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“Research Ethics Reimagined” is a podcast created by Public Responsibility in Medicine and Research (PRIM&R), hosted by Ivy R. Tillman, PRIM&R's executive director. Here, we talk with scientists, researchers, bioethicists and some of the leading minds exploring new frontiers of science. This season, we are going examine research ethics in the 21st century -- and learn why it matters to you.
Nancy Olson has more than twenty years of experience working with institutional review boards, including serving as the director of the Human Research Office at the University of Mississippi Medical Center, and consulting in the field of Human Research Protections. She is currently an IRB analyst at the University of Nebraska Medical Center. Nancy has been a speaker at regional and national meetings, and has contributed to the third edition of the Institutional Review Board Management and Function Guidebook. Nancy was a member of the SACHRP's Subpart A Subcommittee, a consultant to the Office for Human Research Protections, a past co chair of PRIM&R's Advancing Ethical Research Conference, poster abstract subcommittee, a PRIM&R board member, and ARENA president. And for those who do not know what ARENA was, arena stands for Applied Research Ethics National Association.
Ivy Tillman, EdD, CIP:I am also proud to say that Nancy was the winner of PRIM&R's 2024 service award. Nancy has a profound commitment to ethical research practices, fast experience, and tremendous dedication to the professional development of others. I can attest to that. Nancy, we are honored that you are here with us today. Thank you for being here for this conversation.
Nancy Olson, JD:Thank you for asking me. I'm honored to be here.
Ivy Tillman, EdD, CIP:Well, for those who are listening to our podcast, I consider it a treat to lead the podcast conversation today with Nancy. And so I'll begin, Nancy, by asking if you could take a moment because I discussed your tremendous contributions to the field and your past experience, but can you tell us how you landed in human research protections and talk about your career?
Nancy Olson, JD:I can. By training, I'm a lawyer and I was a trial lawyer for many years. And I reached a point where I wanted to do something different, but I didn't know what. And someone that I knew at the medical center reached out to me and described the job as making sure all the I's were dotted and the T's were crossed. I figured I could do that for a little while.
Nancy Olson, JD:I had no clue what I was getting into, what an IRB was, what they did or anything else. And I learned from scratch and I fell in love.
Ivy Tillman, EdD, CIP:We are thankful that you fell in love. And we always find it interesting how our paths land us where we are in in these professions of ethics and oversight. And so our conversation today is focused on research involving individuals with disabilities. Can you provide us some insights on, I know you did a session at our conference recently, but your pathway into advocating for individuals with disabilities and participation in research.
Nancy Olson, JD:Another thing I fell into, I never really gave it much thought or any thought. And then about three years ago, I lost my hearing. Not started to lose my hearing or became hearing impaired. I am deaf. And obviously it took me by surprise.
Nancy Olson, JD:But I really didn't think about how that impacted IRBs and research until one day an application came in that I was reviewing. And on our application, we asked about exclusion criteria. And they had that they were excluding people who were visually impaired or hearing impaired. And before I could even continue my review and think about what that meant or why or anything else, it hit me like a ton of bricks. I took it very personally, and I was surprised that people wouldn't want me in their study.
Nancy Olson, JD:Wow. And I had to really stop that review for a little while and take a step back and think about it. And then I had to take off my take it personally hat and put on my reviewer hat and ask the important questions of why would you have these exclusions? What's the scientific justification? And what came back was not a scientific justification.
Nancy Olson, JD:It was just, we can't afford ASL interpreters. We can't afford to put our documents in braille. And that got me thinking about what it entail and who it excluded and why. And that kind of started me down this path.
Ivy Tillman, EdD, CIP:Amazing. When I think about just what you shared and it is your lived experience that is now shaping the field even more. I see you as being this pioneer at the intersection of this vast experience that you've had and your lived experience now informing how we as ethics and oversight professionals include individuals with disabilities in research. So thank you.
Nancy Olson, JD:You're welcome. I didn't feel like I had a choice. All of a sudden this was happening to me. And now I look at studies differently. I review them differently.
Nancy Olson, JD:I think of more things and I by no means represent everyone with different abilities or disabilities. I learn every single day something else that I can bring to the table or something new that we need to think about. So that's kinda what I started to do. And it's helped me learn. It's helped me be a better reviewer, I believe.
Nancy Olson, JD:And then I'm trying to help others see that it's not something to avoid or be afraid of. There are ways to include people.
Ivy Tillman, EdD, CIP:Absolutely. Absolutely. And you mentioned something really important. You said that your lived experience, which we all carry, right? Your lived experience helped you review and see protocols and reviews differently.
Ivy Tillman, EdD, CIP:Can you describe that a little bit more or do you have any examples that you can share?
