- The process and the compliance that a researcher needs to go through to conduct human subjects research is bothersome, challenging, lengthy. "Why do I have to do this?" But if you don't do it, your science is not gonna move forward. So it's a critical step in truly being a professional researcher. And more attention is being placed by all federal agencies on this, and state agencies, local communities, and just people in general.

- [Announcer] You're listening to "Further Together", the ORAU podcast. Join Michael Holtz and his guests for conversations about all things ORAU. They'll talk about ORAU storied history, our impact on an ever-changing world, our innovative scientific and technical solutions for our customers, and our commitment to the communities where we do business. Welcome to "Further Together", the ORAU podcast.

- Welcome to another episode of "Further Together", the ORAU podcast. As ever, I'm your host, Michael Holtz, from the Communications and Marketing Department at ORAU. So we're talking about a new event for us today. We are co-sponsoring with a couple of other organizations a research community forum, and the topic area centers around human research subjects protection. I've got with me today, Ken Tobin, our Chief Research and University Partnerships Officer, and Cathy Fore, Senior Director of University Partnerships, to talk about this research event coming up. Ken and Cathy, why is this discussion around human subjects research protection so important?

- Well, I'll start. As you know, we manage an institutional review board for human subjects research that impacts not just ORAU, but it's really the site-wide institutional review board, or Oak Ridge site-wide IRB, which encompasses ORNL, us, Y12. We also work with the University of Tennessee and East Tennessee State University, to help manage, review, et cetera, approve, of the human subject research activities that go on within these organizations. And so the national federal overriding organization that we work with or adhere to in terms of policy and direction and such, is from the Health and Human Subjects area. It's the Office of Human Research Protection, so OHRP. And so OHRP hosts an annual event, called The Research Community Forum, all over the country. And they had invited ORAU to sponsor that event for OHRP back in, I think it was 2020, the year, or the year before COVID hit. And so we've actually been planning to hold this event for almost three years, and this is the first opportunity we've had to be able to do it.

- Awesome. Ken, who should attend this event?

- So, really, anybody within the region. It's open nationally. Anybody can come to it. I'll talk a little bit about how you can find out more information in a couple of minutes. But anybody that's doing human subjects research, universities, national laboratories, et cetera, are really who this is intended to participate in the program. And it's a two-day event. It's taking place in Knoxville on March 29 and 30. It's gonna be at the Crown Plaza Hotel down in Knoxville. And, as I said, it's a two-day event. The topic is "Research in the Age of Technology", which is pretty interesting, if you think about it. It's about the impact of innovative and emerging technologies on human subjects research, and I'll get into what that means in just a second. So, typically, the first day is, it's really an OHRP event, the first day. So the Office of Human Research Protection gives seminars, talks, discussions on policy and procedures, and questions and answers, and such, on how to manage research that involves human subjects, to ensure that you're doing things that are transparent, that are safe, that are appropriate, and that type of thing. So day one is really kinda the nuts and bolts of human subjects research. So if you're a new researcher, or even somebody who's been working in the field for a while, if you want to keep up to date on what's happening, in terms of policy and law, and things like this, that's what the first day really focuses on. The second day is kind of a more fun day, in my opinion. It's the day where you bring in guest speakers to talk about a variety of interesting topics. This year's topics, if you think about that overriding title I gave you, "Research in the Age of Technology", it's on artificial intelligence. So think about that. You know, when you're doing research that uses human subject data to try and train AI systems, how do you do that the right way, how do you avoid biases, all those kinds of things. It's about big data and biometric research. How do you correctly, appropriately, use information about people that you're measuring, perhaps out in the wild, perhaps as a part of a research program, that type of thing. Mobile health research, right? So everybody has phones. You can collect information on phones. That's how a lot of our traffic systems, like Waze and Google Maps and things like that, they use information from people's phones. Well, how do you do that in such a way that you're not interfering with people's lives, and that type of thing. And then in online and social media research, right? There's a lot of information out there in Facebook and other areas. How do you use that kind of information appropriately? So the second day is really on those kinds of topics. So should be very, very interesting. In Knoxville. Hope we can get a lot of people there from the region. I will also say we're the primary sponsor. We're putting the contracts in place with the venue, and those kinds of things. But East Tennessee, ETSU, is working with us. UTK is working with us, Oak Ridge National Laboratory is working with us, and OHRP as well. And so it'll be a pretty good event, with a lot of people from the region that are gonna be there. And we'll have people from around the nation that want to come to this particular event to hear what OHRP has going on right now.

