On Research Podcast – Life as an Unaffiliated IRB Member

Jamie Arango: Welcome to this special edition of On Research – with CITI Program. I’m your guest host Jamie Arango. My guest today is Sally Mann, who serves as a non-affiliated IRB member. She joins me today to discuss what it means to be a non-affiliated IRB member, how she first joined an IRB as a non-affiliated IRB member, and what it means to her both personally and professionally to be part of the IRB review of research. Before we get started, I want to quickly note that this podcast is for educational purposes only. It’s 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 are solely those of our guests. And on that note, welcome Sally.

Sally Mann: Thank you.

Jamie Arango: It’s great to have you here with me. Sally and I are talking today about the role of non-affiliated members on institutional review boards IRBs, for the audience that may not be familiar with IRBs, they are the boards at institutions and organizations and sometimes commercial or external ones that review research that involves human subjects before those subjects are enrolled, and the US regulations and Canadian regulations describe memberships of the IRB in some similar ways and in some different ways, but both include a non-affiliated person. Canada adds the community member piece to it, but that individual is not otherwise affiliated with the organization, they’re external, and they play a role.

Sally Mann: Yes, I think exactly, and that’s a way for people like me who’ve retired to give back to society and to the researchers, to the people who might participate in their research and to still continue learning. I just think it’s an opportunity that one should take advantage of.

Jamie Arango: I think that non-affiliated members also have the advantage that because they’re not an employee of the organization, that they can sort of have that external view, maybe not feel the pressures that may exist within the institution or the organization. I think that’s another plus that the non-affiliated member will be.

Sally Mann: I agree, and you may end up pointing out things that are perhaps not equitable within the institution, but that doesn’t mean it shouldn’t be pointed out, and I just think it’s a way to give back, but you also give to yourself because you’re exposed to so much new information and to different viewpoints, and you interact with people who are also giving viewpoints, and it’s just a good community type activity.

Jamie Arango: Why don’t we start by telling us a little bit about your background?

Sally Mann: Well, it’s in some ways, I suppose a little strange. It’s definitely varied. We start, when I went to university, my undergraduate degree is in English with a minor in history. I had always thought about being a teacher, but that didn’t work out so well when Mike and I got married and we moved to Cornell University, because all of the graduate students’ wives wanted to teach, and I had completed my student teaching, so I worked as a secretary and learned a tremendous amount. I think any job I’ve had for me has been a learning experience. Then once Mike graduated and we went to a postdoc in Seattle, we had had our daughter, she was seven months old when we moved, so I decided I’d like to stay home for a while, but then postdocs don’t make a lot of money, so we needed a little more income, and what I found was actually sort of a perfect fit.

We went to a faculty member’s home and took care of their son, who was about the same age as our daughter. They both had playmates, we had activities to do, I came by cars so I could take them to parks to do fun things, and it ended up being a really good experience. I was working for people who were on the faculty at University of Washington, so there was the science still involved. Then after we finished there, Mike took a position at the University of Nebraska Medical Center, and I got a job as an executive secretary for a nonprofit organization. We had another child, and I had been a staying home, but then I was invited to actually come and try working part-time, just helping out in a research lab, and I liked it, and the person who had the full-time position took another job, and so they offered me the full-time position and I was like, “Whoa, okay.” And as we continued, again, I’ve learned a tremendous amount, things I had never done, and I guess that’s one message that I have is that don’t be afraid to try things you’ve never done, to learn.

At the medical center, full-time employees got tuition remission, so you could take classes, and the people I worked for were very accommodating. I could take classes during the day, but they always knew that I worked extra anyway. And I ended up getting a master’s degree in a scientific field because that gave me more credentials than the English, although they are both useful in the things that I’ve done. And so I was the technician for a while, and then I was promoted to be the coordinator for the two laboratories. I organized the graduate students and helped with grant writing, paper writing, all of those things. I worked for them for almost 20 years, and then it got to be a little more difficult, a little physically demanding, and someone who was in the department ran the office of regulatory affairs, and said, “We’re looking for an IRB administrator.” And I’m like, he says, “You could learn it.” And so I transferred over and I did end up learning. As it turned out, our organization was one of the original 10 city organizations that wrote the content and maintained it for several years. So you just keep learning, that new things keep popping up that keeps you engaged and active.

Jamie Arango: You can kind of tell how long you’ve been with the relationship with CITI because everybody knows it originally as a Citi, and then it morphed into CITI.

Sally Mann: Right.

Jamie Arango: I did the same thing. And your master’s is in medical sciences.

Sally Mann: Right. With the emphasis was in hematology and immunology, because that’s the kind of lab I worked in. So we did a lot of translational research with physicians, with the oncologists, and that was a real learning experience too.

Jamie Arango: Sure. Were you a little like me that I didn’t know what IRB meant when the job first appeared? Did you already know what the IRB was?

Sally Mann: Well, yeah, because we had to write IRB applications. Because we used specimens that were going to be discarded, but you still have to have an IRB approval to do that so that they know how you’re going to protect identities. And we didn’t get identities, so I had to help write those.

