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On Research Podcast – The NIH Mandate for Posting IBC Minutes: Guidance for Institutions

Season 3 – Episode 8 – The NIH Mandate for Posting IBC Minutes: Guidance for Institutions

This episode explores how institutions can comply, while also examining the role, membership, and importance of IBCs in research compliance and safety.

 

Podcast Chapters

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To easily navigate through our podcast, simply click on the ☰ icon on the player. This will take you straight to the chapter timestamps, allowing you to jump to specific segments and enjoy the parts you’re most interested in.

  1. Podcast Introduction and Episode Overview (00:00:34) Host introduces the episode, guests, and outlines the focus on new NIH requirements for IBCs.
  2. Dr. Anne Hawkinsbadge interviews Dr. Regina Allen (00:01:59) Dr. Allen shares her career path, experience in biosafety, and how she became IBC Director.
  3. Transition to NIH Mandate Discussion (00:05:19) Host segues from Dr. Allen’s background to the new NIH requirement for posting IBC minutes.
  4. When IBC Committees Are Required (00:05:45) Explanation of when an IBC must be involved in research and NIH funding requirements.
  5. Definitions: Recombinant and Synthetic Nucleic Acids (00:06:30) Clarification of NIH definitions for recombinant and synthetic nucleic acid molecules.
  6. Definition of Institution and IBC Role (00:08:00) Explanation of what constitutes an institution and the IBC’s responsibilities.
  7. NIH Expectations for IBC Committees (00:09:16) Overview of NIH requirements for IBC membership, expertise, and meeting frequency.
  8. Importance of Diverse IBC Membership (00:12:39) Discussion on the need for broad expertise and community representation on IBCs.
  9. Role of Community Members and Transparency (00:14:04) How community members contribute to transparency and public understanding.
  10. History of IBC Minutes Access and New Posting Requirement (00:15:31) Contrast between previous public request process and new online posting mandate.
  11. Transition to Written Procedures for Minutes (00:17:50) Recommendation for SOPs on minute-taking and approval in light of new requirements.
  12. On Campus Commercial (00:19:00) Learn about CITI Program’s other podcast, On Campus.
  13. Website Posting Logistics and Delays (00:19:24) Discussion of practical challenges and potential delays in posting minutes online.
  14. Redaction of Sensitive Information from Minutes (00:23:15) Explanation of what information can be redacted from publicly posted IBC minutes.
  15. Security and Stakeholder Notification (00:27:18) Considerations for informing campus security and other stakeholders about the new policy.
  16. Risk Assessment and Monitoring Public Access (00:28:56) Institutions’ strategies for risk assessment and monitoring public access to posted minutes.
  17. Retention Period for Posted Minutes (00:32:18) NIH requirement to keep IBC minutes posted online for five years.
  18. Auditing and Record-Keeping Plans (00:33:26) Plans for regular audits and internal reviews of the minute posting process.
  19. Final Reflections and Benefits of the New Policy (00:34:47) Dr. Allen’s closing thoughts on process improvements and balancing transparency with privacy.
  20. Podcast Closing and Additional Resources (00:37:12) Host wraps up the episode, thanks guests, and provides information on CITI Program resources.

 


Episode Transcript

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Dr. Regina Allen: I think when this first came out, there was a tendency for panic. And now, as we’ve calm through it and it’s happening, I think the reality of it is that there is no need to panic. However, like anything else, especially when you’re working in an IBC field, risk assessment is always on our plate. It’s always on our minds.

Alexa McClellan: Welcome to On Research with CITI Program, where we bring you conversations on timely topics and emerging trends shaping the research community. I’m your host, Alexa McClellan. Today, we have a special guest host, my colleague, Dr. Anne Hawkinsbadge. Anne is the assistant director of EHS at CITI Program, where she focuses on developing content related to environmental health and safety practices and compliance. She’ll be speaking with Dr. Regina Allen, director of the Virginia Tech Institutional Biosafety Committee Program. Their conversation centers on an important update from the National Institutes of Health regarding new requirements for Institutional Biosafety Committees or IBCs, to post their approved meeting minutes publicly online.

