On Research Podcast – PRIM&R 2024 Conference Recap

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1. Introduction to the Episode (00:00:00) Overview of the podcast episode and the speakers discussing the PRIM&R Conference recap.
2. Initial Impressions of PRIM&R (00:02:29) Speakers share their overall thoughts on the conference atmosphere, energy, and attendance.
3. Reflections on Conference Topics (00:04:25) Jaime reflects on recurring topics and the evolving challenges faced by attendees.
4. The Importance of In-Person Connections (00:05:29) Walden emphasizes the value of in-person interactions and spontaneous conversations at the conference.
5. First-Time Attendee Experience (00:06:43) Nate shares his experience as a first-time attendee and the positive vibe he observed.
6. Common Challenges Discussed (00:07:15) Discussion on recurring themes and challenges faced by attendees, highlighting the shared struggles.
7. Shift in AI Discussions (00:08:18) Jaime notes a shift in AI discussions from fear to ethics and integration in research.
8. AI as a Tool in Research (00:09:23) Karen discusses the recognition of AI as a tool to enhance human review processes.
9. Single IRB Mandate Conversations (00:10:47) Rafael highlights discussions around the FDA’s single IRB mandate and its implications for local IRBs.
10. Navigating the Single IRB Landscape (00:12:07) Discussion on the evolving landscape of single IRB reviews and institutional responsibilities.
11. Combining Conferences: A New Approach (00:14:24) Speakers discuss the benefits of combining IRB and IACUC conferences for better networking.
12. Challenges of Budget Constraints (00:16:16) Discussion on the financial challenges smaller organizations face in attending conferences.
13. Takeaways for Non-Attendees (00:17:00) Speakers share the unique networking opportunities and benefits of attending the conference.
14. Regulatory Agency Interactions (00:18:16) Karen discusses the value of informal conversations with regulatory agencies during the conference.
15. Local Conferences as Alternatives (00:19:04) Speakers suggest attending local conferences and utilizing online resources for those unable to attend.
16. Quality of Content Justifies Attendance (00:20:06) Nate emphasizes the value of the conference content and the importance of engagement.
17. The Importance of Attending Conferences (00:21:11) Discusses the value of attending conferences in person versus virtually and the benefits of networking.
18. Sharing Knowledge in the Industry (00:22:47) Encourages passing on knowledge to others in the industry for collective growth and success.
19. Documenting Institutional Knowledge (00:23:52) Highlights the necessity of documenting procedures and knowledge for continuity in organizations.
20. How to Present at Conferences (00:24:25) Introduces the process of submitting proposals to present at conferences and shares personal experiences.
21. Overcoming First-Time Speaker Anxiety (00:27:20) Encourages new speakers to embrace their experiences and recognize that everyone starts somewhere.
22. Flexibility in Presentation Topics (00:28:46) Stresses the importance of being adaptable with presentation topics to align with conference agendas.
23. Engaging Presentation Topics (00:30:16) Suggests focusing on professional enrichment topics that resonate with new industry entrants.
24. Submission Timeline for Conference Proposals (00:30:55) Clarifies the timeline for submitting presentation proposals and the planning required.
25. Volunteering for Conference Committees (00:31:59) Encourages participation in review committees as a way to gain experience and insight into the selection process.
26. Collaborative Session Ideas (00:33:10) Proposes that unanswered questions during sessions can inspire future presentation topics.
27. Audience Engagement in Presentations (00:34:28) Shares insights on the importance of audience interaction during presentations for enhanced engagement.
28. Discussion on Political Changes Impacting Research (00:35:32) Explores how political changes influence research topics and discussions at conferences.
29. Local Context in Research Regulations (00:36:35) Examines the challenges of managing local contexts in research under varying regulations.
30. Navigating Changes in Research Responsibilities (00:40:18) Discusses the evolving responsibilities of IRB professionals in the face of regulatory changes.
31. Self-Regulation in Non-Covered Entities (00:40:49) Highlights the trend of organizations choosing to self-regulate beyond mandatory regulations.
32. Vendor Perspectives in the Exhibit Hall (00:41:31) Shares insights on how new attendees can approach vendors and navigate the exhibit hall effectively.
33. Conference Atmosphere (00:43:17) Discussion on the vibrant atmosphere and personal interactions experienced at the conference.
34. Exhibitor Engagement Strategies (00:44:13) Recommendations for exhibitors to provide hands-on workshops for better engagement.
35. Exhibitor Theater Concept (00:45:19) Introduction of exhibitor theater sessions to enhance vendor presentations and demonstrations.
36. Conference Size Comparison (00:45:41) Comparison of current conference attendance to pre-COVID levels and expectations for future growth.
37. Physical Space Impact (00:47:28) Exploration of how the physical layout of the conference affects attendee and exhibitor experiences.
38. Lunch Logistics Discussion (00:48:37) Concerns about the absence of lunch and its impact on attendee engagement and networking.
39. Final Thoughts on Conference Value (00:52:46) Participants share key takeaways from the conference and emphasize the importance of interactions.
40. Encouragement to Explore Diverse Sessions (00:55:34) Advice to attend sessions outside one’s area of expertise for broader learning opportunities.

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.

Welcome to a special episode of On Research with CITI Program. This is our annual recap of the PRIMR Conference, and I was thrilled to have an amazing group of research professionals join me for this discussion. I have Jaime Arango, Vice President of Content and Education for CITI Program. Raffaella Hart, the Senior Vice President of IRB, IBC and QA at BRANY, Karen Christianson, the Senior Vice President and Managing Director of the HRP Consulting Group, Walden Leverich, the Senior Vice President and Managing Director of Tech Software, and Nate Ferguson, a consultant and IRB analyst who works with various clients, including footwear and apparel companies engaged in human subject research.

It’s a great group, mixed with experienced PRIMR attendees, and first-timers, sharing their thoughts about the recent PRIMR Conference which took place in Seattle from November 17th through the 20th. This year’s conference had 2050 attendees in person, and 850 virtual attendees. This year also marked PRIMR’s 50th anniversary, and being a staple in the research oversight and compliance conference world, it was nice to be able to reflect on the time and experience at the conference and share those thoughts with you all. We share our key takeaways, standout sessions, topics that came up outside of the sessions, and some of the benefits of attending these conferences in person.