- Gotcha. And Cathy, I was gonna ask you, knowing that ETSU and UTK are among the sponsors, along with the National Lab, this is just another one of those opportunities, right, where there's match-making with our university partners and how we work together to solve problems, but also educate.

- Yeah. And there's an opportunity here for a lot of lessons learned, and best practices too. Sometimes the process and the compliance that a researcher needs to go through to conduct human subjects research is bothersome, challenging, lengthy. "Why do I have to do this?" But if you don't do it, your science is not gonna move forward. So it's a critical step in truly being a professional researcher. And more attention is being placed by all federal agencies on this, and state agencies, local communities, and just people in general. And if we're going to advance health sciences and find new cures, new clinical trials get there faster than they've ever done it before. If this is not part of the portfolio in planning the right kind of direction for research, then we're just not going to get there. So this is part of a critical step forward, and I can envision that ORAU will continue to be a leader in trying to strengthen the knowledge base, both internally and at our universities, about this. And the more we can bring universities together, so it's not like just each university is out there by themselves, but we're trying to cluster them together on what works best, then that's our added value to moving this forward.

- And can you mention some of the the topic areas? You know, things like privacy protection when you're collecting data from people's cell phones, or from social media. Those are critical issues, and issues that are important to everybody these days. So those are things that researchers need to take into consideration. And it's how do you get the data without giving away who exactly that data is coming from?

- Right, right. And it's not just that, it's how do you collect that kind of data and information in a transparent way, so people know what their information's being used for. So, very important, yeah.

- Absolutely.

- And as far as those particular topics go, on that second day in particular, there actually are gonna be some parallel tracks that talk about these things. So there'll be two parallel tracks early in the day. One of 'em is on artificial intelligence and machine learning, looking at how you can reduce the risk that machine learning and AI research could potentially perpetuate, in terms of the biases and information, and what that might mean to the results that AI gives you, and those kinds of things. So very, very timely stuff. And the second one that's parallel to that is on social media interventions, so looking at research interventions that use social media, explaining what populations are more likely to participate in that kinds of research, and discuss the experiences of those participants, and things like that. And then later on that day, there's gonna be two parallel tracks. One is on big data and biometric research. So big data's a big thing. We have a lot of information now that just a decade ago we couldn't access. So now we really have to think carefully about how to use it, how to use it well, and make the proper kinds of decisions from it. And the second one is also very timely, on mobile health technology and mental health, and psychiatric research. So think about all the applications and tools and things that are out there now, for people to have therapy sessions, or these kinds of things over their phone, over their computer.

- Over apps, yeah.

- Yeah. So they're looking at considerations that are incorporating this kind of digital health data. So, anyway, extremely topical areas for us to be talking about.

- Absolutely. And again, still time to register, so--

- Yes, definitely.

- Sign up to attend this meeting. And I know it's on the homepage at orau.org, so--

- Yes, it is.

- if folks are interested, they can hop onto our homepage and find out more about the meeting and get registered.

- Yep. I was gonna give you the URL over the podcast here, but it's too long, nobody is gonna listen to it if I try. So go to the homepage.

- I will also include it in the description, the notes for this episode, so anyone listening can look at the description and see the URL and sign up.

- Excellent.

- Alright, well, thank you both so much for talking about this very timely and very important meeting that's coming up. And again, it's gonna be another great couple of days of learning and sharing best practices, and hopefully finding some solutions to some critical issues. Thank you both for your time. I appreciate it.

- You're welcome.

- Absolutely. Thank you very much, Michael.

- Thank you.

- [Announcer] Thank you for listening to "Further Together", the ORAU podcast. To learn more about any of the topics discussed by our experts, visit www.orau.org. You can also find us on Facebook, Twitter, and LinkedIn, @ORAU, and on Instagram, @ORAUTOGETHER. If you liked "Further Together", the ORAU podcast, we would appreciate you giving us a review on your favorite podcast platform. Your reviews will help more people find the podcast.