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Creating Opportunities for Inclusion, Diversity, Equity and Access In Clinical Research: A Discussion with Tiffany Danielle Pineda, Brian Sevier, and Wendy Tate

December 1, 2021

About the Advarra In Conversations With…

The future of healthcare innovation hinges on research and clinical trials. Advarra sits down with leading experts to dig into pressing issues and explore cornerstone solutions. Join us as we discuss topics and trends impacting the healthcare of tomorrow and advancing clinical research to be safer, smarter, faster.

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About This Episode:

In this episode, Wendy Tate chats with Tiffany Danielle Pineda and Brian Sevier to discuss what the University of Florida Clinical and Translational Science Institute has accomplished to increase diversity, equity, and access in clinical research.

Discussions with:

Wendy Tate
PhD, MS, GStat
Senior Clinical Research Strategist

Tiffany Danielle Pineda
Regulatory Specialist
University of Florida Clinical and Translational Science Institute

Brian Sevier
Chief Operating Officer
University of Florida Clinical and Translational Science Institute

Episode Transcript:

Wendy Tate (00:04): Hello, my name is Wendy Tate and I’m the Senior Clinical Research Strategist here at Advarra. I’m really excited to be joined by Tiffany Danielle Pineda and Brian Sevier for the ninth episode of “Advarra in Conversations With.”  Today, we’re going to delve into the incredible work happening at the University of Florida’s Clinical and Translational Science Institute to make meaningful progress towards inclusion, diversity, equity and access.

Tiffany Danielle Pineda: (00:28): Hello, I’m Tiffany Danielle Pineda. I am a Regulatory Specialist at the University of Florida Clinical and Translational Science Institute. I’m also happy to say I’m the Chair of the Cultural and Competency Council here at the University of Florida and I’m going to toss this over to Brian Sevier to introduce himself.

Brian Sevier (00:45): Good morning, everybody! Hello happy to be here as well, I’m Brian Sevier. I’m actually the Chief Operating Officer for the University of Florida Clinical and Translational Science Institute. Where I’ve had the pleasure for many years to be working with Tiffany Danielle in several different roles and now, I get to work very directly with her through the CTS Diversity and Cultural Competency Council.

Wendy Tate (01:06): Thank you, Brian. Thank you, Tiffany Danielle. I’m really excited to start the conversation, are you ready?

Brian Sevier (01:11): Let’s do this.

Tiffany Danielle Pineda (01:12): I’m excited. Let’s jump in.

Wendy Tate (01:13): Great. First, why don’t you introduce the program and a little bit about what you guys have been doing at the University of Florida to give our audience an idea of the fantastic work and the opportunities going on there?

Tiffany Danielle Pineda (01:24): Under the Diversity and Cultural Competency Council we use multiple nontraditional things to do. One of our biggest things that people have seen has been our “black voices storytelling event,” and this is where we use the voices of different black research professionals, telling their experiences as a research professional: what they have experienced, how that has been being a black biomedical researcher at the University of Florida to get that connection, that people may have. Using the set of workshops and learning about know what is a microaggression, what is racism, sexism?

But just really hearing somebody’s story, so you can get that connection is a real, meaningful way to make that shift for the better. Some of the other things that we’ve been doing is creating a curriculum where you can either take the curriculum yourself as an Anti-racism curriculum, or you can pull out a module as a faculty member and include it in one of your courses that you may be doing. And then you know really use that introspection and self-awareness, to use those tools and to use it as a lesson and not a scar. I think these things are opportunities for lessons to make that paradigm shift and that’s really how we come at this as a passion for change for the better and not so much as a punitive guilt-ridden way of changing the world. Brian, would you like to jump in?

Brian Sevier (02:37): Absolutely, I’d also like to add that, as we started this venture and adventure here at the University of Florida, the CTSI was given the opportunity to take a leadership role. Obviously, as the Clinical Translational Science Institute, we are sort of the home from a disease agnostic perspective, about how we need to advance both the translation of science, but also reduce barriers, not for just conducting the science, but reduce barriers for individuals from all varieties of life, all walks of life to participate or be given clinical research as an alternative for other care options. So this is something that we’re you know sincerely passionate about and truly and honestly, we’ve been blessed that somebody like Tiffany Danielle has this passion herself.