We also had several folks in our group that presented at the conference, and they share some great advice for those interested in speaking at future conferences. And don’t worry, we did a deep dive on the impact of the no-lunch decision this year. So without further ado, I hope you enjoy this special PRIMR recap episode.

Well hey, it’s so exciting to be here. We got a big group with us here to talk about the PRIMR Conference that just happened in Seattle a couple weeks ago. And it has been a couple weeks, we all just came back from PRIMR, and then we had a holiday, enough time to just forget about it. Everybody remember PRIMR?

Raffaella Hart: I know.

Walden Leverich: Not overly, no.

Raffaella Hart: It sounds like a long time ago, yeah.

Justin Osborne: Yes. So now we’re here to sort of recap. So I appreciate everybody being here. I wanted to kick off this discussion with everybody. In a sentence or two, give me your sort of overall opinion of PRIMR. It could be the content of the sessions, the mood or energy, any of your thoughts. So we’ll start with you, Raffaella.

Raffaella Hart: Thanks. I would like to say that I thought it was good to see all the faces in person, both familiar and new. And it’s good to see so many people who still remain interested in this work, and advancing discussions of all these topics. And I also felt a lot of good energy from what I felt like was a little bit of a younger crowd. I mean, I guess I’m getting on in my own years, so I felt like I saw a lot of younger faces there. And similarly, there was a lot of discussion of topics that were old, but being revisited with the lens of today’s challenges, today’s new technologies, or the evolution of some old questions that have new regulations, and new guidances, or new mandates, and new environments that people are thinking about them. So, that’s what I took away from it.

Justin Osborne: That’s awesome, thank you. Karen?

Karen Christianson: I thought it was a great conference. Like Raffaella, I loved to see everybody in person, and I picked up on the same young vibe. Justin and I had experienced that at AHARP as well. As we kind of looked around, we’re like, look at all of these new people. And with the new people comes a new sense of vitality, and engagement and excitement to be present and to learn, which is always great to be around. But I also love seeing those old faces, and the classic Ivor sing-alongs are the absolute best.

Justin Osborne: That’s great, that is great.

Raffaella Hart: Agreed.

Justin Osborne: Thank you. Jaime?

Jaime Arango: Well now since Karen has used the term old faces, I’m glad to say that I belong to the younger group that was at PRIM&R. No, when you started this question, I recall that this is my 21st PRIM&R, something like that. I missed one. And as both Karen and Raffaella have said, it’s interesting to me that some of the same topics… Like, I looked at the sessions, I’m like, “Didn’t we address this issue before? Why is this back?” But then I guess, new people are facing some of the same issues now with new paradigms that go with them. So, I think that’s part of it. I do think that there was a sense, I think there’s a little bit of a tension I think, or maybe stress as to what’s happening in the regulated communities, certainly as the administration changes next year. So I think that, and certainly in some of the sessions that came up. So I think that’s a big thing. And of course there was the changes at OHRP this year, so that’s also a big change.

Justin Osborne: No, that’s great, that’s great. Thank you. Walden?

Walden Leverich: I think the biggest thing for us, or the greatest thing for us about PRIM&R is actually seeing people as others have keyed in on. But it’s that thing I call the water cooler effect that you’re never going to get in the virtual conference, you’re never going to get in a conference call or Zoom meeting, of being next to somebody else, maybe not even in that conversation. And somebody says something and you get to turn around and say, “Wait a minute, what did you say? I have that problem,” or, “I’m experiencing that situation.” And so, I think for the people that come to PRIM&R, certainly as an exhibitor, it’s great to see them. But as an attendee, I think there’s nothing like actually attending conferences in general, and certainly PRIM&R in person. So, I was happy to see more people this year than I think last year. I don’t know that that is actually the statistic, but it certainly seemed that way, and hopefully that trend continues moving forward. But I think seeing the people in person was absolutely the best part of PRIM&R.

Justin Osborne: Yeah, that’s great. Especially since Walden, like you said, most of us, or a lot of us anyway, right?

Walden Leverich: Right.

Justin Osborne: So the fact that we can get in-person to have those conversations, that’s great. And Nate?

Nate Ferguson: Yeah. Thanks, Justin. And unlike Jaime, this was my first conference, so new-ish to research, not new to conferences in general. And there was a good vibe from a lot of the folks. So a new face, meeting a lot of new people. I also liked to people watch, so it was interesting seeing old friends be reunited as well. And from the content perspective, I think the quality of the speakers, and the interaction with the other attendees is what really makes or breaks the sessions. And that was really important, and what contributed to me having a good time there.

Justin Osborne: That’s great, that’s nice to hear. And actually, I’m going to jump off that, Nate. When you’re talking about the sessions and the content, let’s go around and talk about what stood out to you. Thinking about topics or themes specifically, that really stood out as you were either going to sessions or having conversations with people.

Nate Ferguson: So, like it was alluded to earlier in the intro, there are common topics that seem to come up each year, and “Didn’t we talk about that, or didn’t we solve that?” And so, it was interesting to sort of synthesize that everyone seems to be struggling with something, so you’re not alone. There’s somebody out there who has just recently solved that problem, or has recently addressed that, or is experiencing it at the same time. So it was really interesting whether that was a regulation, or staffing and research operations related, or interpersonal issues with IRB members or whatnot. Those common themes came up. And so to see several of the sessions content specifically geared towards those questions was helpful for a first timer, but also left me curious about how come these seem to be so hard to solve if they keep coming up, these problems?

Jaime Arango: That’s fair, that’s fair. So I think for me there was the shift… Last year’s conference was I would say, AI phobic, that almost every other session seemed to be how AI was going to turn into Terminator. And now it seems like we’ve accepted that AI is there. And it seemed to be that almost all the AI sessions were AI ethics. It’s become like it’s now, it’s accepted, it’s going to be here. We are still trying to figure out how we’re going to navigate it, and how the parts are going to play. And I think they’re may be a little bit more into the data space and the data privacy kind of issues that AI brings up. Which for me was a shift from the last year, “Oh my God, AI’s coming in, and it’s going to write all the informed consent forms.”

