On Research Podcast – Dual Use Research of Concern Policy

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1. Podcast Introduction (00:00:32) Justin welcomes listeners and introduces the episode’s focus on Dual Use Research of Concern.
2. Guest Introductions (00:01:05) Justin introduces guest host Anne Hawkinsbadge and primary guest Melissa James, highlighting their expertise.
3. Melissa’s Background (00:03:24) Melissa shares her journey in research, emphasizing her experience in biosafety and laboratory management.
4. Understanding DURC (00:05:04) Melissa explains Dual Use Research of Concern (DURC) and its implications for scientific research.
5. Overview of the New Policy (00:06:33) Discussion on how the new policy consolidates previous regulations regarding Dual Use Research and enhanced pathogens.
6. Impact of Recent Executive Orders (00:09:17) Anne discusses the influence of executive orders on research policy and its implications for institutions.
7. Institutional Preparedness (00:12:39) Discussion on the need for institutions to prepare for expanded regulations under the new Dual Use Research policy.
8. Exempt Quantities and Communication Issues (00:13:05) Melissa addresses potential communication gaps regarding exempt select agent quantities under the new policy.
9. Approval Processes for Select Agents (00:14:46) Explanation of the approval process institutions must undergo to work with select agents.
10. Understanding Risk Groups (00:16:28) Melissa explains the classifications of pathogens into different risk groups and their implications.
11. Importance of Reporting Research (00:18:00) Discussion on the need for researchers to report their work to appropriate committees for compliance.
12. Categories of Research (00:18:50) Melissa describes category one and category two research regarding Dual Use concerns.
13. Preparation for Federal Funding Applications (00:20:31) Advice for researchers to prepare for compliance with the new DURC policy when applying for funding.
14. Contacting Institutional Committees (00:21:17) Guidance on which institutional committees researchers should contact when preparing proposals.
15. Collaboration Across Institutions (00:23:03) Discussion on how multi-site studies manage compliance with the new policy across different institutions.
16. International Implications of the Policy (00:24:04) Melissa addresses how the DURC policy relates to international research and pathogen recognition.
17. Publication Restrictions (00:28:40) Insight into publication reviews and export controls for research findings related to Dual Use concerns.
18. Institutional Review Entity (00:30:02) Requirements for the Institutional Review Entity (IRA) and its role in research oversight.
19. Flexibility of New DURC Policy (00:31:40) Discussion on the adaptability of the new DURC policy for different institutions and research contexts.
20. Key Takeaways for Institutions (00:32:45) Emphasis on understanding the updated policy and its implications for research protocols and resources.
21. Resource Allocation for Compliance (00:33:41) Advice on potential resource needs due to expanded agent lists and compliance with the new policy.
22. Communication with Stakeholders (00:34:47) Importance of involving various institutional roles in understanding and implementing the new policy.
23. Clarification on NIH Funding (00:35:14) Clarification that NIH funding implications apply specifically to the research being funded, not broadly.
24. Advice for Institutions on Policy Implementation (00:36:10) Recommendations for institutions to prepare for the upcoming policy changes and their effective date.
25. Same Team Segment: Collaboration During the Pandemic (00:37:31) Melissa shares her experience with colleagues on disinfecting N95 respirators during the pandemic.
26. Final Thoughts – CITI Content Offerings (00:40:07)

Melissa James: Yeah. So actually, the United States has the most developed DURC policies, and that mostly stems from the 2012 publications that demonstrated mutations in a highly pathogenic avian influenza virus that made it transmissible via air between mammals. And so this work is often called gain of function, and while it’s not technically banned, funding agencies are hesitant to approve it, especially after the COVID pandemic because perception of the risk is one thing that’s heavily considered.

Justin Osborne: Welcome to On Research with CITI Program, your favorite podcast about the research world where we dive into different aspects of the industry with top experts in our field. I’m your host, Justin Osborne, and I appreciate you joining. Before we jump in, as a reminder, 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 views expressed in this podcast are solely those of our guests.