Announced on March 28, this policy became effective on June 1st of this year, and it aims to promote maximal transparency in biosafety oversight. In addition to unpacking the details of this new requirement, Anne and Regina will also discuss the core purposes of IBCs, their membership structure and how they fit into the broader landscape of research compliance and safety. Whether you are responsible for implementing this new policy or you serve as a member on an IBC and you’re concerned about how it might impact you, or perhaps you might just want to learn more about what an IBC is, this episode will offer valuable insight. Here’s Anne with Dr. Regina Allen.

Dr. Anne Hawkinsbadge: Regina, thank you for joining us today. I’m so excited to have you here to have this opportunity to talk about what’s changed in IBC and the new requirements for posting the minutes. But before we get into that, can you give our audience a little background about yourself and how you got here?

Dr. Regina Allen: Sure. Well, thank you for having me. I’m really excited to be here. I started my journey to working with an IBC back when I was a graduate student. So when I was a graduate student, I was working towards my PhD in microbial genetics, it’s cellular and molecular biology, but my lab focused on bacterial genetics. And during that time, I really started looking into why we had to do certain things certain ways. I got to know our EHS folks at that time. They were really helpful. As a biologist, there were a lot of chemical things I would do wrong, and through that, even though that was the chemical side of it, I really started paying attention to why it was important to follow certain requirements and where did those requirements come from.

So after I defended, I actually went into biotech. I did not stay in academia. I did my postdoc at a company that generated mouse models. And again, while I was there, I learned a lot about how a company had to handle various things. We still needed an IACUC, even though we weren’t in academia. And so my first question was why. I thought it was an academic committee, but it’s not. We got into the rules and regulations on what you need to do if you’re going to be working with animals. And then from there, again, I met with the EHS folks that worked with that company and got more information about why we had to follow certain requirements when working with the bacteria we were working with. We were working with Risk Group 1, E. coli.

We were cloning. We weren’t doing anything pathogenic, anything like that, but there were still requirements. There were rules we had to follow. And as I looked more and more into it, I actually started learning more about the NIH guidelines. And then eventually, I made my way to Virginia, still following kind of the same career path. And that was when I came across Virginia Tech’s opening for an IBC administrator. And when I looked at that, it had a lot to do with NIH guidelines, of course, and working closely with their EHS. And so, it really piqued my interest because it just fell in line with something that I had kind of on the side been looking at all along. And so, that’s kind of how I stumbled into this position, but now I’ve been here for 13 years and I love it.

Dr. Anne Hawkinsbadge: That is so wonderful to hear that. As a new PhD student, there’s multiple areas that you can go into. You can stay in academia, you can go in industry. The world is just out there, just for you to go after. That is fantastic. Let me segue into, again, why we’re here today. We’re here because of the NIH mandate that institutions publicly post approved IBC minutes. And this is for meetings that are held on or after June 1st, 2025. So kind of going back, when does an IBC committee come into play?

Dr. Regina Allen: So an IBC committee needs to be involved as soon as any research at an institution is handling or performing work with recombinant or synthetic nucleic acid molecules and if that institution is receiving funding for that work from the NIH. So if you have any funding, regardless of the amount and regardless of how many guidelines or how many experiments are being performed from that funding involve recombinant, synthetic nucleic acid molecules, you would need to involve the IBC at that point.

Dr. Anne Hawkinsbadge: So does NIH define the term recombinant and synthetic nucleic acid molecules?

Dr. Regina Allen: Yes, they do. They have a whole section that actually goes into details about it, but essentially, the word recombinant refers to the joining of nucleic acid molecules, together such that they can still replicate within a living cell. So you can delete, modify, insert those nucleic acid molecules, but as long as they can still replicate within a cell, that would be considered recombinant. Synthetic would be that the nucleic acid sequence is chemically or through another method, synthesized or amplified. So whether you’re purchasing the sequence from a vendor or you are using a method such as PCR to amplify or even to connect those bases, you have now generated a synthetic nucleic acid molecule that is the synthetic part. Now, on top of that, you can also do a combination. So you can use synthetic nucleic acid along with nucleic acids that are obtained through recombinant means and you can actually join them together. So now you have a recombinant synthetic nucleic acid molecule.