Justin Osborne: Well, that’s true Jaime. And I feel like this is the adoption curve. It’s fascinating to me that Research, as much as we’re on the front lines of innovation, we tend to lag in that adoption curve it seems a lot of times. Other industries have adopted and accepted AI with open arms for a little bit, and then now Research is starting to have those kinds of conversations. So that’s interesting.

Karen Christianson: So, it’s also interesting to hear the research compliance folks starting to talk about how they can start to incorporate AI into their work. And how it can be a tool to compliment the human review, to make it more efficient but not replace it. So, it’s not just now about the review of AI, it’s, “Hey, how can we use this stuff to do better?”

Justin Osborne: Yeah, yeah, that’s important.

Walden Leverich: To piggyback on the AI issues, I think it’s also a recognition that it is a tool, Karen, as you just used that word. I mean just for the older of us it’s, “How dare you use a typewriter? You need to hand write your paper in school.” Or, “How dare you use spell check. If you had spell check you’ll never learn how to spell anything.” This is just the next evolution of that same thing. It’s going to replace some jobs, it’s going to replace some activities, and it’s going to create new ones. And we certainly have clients that may do less review on a specific IRB submission. But now they have to do review of an AI project, and how is AI being used specifically? So, we’re moving work from one spot to another, more than eliminating work at times, in a good way. And so, I think it was great to see those conversations as well.

Raffaella Hart: I was thinking about what Nate said about the problems that continue to be there, and still seem like we should be solving them. And the one that rings a bell for me is the single IRB mandate that everybody was talking about, FDA single IRB mandate. And I attended a session where they talked about the impact on your local IRB and your HRPP for single IRB once the FDA’s mandate goes into effect. And it’s interesting, because it has been so many years, like almost 10 years since the first mandate from NIH and company went into effect. And we’ve learned so much about dealing with it. And the speakers were talking about how this new evolution of the mandate is going to cause them to have to rethink a little bit more about their programs.

And some of them, some of the smaller places, we’re talking about how if the FDA requires single IRB review, that’s kind of all their local IRB is reviewing now, FDA regulated clinical trials. So now what are they going to do with all their committee members, and people, and resources? And how will they keep them engaged and learning? And so, there was a lot of interesting questions brought up by this new mandate, which I thought this was a problem solved, we’ve been doing it for so long.

Justin Osborne: Yeah. No, Raffaella, that’s true. I think I saw at least three sessions on this topic, and I said it on one of them myself. And in that session, some of the people we’re talking about, to your point, the larger academic centers, they have this figured out. They’re not worried about it, right? They’ve been doing it anyway. The smaller places though, I think the conversation in that session shifted towards, to your point, they’re outsourcing stuff. But that doesn’t mean that you get rid of your resources, because there is still a reliance piece. And all those conversations again, to everybody’s point here, may come in new. We’ve had this conversation about reliance for so long, now it’s just in a different framework. We’re just talking about the reliance process in the context of the single IRB mandate. We’ve always had that sort of conversation since central IRBs came out. It’s just, now there’s a new lens that we have to look at it through. And so how do we deal with that?

Walden Leverich: I think the other piece in there, and Raffaella, you used the term IRB, and then immediately the term HRPP program. But understanding that what is actually going to be handed off to that central IRB, that single IRB of record, and what is the institution still have on their plate? And I know it’s things in the past I’ve referred to as the Daily News problem, or the New York Post problem being a New Yorker. The last thing you want in your program is to get a call from the newspaper going, “Tell me about this study,” and you going, “What study?” Having that knowledge of what’s going on in your environment, even if an external IRB has regulatory responsibility, you still need to understand what’s going on in your environment. And so, those programs are going to have to still exist in hospitals, in small universities, in social behavioral settings.

Justin Osborne: That’s interesting. So, I did want to ask the group here, while we’re talking about HRPPs and IRBs and stuff, but IACUC was there too, right? And so, this is the second year I think that they’ve done that. What is your take on that? I mean, I know that it does bring more people in. I know there’s several sessions on the overlap. But just in general, what do you think that the vibe is on mixing the two?

Walden Leverich: I think it’s great. Certainly we see across a number of different organizations. And yes, in some organizations these are drastically different people that might wave at each other at a holiday party. But in other organizations, this is a common office. These are I say, the dirty little secret of IRB and IACUC and IBC and everything else is, that they all do the same thing. They have different regulatory magic numbers. They’re looking at different questions on a form. But fundamentally it’s still the same process that the IRB is doing, and the IACUC is doing. Some of the more esoteric coroner cases. Sure, if I’m an IACUC person, I’m not going to go to that IRB session and vice versa. But having it together I think for organizations, especially if you’re going to send people, going back to my comment earlier about, please send people because you can’t get the experience remotely. It’s now one conference I have to send people to, not two conferences I have to send people to. And that helps in budgets and everything else as well.

Justin Osborne: That’s a good point. I think-

Karen Christianson: And from an exhibitor’s standpoint, I think it’s fantastic. We experienced several groups who, one side of the shop would come up and have a conversation with us and they would say, “Wait, you do that too?” And they’d come back later with more people from their organization. And that’s just not something that you experience when the groups are separated.

Justin Osborne: That’s true.

Jaime Arango: Yeah. I would echo what Karen said. I think that as an attendee, I think PRIM&R is still trying to navigate how the programming occurs. I think that’s still is a little unsettled. I think it’s better than last year, because last year was I think a true split between with the overlapping day. Now it seems to be a little bit more of a hodgepodge. It’s got its pros and cons. I think we’re just still navigating what those are.

Justin Osborne: Well, I do want to go back to something Walden just mentioned a minute ago. So, I know one of the struggles, and I talked to a couple organizations there, one of the struggles of the smaller research organizations and institutions is the cost of sending people to these conferences, to your point, Walden. I know PRIM&R had a lot of people attend both in person and virtually like we talked about. But there are so many people out there that cannot come to these for budgetary reasons or whatever. So, for those people that couldn’t come either in person or virtually, what takeaways would you give them? Why do you think people should attend PRIM&R in the future? If you missed out and you’re listening to this and you’re like, “Well, good for you guys. You attended PRIM&R, I couldn’t go,” what do you think the biggest sort of takeaway is?

Jaime Arango: Go ahead.

