and synthetic nucleic acid molecules (rDNA). 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 the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), Occupational Safety and Health Administration (OSHA), the City of Boston Public Health Commission (BPHC), the Massachusetts Department of Public Health (DPH), and Boston University.
It is the responsibility of the IBC to:
- Review technical and safety-related aspects of the use of recombinant or synthetic nucleic acid molecules, infectious agents and any other biohazardous agents;
- Develop and maintain a safety and operations manual for use of etiologic and other potentially biohazardous agents;
- Certify that facilities, procedures, and practices have been reviewed and approved;
- Promulgate a Biosafety program in conjunction with the Director of Research Safety that satisfies federal, state, and local laws and regulations;
- Limit, suspend or revoke an investigator’s authority to use Biohazardous materials if such use presents a hazard to individuals or violates health and safety codes;
- Review the potential of research protocols for any possible Dual Use Research of Concern (DURC) and facilitate remedial actions;
- Implement the provisions of the use of Department of Health and Human Services Select Agents and Toxins;
- Perform other duties to fulfill its charge, as may be required by the Associate Vice Provost of Research Compliance (AVPRC).
The IBC will advise and collaborate with other standing committees, including but not limited to: the Institutional Review Board (IRB), the Institutional Animal Care and Use Committee (IACUCInstitutional Animal Care and Use Committee IACUC oversee...), the Dual Use Research of Concern Review Committee (DURRC), the Laboratory Safety Committee (LSCLaboratory Safety Committee), and any additional relevant BU Committees and subcommittees.
Composition of the Committee
Members are appointed by the AVPRC in consultation with leadership from BU and BMC. All members are appointed for three-year renewable terms, as determined by the AVPRC. The committee’s composition is intended to be representative of the laboratories within its scope of oversight and includes members representing both BU and BMC.
BU IBC adheres to the recommendation of the NIH Guidelines Section IV-B-2-a-(1) on the structure of the committee and is composed of:
- No fewer than five (5) members with collective experience and expertise in recombinant and synthetic nucleic acid molecule technology, the capability to assess research safety, and to identity any potential risk to public health or the environment;
- At least two (2) community members that are not otherwise affiliated with BU;
- Animal containment expert;
- Plant Research expert (when plant research is ongoing);
- Biosafety Officer;
- If needed, appropriate scientific expertise from BU or an outside organization may be added to the committee on an adhoc basis at the Chair’s discretion.
In addition to the committee members required by the NIH guidelines, the BU IBC ordinarily also includes senior or key members from the following offices that significantly contribute to the health, safety and welfare of University workforce members:
- BU Research Occupational Health
- BU Environmental Health and Safety
- BU Facilities and Management
IBC Member Responsibilities
IBC Members are expected to attend all scheduled meetings, which may be held in person, or via video conferencing, as necessary. Members who are assigned to review and present protocols are expected to review all information provided and send a written report to the IBC office ordinarily within five (5) days before the next scheduled meeting. Designated committee members who are unable to attend a meeting may send their comments to the IBC office which may be read by a secondary reviewer or the Chair at the meeting.
Members of the IBC, including the Chair, may not be involved in reviewing any protocol in which they have a conflict of interest (i.e. financial or otherwise, serving as PIPrincipal Investigator View Boston University's policy on... or research personnel), and may not be present for the vote on protocols in which they have such conflicts. IBC members must maintain confidentiality of information they receive in their role on the committee and may not disclose or use the information for any purpose other than to serve on the IBC.
IBC Meetings
The convened IBC ordinarily meets on a monthly basis, at such times and frequency it determines to be necessary or appropriate, or at the discretion of the Chair. A quorum shall be a majority of voting members (fifty percent plus one).
Agenda, Minutes and Reports
The Chair, with assistance from Research Compliance staff, shall be responsible for establishing the agenda for convened meetings. The agenda, drafted minutes, and relevant materials will be sent to IBC members at least five (5) business days in advance of the meeting. Meeting minutes shall be drafted by Research Compliance staff and approved by committee members at the following meeting. Members should report biosafety issues and initiatives within their domain to the IBC and in return, should communicate IBC activities to other members of their departments.
IBC Charter Approval
The IBC Charter and any subsequent amendments to the Charter are reviewed by the members in a regularly convened meeting and will vote on its approval.
What Research Needs IBC Approval?
- Recombinant or synthetic nucleic acid molecules
- Hazardous biological agents (virus, bacteria, fungi, parasite, prion, rickettsia etc.)
