Who is responsible for providing training that is specific to the bioresearch being performed

FDA's Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections, data audits, and remote regulatory assessments designed to monitor all aspects of the conduct and reporting of FDA regulated research. The BIMO program was established to assure the quality and integrity of data submitted to the agency in support of new product approvals and marketing applications, as well as, to provide for protection of the rights and welfare of the thousands of human subjects and animals involved in FDA regulated research. It has become a cornerstone of the FDA preapproval process for new medicines, medical devices, food and color additives, veterinary products and, tobacco products introduced to the U.S. consumer.
The BIMO program also takes part in pharmacovigilance activities for postmarketing drug products. These activities serve to detect, understand, and prevent drug-related problems.

The program is implemented domestically and internationally through eleven multi-center compliance programs resulting in over 1000 inspections annually. These compliance programs address inspections of nonclinical testing laboratories in accordance with Good Laboratory Practice (GLP), clinical investigators in accordance with Good Clinical Practice (GCP), sponsors/Contract Research Organizations (CROs)/clinical trial monitors, in vivo bioequivalence facilities, institutional review boards (IRBs), radioactive drug research committees, postmarketing adverse drug experience reporting (PADE), and risk evaluation and mitigation strategies reporting (REMS).

The BIMO program is unique in the scope of its compliance programs and regulations which are shared by all six of FDA's Centers (CBER, CDER, CDRH, CFSAN, CTP, and CVM).

The program also has international and interagency components. The Bioresearch Monitoring Program Director, located organizationally within FDA's Office of Regulatory Affairs (ORA), Office of Medical Products and Tobacco Operations (OMPTO), Office of Bioresearch Monitoring Operations (OBIMO), is responsible the overall execution of ORA’s BIMO Program.

Prior to beginning research with (or teaching using) any potentially biohazardous material, the principal investigator/teaching lab manager must submit information to the Institutional Biosafety Committee (IBC) for review and approval.
Other approvals may be required from other safety committees if the research will also involve vertebrate animals, use of radiation or radioactive materials, or human subjects.

The Principal Investigator is responsible for ensuring that facility- and research-specific policies and procedures are developed to meet the BSL, ABSL, or ACL requirements determined from the risk assessment.
The main objective of the manual is to communicate policies and procedures that will be utilized to mimimize or eliminate exposure of research personnel, other persons, and the outside environment to potentially hazardous materials.
It is through a combination of facility design, safety equipment, engineering controls, personal protective equipment, and laboratory practice and technique that containment is achieved. There is no single, specific way to achieve containment and all contributing factors must be reviewed before the proper combination of containment strategies can be determined.
Specfic policies and procedures must be incorporated into the manual for other hazards in the lab as well (e.g., chemical, radiological).
All lab personnel with the potential for exposure for that particular facility or research project (e.g., lab personnel, animal care staff) must be familiar with the manual's location and its contents.
Standard/special lab practices that must be included for BSL1, BSL2, and BSL3 facilities

Biological Safety Cabinets (BSCs)
- A Class II (the most commonly used) or Class III biosafety cabinet must be used for all manipulations of potentially infectious materials, whenever practical to minimize the risk of exposure to aerosols.
- Biosafety cabinets must be certified at least annually, at installation, after any repair, or if moved over an extended distance.
- Biosafety cabinets require internal and work surface decontamination prior to moving, maintenance, or disposal if used for Risk Group 2 or Risk Group 3 agents. Work surface decontamination with an appropriate disinfectant may be performed by lab personnel. Internal decontamination (via paraformadehyde gas or equivalent) must be arranged by EHSS.
- Biosafety cabinets must be located away from doors, areas of high traffic, air supply registers, or other equipment that may create air movement.
- Only minute quantities of volatile or toxic chemicals or radionuclides used as an adjunct to the research may be used in a biosafety cabinet. Small quantities of these materials may be used if the cabinet is exhausted to the outside.
- The biosafety cabinet is the principal device used to contain infectious materials generated by many microbiological procedures. Its proper use is key to ensuring infectious aerosols are contained at the source.
Physical Containment Devices
- If it is impractical to work in a BSC, other physical containment devices or approprite personal protective equipment must be used whenever possible to minimize the potential for exposure to biohazardous materials. For example, centrifuges must be used with safety buckets or sealed rotors with sealed centrifuge tubes.
Personal Protective Equipment
- Gloves
  - Gloves must be worn to protect hands from exposure to hazardous materials.
  - Glove selection should be based on an appropriate risk assessment. Alternatives to latex gloves should be available.
  - Gloves are not to be worn outside of the lab in public corridors or areas.
  - In addition, lab personnel must:
    - Change gloves when contaminated, integrity has been compromised, or when otherwise necessary.
    - Wear two pairs of gloves when appropriate.
    - Remove gloves and wash hands when work with hazardous materials has been completed and before leaving the lab for non-lab areas.
    - Not wash or reuse disposable gloves.
    - Dispose of used gloves with other contaminated lab waste and rigorously observe handwashing protocols.
- Lab Clothing
  - Protective lab coats, gowns, smocks, or uniforms designated for lab use only must be worn while working with hazardous materials.
    - BSL1/BSL2 Labs
      - Protective clothing may open in the front (e.g., lab coat).
    - BSL3 Labs
      - Protective clothing must have a solid-front such as a tie-back or wrap-around gown, scrub suit, or coveralls.
  - Lab clothing must be removed before leaving the lab for non-lab areas.
  - Reuseable clothing must be decontaminated (either with appropriate disinfectant or by autoclaving) before being laundered. Lab clothing must not be taken home for laundering.
  - Clothing is changed when contaminated, integrity has been compromised, or when otherwise necessary.
- Eye/Face Protection
  - Eye and face protection (e.g., goggles, mask, face shield, or other splatter guard) is used for anticipated splashes or sprays of infectious or other hazardous materials.
  - Eye and face protection must be disposed of with other contaminated lab waste or decontaminated before reuse.
  - BSL1/BSL2 Labs
    - Persons who wear contact lenses in the lab should also wear eye protection.
  - BSL3 Labs
    - Persons who wear contact lenses in the lab must also wear eye protection.

EHSS will evaluate all Virginia Tech operated labs and animal research areas based on the risk of the agent/toxin used and the activities involved to ensure compliance with local, state, and federal regulations/guidelines. This will include a review of:
- the lab, animal room, or arthropod facility and how its managed and maintained;
- safety equipment;
- PPE use and maintenance; and
- facility-specific safety manuals and other appropriate records (e.g., training).
Interviews of personnel will be conducted during evaluations to ensure personnel are aware of proper laboratory and emergency protocols and the hazards of the agents to which they may be exposed.
In addition to EHSS evaluations, each Principal Investigator and Animal Facility Director must routinely inspect their own lab(s) or animal room(s) for deficiencies.