Raffaella Hart: No, I was going to say, I would go back to Walden’s comment about being able to bump into somebody, and have a conversation that you otherwise wouldn’t have. It’s a unique environment, the PRIM&R Conference, where there’s people who do what you do. I can’t tell half my family members anything about what I do for a living because they really don’t get it. Or I have to do a long explanation and their eyes glaze over. So, it’s a unique environment. You can really bring your own program’s questions and get answers by networking, running into exhibitors, asking other professionals, overhearing a conversation. And even if you’re too shy to ask a question like that at a session during the Q&A, you could hear others get up there.

You could maybe get the courage after hearing others get up there. Or, you could just end up sitting next to somebody at a table who becomes somebody that you realize does what you do, has the same issues that you have. And you exchange your email address and suddenly you have somebody to bounce ideas off of. So, it’s really a unique environment for that. And you can’t get that same level of interaction or networking virtually.

Justin Osborne: That’s true.

Karen Christianson: I think it’s also great how they have the regulatory agency and accrediting agency office hours. Because you can go and sit with these people at a small round table and have a conversation, which is a lot less intimidating than going and standing up at the mic in the conference.

Walden Leverich: I think one of the at-conference advantages is, and you can do this off-conference too, but speaking certainly as for us as a vendor, we’ve had clients stop by and just friends stop by and say, “I can’t ask this question of the regulatory agency because I don’t want them to know who’s asking. But can you ask this question of the regulatory agency?” And we’re happy to do that. I’m sure, Karen, your team’s happy to do that. Where the regulatory agencies then have no idea who’s asking this question. And so the ability to have, yes, if you’re willing to sit down, that’s a better approach. But certainly remember you always have friends that can go and do that as well. I think too, speaking of budgetary constraints, if you can’t attend a national session, a national conference like PRIM&R, there are local ones perhaps that you can smaller groups.

But still, whether it’s a local OHRP or an AHRB conference or something like that, or certainly there may be listeners that aren’t aware of the PRIM&R mailing list and things like that. Where you can anonymously if you want to, ask questions and get the feedback. It’s still not the same as having that face-to-face conversation. But those are for people that are really struggling with budgetary constraints, that’s certainly make sure you’re taking advantage of the free resources that are out there.

Justin Osborne: Yeah. No, that’s great, good advice.

Nate Ferguson: I would say that the quality and variety of the content, or the sessions absolutely justifies at least the virtual attendance if you can’t make it in person. But like many things, you get out what you put in. And so, I found the sessions that I enjoyed more, or walked away with a better understanding of something, were ones where I asked questions of my table mates, or listened and then followed up with someone who asked a question at the Q&A. Or just had side conversations with people who were reviewing the posters and the presentation. So, that in-person interaction is worth so much, and it’s hard to replicate online. But even as an in-person attendee, I was curious what the virtual experience was like. And so, I actually joined one of the rooms and watched that presentation virtually. And it was I’d say, well-produced. I’ve been at other conferences where it was maybe a bit more cobbled together. So just from an execution perspective, it was delivered at quality, very accessible sort of fashion.

Justin Osborne: Nice, nice. Good to know.

Walden Leverich: One other comment on virtual conferences. If you do go virtually, go virtually. I know I spoke to a number of people after the conference that have said, “Yeah, we signed up for it virtually, but then we got distracted and we didn’t do this, and we didn’t do that.” I mean so, if you are at least able to get the money to attend virtually, actually attend, and get the benefit that you’re paying for.

Justin Osborne: Yeah, yeah. No, that’s good advice. Like Nate said, you get out of it what you put into it, right, with all this stuff? And I agree. I think we’ve touched on networking a lot here too. But I think just the in-person stuff as a vendor, those networking sessions and the receptions that they have after the long days, and everyone’s just exhausted from learning so much. And then they give you the drink tickets, and everybody’s excited. And those times are, you can’t replace that. There’s so much, there’s so many good conversations that happen in that setting that I think whether… And from our standpoint as a vendor, it’s nice to build relationships and whatnot. But if you’re just going as an attendee, that’s where you meet people to add to your network.

And this is why personally, this industry is full of people who want to help other people. And that to me is the sort of key to success of longevity in this industry, is building up your own personal network of people at multiple organizations that you can kind of go to. And then as you build up, you can share knowledge with the next person. So I think that is, you can’t replace that stuff. So I love going in-person to these things, obviously, but I’ve never done the virtual stuff. So it’s good to hear that it’s executed well.

Walden Leverich: But I want to piggyback on something you just said there, Justin, about, you can hand that knowledge off to the next person. For the love of God, please hand that knowledge off to the next person. People move around in this industry. And if you have the opportunity to document in your organization what it is you’re doing, why it is you’re doing it, and hopefully explain that to the next person before you depart. That will make such a difference in this industry that it’s unbelievable.

Justin Osborne: Yeah. No, that’s great. That’s great advice. Walden. Somebody had told me years ago at an academic medical center, that their currency is knowledge and information. And so, a lot of people do feel the need to withhold knowledge, because that becomes their currency, and then they don’t pass it on. And I feel like we should be passing stuff on. This is what makes this industry continue, and evolve, and grow and all that stuff. So I’m with you.

Karen Christianson: It’s funny for me, because from a nursing background, and from when I first became a clinical trial nurse, if you don’t document it, it didn’t happen.

Justin Osborne: Absolutely.

Karen Christianson: So, I’m amazed at people who don’t write down all of the procedures that they’re doing, and why they do them. But if people are super busy and it happens, you’re just trying to keep the ship in motion, and you don’t take the time to record that institutional knowledge that can be so important.

Justin Osborne: Yeah, that’s good. So, I did want to talk to the group about presenting. So, a couple of you presented at PRIM&R this year. But I want to hear from you, Raffaella and Karen specifically. For those of you listening, or those people listening that are maybe interested in presenting in the future, and how do you do that? What is the process? How do you apply? I’m sure it’s pretty consistent across conferences, but kind of walk us through the steps.

Raffaella Hart: Sure. For me, I submitted a session proposal with two of my colleagues, one from my organization and one from another organization. And we waited, and we got rejected, our proposal got rejected. Shortly after the notice that the proposal got rejected, I received a request to be a speaker on a session that was very similar. I guess they had already decided on a session that was very similar to the proposal that we made. And in fact, one of the other speakers that made the proposal with mem was also offered a request to be a speaker on the same topic. So, that’s how it happened for me this time. So we made a submission proposal and waited, and then we got rejected, and then we were asked to be speakers on a very similar topic-

Justin Osborne: That’s interesting.