Dr. Anne Hawkinsbadge: Sounds like a tongue-tie, but that really makes a lot of sense. Now, when we use the word institution and institution biosafety committee, how does the NIH use it in their guidelines and what does it mean?

Dr. Regina Allen: So institution refers to any public or private entity. So it does not refer to any specific type of organization such as academia. Now, when we’re talking about the NIH guidelines specifically, of course, we’re talking about any public or private entity that’s receiving funding from the NIH to perform work that would be applicable to the NIH guidelines. Now, the IBC committee is a committee that’s going to be designated by that institution to be responsible to review, approve, and oversee all of that work that is applicable to the NIH guidelines. So the committee works for the institution to maintain that institution and compliance, with the NIH guidelines.

Dr. Anne Hawkinsbadge: Okay. Now that we have a working knowledge of IBC, let’s talk a little bit about NIH expectations for the IBC committee. Can you tell me, do they set specific requirements of who they want on the committee, how often the committee should meet?

Dr. Regina Allen: Yes, there are quite a few expectations, and the NIH guideline goes through each of those in detail so that everyone’s aware. The NIH guidelines are not so detailed that there is not room for each institution to mold their IBC around their specific needs. But the NIH guidelines do provide requirements that every committee needs to meet. So the minimum membership on an IBC needs to be five. So you have to have a minimum of five members on that committee. However, depending on the work being performed at the institution, you may also be required to have a transgenic plant containment expert, a transgenic animal containment expert, a gene drive modified organism expert, as well as members who are able to assess the risks to the environment when a gene drive modified organism is being used.

If you have any high-containment experiments or large-scale volume experiments, you would have to have a biosafety officer on the committee. Also, if there are any gene transfer experiments being performed, so like a human clinical trial with a biological recombinant biological material, that would require a membership of people who are kind of expertise in that area as well. So essentially whatever work is being performed that involves recombinant, synthetic nucleic acid molecules, you need experts on the committee who are able to review that work. So first, they need to understand what is being described to them, but also, they need to be able to review the risks associated with performing that work, not only to the members in the lab, but for public health and the environment.

So that is the main goal of the IBC. They really need to do a risk assessment of the work being performed for the personnel working as well as the environment and public health. And so along with that, there is the requirement that the IBC has at minimum, two members who are not affiliated with the institution and those members are supposed to represent the local community in the areas of public health and the environment. So they’re there to help raise any concerns that the public has and receive that information from the experts about how this work could affect public health and the environment. And also, they would be the institution’s way for the public to interact with the committee on a regular basis.

Dr. Anne Hawkinsbadge: I think it’s really important for everyone to understand how broad this committee can be and is encouraged to be, to bring in the knowledge to do the right type of assessment based on the organisms that are involved, whether they’re plant, animal, etc. I think that’s really, really important that I feel a lot of people do not understand or do not hear that.

Dr. Regina Allen: Yes, I think it’s really important to understand that IBCs are not composed of just a set type of membership. Like I said, there are certain areas where you’re required to make sure you have a specific type of members, such as the animal containment or the biosafety officer. However, the main goal of that committee is to match what is being done at the university. You need the expertise to understand what’s being done, what materials and organisms are being used, and then the risks that can be associated with the use of those materials. Everyone has a heart to play, whether or not it’s their specific area. And even with the local community members, they are not always knowledgeable of every application being described, yet they’re there. And part of that is they ask questions, which is very helpful because that helps us understand where would the disconnect go between the experts on the committee and the public.