We’ve been able to sort of jump on this with full force basically because she has a passion for it, there’s a high degree of altruism and sincerity from Tiffany Danielle. But also, I would let you know that as an organization, we sort of put people in boxes, we call them position descriptions. And we were blessed to actually knock all the boundaries off of Tiffany Danielle’s position description and say take us somewhere where we can actually make a difference, make an impact, and not just change what we do for UF and our local community, but how can we advance this topic for others and the CTSA consortium

as well as folks that are heavily involved in clinical research here large. So Wendy that’s how we’ve gotten to where we are and thank you, Advarra for giving us a platform and a stage to share some of the things that we’ve done, and we’re blessed and humbled by the fact that you picked us to tell our story.

Wendy Tate (04:07): Yeah, the passion is evident and it’s really exciting just to keep hearing your story. We really have enjoyed talking to talking with you about this, and just the opportunity that the UF has brought forward. I’d like to dive a little bit into, Tiffany Danielle, your passions specifically. You mentioned this opportunity that’s been brought to you, Brian you mentioned the position description kind of being “let loose” and maybe allowing this to take fruition, but Tiffany Danielle, can you just give a little bit more on how did this opportunity come up? How did you approach this with UF and basically, how did this idea get birthed into the great program that it is?

Tiffany Danielle Pineda (04:46): Part of what I really thought about was if I did not have any hindrances, how would I change things for the better related to inclusivity, diversity, equity, and access? And though that was like a scary and daunting thing, I then went to think about how some of the major paradigms were shifts that I had. And that brought me back to the almost decade, I was on the IRB at the University of Florida, and I realized that those paradigm shifts happen in nontraditional ways.

And when somebody took an interest in me and said, something that you know, was not based on you know, this is the way we do things, but how do you want to make a difference or something that they saw in me.

And just reached out to me as a person as an individual, and so I wanted to do that. And that’s one of the things that we’re doing at DC3 is with our co-mentoring circles. So right now, we’re working with Ohio State University and giving people a really brave, safe space to explore themselves explore the opportunities for diversity, equity, inclusion in a way that is not traditional. We’re not using so much the terms of microaggressions and going from being an actor to an activist to an accomplice and changing things for the better. How would you go beyond what you would normally do and see things and go beyond labels and to just what is the right thing to do, what is the ethical thing to do and how would you do that if there weren’t any constraints on that? It really, that is, is reaching people where they are. And I think Brian also can see that we really are trying to reach people where they are and shift them to them elevated ourselves.

Brian Sevier (06:16): Absolutely and I’m actually going to you know I’m going to put Tiffany Danielle on a pedestal. She deserves to be, but I actually want to highlight the fact that this was an idea that she approached leadership herself with.

The establishment of our DC3 Council was born from observations, and I’m going to sort of set Tiffany Danielle up just to tell some of these stories what were some of the opportunities that she was faced with both in her IRB career and then actually stepping in as an IRB and regulatory consultant, with the CTSI what were some of those DC3 changing or DC3 birthing moments in her career that sort of helped us go down this pathway, but really the big story here is we had an individual that wanted to make a difference, anything that we talked about in today’s podcast today, Wendy and Tiffany Danielle, is simply making the point that one person can impact change one person can advance a narrative one person can in fact make a significant difference. So for us, that is Tiffany Danielle. We want to celebrate that with her, but at the same time, I’m going to set her up with a quick question. Tiffany Danielle, can you tell Wendy and me about one of those moments? I think I know the story you’re probably going to tell it was about when a physician actually came to visit with you in your IRB role?

Tiffany Danielle Pineda (07:38): One person can make a difference, I actually had a clinician, a physician herself, come to me, a beautiful woman came to my office and she said Tiffany I need help setting up a research study, which is one of the roles that I had in the IRB and I said, “That’s what I’m here to do, how can I help you?” and she said, I wanted to be first and I almost died from prostate cancer. And I’m looking at this, amazingly beautiful feminine presenting woman and she said, “because I am feminine presenting, physicians never asked me, did I need a prostate exam or did I how my prostate health was” and because our clinical haven’t asked questions based on just what you need to be done clinically just based on how you present or how you identify I could have died, by the time it was caught, I was stage four and almost died from it when it could have been caught early. And then, treated easier and preventable had I been getting the treatment earlier on, rather than just going by how to present but rather than what treatment, do you need and how is your prostate going.