Raffaella Hart: … which worked out, yeah. And the third person that was added, I guess, was the person who proposed the similar topic.

Justin Osborne: And what about you, Karen?

Karen Christianson: Yeah. So, I had submitted a session proposal with a client university, and we were accepted. But it was interesting because they added a third person on, which is welcome for that variety of perspective, but made that third person the facilitator. And she ended up not wanting to take on that role, because this was only her second PRIM&R. And she didn’t want to have to deal with the logistics and corralling everybody and pulling everything together. So, I think she did a wonderful job. I think she brought additional perspective to our presentation. But one of the things to keep in mind as you’re preparing and planning, especially if you have speakers from three or more organizations is, there is a lot of coordination of people’s schedules. And there’s a lot of time involved to be able to pull your content together, come to agreement on everything, and get everything formatted properly. Every year I go into this saying that I’m not going to be doing this the last week when the slides are due. Every year I’m still doing it the last week when the slides are due, so don’t be me.

Walden Leverich: You managed to do it before the slides are due? I never could work that one out, I was always late with slides. I just want to touch on, we commented earlier about there being a number of new faces. And I think if people are looking at presenting at PRIM&R or at any conference, we’re kind of all looking at the people that are presenting now. And these are people that, I want to remind the new people that, these are people that have done it for a while in some cases, and are very polished. Don’t be necessarily afraid by looking at somebody up on stage singing an IRB song, or somebody telling stories of 70 years of IRB history. We all were not speakers at some point. We’ve all been the first time speaker if you’ve ever been a speaker.

And so, if you ever want to learn something, figure out how to teach it. And so, if you can do a presentation on what it’s like to be new in the industry, what it’s like to struggle with this situation in a small university, in a large university. And your perspective is different from many others, and it’s something that you’ve got to just go and do, and it’s not easy in a good way. Everyone that does it well did it badly the first time. So go ahead and do it anyway.

Jaime Arango: I hope Walden closes out this podcast with a musical number that we won. A little bit of something that Raffaella said which I think is important is that, when you think about speaking or being on a session at PRIM&R or any conference, but I think in particular in PRIM&R, is the flexibility that you bring. Because it more often than not will be that your initial idea you may think is great, but will be morphed into something that fits the overarching agenda that they’ve got going on, because they’re trying to avoid obviously duplication in other pieces. And I think having that flexibility increases your chances of really being a presenter, if you can kind of pivot. The other thing that I was going to say, the other thing that I think about when I presented is that, when we submit proposals. You have a tendency to focus sometimes on very procedural kinds of things in the day-to-day.

But I think sometimes some of the most interesting topics to me are those that are that professional enrichment pieces. How do you succession plan? How do you onboard new people? All those new faces that we were talking about are folks that I can promise you didn’t think, “I’m going to be an IRB person or an IACUC person in my future.” And so, all of those kinds of concessions also I think are really, really helpful, particularly for those who are new to the field.

Justin Osborne: Yeah. No, that’s great, that’s great. I agree. I think there’s probably a lot of people out there that are… We talked about the new faces. But people who have been in it for a couple years, and they might have some good ideas, but it’s just, you go to a lot of these conferences. And if you go to multiple, you start to see some of the same names. Because there are people obviously who just come around and they talk at all these things, which is great, and they have a lot of wisdom to share. But I do think it’s a little nerve wracking to think about like, “How do I actually get started and share my ideas with people?” I am curious about this process, just to go back to the actual process side of it. How early did you all have to submit your ideas to PRIM&R before?

Karen Christianson: I believe it was a February due date. We got notification in July.

Justin Osborne: Okay, okay. For November?

Karen Christianson: Yeah.

Justin Osborne: Yeah. Okay. So again, for those listening, I mean, this is not something that you can think about in the fall and submit, and then speak at that conference. It takes some planning and time to come up with an idea and submit it.

Jaime Arango: And I think also, I mean, that sometimes I’ve done multiples, because you don’t know which one they’ll pick, so you might do two or three. Sometimes variation on a theme, and the other thing we didn’t talk about, but PRIM&R always asks for volunteers for the committees that review both the session suggestions and the posters. That’s also a good way to get experience, because you actually then see what folks submit, and how they write it, and what makes it. And I haven’t done that process in a while, but it used to be that you were paired with people who were… You had your set of items that you reviewed. And then you got some good discussion as to why I don’t like that session, why I do like this session, could this fit in one way or another?

Justin Osborne: Yeah. No, that’s good, good advice.

Raffaella Hart: I’ll also add that, we were talking a little bit earlier about the budgetary constraints on being able to attend PRIM&R. And actually, if you end up as a speaker, they do offer a discount on your registration. So that’s another reason to throw your hat in the ring I guess.

Justin Osborne: That is a great point.

Nate Ferguson: I’m very appreciative to everybody who submits, especially that early on. And I’d encourage folks, there’s probably someone with a similar idea that you have out there, like we heard earlier on, and with that flexibility Jaime talked about. Hopefully you can land in a place to be able to talk about something you’re passionate about, something you have a point of view on. Or some maybe long-term well-earned insight or knowledge about something that other people would benefit from hearing from you about. So, if you have any one of those things, that’s what I would suggest, reflect and think about getting on that. The due date I imagine is coming up soon for next year’s conference.

Jaime Arango: The other thing is, it used to be too that sometimes PRIM&R has the idea, or the session, and then tries to populate it with the speakers. So, reaching out to the conference committee and volunteering is another way of maybe getting onto the agenda to be a speaker.

Raffaella Hart: Another thing I had is that, during one of the sessions, one of my colleagues got up and asked a question. And the speakers said, “We’re not sure of the answer. You know what? You should propose a PRIM&R session on that for next year.”

Justin Osborne: There you go.

Raffaella Hart: We’ll all get together and we’ll work on a session, and maybe we’ll get some answers. So it’s another way topics come up, I suppose, unanswered questions.

Justin Osborne: Yeah. No, that’s good.

