Why are biosafety professionals leaving academia? Pandemic? Better pay? Limited travel funds for training & professional meetings? Limited office support personnel? Limited senior leadership support?
Dr Byron S. Tepper and I spent years running bench basic research at medical schools where we picked up lots of practical biosafety by personal experience in our laboratories and working with other bench researchers.
Hands on laboratory biomedical bench research experience, in my opinion, is required for biosafety professionals. Knowledge of current guidelines and practices can be learned.
Recruting PIs, postdocs, and senior research technicians working in the microbiology-related fields are critical for the growth of the biosafety profession.
Animal welfare and human subjects research protections are covered by Public Laws.
Worker, public, and environmental protections from biohazards are not covered by Public Law [except select agents].
I was PI for NIH-funded basic microbiology research for years and also directed the second-year medical student/graduate student microbiology and immunology course with 40 hours of wet lab at a Philadelphia school of medicine in addition to working with the chief of infectious diseases (ID) on a book chapter, collaborating and publishing clinical research papers, and helping the ID department train new ID residents on diagnostic microbiology.
I mention this because the above clinical experience and my later collaboration with the former Johns Hopkins’ Chief of Infectious Diseases, Dr John Bartlett, at ID grand rounds as well as participating in the monthly hospital patient microbial disease reviews has led me to the conclusion that the clinical/medical side of biosafety [including CDC] is substantially different from biosafety as applied to biomedical bench research. Often, the bench and clinical research areas have different goals and outcomes.
Today, biosafety managers/officers ask biosafety questions that were answered years ago and covered during our Control of Biohazards in the Laboratory course and other courses.
Staffing and funding of IACUCs and IRBs is strong, but instititional support for biosafety programs is often weak.
I have discussed this issue with deans and vice presidents at institutions – this is their question – “If biosafety sections/officers and Institutional Biosafety Committees were based in a regulation/public law, we would pay more attention to them – especially when we don’t have anybody working on research covered by the NIH Guidelines.”
IACUCs are derived from the Health Research Extension Act of 1985 (Public Law 99-158) November 20, 1985, “Animals in Research” Sec.495.
IRBs are derived from the The National Research Act (Public Law 93-348) July 12, 1974 that created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
IBCs are not connected to a public law, only guidelines.
An example of a recent, significant change in biosafety practice was removal of Biosafety Level Terminology from the World Health Organization’s Laboratory Biosafety Manual 4th Edition. The Forward to the 4th edition states: “Previous versions of the manual described the classification of biological agents and laboratories in terms of risk/hazard groups and biosafety/containment levels. While this may be a logical starting point for the handling and containment of biological agents, it has led to the misconception that the risk group of a biological agent directly corresponds to the biosafety level of a laboratory. In fact, the actual risk of a given scenario is influenced not only by the agent being handled, but also by the procedure being performed and the competency of the laboratory personnel engaging in the activity.”
”In my opinion, this is a positive, significant change that will restore the scientific method to risk analysis.
Biosafety Level terminology began in 1984 with the BMBL 1st Edition. Health Canada removed BSL terminology a few years ago.”
Laboratory facility design current specifications are available from the NIH Design Requirements Manual and Desk Guide – NOT the BMBL.