How would the public view this? If they’re asking certain questions, it’s not that necessarily anything is wrong, it’s just maybe the explanation of what is being done was not to the degree it should have been. And so, that’s where the local community members come in very handy. They’re very helpful, just when they ask a simple question sometimes because they opened your eyes to, “Oh, we didn’t realize that wasn’t something that everyone knows. That’s something that you need to be in this field to understand.” And that is part of the IBC being transparent with that community and trying to help everyone understand not only what’s being done from the experiment side, but also, how it’s being contained and how it’s being done safely. There are certain terms that to those of us involved in it on a regular basis, seems straightforward. They seem every day common language, but it’s not. And if it’s misunderstood by someone like our community member, then we can assume that the public would misunderstand it as well.

Dr. Anne Hawkinsbadge: That’s perfect. And that just went right into a fantastic transition to talk about this new requirement that NIH has for IBC to post their approved minutes. So let’s jump into that. Can we talk a little bit about the history? In the past, you didn’t have to post the minutes if I understand correctly, but you had to make them available if somebody requested. Is that correct?

Dr. Regina Allen: Correct. So previously and currently, the public can request the minutes from IBC meetings as well as any other documents that the IBC would submit to the NIH. So that would include something like NIH guidelines, applicable incident report. So those types of information can be requested from the public. So they would contact, say the IBC office and make a request for those documents. And we would need to process them and provide the information to the individual or individuals that requested it. So now as of June 1st, 2025, the IBC meeting minutes, starting with our June meetings, are going to need to be posted online.

So they need to be on our website and they need to be posted immediately after they’re approved. So these would be the approved minutes that are getting posted online. And so, this way, the public no longer would need to request minutes as of June 1st, 2025. So that’s why I said, we are still having to follow the previous requirement when a request comes through because anything prior to June 1st, 2025 would not necessarily be on our websites. It can be if we would like, but actually a lot of work to get things posted online. So many institutions most likely will still have to have things prior to June 1st be requested by contacting the IBC office.

Dr. Anne Hawkinsbadge: That seems like a logical approach because as you said, there’s a lot of work to get them online. So do you recommend that IBC committee has a written procedure on how to take their minutes and go through the approval process?

Dr. Regina Allen: Yes, I do. We’ve had an SOP outline that process for us even before these changes came, and it’s for two purposes. One is, it’s just good to have a process in place so everyone understands what is going to happen, but also for the public or for anyone else that comes to the institution and asks what our process is. No matter who’s being asked, the answer should be the same because there is an SOP or there’s a standard of some sort written out that describes the overall process. And as part of this change, we’ve actually had to update our standard to incorporate placing the minutes online.

Ed Butch: I hope you’re enjoying this episode of On Research. If you’re interested in important and diverse topics, the latest trends in the ever-changing landscape of universities, join me, Ed Butch for CITI Program’s original podcast On Campus. New episodes released monthly. Now, back to On Research.

Dr. Anne Hawkinsbadge: Would it be fair to say that the IBC may not be the individual that puts the minutes up online, so there might be a delay in that? Should we talk a little bit about that in the potential that that might exist?

Dr. Regina Allen: Oh, yes, definitely. So even though I am going to be writing the minutes and I am the person that will go in and update the website from the editing side to put the minutes there, I don’t have control over the actual publishing of the website. So whether individuals or institutions have that type of scenario or if you actually have to send the approved minutes to another department to even edit the website, let alone publish it, you do have to work with that other department because that does cause a potential for a delay. First, that department may not be aware of the actual requirement we have now been given by the NIH. They may not understand what the NIH guidelines are and the importance of why these updates to the website are going to be needed quickly. The way the NIH has provided this requirement, it says immediately.

Now, what immediately does not have an actual timeframe with it. In my situation, the IBC meets from 2:00 to 5:00 PM. Even if I were to edit the website, I can tell you, our web publisher person is not going to be in the office waiting for me after 5:00 PM. So for me, I’ve determined that immediately is going to have to mean within 24 hours. So yes, I am planning and I have what legal services know at our institution that we will have to put a timeframe in place. Immediate is not a timeframe. Yes, we will. It’ll be the priority on my list within that 24 hour period. That also gives me time to work with that other department that actually publishes our website, so that I can email. I can call. I can bug them as much as possible, but it also gives me the ability to not panic and to instead, work with that individual and not cause any friction between our departments, while still maintaining compliance with the NIH guidelines requirement to get those minutes up and published.

