Inactivated Biological Sample Use

The purpose of the Inactivated Biological Samples Use policy is to develop a process whereby samples generated as BSL-3 and BSL-4 can be used safely at lower biosafety levels. Inactivation of biological samples renders them non-infectious and therefore they can be handled as Risk Group 1 (RG1) agent under BSL-1 conditions.

This policy requires that the use of inactivated, non-infectious biological samples derived from BSL-3 and BSL-4 agents be reviewed and approved by both Environmental Health and Safety (EHS) and the Chair of the IBC prior to being received and used at Boston University (BU) and Boston Medical Center (BMC).

It is the responsibility of the IBC to ensure that any biological materials that are received at BU or BMC are handled in a safe manner. This includes establishing criteria that ensure that any pathogenic materials that are received as “inactivated” are indeed free of pathogens. In meeting its obligation the IBC is required to ensure that the institution providing the materials to BU or BMC researchers have established inactivation protocols that are acceptable to the IBC.

Acceptable Inactivation Methods

BSL-3 and BSL-4 laboratories at entities outside of BU and BMC collaborate and share inactivated, non-infectious samples with BU and BMC laboratories. BU and BMC recognize that all of these entities have standing policies and procedures for the inactivation and shipment of samples. BU will accept these inactivated, non-infectious materials when the source institution employs the following inactivation methods acceptable to BU. Although these inactivated materials are no longer infectious, BU and BMC developed and implemented this process in order to provide security and assurance that these materials (previously derived from infectious BSL-3 and BSL-4 agents) have undergone inactivation methods that are both acceptable to BU and BMC and have proven efficacy. As part of its due diligence, BU conducts on-going review of inactivation literature and engages in discussion with other BSL-3 and BSL-4 laboratories for assurance that the inactivation methods continue to be appropriate and effective.

• Irradiation: Biological agents may be inactivated by exposure to ionizing radiation (generally gamma radiation) at high radiation doses (typically 5 Mega-rads or above).
• Heat: Biological samples may be inactivated by exposing the samples to a thermal process for a period of time approved by the institution.
• Chemical: Inactivation of BSL-3 or BSL-4 agents by chemical means must include the use of chemicals at concentrations known to be effective for deactivation.
• Fixation: BSL-3 or BSL-4 samples that have been fixed at the source.
• Combination: a combination of two or more of the above.

Documentation

The source institution sending the samples must submit a certificate (e.g. a letter signed by the authorized institutional official) for each shipment attesting that the samples have been processed using their institutionally approved methods for inactivating and removing samples from the BSL-3 or BSL-4 laboratory.

The receiving PI is responsible for maintaining the inactivation certificate and shipment documents (e.g. list of samples, DOT shipping papers, etc.) which will be reviewed by the Research Safety office during their routine laboratory inspections. It is recommended that the documents be filed in the Biological Safety Logbook under the “Shipping Tab.”

Requirements

Investigators who do not have an approved IBC protocol must submit a completed IBC application via RIMS and have it approved by the IBC.

Investigators who have existing protocols must file an amendment and complete the Inactivated Biological Samples Use section in RIMS for review and approval by EHS and the Chair of the IBC.

The use of inactivated, non-infectious biological samples derived from BSL-3 and BSL-4 agents must be reviewed and approved prior to being received and used at BU and BUMC.

Principal Investigator must confirm submission when submitting an IBC Application or Amendment via RIMS and contact the IBC Office at ibc@bu.edu or 617-638-4263 if questions arise or assistance is required for this process.