This is an exciting episode we have. I had a wonderful guest host with me today, Anne Hawkinsbadge. Anne is the assistant director of Environmental Health and Safety with CITI Program. She has her doctorate in health science and has worked in the EHS spaces, including pharmaceutical, healthcare, academia, and chemical manufacturing. Anne and I had the pleasure of sitting down with Melissa James, who you heard a clip from at the beginning. Melissa is the BSL-3 facility manager for Yale University. She got her master’s in Homeland Security from Penn State focusing on public health preparedness for disasters and bioterrorism. And these are two of the best people to talk to about our topic this episode, which is the recently updated Dual Use Research of Concern policy. If you don’t know much about Dual Use Research of Concern, this conversation will be a fantastic primer. We talk about what Dual Use means, the policy updates, how these updates could impact your research institution and why all of this matters.

Also of note, we recorded this episode a couple of weeks ago in the midst of the many executive orders impacting research. Anne and Melissa do share their thoughts on how you should move forward with this gray area we’ve all found ourselves in, but we always encourage folks to stay up to date as much as possible on the evolving landscape. And with that, I hope you enjoy this conversation.

Welcome, everybody. I’m super excited about this topic today and this episode, I actually have a special guest host with me, Anne Hawkinsbadge. I’d like to welcome you as my co-host for this episode.

Anne Hawkinsbadge: Thank you very much. I’m excited to be here.

Justin Osborne: Anne, if you don’t mind giving us a little background and tell us a little bit about yourself.

Anne Hawkinsbadge: I’m currently employed at CITI Program, CITI Program, and I am the content developer for environmental health and safety. I have an extensive background in environmental health and safety in the areas of academia, automotive, biodefense, and I’m a certified safety professional. So I’m really excited to be here. I’m excited to talk to our guests.

Justin Osborne: Yes. Awesome. Awesome. Well, thank you, Anne, so much. You know a lot more about this topic than I do, so this is going to be fantastic. So, Anne, we have Melissa James with us. So, Melissa, thank you so much for jumping on the podcast and talking to us today.

Melissa James: Thanks for having me. I’m happy to be here.

Justin Osborne: So first, before we get into the topic and before we let you educate us on everything that you’re going to talk about, could you tell us how you got into the research industry in the first place and then what your current role is now?

Melissa James: Sure. So I’ve always loved animals and science. So I originally went to school thinking I would become a veterinarian. And while I was pursuing my undergraduate degree in biology, I took a class called Physiological Psychology where we were able to perform psychology experiments with rat. And I discovered there were lots of other careers besides veterinary medicine where I could apply my interest. So from there, I completed two independent research projects and delved into the world of animal research.

I worked in the neuroscience field for a little while performing behavioral studies with non-human primates, and we were focused on developing brain machine interfaces to help with the development of neuroprosthetics. And then from there, I transitioned to a job supporting the construction and startup of a new biosafety level three laboratory. And so we focused on vaccine testing and development of therapeutics for diseases that didn’t have vaccines previously or effective treatment.

And after being mentored by experts in biosafety level three operations, I moved into a management position, got my master’s in Homeland Security and my registered biosafety professional credentials. And I’ve stayed and grown on the field ever since. So now I currently manage the biosafety level three facilities at a university, and continuously try to improve the program.

Justin Osborne: That’s amazing. That’s amazing. What a background. That’s fantastic. You are absolutely an expert. So this is great. This is who we like to talk to on this.

Anne Hawkinsbadge: Well, let’s talk about DURC. Can you tell our audience what DURC is, specifically the acronym and also the particular policy that we’re discussing today?

Melissa James: Sure. Sure. So DURC, or Dual Use Research of Concern, is any life science research where the information or technology that’s developed for benevolent purposes may be manipulated to cause harm instead. For example, scientists may ask, “What if the disease suddenly developed in society that was resistant to the drugs that we currently use to treat it?” Maybe they’d want to test new treatments for that disease, but first they’d have to take away or alter the components of the bacteria or virus to make those particular drugs effective. And so in doing so, or more importantly, publishing the methods on how to do this, the scientists could be giving people with bad intentions a roadmap to creating a disease for which we have no effective treatment.