Dr. Anne Hawkinsbadge: I think that’s really important for people to remember that because that’s one of the things with the NIH guidelines that I’m seeing. There tend to be more performance rather than specifically calling out, “This step must be completed by this time. This step must be completed by this time.” So it allows the institutions to identify their best pathway forward to put those approved minutes up. I think that’s fantastic how you’re going to be able to implement that.

Dr. Regina Allen: Exactly, yeah. And I think when you look through the guidelines, you’re right. That is exactly how they’re written. They have enough detail for us to know what’s expected. But at the same time, they give us enough room to make decisions based on the needs and the abilities of our institutions. Not every institution has the same resources available.

Dr. Anne Hawkinsbadge: So basically, what we’ve said here in a roundabout way is that the institution is responsible for the generation of these approved minutes. Now, the next question I have is, can certain things be redacted from these minutes and can you talk a little bit about that?

Dr. Regina Allen: Sure. So yes, technically, things can redacted from the minutes. However, there are very specific items that are allowed to be redacted. So things such as proprietary information. So again, we’re talking about people’s research, which may not have been published, any aspect of it at this time. We also have researchers who work with private collaborators. So you may have a researcher that is testing a material that was developed by industry. And so, they’re collaborating on it, but that industry is not going to want their proprietary molecule or whatever it is, put into those minutes, especially now that it’s anytime the public can request those minutes. So that kind of information can be redacted. Also, student names, the NIH is actually, even in incident reports has told us, do not put student names. That is part of FOIA as well. There are certain individuals whose information we protect, even with the name.

So yes, students don’t go into the minutes. Also, personal information. So if for some reason you are putting phone numbers, addresses, things like that, personal phone numbers and addresses or birthdates, anything like that, into your discussion, you can redact that information. That doesn’t have to in the minutes. However, the principal investigator or the PI’s name, that cannot be redacted. So it is not that every name can be redacted from the minutes. We are talking about very specifically, the students’ names can be redacted from the minutes. Any sensitive information, so something like the location, and they’re talking about the very specific location of certain pathogens such as select agents and toxins, that can be redacted. So sometimes during a discussion you do need to discuss that information. There may be questions, and it may be part of the discussion, that information can be redacted out of your minutes. But aside from that, it’s the proprietary, the student names and personal information and sensitive information. That’s actually all we are allowed to redact.

Dr. Anne Hawkinsbadge: Well, that makes sense because if you’re talking about a select agent, the general public doesn’t need to know that it’s in a particular building. They just need to know what you’re working with. And I like hearing the fact that the students’ names will be protected. And I also like hearing the fact, or at least this is my understanding, that say for example, your community members will feel more comfortable serving on the IBC committee because their information, their personal phone number, et cetera, won’t be out there. And I think that’s critical too.

Dr. Regina Allen: Exactly, yes. We do not provide that information in the minutes at all. Now, the members are all noted. I mean, and that’s in any committee meeting. That has nothing to do with the IBC, but everyone who attends the meetings, all of our members are listed as well as their role on the committee. But yeah, there is no personal information that we put into the minutes like that.

Dr. Anne Hawkinsbadge: So with this new posting requirement for the IBC approved minutes to be posted publicly, do you think institutions should advise if they have, for example, a security detail or campus police or whatever, of this change in NIH in the event something else happens? Or do you see any advanced planning that institutions should have to do?

Dr. Regina Allen: Yes, but I don’t think, we don’t need to panic at this point.

Dr. Anne Hawkinsbadge: Oh, well, yes. By all means.