- Other potentially infectious materials (human or non-human primate blood, serum, plasma, body fluids, unfixed tissue, organ and cells)
- Biological toxins including select agent toxins
- Inactivated Biological Samples derived from BSL-3 or BSL-4 agents
- Attenuated pathogens derived from BSL-3 or BSL-4 agents
- Human gene transfer
- Transgenic animals or plants
- Sheep and any tissues derived from them (these tissues can transmit Coxiella burnetii, the causative agent of Q-fever)
- Field studies with wild animals and their tissues inherently infected or would be experimentally infected with BSL-2 or higher agents
Note:
IBC Application Process
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.
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:
Research involving the following may require additional review
- Select Agent
- Biological agents with potential to cause Laboratory Infection (LAI)
IBC Training and Health Clearance Requirements
I. Purpose
Boston University (“BU”) is committed to observing federal, state, and local regulations and the National Institute of Health (“NIH”) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (“NIH Guidelines”). The purpose of this policy is to set forth the training and health clearance requirements for individuals listed on active IBC protocols who will be constructing and handling the following: recombinant nucleic acid (“rDNA”) molecules; synthetic nucleic acid molecules, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules; cells, organisms and viruses containing such molecules; and biohazardous materials, hereinafter referred to collectively as “activities”.
II. Scope
This policy is applicable to all personnel who are listed on active IBC protocols and are responsible for conducting research, teaching, training and related activities at or under the auspices of Boston University (“BU”).
III. Policy
All individuals listed on an active IBC protocol must complete the following training and health clearance requirements before engaging in any protocol related activities:
- Laboratory Safety Training;
- Health Questionnaire; and
- Laboratory Specific Training.
All Principal Investigators (“PIs”) listed on an active IBC protocol and all individuals listed on an active IBC protocol involving recombinant or synthetic nucleic acids must complete the following training before engaging in any protocol related activities:
- IBC Policy /Recombinant DNA Training and Quiz.
IV.Procedures
Schedule and Types of Mandatory Training:
Laboratory Safety Training.
All individuals listed on an active IBC protocol must complete the Laboratory Safety Training requirement before engaging in any protocol activities and on an annual basis thereafter. This requirement may be fulfilled by attending a “Classroom Laboratory Safety Training” or completing an online “Laboratory Safety Training.” The online training requires the completion of the “Universal Lab Safety Module” and additional modules as applicable to the laboratory work being conducted (e.g., Biosafety Training Level 1 & 2, Chemical Safety Training, Bloodborne Pathogens). After completing the initial classroom or online training, the annual refresher requirement may be fulfilled by either repeating the classroom training or completing the online “Laboratory Safety Annual Refresher Module."
Health Questionnaire
All individuals listed on an active IBC protocol must complete an Initial Health Questionnaire and be cleared by the Research Occupational Health Program (“ROHP”) before engaging in any protocol activities. If the individual’s work environment changes to working with a new agent or hazard and they are listed on an active IBC protocol, they must complete and submit an updated Health Questionnaire to ROHP and be cleared by before engaging in the protocol activities. On an annual basis, individuals listed on active IBC protocols must complete the Annual Health Status Questionnaire and be cleared by ROHPResearch Occupational Health Program ROHP is part of BU R... before continuing to engage in the protocol activities. In some cases, a physical exam, a TB test, vaccinations, or respirator fit testing may be required for clearance.
Training and knowledge of the NIH Guidelines and IBC policies.
All PIs listed on an active IBC protocol and all individuals listed on an active IBC protocol involving recombinant or synthetic nucleic acids are required to complete the online “IBC Policy / Recombinant DNA Training” and Quiz before engaging in any protocol activities and at the time of three-year renewal before continuing to engage in the protocol activities. This is a requirement for all PIs listed on an active IBC protocol regardless of whether or not they currently work with recombinant or synthetic nucleic acids.
Specialized Biohazard Safety Training.
Use of some biohazardous agents will require additional safety training that is more specialized than what is offered in the Laboratory Safety Training. These training requirements will be determined by the PI on an as needed basis and include, but are not limited to: BSL-3 Annual Training; Select Agent Training; Agent-Specific Training for Francisella Tularensis, Tuberculosis, and Y Pestis; and Shipping Biologicals Training. In addition to agent specific training, Agent Information Sheets (“AIS”) and Agent Specific Identification Cards must be made available to individuals using biological agents with the potential to cause Laboratory Acquired Infection (“LAI”).
Specialized Laboratory Safety Training.
The PI is responsible for ensuring that all individuals listed on their active IBC protocol are appropriately trained. Hands-on training and demonstrations for performing protocol specific procedures may be required to ensure that individuals listed on an active IBC protocol understand the protocol and how to safely perform their duties.