Karen Christianson: And just kind of building off of Nate’s point about being truly interested yourself in the topic that you’re presenting, and having that energy around it, I do think it makes a huge difference. In our session this year we planned for a lot of audience interaction, and then found ourselves plugged into a ballroom. So, I was very nervous about that, and the impact it would have. But the audience was great. And one of my co-speakers was running around the room with a microphone so that people could line up and navigate the tables. And it was absolutely fantastic, we had so much engagement. And I do think that that’s in part because, not only the speakers, but the attendees attended this session because of their interest in this specific topic.

Justin Osborne: Absolutely, absolutely. And, Karen, not to put you on the spot, what was your topic again, the title of it?

Karen Christianson: It was about IRB review of politicized subject matter and populations.

Justin Osborne: I mean, I sat in of course, I loved it, it was a fantastic session. And you’re right, everybody was engaged, everybody was excited. And what’s his name, Michael? Running around with a microphone was pretty hilarious. But to that point, I wanted to piggyback off your session actually, Karen, and ask the group. Jaime, you had mentioned this earlier but, I know I had several conversations with clients and friends there about the sort of change in administration. And I think these topics about polarizing ideas and whatnot in Research. With all this change coming up, what was your sense? Did you all have conversations with people about that? What does the future look like? I mean, we’re thinking about Research down the road with sessions at PRIM&R. I mean, this stuff happened so close to PRIM&R, it happened after the February cutoff, so nobody really could talk about this in a session. But this is all, again, out of session conversations you have when you go there. But, anything anybody wants to share on that?

Karen Christianson: One of the things we kind of left unanswered with some suggestions in our presentation is, how would single IRB and the differences in legislation across so many states and countries, how a single IRB can manage that local context? And who’s responsible for providing that information? When you’re relying site might just have a simple list of studies that they’re relying on other organizations for, that don’t have any elements that would allow them to identify, “Oh, I need to tell so-and-so about this change.” Or, “I need to tell this IRB about that change.” So I think that that’s something including with the FDA mandate coming on, that we’re all going to have to think about is, local context is very different now. It’s not just what’s the age of a minor in your state?

Justin Osborne: Very true, very true.

Jaime Arango: I think the other takeaway for me from the one session where the uncertainty in coming into next year is that, I do think IRB, and IACUC people, and IBC people… I’m afraid we’re going to miss I’s, so I’m just going to say everybody, three I’s, no, that’s a different conference, are resilient people. So I think we move around and navigate. And that’s probably because I think we navigate the politics of our own organizations and our own institutions, and so you kind of learn to do that. But I do think it’ll be an interesting time. And this is now the second or third year that there has been a significant change. I mean, there was a session, I think it was in last year’s, where if your research was funded by the Federal Government, but your State Government precludes you from doing the results of the research in that state. So, it’s not entirely new, but I do think it’s a tribute to the group en mas, that is resilient as we navigate the challenges together.

Justin Osborne: Yeah, that’s a good point.

Nate Ferguson: I definitely feel for all of you and the other participants with the impact of whatever changes may happen or not. But working at a non-covered entity, so a global footwear, and a sports apparel manufacturer and retailer, and RIFB, we get to pick and choose the things that affect us, and how we interpret and adopt the best practices and the regulations. We’re definitely concerned with the larger geopolitical landscape from business perspective, but when it comes to Research, that’s going to be a real struggle. So I feel for you guys. And I’d walk away with more of an appreciation for those struggles that folks have talking with different institutions. Because those questions that researchers bring up are important, maybe more important to some populations. And we’ll just have to see how some of that shakes out.

Justin Osborne: Yeah. No, I think that’s a great point, Nate, thank you for those comments. Because I feel like, and I was just thinking about this as we’re all talking about all the new faces in research… And even for myself, when I joined Research, it was a pretty structured thing. My training was like, “This is how it’s been done for 25 years. Just do it. Just do it this way.” That nothing’s really changed that much, like the little tweaks here and there. I feel like the last handful of years there’s been a lot of changes, I mean I guess, short memory syndrome, like Common Rule on… It’s just a lot of people got out during the Common Rule because they didn’t want to deal with the changes. There’s a lot shifting.

So for these new people to come in to an industry, and be landed with all the stuff that they’re having to navigate and deal with, on top of just learning the basics. We’re so busy talking about these other moving pieces, that was the Belmont Report mentioned in the basic training? Like, that’s where the basic stuff was when I was entering the industry. So I just feel like it’s interesting to think about these new people coming in. I know, Nate, to your point, you guys don’t… You can sort of play on the card a little bit. But for those that can’t, this would be tough, I feel like, for new people coming in.

Jaime Arango: Well, I think too, when I joined the IRB just did IRB stuff. It was just human subjects. And you said, “Oh, they’re dead? Well, they’re not even my subject.” And it was kind of that. But now a lot of the IRB people are being tasked with some of the other elements related to research governance. So, they may have research security, they may be intermingled with the export compliance or some amalgam at their institution. So it’s not just a singular responsibility anymore. So I think that also makes it hard.

Justin Osborne: Yeah.

Karen Christianson: I do want to say that I very much appreciate, and I’m excited by organizations which aren’t subject to regulations who choose to self-regulate. I think that says a lot about our society. And we see a growing number of clients who are choosing to engage. And it is nice working with them, because they can decide to what extent do they want to follow the letter of the regulation, what makes sense for them? And what are other ethical principles that may be more important to the work that they do?

Nate Ferguson: Yeah. We definitely see it as the right thing to do when working with humans. Our work doesn’t involve animals. So the IACUC stuff was curious to me, but really not relevant to the work I did. And same thing with, you mentioned the FDA, single IRB mandate before. We’re a pretty small operation, we don’t do multi-site clinical studies in that regard. But what I find really helpful is to sort of triangulate off of all these other experiences, and how people are interacting, and the successes or the challenges they interface. And try to then synthesize a position for our organization to figure out, “Okay, if this works over here, and this works over there, here are some patterns that are the same.” And then how can we apply those here to uphold the basics, like you mentioned, Justin, the Belmont Report and the Common Rule and things like that?