Dr. Regina Allen: That’s one thing that’s really important, I think. When this first came out, there was a tendency for panic. And now, as we’ve calm through it and it’s happening, I think the reality of it is that there is no need to panic. However, like anything else, especially when you’re working in an IBC field, risk assessment is always on our plate. It’s always on our minds. And so yes, you need to do a risk assessment. You need to be aware that the big difference between the public being able to previously request the minutes and now the minutes being on our websites is that, individuals who don’t actually know about IBCs, don’t know the NIH guidelines, will now have access, whether inadvertently because they happen to Google the right keywords and they came across the minutes or because they’re looking for very specific things, such as, they were looking for something with an IACUC and it pops up with your IBC minutes now.

That information is now available to those individuals who may not have realized that they previously could request IBC minutes. And so for that reason, there are certain stakeholders that should be made aware of the fact that the minutes are now going to be posted online. And so, at our institution, we let the IACUCs know. We let the university veterinarian’s office know, as well as the faculty. I mean, we sent out a general notice, but specifically, we spoke to the IACUCs, the veterinarians. We spoke with our legal counsel is aware, and then our risk management office, is how we handled it. So risk management is aware of what had happened and then we are allowing them to make the decision of who else would need to be further informed of it. And that’s kind of how we handle the not panic portion of it because risk management office, they’re used to handling these situations. They’re the ones that handle all of the, sky is falling moments, if you will.

And they can take it down the level and take that step back to say, “Okay, this is good information. We don’t need to inform every single person about this.” The reports about who is accessing the website, the pages on our website that are being accessed, so we’re going to take those reports and look at them more closely, especially the hits onto our pages for the minutes and we’re going to monitor feedback from our researchers to see if they’ve had any additional contact from the public or on their websites, if anything, or emails, anything like that, to see what’s happening. And then we’re going to handle the situations as they arise. We do know some institutions have had their minutes on the web for a while now, even before these requirements came out, not a lot, but there are institutions that do that.

Also, our researchers have their own web pages as well as departmental pages. So right now, the way our minutes are being written, we don’t believe we’re putting that much more information out to the public than what may already be available through those websites that already existed as well as publications that the researchers put out. So, for that reason, we’re going to take this approach if we’re just going to keep an eye on it and handle the situation, if we see that anything concerning is happening. We are not closing our eyes to it because as we mentioned, there is a risk.

Dr. Anne Hawkinsbadge: I like that. I like what you did because number one, you did essentially, you’re doing risk assessments. Essentially you’re doing a form of auditing as you go along, not at a certain period of time. You’ve informed the people. You have a complete circle that’s going on. I like that concept. Now, how long do these minutes have to be posted out there? For what length of time does NIH require them?

Dr. Regina Allen: Good question, because previously, we did not have that information, but now we have that the minutes need to be posted for five years. Of course, you have to follow any other guidance from the institution. So if the institution has a policy that says you have to keep those types of documents longer, then obviously, you might have to follow that. But the NIH has told us five years. So that is also the new timeframe that we are going to use even for the minutes that were previously kept offline. So we are now going to use that five-year limit as our document retention policy for the IBC.

Dr. Anne Hawkinsbadge: Perfect. So you’re going through your record-keeping and correlating it, so it all goes back to the five years for your documentation?

Dr. Regina Allen: Yes. Yeah.

Dr. Anne Hawkinsbadge: Wonderful. So next question I have is that, how often do you think you’ll audit? What are your auditing plans on this, just high level?

Dr. Regina Allen: Oh, yeah. So for us, the report on the website comes out monthly, so we will be checking on that monthly. We will also be checking in, I guess, monthly is going to be our auditing timeframe because the researchers as well, we don’t want to inundate people with too much. Also, we will have internal audit. We’ll be looking at our process too. That actually happens closer to every two years, the IBC specifically. We do get caught up in other internal audits. So someone’s looking at something generally annually. The IBC itself, which would now include this published minutes section of our process, would be part of our internal audit. So we’re trying our best to capture anything that’s changed as a result of us publishing the minutes. But every risk assessment, can use its own risk assessment. And so, the internal audit will be useful to help us catch any gaps in our surveillance of what’s happening with this.

Dr. Anne Hawkinsbadge: Regina, this has been absolutely fantastic. I really enjoy talking to you about this and I think hopefully, our audience has learned a lot. I have. Do you have any final comments for us?