Jamie Arango: It’s kind of interesting given the recent Henrietta Lacks decision, that background.

Sally Mann: And we actually did use HeLa cells sometimes, but without knowing. But I mean, I don’t think for the most part, I don’t think people would object if they knew specimens were going to be thrown in the trash and burned. I think people are generous and for the most part, if we needed an extra bone marrow sample or something, patients would agree to do it.

Jamie Arango: Tell me a little bit, what was your life like as an IRB administrator?

Sally Mann: Oh, well, I mean, it’s an intense job. There are lots of things to remember as far as documentation and trying to help people write up their studies. It’s not intuitive, I don’t think for researchers, although when you make an application questions, you try to guide them and help them out that way, but it was intense that there could be difficult researchers as in any profession. But it was just interesting. It wasn’t something I knew we had to do the applications from the research, but didn’t realize the history behind it until we had to take training. And I learned a tremendous amount and it gave me a different perspective, but I also think that I brought a different perspective to that job because of my research experience.

Jamie Arango: Sure, sure. So let’s pivot a minute now. So what does it mean to be a non-affiliated IRB member?

Sally Mann: Well, it means that you are not an employee of the organization that hosts the IRB. In the US, it also means that you are not a relative of someone who is employed by that organization. That’s not the case in Canada, or at least it’s not specified in their regulation. And what’s different, it’s not for the unaffiliated part, but the thing that’s different in Canada is that you have to have a lawyer, because apparently my understanding is that a lot of the requirements are actually codified in law. So you need a lawyer to tell you if you’re approving something that’s illegal.

Jamie Arango: And the lawyer is not necessarily a non-affiliated member, right?

Sally Mann: No. Right. They serve as the lawyer.

Jamie Arango: We should mention for the audience that you introduced Canada because you and Mike-

Sally Mann: Yes. Okay. So another part of my varied story, our daughter was a graduate student at Boston University. She met a young man from Jonquiere, Quebec who was a postdoc at MIT, and they hit it off. And when she graduated, Mario had already come back to Quebec. And so Corrine, our daughter, found a job as a postdoc up here. Then ultimately they were married. They had a little girl, but she was born three months early, and was signed up for a clinical trial. And our son-in-law’s family suggested that since we were getting close to retirement, it would be very helpful to have all the grandparents here in case they needed help. And as it turns out, it’s been wonderful. She is now 20 years old and she’s starting her second year at university. So she didn’t need a lot of help, but we were here to be the respite people. If she was sick and couldn’t go to daycare, we also got to host her on all the teachers’ holidays, and we would usually get a week or two in the summer where we could plan some fun thing to do. That’s how we ended up here.

Jamie Arango: Then once you were there, if I recall correctly, you wanted to remain sort of engaged in that research in the IRB kind of space?

Sally Mann: I guess I appreciated how important it was, and I knew that it was very difficult to find people who would volunteer to be an unaffiliated member, to volunteer position. It does take time, but at the same time, you are exposed to all kinds of information that you would not encounter, and they can be useful if you or any member of your family is potentially invited to participate in research. And you also are being the voice of all the people in the community, because researchers intuitively do not know what a community individual, somebody who they’re recruiting for their studies really needs to know. They can explain the science to them, but there are other questions that can be asked or things can be explained in an easier way so that people actually understand when they’re looking at a consent form or they know questions to ask, then it’s just helpful.

Jamie Arango: You mentioned community member, and you’ve kind of used the term a little bit interchangeably with the non-affiliated. When I started in IRB spaces in human subjects protections, we generally also used to the term community member, although I recall correctly, and we can sort of touch on it, the US regs are a little different in that, it only speaks to non-affiliated, where the Canadian one actually does mention community member.

Sally Mann: Yes. The Canadian regulations call for five members, including both men and women. Two members have to have experience in relevant research disciplines, fields and methodology. One member has to be knowledgeable in ethics, and one member is knowledgeable in their law, relevant law, and then one community member who has no affiliation with the institution.

Jamie Arango: Interesting. When I have worked with community members or non-affiliated members in the US, while their title may have not said community member, I think many have worn the hat with that mindset built in that they are sort of watching or being thoughtful when it comes to the communities where the research may occur.

Sally Mann: Yeah, I mean, I think that’s true, that members of the general public are not typically involved in designing studies, but they certainly may be invited to participate in them. And so it’s good to have that viewpoint. I think it helps the researchers and ultimately helps members of the community if they’re invited.

Jamie Arango: Absolutely. So given that, Sally, talk to us about your experience serving on the boards as a unaffiliated or community member.

Sally Mann: Well, it’s been a positive experience. You meet people from all kinds of disciplines. Here on the board that I serve on, there’s more than one unaffiliated member. So we discuss things and the other members always look to us to correct misstatements or request clarifications. So you don’t get the feeling that you’re excluded, you’re a member of the team.

Jamie Arango: Sure.