V. Responsible Parties
EHSEnvironmental Health & Safety is responsible for supporting PIs and laboratory staff through training, auditing of procedures, audit and emergency response.
The IBC is responsible for overall oversight of the Biosafety Program at BU.
Principal Investigators are responsible for ensuring compliance with this policy and ensuring all personnel who work under their supervision and occupy their laboratory space are aware of this policy and understand how it applies to their areas.
ROHP is responsible for establishing and performing appropriate medical surveillance for all personnel performing or supporting research.
VI. Definitions
Medical Surveillance is the systematic assessment of employees exposed or potentially exposed to occupational hazards. This assessment monitors individuals for adverse health effects and determines the effectiveness of exposure prevention strategies. A medical surveillance program includes the analysis of both individual and aggregate surveillance data over time, with the goal of reducing and ultimately preventing occupational illness and injury.
Recombinant and Synthetic Nucleic Acid Molecules are defined as:
- molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids;
- nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or
- molecules that result from the replication of those described in (i) or (ii) above.
VII. Related Documents
BU Biosafety Manual
Responsibility of the Principal Investigator
VIII. History
Original Date Approved: 2011
Revised: 5/17/16
Next Review Date: May 2019
Completing the IBC Training Requirements
Training is a critical component of any integrated biological safety program. Training is intended to provide the understanding, technical knowledge, and tools that the trainee can use to improve his or her daily laboratory safety practices.
The PI is responsible for ensuring that his or her employees receive proper training in the biohazards and controls specific to his or her laboratory and the safe conduct of the experimental procedures to be used. The Biosafety Program provides different types of training associated with the BU and BMC biological, chemical, and radiological safety programs. Each of these has its own driver and emphasis.
Mandated general biosafety training is required for all laboratory workers (faculty, staff, students, and visiting scientists) at BU and BMC. The exact training required for a particular person will depend on the hazards to which he or she is exposed. “Laboratory Safety Training” is a training program offered by Environmental Health & Safety (EHS) that is designed for those working in laboratories.
The BU Laboratory Safety Training is now available in two formats, both accessible from the BioRAFT platform.
BU Laboratory Safety Training
Formats | Material Covered | Who can take this? |
Classroom | Covers all topics | Anyone required to complete Lab safety training, BSL1/2 training, Blood Borne Pathogen training or Chemical Safety training |
Online | Broken down into modules | Anyone taking any single module training or all of the above training |
Laboratory safety training satisfies the basic competency regulatory requirements for those working in labs. It does not satisfy the need for department-specific training, shipment of infectious agents, select agents, Biosafety Level 3 or 4 work, or other specialized training.
In addition to Annual Laboratory Safety Training, all personnel listed on an IBC protocol must register with the Research Occupation Health Program. (Please contact them directly at rohp@bu.edu or 617-358-7647.)
Accessing and Completing Office of Research Compliance Laboratory Safety Training
Step 1: Access and Registration
Go to the BioRAFT.
Step 2: Available Trainings
Once you are logged in BioRAFT, all available Training courses can be found out by clicking the Training link (see below):
Course Directory sublink will then display all the available courses.
If you would prefer to take the course in person, classroom training sign up link will also be visible from the same course list.
Step 3: Course Information
To get more information on a particular course, click the name of the course as shown below:
Step 4: Taking the Course
To take a particular training, launch the training by clicking the link to the right of the name of the course as circled above. A new window will open up as displayed below. Follow on screen directions to take the course.
Step 5: Quiz
To complete the course you must also take the quiz as indicated on the bottom of the start page of the course. An example of such note is shown in the screenshot below. You must get a score greater than 80% or as specified for that particular test to successfully complete the quiz.
Step 6: Training Modules Requirement
Which Lab Safety Training Modules apply to me?
Required for all IBC protocols
Laboratory Safety Training: The Lab Safety Training is required for all members of laboratories and covers basic lab safety, including but not limited to fire safety, emergency evacuation, safety equipment, and hazard communication.
Biosafety Level 1 and 2 Training: Defines basic principles and safe practices to ensure labs work safely at biosafety levels 1 and 2.
Required for IBC protocols involving Hazardous Chemicals
Chemical Safety Training: Provides important information to ensure labs using hazardous chemicals can do so safely and in compliance with all regulations.
Required for IBC protocols using Human Materials
Bloodborne Pathogen Training: Raises awareness of blood borne pathogens, the BBP regulation, and exposure control in the work place.
Do I need to complete any other training to be compliant with the IBC?
Depending on the research project you will be working on and your exposure to various risk group agents or laboratory set-up, you may need to take additional training as defined by the IBC (which may include rDNA/IBC policy training, various agent-specific training, BSL-3 training, BSL-4 training and others).