Justin Osborne: That is fascinating. No, that’s a lot, right? To take in. So Dual Use Research of Concern is DURC. Thank you. And I love the acronyms. And this makes perfect sense, but this seems like a very important, I guess, potentially dangerous area of research and just mentioned that the policy, so what does this policy that we’re going to talk about?

Melissa James: Yeah. So the policy brings together previous policies that had been developed in trying to control or mitigate some of these risks. And so it’s a consolidation of a few different policies. So we’re looking at Dual Use Research of Concern, but also pathogens with enhanced endemic potential, or it’s abbreviated PEPP or PEPP.

Justin Osborne: Okay. So those are two separate things?

Melissa James: In the past they had been, and now they are combined into a single policy.

Justin Osborne: Okay. I mean, from my point of view, I guess, it makes sense that they would, right? That these two things are similar in their nature, in the fact that you described about the Dual Use stuff that these are all research… you’re researching stuff that could be used for bad stuff, like potentially bad situations?

Melissa James: Exactly. So usually when you think of DURC, it’s intentionally manipulated to be used for nefarious purposes. And for PEPP or the pathogens with enhanced endemic potential, they could be used for nefarious reasons or it could be an accident release.

Justin Osborne: Okay. Okay. That is very helpful.

Anne Hawkinsbadge: Justin and Melissa, I think there’s something we should bring up here. With the inauguration of President Trump, he has signed several executive orders on the 20th of January 2025. And during the signing, it appears that the Office of Science and Technology was revoked. And so therefore, this policy which would have been issued through that Office of Science and Technology in accordance with the directives established in the 2022 National Biodefense Strategy and Implementation Plan as directed underneath or by the National Security Memorandum 15, may not be in existence through that way. However, the policy was also issues prudent to Section 23115 of the Consolidated Appropriation Act of 2023, which is underneath the 42 USC 6627, which I believe is our public health, which then goes back to NIH.

So NIH believe can still use this. So I think as we talk about it, we’ll talk as if the policy is still there because we need to prepare for it, because the effective date is May of 2025.

Justin Osborne: Got it. No, thank you, Anne. That’s actually really helpful. And again, everything you just went through all these executive orders recently signed, it obviously impacts this policy. It impacts everything else too, right? Basically everything’s on hold until the new administration gets in and review stuff. But to your point, obviously we need to move forward. This is going to move forward as it was initially going to.

Anne Hawkinsbadge: So keep moving forward. Melissa, can you give us an overview of how the old policies are combined to make this new policy?

Melissa James: Sure. Yeah. So the old policies had directives for institutions and directives for federal agencies and directives for the investigators who are proposing this work. And so, one of the major changes that has occurred within implementation of the new policy is the number of pathogens that must now be considered for Dual Use. Before it was 15 agents that were already tightly controlled under the select agent regulations, and now it encompasses all select agents, which there are currently 63, all risk group four pathogens, which are things like Ebola and other pathogens that cause very deadly diseases with limited options for treatment. And most of the risk group three pathogens, which can cause serious or fatal disease, mainly by inhalation of something.

Justin Osborne: So what was the total of that? So the old policy have 15, now the number is what?

Melissa James: So currently it’s 91, but some of those agents are in flux. So the CDC and the NIH have reduced the risk group of SARS-CoV-2, which is the cause of aging of COVID-19. So that is one that will likely be removed. Some other pathogens like West Nile virus and St. Louis encephalitis virus should have already been removed from that policy. So the actual number is going to change a little bit as some of those things change, but it’s around 90 pathogens right now up from 15.

Justin Osborne: Wow, that’s a lot. That seems like a huge jump. That’s a big jump from 15 to 90 something or even 80 something. I’m just thinking what’s the impact of that? Is it possible that there are institutions out there doing research with some of the ones that were in number 16 through 91 that are now going to be implicated and they don’t know it? Or how does that work?

Melissa James: Definitely. So some institutions who are already approved to work with select agents, and those 15 that were on the list originally have staff and policies in place and committees that are ready to handle this. But because there are so many new agents and it encompasses so many more that are commonly used in multiple laboratories in the United States, the institutions need to prepare. They need to know the policies, prepare with staffing and time commitments to review all these research protocols, and make sure that the investigators are following the policy.