So, she wanted to make a change in clinical treatment and translate what you know from the research question to clinical treatment on how we get clinicians to ask questions beyond just how I present or how I identify to what treatment, do you need as an individual, and that was an amazing opportunity for me to help this amazing physician design a study to help clinicians ask questions beyond just how I may look or how am I identify to what do I need to do to have the best health care that I need.

And that was one of the first steps that I realized that we as healthcare providers as research professionals have to think beyond the box beyond the labels that we place on people. And for me to be able to be one of those people to help them go okay you’re asking these questions, but you’re asking them typical questions.

Wendy Tate (09:24): Yeah, what a great story and I’d love to broaden that now so because, obviously, a passionate area for you. Something I think a lot of people in the research room really want to also be able to do so, how do you think Academic Medical Centers, how can IRBs, how can people who are writing protocols or are helping get protocols up and going, how can they become better in these types of diversity, inclusion, equity, access efforts? How can they become more thoughtful or more prospectively thinking about some of these issues to really help bring the entire population into clinical research and really maximize the ability to meet people where they’re at to do good science?

Tiffany Danielle Pineda (10:09): I would like to say, think below the iceberg. Like we present the tip of the iceberg to people when we come in contact with them and to go beyond that, to go deeper with the connection. Treatment really is about treating the entire person, and if we don’t go beyond what is just a tip of the iceberg and what presents when they first come into the exam room, we’ll never really treat the whole person and we could have someone like this physician who almost died who you know later on helped come up with a cure who may not have done that if she had not lived because she wasn’t asked the right question so treating the whole and going beyond the tip of the iceberg to what dells below and deepens. It then also starts with how we know ourselves so that we can transfer that to how we treat patients when they come into the room, and if we know ourselves a little deeper, we can also translate to how we treat our subjects, a little bit deeper how we treat our patients, a little deeper. Brian, I think you’d agree with that as well.

Brian Sevier (11:00): Absolutely, and I think pragmatically, you know, in addition to not just what we see at the surface, but what can we do to impart some of that change. Tiffany Danielle’s experience in both our IRB. We are a large health system here in Northcentral Florida, we actually have a fairly diverse population. But I think one of the things that’s most important here is Tiffany Danielle’s role now gets back into the box that she gets to set in and shine in. Part of her role is she’s actually a part of our Recruitment Center, so we actually offer free consulting services for our faculty members. One of the things that are really interesting from her IRB background and experience. One: how do we fast-track studies to get them through and properly reviewed and have a lot of the pitfalls already filled in before we get there? But ultimately, the biggest issue is: We worry about recruitment and target enrollment and that’s not just hit your target enrollment. But how do you express a study from a literacy perspective and a consent perspective that broadens access to the most diverse population possible? So Tiffany actually helps with culturally sensitive language inclusivity, identifying verbiage and changes and statements and consent forms. And that’s just a practical approach. The other thing that she’s been able to go through is both DC3 and her curriculum delivery is she’s been able to really create, maybe I should let her I don’t want to steal her thunder but.

Tiffany Danielle, let me set this up as a question some of the things that we’ve done that are atypical. Let’s talk about some of your training activities where we create Zoom rooms or safe rooms, to talk about certain activities?

Tiffany Danielle (12:30): So, we do a bi-weekly Zoom room. It initially started out weekly, but we switched it to bi-weekly. So really what it is, is I know we typically talk about safe spaces, but really, we turned it into a brave space where we’re able to be vulnerable and show some of the areas where we have some bandwidth to grow and grow in.

We talked about things like Dr. Susan Moore, who passed away as a physician herself because her doctors were not listening to her, where we can talk about are, we clearly listening to the subject really talk to us? Are we listening to when they may describe it as you know raised skin, as opposed to a rash? Do we hear if it’s not the typical language that we understand subjects to come in and talk about things?