The IBC may require additional trainings be completed as deemed appropriate.
Contact Info
For questions related to:
- RIMSResearch Information Management System Learn more and acc...: Sajal Ghosh
- BioRAFT: Sony Heir, EHS
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 April 27, 2021
- WEB Biosafety Guidance for Inactivated SARS‐CoV‐2 Updated January 29, 2021
- 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 Enhanced Biosafety Level 2 (BSL-2+) Guidance Updated November 22, 2021
- 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 Incident Reporting Requirements for Research Involving Recombinant or Synthetic Nucleic Acid Molecules Updated May 17, 2016
- WEB Obtaining USDA and CDC Permits for Importing and Transferring Animal Pathogens and Related Biological Materials Updated June 17, 2016
- DOCX Policy on the Acquisition and Documentation of Postmortem Human Samples Updated April 28, 2021
- WEB Research Compliance Guidance on the Use of SARS-CoV-2 Variants Updated March 26, 2021
- WEB Training Policy for IBC Updated September 29, 2016
- WEB Transgenic Rodent Guidelines Updated October 20, 2015
- 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.
PLEASE NOTE: The below link in green is the approved 2022 version of the BU Biosafety Manual. The links to individual pages are being updated at this time.
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)
- WEB Biosafety Guidance for Inactivated SARS‐CoV‐2 Updated January 29, 2021
- WEB Biosafety Manual Updated July 25, 2019
- WEB Enhanced Biosafety Level 2 (BSL-2+) Guidance Updated November 22, 2021
- WEB Obtaining USDA and CDC Permits for Importing and Transferring Animal Pathogens and Related Biological Materials Updated June 17, 2016
- WEB Research Compliance Guidance on the Use of SARS-CoV-2 Variants Updated March 26, 2021
IBC Meetings
Meeting Dates and Submission Deadlines
IBC meetings are open to the public, if you are interested in attending a IBC meeting, please contact IBC@bu.edu
Submission Deadline | Meeting Date |
---|---|
September 27, 2022 | October 18, 2022 |
October 25, 2022 | November 15, 2022 |
November 22, 2022 | December 13, 2022 |
January 6, 2023 | January 24, 2023 |
January 24, 2023 | February 14, 2023 |
February 28, 2023 | March 21, 2023 |
April 4, 2023 | April 25, 2023 |
May 2, 2023 | May 23, 2023 |
May 30, 2023 | June 20, 2023 |
June 27, 2023 | July 18, 2023 |
July 25, 2023 | August 15, 2023 |
August, 29, 2023 | September 19, 2023 |
September 26, 2023 | October 17, 2023 |
October 24, 2023 | November 14, 2023 |
November 21, 2023 | December 12, 2023 |
*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
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.
- For updates to lab personnel: On the PERSONNEL page, delete and add personnel as appropriate.
- 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 |
---|---|---|
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) |
IBC Meeting Minutes
Minutes
Minutes from the BU Institutional Biosafety Committee (IBC) meetings are provided below.
2022
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- January 2022 Meeting Minutes
- February 2022 Meeting Minutes
- March 2022 Meeting Minutes
- April 2022 Meeting Minutes
- May 2022 Meeting Minutes
- June 2022 Meeting Minutes
- July 2022 Meeting Minutes
- August 2022 Meeting Minutes
- September 2022 Meeting Minutes
- October 2022 Meeting Minutes
- November 2022 Meeting Minutes
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2021
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- January 2021 Meeting Minutes
- February 2021 Meeting Minutes
- March 2021 Meeting Minutes
- April 2021 Meeting Minutes
- May 2021 Meeting Minutes
- June 2021 Meeting Minutes
- July 2021 Meeting Minutes
- August 2021 Meeting Minutes
- September 2021 Meeting Minutes
- October 2021 Meeting Minutes
- November 2021 Meeting Minutes
- December 2021 Meeting Minutes
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2020
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- January 2020 Meeting Minutes
- February 14 2020 Meeting Minutes
- February 25 2020 Meeting Minutes
- March 2020 Meeting Minutes
- April 14 2020 Meeting Minutes
- April 28 2020 Meeting Minutes
- May 2020 Meeting Minutes
- June 2020 Meeting Minutes
- July 2020 Meeting Minutes
- August 2020 Meeting Minutes
- September 2020 Meeting Minutes
- October 2020 Meeting Minutes
- November 2020 Meeting Minutes
- December 2020 Meeting Minutes
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Archived Minutes
For minutes from 2019 or earlier, please contact the Safety & Quality Assurance Program staff at ibc@bu.edu.
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 any questions or need help, our contact information can be found below.