Justin Osborne: Well, and Nate, I want to stay on you for a second too. Because looking at this group, everybody except you were vendors. We’re in the exhibit hall, we’re standing at a booth, we’re selling services of some kind. From your perspective, because I also feel like I’ve talked to plenty of people who are newer to the industry, and they get a little nervous walking through the exhibit hall. You’re kind of a little cautious with vendors. And aren’t really… They’re afraid we’re all used car salesmen. So, what’s your opinion? What are your thoughts? What can you share with other people that are attending from our other conferences? How do you approach the exhibit hall and the vendors?

Nate Ferguson: Yeah. So, I thought there was a fair number of vendors, not an overwhelming amount. I mean, it wasn’t like a sea of vendors and I can’t see the edge of it type of thing. I also don’t know, was this 80% of the market represented here in terms of people who are offering services or product related to research compliance and ethics and the like? So, I don’t really have a good sense for that. But it did seem like there was a good variety. I did find it a little hard to understand, again, being new, the differentiation between some of the exhibitors or vendors. The names aren’t always intuitive to me. And so, it’s a little hard to tell. And so if you are a little bit shy or unsure, do I really want to approach them to find out what they do to see if it’s relevant to me?

My advice and my approach in that case a lot of times is I just start off, this is, “I’m Nate, this is what I do. This is my role, this is what my organization does. Tell me a bit about what you do.” And that helps whoever I’m talking with, exhibitor or vendor, maybe tailor or focus their presentation, if you will, or how they engage with me. Rather than trying to figure out if there’s a mystery connection here or not. That just makes it much more human interaction. You talk about that type of… Nobody really wants to be the hard sell, if you will.

Justin Osborne: Right. No, that’s great, that’s great feedback. I’m really trying to get you to say that we’re all good people and we’re fine. The vendors are nice.

Nate Ferguson: Well, I had a great time talking with you, Justin, yes.

Justin Osborne: Oh, my goodness.

Nate Ferguson: It was always a delight. Yes, I had several individual and personal interactions with vendors or partners that we work with on a regular basis. So CITI and HRP Consulting, and talking with the AHARP folks. I’m just naturally curious too, so even if there was a vendor or exhibitor providing something that wasn’t applicable to our institution, I was just curious how they do business, and what their success is like, and who else they work with? And so, it was all very informative. From a logistics and layout perspective, it was hard to get down to the exhibit hall sometimes. So if you guys put the hard work in to be there at your booths, good job on you for doing that. It was a large facility. It was nice to have space, but you had to traverse quite a few stairs or escalators to get to different places.

Justin Osborne: That’s true. There were like five floors, right?

Nate Ferguson: Yes, yes, quite a bit. And one thing I’d recommend for folks as exhibitors or vendors, sometimes it’s nice to have workshop type sessions that demonstrate or illustrate a way that a product or service or a combination of things can be applied in a certain situation. So not quite having someone as a member of a panel in a discussion necessarily, but a more hands-on practical way that you can see different use cases, things like that. And you can talk with others who may be users, that’s the helpful thing. And so, it’s also a bit of a way of like, “Well, I’m not sure if I really want to engage in a selling type situation,” but I do want to learn more of those types of interactions I’ve had at conferences in the past that have been super helpful.

Jaime Arango: And I think PRIM&R added that exhibitor theater kind of concept. It was towards the back. So, I think maybe they’re taking that from some of the more commercial kind of conferences, where there is that opportunity for the vendors to exhibit… Not just exhibit, but to actually have a theater scenario, where they can present a demo like Nate’s talking about.

Justin Osborne: Yeah.

Karen Christianson: Yeah. I think they had introduced it last year, but there was really a small uptake, because it was the first time. And this year there seemed to be bigger uptake of that.

Justin Osborne: Yeah, that’s good. So, for the rest of us vendors, how does this compare to past PRIM&Rs or other conferences? What did you think about on our side of the conference?

Walden Leverich: Well, I think the first thing you have to look at is, are you comparing it to past conferences pre or post-COVID?

Justin Osborne: That’s fair.

Walden Leverich: And I think, the 100% reality is, none of the conferences have gotten back to where they were in 2019. It’s the unfortunate reality. I can’t imagine what the conference producers have to deal with. Because they book things four, five, six, seven years out. And if you look at PRIM&Rs growth trajectories in 2017 or 2018, not where they are now because of COVID. So, it’s certainly smaller than it was pre-COVID. But this year I think was much better than last year. And in talking to some of the PRIM&R people, and talking to the people that will be running the conference next year, I fully expect that next year will be much better than this year was. And this year was very good.

But certainly you have a professional group there that knows how to run a conference, and it’s only going to get better. But for people that kind of are trying to compare it to, “What was it like in 2017 or 2018?” I’d say you’re more comparing it to, what was it like in 2012? Depending on how long, for us graybeards that have been going for a while, but it’ll grow again. So I think that’s from an exhibitor point of view, we’ve got to just level set what are we expecting? And I think if you have the right expectations, it’s absolutely a great conference.

Jaime Arango: I think the other thing too is, it really dawned on me on this one because it was a new space, is the physicality of the space really affects the experience, both as an attendee and as an exhibitor. Some conferences where the space is such that you have a constant drive of folks at your exhibit. And then sometimes just because the way the traffic pattern develops, and we seem to all go in the same, like cars on the highway. You could have an empty aisle, where just the exhibitors are sitting there, because folks have decided to walk on the outer edge. So I think there’s definitely that experience. And PRIM&R and other conferences, it’s every year because of that physicality, it can vary. Sometimes you can say, “I am so overwhelmed with so many people stopping by the booth. I wish they could just go away for a while.” And sometimes it’s like, “Where is everybody during the break?”

Walden Leverich: I think the other thing we probably should address from an exhibitor point of view and an attendee point of view, was lunch or the lack thereof.

Jaime Arango: Oh yeah, this is the first year, right?

Walden Leverich: Yep.

Jaime Arango: First year. This took go around, because if you go long enough to PRIM&R, you remember that there was a food drought.

Walden Leverich: Lunch, sure, questionable box lunch in the basement of the Town and Country, or some such thing. Yes, yes, yes. I won’t disclose numbers because I don’t know if they’re public. But PRIM&R saved a lot of money by not doing lunch. And again, back to conference planners and things like that, you’re trying to guess how many of these attendees that are here are actually going to get lunch. And I promise you the conference center is not going to give you a credit for the lunches that you bought that weren’t eaten. So they have to plan in a crazy way for it.

