Approval Process

Obtaining Approval for New Projects

To get started as a Principal Investigator working with the following agents, you must fulfill steps 1 through 4.

• “biohazardous materials”
• infectious agents
• human blood/tissue
• human cells and cell lines
• rDNA
• “select agents”

STEP 1: IBC APPROVAL

The PI must obtain approval from the Institutional Biosafety Committee (IBC) for research protocols involving work with any of the above biological agents. Your IBC approval will also determine whether you are working with any BSL-3 Agents or High-risk Agents. If so, additional training from the Office of Environmental Health and Safety, Medical Surveillance, and/or laboratory registration with the Boston Public Health Commission may be required by the IBC.

To apply for IBC approval, complete the Biological Use Authorization (BUA) application by logging in to RIMS. The RIMS site also contains Tutorials and Frequently Asked Questions for the BUA (IBC) application. Investigators seeking IBC approval for the first time also need to submit a curriculum vitae (CV) with their application.

To find out whether you are listed in an approved protocol, contact the IBC.

STEP 2: SELECT AGENT APPROVAL/REGISTRATION

The Office of Environmental Health and Safety and the IBC will determine whether you will be working with select agents. If so, in addition to IBC approval, you must obtain approval from the University Responsible Official (RO) for Select Agent Programs before you order, ship, store, or work with any select agents.

STEP 3: HIGH-RISK AGENTS

The IBC will determine whether you will be working with “high-risk agents.” If you will be working with high-risk agents, in addition to IBC approval, you must ensure that the Office of Environmental Health and Safety registers your laboratory with the Boston Public Health Commission. You must also work with the Occupational Health Officer (OHO) to prepare a plan acceptable to the Occupational Health Officer for disease surveillance.

STEP 4: ATTENUATED PATHOGENS

The IBC will determine whether you will be working with an attenuated pathogen(s). If you will be working with an attenuated pathogen, in addition to obtaining IBC approval for the project, you must verify the identity of the attenuated pathogen using an IBC approved method under Boston University’s verification policy.

Description of IBC Protocol Review Outcomes

Approved

A protocol that receives full approval requires no (additional) changes or clarifications to comply with Committee policies. 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 complete a renewal form annually after the first and second year after initial approval.

The Boston Public Health Commission requires notification upon IBC approval of any new BSL-3 project at least thirty (30) days before initiating any project experimentation activity requiring the IBC’s approval pursuant to section 2.04.b of the “Boston Public Health Commission Regulation Biological Laboratory Regulations”.

Approved Pending

The granting of ‘approval pending’ is used when a protocol requires some relatively minor changes to bring the protocol into compliance with Committee policies but does not need to be re-reviewed. The PI must respond in writing to the particular issues and these may be administratively modified.

Conditionally Approved

The Committee votes for ‘conditional approval’ when minor changes or clarifications are required to bring the protocol into compliance with Committee policies. The investigator must respond in writing to the Committee’s notice of conditional approval. The response will be reviewed by the primary reviewer of the protocol. If no response is received within 60 days from the date of the conditional approval letter, the protocol is closed.

Tabled

The Committee votes to ‘table’ a protocol when numerous and/or major changes or clarifications are required to bring the protocol into compliance with Committee policies. A ‘tabled’ protocol will need to be entirely re-written by the Principal Investigator. The modified protocol will be reviewed at the next regular Committee meeting.

Rejected

A protocol may be rejected by the Committee if it contains serious violations of Committee policy and/or if repeated attempts to bring the protocol in compliance with Committee policy have failed.

Deferred

A protocol may be deferred when there is insufficient time at the IBC meeting to conduct review of the item.

Related Information:

Submission Deadlines & Meeting Dates

Maintaining Approval: Renewals and Amendments