Justin Osborne: Yeah, that makes sense. Go ahead, Anne.

Anne Hawkinsbadge: Melissa, I think the thing here too is what about quantities? There were exempt select agent quantities at one time. How is that being impacted?

Melissa James: Exactly. Yes. So there are exempt select agent toxins in quantities, but that does not apply to this. So Botox, for example, botulinum toxin, there are exempt quantities of that in select agent regulations, but that does not apply to this new policy for Dual Use research. So any amount of that select agent toxin is may be subject to this policy.

Anne Hawkinsbadge: So that sounds like to me a massive communication issue that some of the institutions may be facing to get the word out to those people who have the exempt quantities as well as to make sure they understand they’re no longer… how they might be impacted, I should say, by this new policy.

Justin Osborne: Yeah, that’s really interesting. And you had made a comment, Melissa, that institutions that were already, I think you said approved to work with the 15 agents.

Melissa James: Agents or penalties.

Justin Osborne: Thank you. Yeah. So if you’re working with these agents now that fall within the scope of this policy, this new policy, when you say approved, what does that mean? Do you have to go through a specific process to work with these in the first place?

Melissa James: Well, so if they are select agents, one of the 63 that are listed as select agents, the institution needs to go through a review process. So you put together an application, submit it to the federal select agent program, and they go through a very lengthy review process, FBI background checks for all the personnel who are going to have access to this. They go through very extensive security incident response and biosafety procedures. They want to look at all your SOPs and make sure every detail is in place before they issue an approval.

Justin Osborne: Wow, that’s a lot. So you’re saying, and like Anne was saying, if you’re an institution and you don’t realize that you might fall on this list and you now have to go through this process, you have to have, it sounds like all these policies in place before you get approved because they’re going to want to make sure that you have all those protections and risks mitigated before they say, “Yes, go ahead. You can work with these select agents,” right?

Melissa James: Correct. For the select agents specifically, yes, you do have to go through those procedures, but because it incorporates risk group three pathogens, which are not all select agents, people can work with those if they’re approved by their institution. So maybe the Institutional Biosafety Committee looks at the space, looks at the research proposed and their SOPs and says, “You can do this work safely in this type of facility that has minimum requirements for the facility, and then you can apply these procedures that make it safer for you to work with these pathogens.”

Anne Hawkinsbadge: Would it be fair to say that the new DURC policy really doesn’t impact the select agent regulation as far as how the select agent’s regulation is written and implemented, but it uses that for the policy, it commingles with it?

Melissa James: Exactly, yes. So the policy on DURC specifically states that it doesn’t supersede any existing federal regulations like the select agent regulations. So those will stay in place as they have been. But because the new policy incorporates all of the select agents instead of the original 15, it’s going to be expanded to people and institutions who are working with these select agents, who may already be approved, but now they have to apply the additional policy.

Justin Osborne: Okay. Okay, that makes sense. So the net’s just a lot wider now with this new policy.

Melissa James: Yeah.

Justin Osborne: So, Melissa, you said earlier you were mentioning risk group three and different risk group. Help us understand what these different risk groups are in the context of this policy.

Melissa James: So there’s a book called Biosafety and Microbiological and Biomedical Laboratories called the BMBL, and it’s issued by the Centers for Disease Control and the National Institutes of Health. In this book, they define agents that are categorized as risk group one, risk group two, risk group three, and risk group four. So this is the book that tells you what risk group that agent falls on. And so…

Justin Osborne: Okay. Who’s making that determination? Is that some federal committee? Is that…

Melissa James: So there are experts that weigh in on this and is actually updated in 2020. And there are primary authors, technical experts that look at each agent without any risk mitigation controls agent by itself. How is it transmitted? Is it transmitted by a vector? Which means that it could be transmitted by a mosquito or potentially a needle stick in the laboratory. So they prefer that risk there. And then from there, you take each the starting risk group and you apply controls to mitigate the risk to prevent potential exposures to people in the laboratory.

Justin Osborne: Okay.

