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The Clinical Research Profession: Biosafety and Ethics Careers

With Special Guest Chris Jenkins, PhD, Founder of Sabai Global

Christine Senn: 

Today, I'm so excited to welcome Dr. Chris Jenkins, who has such energy around ethics and biosafety. It’s one of those topics that we don't always think about as being an amazing part of our field, but it really is, and I think Dr. Jenkins really brings that out. He is going to describe, among other things, what an Institutional Review Board is (an IRB) and an Institutional Biosafety Committee (an IBC), and why biosafety is so important and exciting. I learned a lot, and I hope you do too.  

 

Chris, you are the owner and Chief Scientific Officer for Sabai Global, which has several subsidiaries. The two that I was most interested in talking to you about today are Biosafety Services and Castle Institutional Review Board IRB. The reason I want to talk to you about this is because our industry has a critical workforce issue, and that's what the series is addressing-- that people don't generally intentionally enter clinical research. We don't have enough clinical research professionals entering the field, and that makes it difficult to conduct trials in a timely fashion. I must imagine that the ethics and biosafety sides of clinical research are even less known career choices. If you could, please describe what an IRB and an IBC are. I would love that for our audience. 

Chris Jenkins: 

Yes, for an IRB, which is an Institutional Review Board, this goes back to the mid-1900s. An IRB is required under both international law, as well as the Belmont Report. [It states] that if you are doing research on fellow humans of any kind, you need to get their consent to do so. And in order to do so, you need to have the science behind the research there in order to understand, as a participant, what risks and benefits you're enrolling into. The person sponsoring the research has to present those risks and benefits to a third party: the Institutional Review Board, which is composed of experts in that field to say, yes, this is safe research to do for the risk-benefit, or you need to change your protocol before we can allow this to go into humans. It can range from anything from taking blood samples out of people, so that you get consent for blood draws, or to having an experimental drug or device implanted into somebody or given to somebody to treat a rare form of disease or cancer. You're doing something to someone else's body, and you have to get consent for that. That's approved by an Institutional Review Board. 

For an IBC-- I like to think of the IBC as, “Where is the drug at all times?” A biosafety committee is concerned with the patient and the research subject, but what they're actually more concerned about is the drug only going into that patient and how do we minimize it going to the clinic, the exposure to the pharmacist, to the nurse, to the doctor. There are certain diseases where the family members are being treated-- and I always use Duchenne's Muscular Dystrophy or spinal muscular atrophy as an example of this-- where they're using a virus to carry the gene to correct a form of this rare disease. The virus is a biologic, so if you're exposed... For example, you're treating a 2-year-old child with this virus, and the brother is 5-years-old but also has the disease. If the brother is accidentally exposed to a low level of the virus, they'll develop antibodies, and future treatment for them will be useless because their body will negate it if they're exposed. Therefore, an IBC is concerned with how we keep the virus or treatment or the biologic inside of the patient only and not elsewhere, not into the pharmacist's eyes while pulling it out of the vial and drafting the bag and from the nurse who's doing the infusion line or putting it into the patient, or family members who have to treat the wound site or change the bandages. Biosafety is how we keep that drug in the patient and minimally handled at all times. The other phrase I like to say is: We’re trying to prevent the zombie outbreak. That's really what we're trying to do here, and everyone seems to get it when I say it that way.  

 

Christine Senn: 

I've been in this industry for 18 years and that is the best description I've ever heard of Biosafety. That was absolutely fantastic. Thank you for that. It sounds to me, please correct me if I'm wrong, that if you are in biosafety, you probably have a background in biology – or is that not a necessary path to biosafety? 

 

Chris Jenkins: 

It's not necessarily. We have a ton of people in our organization that come from backgrounds outside of what I'll call the traditional bench sciences of microbiology, virology, general sciences. Folks often come up through regulatory pathway, usually through like an Office of Research Compliance in a hospital, or there'll be a clinical research regulatory coordinator responsible for doing submissions to the IRB or IBC or to the various committees inside of their hospital system or academic medical center. Those folks get familiar with what's required to dot the Is and cross the Ts on a clinical trial, so those are the kind of folks that we really like to hire into our organization. They typically have high attention to detail and can review really complicated science. They don't necessarily have to understand the science; they just have to know where it fits into a category of regulatory requirements. For example, does this detail mean it needs a full board review or can it be reviewed by a single reviewer? Or perhaps, is it something that is going to harm the patient more or less? Having the sciences is helpful but not necessary. Some of our best IRB reviewers come from psychology backgrounds or are former librarians and schoolteachers. They have lots of ability to wrangle little details. I will say that the typical pathway for biosafety is a bench scientist who got tired of living off soft money. They transitioned into research regulatory at their university and then they came over to us on the IRB side. They usually were doing psychology or general research, and then got into their university IRB, and then they came over to us. 



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