We talk about how our own biases may have shown up, but we may not have approached somebody because they did not look like a typical Latino to us and how we may have been programmed by society to not approach somebody.

We talk about how Minister Farrakhan talks about research and how we can be prepared for that when we come up to someone who presents are identifies as black and know how to approach them and just in a very clear and transparent way, say, I know you may have heard these things. But be prepared to talk to them clearly and transparently know these things in advance so that we can have that in our tool belt in advance.

I think that’s kind of hard to do, but if we don’t do it in a safe place before they get in front of this subject it’s a little bit more daunting rather than after they’ve already had the experiences wondering why subjects aren’t enrolling.

We talk about some of the ways to not hurt their own advancement with dealing with subjects, why they may not be showing up for appointments, how they may not have connected with them. Because if they don’t finish the research, did you have scientific merit, have you’ve exposed them to risk for no reason. So why they may have withdrawn and dropped out. We talked about those things in advance in a safe way and what language may have been used inadvertently that they put up a wall but stop them from attending and I can see you responding to that Wendy in your facial expression.

Wendy Tate (14:33): Yeah definitely. There’s so much good stuff here and I want to definitely get to that subject perspective and their inclusion and research and perspective of research, but before we do that, I want to jump back really quick back to Bryan. Because Bryan we’re talking about a lot of really great programmatic work that’s being done here by Tiffany Danielle, but I’d like to ask you, as the administrator as someone who is running the operations with Florida.

How programmatically and administratively, are you guys approaching this as an institution? And how can other institutions really get this as part of their culture? This isn’t just an administrative department that you’re checking a box on. This is very clear, this is being woven into our culture of UF. And so, how as an administrator are you doing this so that other administrators can also take this on?

Brian Sever (15:19):  Well, the first thing I would like to say is to thank you Wendy for asking those questions. When you have institutional leaders that actually believe in this mission as strongly as Tiffany Danielle and I do, then it makes this easier we’re not salmon swimming upstream we’re actually we’re running with the current. The University of Florida has equipped us empowered us and we’ve extended that empowerment. I think that’s really the strongest word we’ve extended that empowerment to Tiffany Danielle.

The sky’s the limit so let’s look at where there are practical issues and barriers and how do we find ways to lower those barriers, while also doing what every Academic Medical Center is charged with: reach your target enrollment, open studies in a fast way, do good science and treat patients in an amazing and compassionate way. So how do we do that, while also addressing our bright idea?

Wendy Tate (16:08): That’s very powerful Brian and I think that ties back into what Tiffany Danielle was saying about reaching the participants, so why don’t you give us some examples of the impact that you have seen in the participants at UF and in their research? And taking this beyond just “we’ve checked the box and we’re doing great things” like how are we seeing this manifest into positive research experiences with the people that are participating in UF clinical trials?

Tiffany Danielle (16:34): So, I also just jump in and add really quickly to that attending these zoom rooms also back to what Brian said does not just study coordinators, but this faculty as well. The other clinicians as well and even some of the grant administrators and it’s also not just the University of Florida, we have Duke attendees, we have Florida State University attendees. So, there are multiple layers of attendees that are coming. That manifests, in what you were asking about Wendy, on how it shows up in and the ability to reflect in the population. So I think one of the biggest examples I see of, that is, we had one investigator who was targeting Newly Haitian immigrants and we’re coming into the country and looking at them for tuberculosis and she was not getting any enrollment she was working with the Department of Health. And tuberculosis is really an important issue for New Haitian immigrants, and she was trying to figure out how she could the system, but she was not getting any enrollment. And so, I took a look at our study, one of the first things I realized, is that the documents were translated into Creole, not Haitian Creole.

So just that first assistance with just helping her get the documents in the right language, she started getting some enrollment. She went from no enrollments to getting some subjects enrolled. The next thing was just changing where she was sitting when she was coming, and she was in a very open area. There was no privacy. Talking to the Department of Health administration, she was able to move to a private area get an area dedicated, and then she was getting even more enrollment at that point, and then the subject was able to not just talk to her about tuberculosis and that particular study, but she was able to get information about food insecurity and housing insecurity. It made a difference, not just with that tuberculosis, but their quality of life. She had three more studies from that and so that’s really what we want to do is it started out as one small thing of “I’m not getting anybody enrolled Tiffany” to making an impact on you know people that were sleeping in the streets and that went to actually have housing.