Anne Hawkinsbadge: Because the new DURC policy has expanded so much, what do you think institutions should do to make sure the information from the researcher about what they’re working with gets back to the appropriate committee such as the IRE?

Melissa James: So it’s important for the research institution to ensure that the principal investigators or PIs are trained to assess their work, to report it to the appropriate committees or their funding agency, have it reviewed, and provide the appropriate information. And there’s an initial assessment and then an ongoing assessment. So if at any time there’s something that changes in the research that may make this policy applicable when it was evaluated to not be applicable in the beginning initially, then it has to be reevaluated.

Anne Hawkinsbadge: Okay. So as we talk about evaluation, I’ve heard the terminology category one and category two. Can you give me a little bit of information on that?

Melissa James: Sure. So category one research meets the three criteria. One, it has to have one of the agents involved. So one of the 90, 91 agents that we’ve been taught. Also has to be reasonably anticipated to result in one of the experimental outcomes that are defined by the policy. And so that could be increasing the transmissibility, increasing the virulence or the toxicity of a pathogen or toxin, decreasing the effectiveness of disinfectants that are effective against that, and a number of other things. We can talk about all of them if you…

But it has to meet one of the experimental outcomes, and it has to meet the definition of Dual Use Research of Concern. So it has to be one of the agents has to meet one of the experimental outcomes, and it has to be considered Dual Use Research of a Concern or that it could be used to do harm. And that’s category one. Category two has to do with pathogens that could be manipulated to potentially lead to a pandemic. So pathogens with pandemic potential or PPP is something that’s likely capable of wide and uncontrollable spread in a human population and would likely cause moderate or severe disease or mortality in humans. Category two is more about pathogens that could cause a pandemic.

Anne Hawkinsbadge: So when a researcher applies for federal funding, should he or she be already prepared to comply with the new DURC policy?

Melissa James: I would say yes, because there are so many things that need to be implemented before the research can be approved and started. Often the funding is tied to that approval. And so to be prepared with answers to the questions, is this one of the agents that is listed in the policy? Am I going to do an experiment that results in one of the outcomes that are listed in the policy? And could the results that I publish be used to do harm?

Anne Hawkinsbadge: So as this researcher begins to prepare, what positions or committees within an institution should he contact and let them know of his intent?

Melissa James: When researchers are preparing to submit a proposal for infectious disease research, they’ll contact the Institutional Biosafety Committee. And this committee is the one that decides what biosafety level they should work at, whether it’s biosafety level two, biosafety level three, and whether the procedures that they have proposed are appropriate for the work that’s going to take place.

So the IBC or the Institutional Biosafety Committee will have eyes on this. And then there’s another committee called the Institutional Review Entity. If an institution has research that could potentially be Dual Use Research of Concern, they must have an IRE. And so that is the committee that will communicate with the Federal Funding Agency and the PI and help with development of risk mitigation plans and risk benefit analysis.

Justin Osborne: So speaking of those different committees, and there’s so many committees and oversight groups to look at these things, obviously this is for good reason, it sounds like. The IRE, does that have to be an institution? I know IBC can be sort of independent or you can find Central IBC services kind of thing. Is IRE the same or does that have to be at the institution?

Melissa James: So it can be external to the institution as well.

Justin Osborne: Okay.

Melissa James: So some institutions use their already established committees, their full IBC or a subset of the IBC because they have expertise in that area. And then some may choose to compile a whole different committee with subject matter experts, or like you said, use the externally administered committee.

Justin Osborne: So just from this process standpoint, is it similar to IRB where you can have multi-site studies? I assume there’s a lot of this research collaboratively working together, right? With multiple institutions and multiple researchers. Can they all review or rely on one IRE or IBC, or does it have to be done independently?

Melissa James: So there is one person who receives the funding, so whoever that principal investigator is responsible for the other sites. So if that person receives the funding and then they distribute it to other sites, they’re ultimately responsible for ensuring that they’re compliant with the policy too.

Justin Osborne: Okay.

Anne Hawkinsbadge: What you just described is also true if the other site is not in United States?

Melissa James: That’s correct. If the money is coming from the United States government, then the policy applies.

