I want to talk about compliance. I mean, I REALLY want to talk about compliance. Research compliance, that is. I know you are all wondering WHY… well, I’ve just spent a month in recovery from this particularly delightful aspect of my job.
In all seriousness, research compliance is a very important part of conducting research in an academic setting, that … once again… nobody teaches you before you hit the door of your first faculty job. This includes compliance to all regulations relevant to research involving animals, recombinant DNA, dangerous chemicals, and biohazards. You are not going to believe it when I say this, because everyone thinks AUPs are so onerous, but the AUPs are the easiest part of the whole business for me (that’s Animal Care and Use Protocols to the uninitiated). At my institution, as I assume at most institutions, there is an ‘office of research compliance’ or some such, that handles all these issues in separate sub-domains. There are federal regulations and guidelines for every those areas that we must follow.
The bane of my existence today is compliance in the area of biohazards, I think that I have alluded to this before once or twice. This is an area of my job about which I was totally and utterly clueless as a student and as a post-doc, but that I now need to know a whole lot about. You see, I work with pathogens infectious to humans. And that wouldn’t be a problem for me because I know the risks, risk factors, and appropriate safety practices to protect myself from infection with my favorite pathogen (MFP), and they are really pretty basic common-sensical type stuff. And I can’t find a single case of laboratory-exposure related infection with MFP in the literature… nor have I ever met one in person… and the resulting human disease is generally mild and self-limiting.
I am, however, responsible for the safety of people that work in my lab, and who are exposed to MFP. I take this responsibility quite seriously, but I walk a fine line here. I transfer my knowledge of risk and appropriate safety procedures to those that work in my lab during a safety training specifically about MFP…but I do not want to scare them. I want them to realistically understand the risks that they may face, and know the proper way to avoid or minimize those risks to themselves and their lab mates. I would never want to minimize the importance of this training – that’s why we do a pathogen specific safety training- but there will always be a risk to working with these pathogens, no matter how small.
Let me say that one more time:
There will always be a risk to working with these pathogens. We do the best we can to mitigate that risk, but it can never be totally eliminated unless we stop doing this kind of work.
There, ok, I feel better now that we’ve got that out there. There is a set of federal ‘guidelines’ that set out a blanket set of suggested procedures for safely working pathogens in different biosafety catetories called the BMBL for short (Biosafety in Microbiological and Biomedical Laboratories– put out by the CDC). Some of these procedures, for example if you are working with highly infectious agents, select agents, agents for which there is no treatment etc, must be strictly adhered to. Again, this seems like good common sense.
More moderately infectious (let’s say) and essentially non-pathogens also have a set of basic regulations that must be adhered to… i.e. no mouth pipeting, no eating-drinking-smoking in lab, no food in the fridge where you store the pathogens etc. Again, pretty straight forward.
However, there is also a more onerous set of procedures for pathogens that are let’s say- moderate individual risk of rarely serious disease for which preventative or therapeutic tx is available, and low community risk. Now, there are quite a few pathogens that fall into this category – all with different infectious doses, routes of infection, routes of transmission etc.- all with different ‘risks’ if you will. Many of these pathogens you could more easily contract from your local environment- the food in local restaurants, the supermarket, sometimes just from digging around in the dirt.
So- how do we properly apply an onerous set of guidelines to a group of pathogens that are very diverse in terms of the actual ‘risk’ that they pose? Do we treat absolutely everything that we work with as the most risky member of the group- or is there leeway for the investigator (who usually knows quite a lot about the pathogen that is the subject of their life’s work) to make a determination about which prescribed blanket procedures mitigate an actual risk for their particular favorite pathogen, or not?
What say you.