And that’s one of the biggest success stories, and they were able to tell other people about this study and word of mouth is, is an amazing way of recruiting once people have a positive experience. This investigator cared enough beyond, “Can I get a TV screen?.” I told her I didn’t have any word stage, she helped me find resources, and then you know submitted another research grant to get the assistance that I needed. And that’s where we really make that impact because we need people to see us as there to help to make a difference, Not just to get our research questions answered, but to change their quality of life and the health care that they received.

Wendy Tate (19:03): It’s really great to hear about the work being done at UF. Tiffany Danielle, a little bit earlier you alluded to working with other institutions like Ohio State. Why don’t you talk about the excitement that you’re seeing from other organizations and this bright idea actually now being spread across the nation?

Tiffany Danielle (19:19): I am really glad about that because I think that you know it is not about just making the University of Florida bright, but about making our nation bright as well. So we started with Ohio State with co-mentoring circles, and that is essentially using small groups where we have the mentoring goes both ways. Where we’re not just you know one is a mentor and others a mentee, but we’re all getting some aspects of being a mentor or mentee we’re all growing from it.

The primary aspect being along with the diversity and equity inclusive of the ideas and being able to, I steal this from Dr. Temple to being agnostic you know, removing that agonistic game idea from those aims, so that we can see beyond that, to really being intentional about access and inclusivity. It’s still in the beginning stages, but Washington University got a little bit of wind of it and they want to be. They want us to start working with them, as well as the Houston Medical Center that a bit of a line working for that call a mentoring circle, even though it’s at the very beginning stages of it, it seems to be going so well. Other institutions like the idea and trying to keep it small we’re keeping at about 10 with just monthly meetings but also checking in between, but just that one-time meeting once a month and then checking in with one another and then being able to in a very brave and safe space also keeping that we don’t talk about what happens outside of it but being able to talk very clearly and individually, as well as in the group.

The other thing is working with MSU, where they have a very high Gullah Geechee population there and they were having problems enrolling the Gullah population there, African Americans there. I was able to sit down with some of the investigators there and talk to them about how they were recruiting, some of the materials that they were using, and they weren’t really getting any enrollment. Helping them change some of their enrollment processes, more along the lines of how they were reaching out, rather than the materials and giving some points that their teams could use to reach out in a different mechanism to be a little more transparent and said to open those doors. That helped them get some enrollment going at MSU, because it really matters, how you reach out even more so than the materials that you use when you reach out.

So, looking at it in multiple ways, you know not just how are you reaching out, but what are you reaching out with and, what is your follow up and your follow-through? People really want to know not just when are you coming here to get what also what are you giving and what is the heart behind the context of what you’re doing here? And I think that’s what I’m helping other institutions do. We are a state institution so we’re different than maybe some of the private institutions but helping people see that no matter what your institution is, what the framework is of your institution, you can still build a DC3 type framework at your institution. How you can look at your institutional identity and still transform that and use what we do here, I think, Brian is aware of that as well, I think.

Brian Sever (22:02): Absolutely, I think some of the pieces that I would recommend other institutions consider look at is, One, aside from us being the academic calm of the international mentoring association, but as an institution and actually as the host institution for the southeast conference we actually host a certificate program and multicultural mentoring. That is a huge thing. This isn’t just for staff, this is actually for leadership we want to grow, the next, and the best.

So how do we grow the next in the best? It’s having that awareness and that sensitivity and part of that begins with multicultural awareness. A multicultural mentoring program, that is an institutional investment. The second piece is the institution is a very, very, very strong participant in a curriculum called “crucial conversations”. Wendy, I know you’re familiar with that, as Advarra participated in that as well. I think crucial conversations are a really strong step towards setting the tone and taking the right direction towards difficult conversations aren’t easy to have, but you have to have them, but how do you do that, in a way, where you establish trust.