Justin Osborne: That’s interesting. So to piggyback off that, and good question, the international piece of this, like if this policy that we’re talking about, this DURC policy, it is now expanded to 91 agents, I assume that… Are these a list of agents that are recognized and agreed upon across the globe, or I assume each country maybe has their own list? I mean, how does that work?

Melissa James: Yeah. So actually the United States has the most developed DURC policies, and that mostly stems from the 2012 publications that demonstrated mutations in a highly pathogenic avian influenza virus that made it transmissible via air between mammals. And so this work is often called gain of function. And while it’s not technically banned, funding agencies are hesitant to approve it, especially after the COVID pandemic because perception of the risk is one thing that’s heavily considered.

Other countries have started to develop some frameworks and the biological weapons convention had some discussion about policies. But it seems like other countries are hesitant to implement something as strict as the US oversight, mostly for fear that it will restrict the research progress. And so they have identified some areas of research that are concerning, and they have some policies around it, but it’s not as strict as the US policy.

Justin Osborne: Okay. So if somebody is partnering with a researcher outside of this country, we have the most strict policies around this protecting this kind of research. And so I assume that even if say funding comes from outside of the US and a researcher in the US is doing this kind of research, if you’re conducting this research in the US still this policy still applies, right? It’s not like there’s some loophole that because this other country you’re working with doesn’t have this agent on their list that you can do research and go around this policy. How does that work?

Melissa James: So technically, if the funding does not come from the US federal government, the policy does not apply. But they do have some wording, some language in the policy that says, as members of society, you should consider implementing this policy as if it were required.

Justin Osborne: Gotcha. Okay. Okay. So just be a good person, but we’re not going to require it, but… Okay.

Anne Hawkinsbadge: But circling back on that, if the individual was on a select agent, then the select agent regulation would apply and not necessarily the new DURC. So that’s how it would come in that way.

Justin Osborne: Okay. That makes sense.

Melissa James: Yeah. And actually select agents are only something that’s regulated in the United States.

Justin Osborne: Okay. Okay. Yeah. And that makes sense, right? That there’s layers to this, and so hopefully there’s not an entire loophole to get out of these protections and whatnot. I wanted to go back. Melissa, you had mentioned, I think when you were defining category one that one of the criteria was that you used it, the findings have to be what potentially hazardous or something? What was the…

Melissa James: Yeah. So the wording is reasonably anticipated to result in one of the experimental outcomes. So if you are increasing the resistant to current treatments, if you’re increasing the susceptibility of a host population, if you’re altering the host range, this could only infect mice and now you altered it to infect humans. And so if you make a change that is potentially detrimental to public health, that would fall under this category one.

Justin Osborne: Thank you. So then I guess my question is, and I don’t know too much about the publication side of this, but if you’re publishing these kinds of results, right? There’s been a big push in the research science area to publish everything, right? Good or bad, we should be letting people know what’s working, and almost as importantly, what’s not working, right?

In this area, this seems like a, “Gosh, do we want to put this kind of publication out there for potentially the world and others bad players to see the science behind how you can manipulate something to make it harmful,” right? I mean, are there additional restrictions or guidances on the publication side of this kind of research?

Melissa James: Yes. So there are reviews of the publications and what should and should not be included. There are also export controls. So if you’re presenting something in another country or a different location, there are certain things that you can and cannot say during that presentation.

Anne Hawkinsbadge: So going back to that, your funding agency would probably establish those requirements. Would that be a fair thing to say because they also oversee to a certain extent the rate up?

Melissa James: So the NIH did issue guidance for implementation of this policy for funding that they provide. And not all funding comes from the NIH, but a lot of it does. So I think part of the risk mitigation plan is what would be published and what would be presented. So as you’re going back and forth with the funding agency and the PI discussing what mitigation measures are going to be in place for protection of people, protection of public health, protection of the information, that’s where you would define what can be published and what cannot.

Justin Osborne: Yeah, that is interesting.

Anne Hawkinsbadge: Melissa, may we circle back to IRE committee. Are there any specific requirements to the type of individuals that should be members on that committee?