So as an exhibitor, I really wish there was lunch, because it drew people to that show floor. That was one of the things that drew people through the exhibit hall. I know we gave out pretzels. I know somebody else gave out chocolate chip cookies. So, we’ll try and make up that slack. But for the attendees, I understand it’s frustrating. But it is significant money that can be invested elsewhere in the conference, or conference fees that don’t have to go up by potentially hundreds of dollars an attendee to avoid the lunches. So, as much grief as I’d like to give PRIM&R for it, I also understand why it was done.

Karen Christianson: I would say that I understand, but it doesn’t just impact the exhibitors. It also impacts the speakers and the attendees because-

Justin Osborne: Mm-hmm, it does.

Walden Leverich: It does.

Raffaella Hart: 100%.

Karen Christianson: .. what a lot of people were complaining about is if they didn’t leave sessions early, they couldn’t get a seat in the perimeter restaurants.

Walden Leverich: Right.

Justin Osborne: Mm-hmm. Yeah.

Karen Christianson: So they would stay-

Walden Leverich: Yeah, it’s one… That’s a very good point.

Karen Christianson: They would stay later to be able to get a seat, and they’d end up missing at least parts of sessions on either end, if not full sessions.

Walden Leverich: Right. Because plenty of restaurants. But there are also plenty of people trying to get into those restaurants all at the same exact time.

Karen Christianson: Yeah.

Justin Osborne: Right, right.

Nate Ferguson: There weren’t enough quick serve type of restaurants in the near vicinity. There were plenty of nice restaurants that would sit down and take too long and all that. And so I was always anxious as an attendee, strategizing where you want to go. I just would’ve expected more in that part of a developed downtown, around a conference center like that. So I don’t necessarily dislike the idea. I miss out. You have to either make specific plans to go with someone, or just bump into people. So you do miss that sort of collegial interaction that you would otherwise have if food is provided.

Raffaella Hart: Exactly, Nate, that’s what I was going to say. The element I missed about it was bumping into people, or having the opportunity to say hi to somebody who I didn’t have chance to say hi to, or meet somebody new. That was a big part of networking was, being forced to sit down at a table because that’s the only space available in the exhibit hall to eat the lunch. And then you’d meet a whole bunch of new people, who then you uniquely found out that they had the same issues that you were having, and then new relationships. So I miss that part of it.

Justin Osborne: Yeah. No, that’s great.

Walden Leverich: I wonder, and we can take it back to PRIM&R, I wonder if what they can do is sign up for lunch. So, if you want PRIM&R provided lunch here it’s going to cost you, put it in your budget. I need another $300 to attend, and now you’ve paid for lunch. And if you didn’t pay for lunch, go see some of those restaurants.

Justin Osborne: Absolutely.

Walden Leverich: That might be an approach for it. We can certainly mention it to Catherine.

Justin Osborne: Yeah. I think that’s a good idea. Well guys, I know we’re pushing time. And to sort of wrap things up here on this PRIM&R recap, what’s one final thought or takeaway, something you want to share that you either learned, or picked up, or thought about after the fact?

Karen Christianson: I didn’t get to attend many sessions. I end up viewing after the fact as I have time, because I’m at the booth most of the time. But I did have some good conversations with FDA, with AHARP, with OHRP, that provided me with clarity on a few issues. So I found that aspect to be very helpful.

Justin Osborne: That’s great. And again, they’re there so you can have those conversations, yeah.

Karen Christianson: And it’s a lot more than what you get in an email exchange.

Justin Osborne: Yes, I’m sure.

Walden Leverich: I think for us, it’s going back to what I said at the beginning. It’s the opportunity to see people, and for attendees to talk to each other. But as an exhibitor, the ability for us to talk to certainly prospects, absolutely, that’s why we’re there. But to talk to existing customers, and have substantive conversations about, “You’re doing what? How? Why.” And have that interaction and say, “That’s a novel use. We hadn’t thought of it,” or, “That’s an interesting idea. We can improve the product.” To be able to have those conversations with whoever your vendor is, is valuable to improve the products or services that your paying for as an attendee. Take advantage of the exhibitors in reverse. We’re there to sell you something, but if you’re a client, come see us and say, “Hey, here’s a problem I have. Here’s a solution I’m looking for.” And that’s time you’re not going to get on a phone or over an email.

Justin Osborne: Yeah, that’s good.

Nate Ferguson: I would say that it’s what you make of it. So whether you attend virtually or in person, put the effort into choosing the right sessions that are interesting, take notes and then act on those. That was a little bit of what I did the last week or the following week after the conference, was kind of in the quiet around the office during the Thanksgiving break, follow up on those things. Like, “Hey, that’s a really good idea that someone else said,” or, “I should really look into this regulation or guidance a bit more.” And so, act on that quicker. So then you can capitalize on the value, the expense that you put into it and the time away. Then you can deliver real results and hopefully elevate your program, or make those changes that you need to do, or solve those problems or write the things down that you know should be doing all along. So, take quick action afterwards and then follow up with those networking connections.

Raffaella Hart: For me it was, everything old is new again, is kind of how I felt about it. I went to a lot of sessions on topics as we’ve mentioned before, that I’ve been around for a while. But I picked up little nuggets of new information, or new ways to look or think about these topics. And I felt like that was really helpful. So, don’t be afraid to go to a session on a topic that you think is old because you’ll learn something new.

Justin Osborne: That’s great advice, I like that.

Jaime Arango: And I think kind of piggybacking on Raffaella’s comment is that, go to sessions that maybe are not in your wheelhouse. Because I think that’s the other tendency you tend to have. I’m a biomedical, I go to the biomedical ones and social behavioral, I’ll go over here. But I think you lose the opportunity to learn from folks who are doing other areas, and because they’re not your area, and so you’re hearing a difference. So try to go to those other sessions as well.

Justin Osborne: That’s great advice as well. This is awesome. Well, thanks everybody for your time.

Jaime Arango: You’re welcome.

Justin Osborne: Good to see everybody.

Raffaella Hart: Thanks everybody, good to see you.

Nate Ferguson: Nice to meet y’all.

Walden Leverich: Thanks everyone.

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.