I think a lot of folks think that trust builds relationships. I think it’s actually the opposite relationship that builds trust. So, with multicultural sensitivity or cultural sensitivity period, you can establish a relationship with relationship and better communication, then you can establish trust with trust you can therefore make inroads and have better successful outcomes, with the communities that you serve and the individuals that you serve.

Wendy Tate (23:25): Yeah, and it definitely sounds like these skills, you know, are just so applicable like you said, not just in clinical research and actually not just within your workplace but just as a person in general and meeting people where they’re at and expanding our relationship with society as a whole. It is just so exciting to se. Being in research my whole career, I love seeing how research ideas, then become ingrained into medicine or public health practice but I mean this is even broader.

This is a movement that you know initially starts as trying to help the research mission, but it’s applicable to really every aspect of life, from what I’m hearing and that’s just such a beautiful thing. So, we’ve talked about where this started, we’re talking about what you’re doing now, but where do you see this going? I’m really excited to hear: What’s the next step, Tiffany Danielle? Like where does this bright idea go, how does it shine even farther?

Tiffany Danielle (24:16): You know, one of the things that we’re looking at as a human library is again another version of telling stories and having interactions in the brief safe space so that people can make have those paradigm shifts and have those conversations that they may have never had. You may have never had a conversation with a felon before, or never had a conversation with somebody who was a first-generation student. You may have never had a conversation with someone who had to work their way through college, or never had a conversation with someone who was raised in a single-parent household.

But having those conversations, so that you can see a different vantage point than your own and grow from that and that’s all that will happen is when you have conversations with someone who has a different vantage point from you is that you’ll grow from that and have different ideas and will solve the problems that America has faster and better because we have different vantage points and viewpoints in the room. Then we’ll go to get to the point where I hope to put us out of business that it’ll be such an ingrained part of what the institution does, it will be a part of history that you know, “This is what Tiffany Danielle used to do, but now she’s moved on to something else because it’s so ingrained in what we do that we no longer need tiffany Danielle to do that.”

Wendy Tate (25:19): That’s great. We’re coming near the end of our time; I want to make sure that there’s a couple of minutes here for each of you if you have any closing statements any other information you want to give our audience about the program or about the mission or anything that they can do any parting comments or charges of call to action before we leave this today?

Brian Sever (25:42): For those of you out there that are in leadership roles when somebody comes to you and says, “Can I just run with the ball and do something that I think is a great idea,” be brave enough and have enough trust in your team members to let them do this. I’ve said this more than once and on multiple forums.

I’m thankful many, many times for my team members, but in this case, I’m on Tiffany Danielle’s team, she is the leader running this initiative. So has that brave spot where you can say that you can empower the individual to run with an amazing idea and then give them the tools and resources that they need.

Tiffany Danielle (26:18): Know that you can make a difference, one person can make a difference. And two, know that you are going to be afraid that you will do it with trepidation, but do it anyway, ask the questions, approach your leadership, because you never know it may have already been on their mind and may not have been on their mind, but the question needs to be asked to go and ask, can I do this because it matters. One person can make a difference for the better.

And the other thing I would say is that each opportunity that you come across somebody each interaction is a time that you can either leave a lesson or a scar. Be intentional about leaving lessons and that lesson can be for you or for them so be intentional about having those interactions be a lesson, where you can grow, or they can grow hopefully both of you can grow by having that interaction and so.

Even in this interaction today with Advarra, I’m grateful I have grown, it has been wonderful, I know, Brian would echo that as well, so I’m thankful for this opportunity and I’m hoping that this was a lesson for each of the listeners today.

Wendy Tate (27:16): I am thankful. Thank you and I appreciate both of you joining us today and Just really engaging in this and bringing this to a broader audience and I hope that our audience is just as thankful for the interactions and. Brian, Tiffany Danielle I know you have incredibly busy schedules so taking the time out and being able to share your story was just a really great treat for us, so thank you very much.

And with that, we are going to conclude the ninth episode of “Advarra In Conversations With…” if you enjoyed today’s discussion, please keep a lookout on our social channels and on Advarra.com our next episode.

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