Melissa James: Yes. I’m glad you asked that. So the Institutional Review Entity or the IRE has to have at least five members, and those members have to have sufficient expertise to assess the applicability of the policy and understand the biosafety and biosecurity implications. They also have to have knowledge of the institutional policies and the federal policies, have knowledge of potential pandemic pathogens, and Dual Use concerns. And they also, as a committee, had to be empowered by the institution to ensure research oversight policies are followed.

Justin Osborne: Okay.

Anne Hawkinsbadge: Another question I have about that. Your Internal Biosafety Committee, could that serve as an IRE or could the IRE be a subcommittee of the Internal Biosafety Committee or whatever the institution finds most acceptable to their processes?

Melissa James: Yes, it could be any of those. So the institution I’m currently working at uses the entire IBC as their IRE. Where I worked previously, they use the subcommittee, subset of the IBC to serve on the IRE.

Justin Osborne: Okay.

Anne Hawkinsbadge: So based on everything we’ve talked about so far, it seems like this new DURC policy is very complex, but it also appears to be somewhat flexible so that your institution can use what’s currently there and modify it. Would that be correct to say?

Melissa James: Yes, as long as it’s meeting all the criteria of the policy, the implementation of it can be site specific.

Justin Osborne: That’s good to hear. I mean, there’s been a lot of policies and research, right? If you just look across the research, there’s a lot of updates going on in the last several years, and a lot of policies and regulations kind of changing and altered. But I do like the fact that a lot of these updates are remaining flexible, like Anne said, right? You have to figure it out. You have to make it work within your own institution because every institution is different, right? And how you perform research. Like we always say there’s not one way to do research.

Help us understand, I guess, takeaways, right? From this policy. In your opinion, what’s the biggest takeaway? If I’m an institution, I’m listening to this and like, “Oh, man, this might apply to us,” or, “We’ve been doing research in this area, and so now we just need to learn the new stuff.” Or maybe we’re part of this group that we talked about that this now triggers us into this bucket and this wider net is catching us. So what’s the biggest takeaway in your mind?

Melissa James: So I would say it’s important for institutions to know the policy, prepare for the time commitment and the staff that it’s going to take to review the research protocols and the ongoing research that could fall under the policy, and ensure that they’re communicating with the funding agencies on what they specifically require and back and forth with the investigators on what specifically their research is, the agents and the potential experimental outcomes.

Justin Osborne: Okay. That’s good. So then I guess just to follow up on that. One more question about the takeaway. You said that you have to know the policy, and we’ve kind of gone through some of the specifics, but is there anything in this policy that would maybe require institutions to add more resources somewhere that they don’t currently have because of the old policy maybe didn’t require it? Is there any of that in this new policy update?

Melissa James: I think so, because the number of agents has expanded so significantly, and there are a number of biosafety level three laboratories who work with risk group three agents that would fall under this policy that do not work with select agents. And so they wouldn’t have resources in place that an institution working with select agents already does. And so you might have to establish an IRE.

Justin Osborne: Okay. No, that’s really helpful, right? Again, for the listeners, I mean, everybody knows if you work at an institution or a research organization. Adding resources always takes a while. So that’s important, I think, for people to know.

Anne Hawkinsbadge: So when an institution is looking at the new DURC policy, and they’re try and identify the individuals that they need to communicate with on this policy, should they also communicate to the people who are not directly involved with the research that maybe say, for example, are involved with receiving the funds or anything like that? Should they have some knowledge about the new policy?

Melissa James: Sure. Yes. So you do want to talk to research administrators and financial administrators, compliance officers, Office of General Counsel. So they’re important to involve in these areas so they know what to expect and they know the right questions to ask.

Anne Hawkinsbadge: Melissa, this is one I need help on. If you receive NIH funding for something other than DURC, you still need to qualify?

Melissa James: Yeah. So under the NIH guidelines for recombinant and synthetic work with nucleic acids, if the institution receives any federal funding for any research project, all of the research falls under those requirements. This does not apply, it’s very specific to the research that’s being funded. So even though institutions may adopt a policy that is broad for all investigators and agents that might fall under this policy, it’s not required. It’s only required for the specific project that’s receiving that fund.