Nancy Olson, JD:I now know to ask investigators to think about these things ahead of time. How will you include other people in trying to get them to expand and be prepared? Don't wait until somebody comes in the door to be in your study and oops, you don't have anything that they can use and you tell them to come back in a few weeks or months or people don't have that kind of time. They aren't going to keep returning. But if you prepare ahead of time and it doesn't take much, there's so many different ways to do things.
Nancy Olson, JD:For the first couple of years, I would go to the doctor's office and they would say to me, oh, we're gonna have to reschedule your appointment because we don't have a sign language interpreter available. They nobody ever asked me if I knew sign language. Wow. And I didn't need an interpreter. I used my phone.
Ivy Tillman, EdD, CIP:Exactly.
Nancy Olson, JD:There's so many things these days and every day it seems like there's more with technology advancing that can help people with different abilities and disabilities. So if you think about those things ahead of time, your study will be stronger. You'll be ready for anybody who walks in the door and not just a limited number of people. And so I think that's important to try to expand and learn more about these things.
Ivy Tillman, EdD, CIP:I agree. And so you mentioned at the researcher level, do you think that IRBs, HRPPs, institutions play a role in assisting the researcher in preparing to include all individuals in research?
Nancy Olson, JD:I do. I think IRBs have to learn it as well. I have to learn to ask the questions. You get an application and somebody gives you 48 documents that they're going to use. And you have to ask them what they're going to do if the person that comes in can't read or is visually impaired.
Nancy Olson, JD:Are they going to have documents available in larger texts? Are they gonna have readers available? They just need to learn all those kind of things. And I think that IRBs slowly but surely will learn to ask those same questions so that you know what they're going to do. At my institution, when this first happened to me, we have a policy on obtaining consent from certain populations.
Nancy Olson, JD:They told you what you needed to know and what you had to have available if your study was going to have mostly people with low vision capabilities or people who couldn't hear. But then we also had when forward with if you get somebody in your study that you weren't expecting and they have a hearing impairment or a vision impairment. Here's the types of things that you need to do. And when I first looked at it, it seemed that we required an additional process and someone else to take a look at it. So I raised the discussion of what's that process look like, what are we expected to look for.
Nancy Olson, JD:And after many discussions, we ended up revising our policies so that it was just we didn't need an additional someone to take a look, that we have whatever the subject uses normally day to day, they can use during that consent process to help them. And so I think this is the opportunity for researchers, for their staff, for IRBs to learn more about what is available, often at very little to no cost, but to just be prepared. Otherwise, you end up with a study and you're just telling people they can't be in it. And we always talk about how difficult it is to enroll people in studies and be prepared for everybody that comes in the door as much as you can. So I do think it's an opportunity for IRBs and HRPPs to think through those things.
Ivy Tillman, EdD, CIP:Wow, Absolutely. And so you talked about how matching your deep regulatory experience with your lived experience has really begun to shape your IRB's considerations. Are you seeing that translate further within the HRPP or within the institution? Are individuals receptive?
Ivy Tillman, EdD, CIP:Is it do you find it's more of just an awareness of barriers that exist?
Nancy Olson, JD:I think it was more of just an awareness. You know, people take time to learn new things and so start out making them aware, then start out showing them what's available. But Title XI, I think has just jumped in and helped push it forward because they have some new requirements. While Title XI doesn't apply institutions and all IRBs, I think it really helped to move forward what people need to think about and how to make information more accessible to everybody. And at my institution, I didn't even know this was going on, but we got an email notice one day about changes to Title XI and what the institution had put in place.
Nancy Olson, JD:And there were all sorts of places to go to look for apps to help you design web pages to make them more accessible and all these things that I had never thought of. So I think it's helping me learn, and it's also helping everybody else learn. Or we're moving beyond or shortly, we'll move beyond the being aware of to actually doing.
Ivy Tillman, EdD, CIP:I love that. And so it's like a road map. You're and it's happening probably organically, a road map from awareness to implementation. Right? And so you've made a really important point recently at one of our conference sessions.
Ivy Tillman, EdD, CIP:You said that two people with the same diagnosis may need entirely different supports to participate in a study. With that in mind, how should researchers design their protocols then?
Nancy Olson, JD:I think it doesn't as much affect the protocol as it does the consent process and how you provide information and how you communicate with people. I think the best thing you can do is ask them, what do they need? What can we do to make this visit better for you? How can we communicate with you? What's the best way?
Nancy Olson, JD:Someone, I was about maybe a year and a half into this and went to dinner with a group of people. I didn't have this program at the time and communication was very difficult. But someone sat me down and said, tell me what's the best way to communicate with you. I had never thought about that. No one had ever asked me that.