Dr. Regina Allen: Only that I think we… We were initially, I think all kind of nervous about this. I think now that we are in it and it’s happening, to be honest on my side, some good is coming of it. Like I said, we have our own audit processes that we’re putting in place. We have refined our minutes actually, to make sure that they are concise with what is needed without all that extraneous information that it wasn’t even necessary. It didn’t provide any information, it just made people nervous, as you said, like our community members. Nobody needs to know who said what at what stage, only the discussions that were had. So I think in the end, I hope that this will help us actually develop processes that just make our entire review process better.

And I hope that the public understands that none of this is about trying to hide information. We’re walking a very close line between protecting our personnel, their private lives, versus providing the information that everyone needs. And we want to let people know what we do. I mean, researchers love to tell people what they’re doing. That’s not a problem at all. So there is nothing like that that we want to hide. It’s just making sure that the information that is out there is accurate too, and that it can’t be misunderstood, which falls on us, is the burden to make sure that it’s understandable for everyone, which is not an easy task to do. It’s very difficult to take science language and make it understandable for everyone. But that is the goal and hopefully we’ll achieve that.

Alexa McClellan: And that’s it for today’s episode. I’d like to thank our guest host, Dr. Anne Hawkinsbadge and our guest, Dr. Regina Allen for sharing their expertise on the new NIH requirements for IBC meeting minutes and for helping us better understand the purpose and membership’s institutional biosafety committees. CITI Program offers self-paced courses in research compliance, including on animal and human subjects research, responsible conduct of research and research security. You will also find role-based training for clinical research coordinators, principal investigators and clinical research associates. Enhance your skills, deepen your expertise, and lead with integrity across research settings.

If you’re not currently affiliated with the subscribing organization, you can sign up as an independent learner and access CITI Program’s full course catalog. Check out the link in this episode’s description to learn more. As a reminder, I want to quickly note this podcast is for educational purposes only. It is not designed to provide legal advice or legal guidance. You should consult with your organization’s attorneys if you have questions or concerns about the relevant laws and regulations that may be discussed in this podcast. In addition, the viewers expressed in this podcast are solely those of our guests. Cynthia Belas is our guest experience producer and Evelyn Fornell is our line producer. Production and distribution support provided by Raymond Longaray and Megan Stuart. Thanks for listening.

 


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Meet the Guest

content contributor Regina Allen

Regina Allen PhD, CPBCA – Virginia Tech

Regina Allen joined the Virginia Tech Institutional Biosafety Committee Program in 2012. She has over 20 years of experience in cell and molecular biology, earning her PhD in cell and molecular biology from the University of Rhode Island. She has been a Certified Professional Biosafety Compliance Administrator (CPBCA) since 2023.

 


Meet the Host

Team Member Alexa McClellan

Alexa McClellan, MA, Host, On Research Podcast – CITI Program

Alexa McClellan is the host of CITI Program’s On Research Podcast. She is the Associate Director of Research Foundations at CITI Program. Alexa focuses on developing content related to academic and clinical research compliance, including human subjects research, animal care and use, responsible conduct of research, and conflict of interests. She has over 17 years of experience working in research administration in higher education.

 


Meet the Guest Host

Team Member Anne Hawkinsbadge

Anne Hawkinsbadge, DHSc, MSPH, MA, CSP, CHSP, CHEP, C(ASCP), Assistant Director, Environmental Health & Safety – CITI Program

Anne Hawkinsbadge, DHSc is the Assistant Director of EHS. She focuses on developing content related to environmental, health, and safety practices and compliance. She received her doctorate in Health Science from Nova Southeastern University, MSPH in industrial hygiene and graduate certificate in disaster management from Tulane University, MA in public health from Central Michigan University, BS in mechanical engineering technology and BS in biochemistry from Saginaw Valley State University. She is a certified safety professional, certified healthcare safety professional, certified healthcare emergency professional and a chemist with the American Society of Clinical Pathologists.