Justin Osborne: That’s a nice clarification. This is all fantastic information, Melissa. Thank you so much for educating us. I guess, last question here, any other advice that you want to give institutions or researchers around this whole new policy and everything we’ve talked about?

Melissa James: Well, I would say review the policy and know what implications it has for your research institution and how you are going to implement it. The effective date currently is May 2025. However, with the new administration and executive order signed, we’re not exactly sure when this policy will take effect, but I would say be prepared for that date, May 2025, to implement the policy.

Justin Osborne: That’s great. That’s great.

Anne Hawkinsbadge: As part of the show notes to this podcast, we will provide you with the link to the new DURC policy.

Justin Osborne: Well, Melissa, this has been awesome. Thank you so much for talking to us about this topic. And thank you for co-hosting, I really appreciate it.

Anne Hawkinsbadge: Thanks, Melissa.

Melissa James: Thank you for having me. Yes, I really enjoyed talking about the new policy.

Justin Osborne: Welcome back to the podcast. This is the same team segment, and I have our guest, Melissa, and my co-host, Anne. So we’re going to get two stories today, which is fantastic.

So it’s easy to get bogged down in the weeds of our day-to-day jobs, but I do believe people stay in this research industry because we genuinely care about helping people and improving the health of others. So can you give me an experience or an example from your career that connects you with this idea that we’re all on the same team?

Melissa James: Sure. So during the height of the pandemic, early to mid-2020 when PPE was limited and people were exploring the possibility of disinfecting N95 respirators for reuse, my colleagues and many others around the country set up experiments to verify that N95s could be safely disinfected. And in our procedures, we use vaporized hydrogen peroxide, but other people had used different procedures. So we tested the respirators in different conditions and even inoculated them with viable pathogens to prove that in addition to standard spore tests, that actual virus on the respirators was inactivated by the procedure we use. We involved employee health to perform fit tests on the N95 after we decontaminated them to ensure that the integrity of the material remained after multiple cycles and multiple wearings. And so it was really great to work with our team trying to solve a real world problem using each of our expertise in our field.

Justin Osborne: Oh, that’s fantastic, Melissa, to talk about that example and that part of our lives, and it feels like so long ago. But that to me is when the research world came together to help a global issue that was just affecting everybody. So thank you for that. Thank you for your work on that. And, Anne, how would you like to share a story?

Anne Hawkinsbadge: Sure. To basically build off what Melissa did, I was working at an academic institution at that time, and that academic institution offered a degree in dental hygiene. So we wanted to make sure our students were still able to learn and get through their courses during this pandemic. Obviously many of the classes were off-site, but we still had to do clinicals. So when you’re doing clinicals and you may maybe have 40 dental hygienist chairs there performing oral exam and performing tooth cleaning, obviously you know there’s going to be aerosols there. So we were using the information similar to what Melissa generated on what N95s to use, as well as we did the research to find out what local ventilations we could put near the patient in order to capture that so the dental hygienist student and their professor would have the reduced amount of exposure. So I think combining what we did is actually taking, like I said, the great things that Melissa did, and applying it so that the students could get through the course.

Justin Osborne: Wow, full circle. That’s amazing. That’s amazing. Those are fantastic examples. I really love hearing stories like that about everybody had their role that they played in that time, but also just in research. It’s just nice to see and connect dots and see how we’re all doing our part to help move things forward.

Anne Hawkinsbadge: Yup.

Justin Osborne: Well, thank you. Thank you both. Thank you, Anne, for co-hosting. Thank you, Melissa, for joining us. This is a lot of fun. Thanks for educating us.

Anne Hawkinsbadge: Thank you.

Melissa James: Absolutely. Thanks for having me.

Justin Osborne: Be sure to follow, like, and subscribe to On Research with CITI Program. If you enjoyed this episode, you may be interested in other podcasts in the CITI Program universe, including On Campus and On Tech Ethics. You can listen to all our podcasts on Apple Podcasts, Spotify, and other streaming services. You should also review our content offerings regularly as we continually add new courses, subscriptions, and webinars. Thanks for listening.