Nancy Olson, JD:And it just, I felt seen and heard, and it really started me thinking about it. And I think researchers can do the same thing. Think ahead of time of how to have documents accessible, how if maybe somebody doesn't read well or has reading difficulties, have things available with audio descriptions and those types of things. And I think the best thing we can do is don't assume. And I would say the more I think about this, it applies to everybody, not just people you think have a disability or have different abilities.
Nancy Olson, JD:Plus to everybody, ask people what they need and how they communicate best instead of just giving them a lot of documents and saying, here, I'll look this over.
Ivy Tillman, EdD, CIP:You are so correct. And as you were describing that, I came to that same conclusion. This applies across the board. People who volunteer to participate in research want to be seen and known and valued. And there are ways that we can do that.
Ivy Tillman, EdD, CIP:And you're giving many examples for our community to not only consider, but advocate for implementation. And so another story that you told was about an IRB member with ALS, a fully ADA compliant meeting room, but an inaccessible 50 yard stretch to get there. So if you don't mind telling that story, but also what does that story tell us about how we tend to think about accessibility overall, but also in research settings?
Nancy Olson, JD:I think we have to think very hard about accessibility. And I was guilty of this all along. People say we have an our building is ADA compliant. It's accessible. It's just it's that.
Nancy Olson, JD:And it was. I had the perfect building with a large conference room, plenty of space, accessible hallways, accessible doorways, accessible elevators, close parking that was covered. I couldn't imagine anything better. And I really wanted this IRB member. I talked to him and convinced him eventually that this is something he wanted to do.
Nancy Olson, JD:And he was very excited. But what I did not think about was if he happened to be on campus, he was a faculty member. If he was on campus and was in his office, which was also completely accessible, how would he get to me? And it turned out that how he would get to me, at one point, he had to go to a certain floor, go down a hallway, get on another elevator to go to a different floor, to then go down another hallway to get to another elevator before he could get to me. If and we've all been there.
Nancy Olson, JD:You've gone to conferences where to get to one floor, you have to take two elevators. And and it was that type of thing that made it almost impossible for him to get to me and to an IRB meeting. He did it once, and that was it. And so I think when we're all thinking about our buildings are accessible, We need to look beyond how will people get to us and make sure that there is a way to easily get to wherever we're conducting our study. You have to think about it's not just we have Zoom captioning available.
Nancy Olson, JD:Are there good enough connections? I cannot live without my phone anymore. Talk to text. It's wonderful. However, if I go somewhere that doesn't have good Wi Fi connection, I cannot communicate with anybody.
Nancy Olson, JD:So I think as we're planning our studies and thinking about how to make things accessible, we have to look beyond just the immediate and think about those types of details. There's different types of captioning available. There's different accessories for visually impaired people to use. You have to think through all of those things. And if you're going to have somebody who perhaps is in a wheelchair or needs a walker, make sure that they can access you easily.
Nancy Olson, JD:If they need, perhaps you have someone who wants to be in your study who is nonverbal, Make sure you have accommodations and space for whatever they need. You just have to, it takes some time on the front end, but you'll be prepared and have more participation on the back end.
Ivy Tillman, EdD, CIP:Wow. I think you summed it up. It takes preparation and intention. Right?
Nancy Olson, JD:Yep.
Ivy Tillman, EdD, CIP:So my final question, and we could talk for for hours because I so appreciate your insights. And those who are listening, if you are in any of these fields and you're interacting with participants and policies and reviews, I think you've picked up on a lot of nuggets as I have. Nancy, what's the one thing you most want researchers and IRB professionals and anybody listening to leave this conversation knowing that they probably don't know yet?
Nancy Olson, JD:I'm not sure any of us know the answer. Like I said, I learn something new every day about how to accommodate and make things accessible for others. Mostly I learned from my own personal experience, but I'm trying to broaden that. And so I think the best thing that we can all do is don't assume that you know what people need and don't be afraid to ask what people need. It's not I used to be afraid to ask what people need.
Nancy Olson, JD:As this started, I was embarrassed to tell people, I don't understand what you said. So it's taken some time. And I think researchers and IRBs start asking those questions and they'll get used to it and they'll learn more and they'll be better prepared and the studies will be stronger and more people will be enrolled. You'll have a wider diversity. I think that's what we all want so that we can then learn more from our research.
Ivy Tillman, EdD, CIP:I agree. Absolutely. Nancy, thank you for your time with me today and thank you for sharing your experience, but also those rich nuggets of guidance for our community to ensure inclusion of everyone in research. So thank you for listening. Bye.
Ivy Tillman, EdD, CIP:Thank you.