Sally Mann: It does take effort because you have to read all of the protocols that are going to be reviewed. And typically there can be between, I don’t know, five and 10, and they can range up to 100 pages, but they depend on us to actually read them. We’ve had sometimes if an investigator, a researcher is having difficulty getting his study approved and doesn’t seem to be able to understand the questions that are transmitted to him in a review letter, he’ll be invited to come and talk with the committee. And I was waiting in the hall for the room to empty out one time, and he’s like, “What do you do?”

I’m like, “I am a community member, somebody who presents the general community, not a researcher.” And he says, “Oh, yeah, well, but you don’t pay attention.” And I’m like, “Actually, I do read every page that’s submitted to us.” And he’s like, “Really?” And I’m like, so I think they appreciate when we find discrepancies, they may describe things one way in a protocol, a different way in the consent form and in supporting documents. And so if you’re going to be invited to take part in that study, you’d need to actually know how much time it’s going to take. If they say five hours one place, and two hours another, and four visits one place and only one visit another, they need to make that consistent and clear. And so that’s one of the things that we can do.

Jamie Arango: So in that space, I know that many IRBs really encourage the investigators to write the protocols and certainly the consent forms and the subject materials in lay language. Do you find yourself sometimes as a non-affiliated member wrestling with that space? Do you feel like your science background, helps when they’re maybe not as lay as they could be in their explanations?

Sally Mann: Well, I think it’s certainly pretty obvious when they’re not writing in lay terms. So a typical comment would be, I don’t think somebody would understand this phrase. It more simply, they don’t need to know all these technical terms. So I think that’s another value that we have.

Jamie Arango: It’s important to note that non-affiliated members, community members review all the same materials that regular members of the IRB review. And that’s sometimes hard for community members to work through. I think as IRBs, they really do try to get investigators to write their protocols that cover the IRB in as lay language as possible. But it certainly is a challenge.

Sally Mann: Oh, sure. It’s a challenge for them because they have their own vocabulary. Actually Google helps a lot. If I find terms that I have no idea what they’re referring to, I can Google it. And oftentimes I’m like, “Oh, okay, yeah, I understand.” But then I also have a way to suggest that perhaps it’d be rephrased in these terms.

Jamie Arango: Yeah, that’s actually really helpful. I had never thought about doing that. That external source can give you a way of bringing suggestions back to the committee. And I would imagine that in certain areas like, things that are human subjects facing consent forms and recruitment materials, that can be really valuable because you can put it in language that they could potentially look at.

Sally Mann: I just find that useful.

Jamie Arango: So pivoting a little bit in terms of changes in regulations, and as you know, the common rule not too long ago went through its change. There’s changes in guidance and new guidance. How do you stay current as a non-affiliated member? It’s kind of easier when you’re in an IRB role to stay because your job sort of encourages it. But when you’re not doing this full-time or not even doing it part-time, how do you do that as part of your role as a non-affiliated member?

Sally Mann: Well, I suppose in some ways it’s a little holdover from when I was employed, but I’ve signed up for numerous Listservs that are from the FDA, from OHRP, from NIH, and you can find similar things here in Canada. And they send updates. I mean, you usually get a communication at least once a week from them, and then you can go out and find the source material. They’ll usually have links. It’s helpful to me because then I know more about things if I should be approached to take part in a study, I would know questions to ask, where to go for more information and how to judge the information whether it’s a good benefit or not.

Jamie Arango: Sure. In that space of staying current, some IRBs have rotating memberships, both non-affiliated, affiliated. Do you have a sense, is that good from your perspective? Is that a wise approach? Do you feel like staying old and having longevity has its own set of merits?

Sally Mann: I think that consistency is important. I’ve never been on a board that had rotating memberships, so I don’t know until you experience it, you may not know how it works. Another way that you can stay current is that here, and I think maybe on some boards in the states, the board will send out educational material and they may also encourage you to attend a meeting. Those are really good places to get new information.

Jamie Arango: Yeah, it’s interesting because I’ve attended many conferences sometimes with you, and it’s always been a bit of a surprise when I do hear and you meet folks who are community members and non-affiliated members, and that the board has sent them as part of the ongoing education. I mean, it’s great. You have them engaged, and it’s a way of providing information and they make a network, which is something also I think in our fields, it has always been valuable, is that ability to network with folks who may have experienced something that you’re now experiencing. How did you survive it and what did you do, et cetera. And I think that there’s so much value in that personal interaction.

Sally Mann: Oh, I agree. Absolutely.

Jamie Arango: So Sally, let’s talk a little bit about giving folks who might have an interest in becoming a non-affiliated member. Or let’s say someone just gets asked, hopefully they know what an IRB is. What suggestions would you have for those individuals who might want to serve as a non-affiliated member?

Sally Mann: I guess my biggest suggestion is be open to new experiences. Be open to learning. You are going to bring things that others may not have, and you’re going to get information and perspectives that you may not have yet. And the whole idea of encountering new areas of information and knowledge is a plus. I mean, that’s an advantage for a member, I think.

Jamie Arango: Do you have any thoughts, because in my experience, sometimes the non-affiliated member, there is a big difference from their background versus the members of the board, often very esteemed PIs, people with long academic experience, et cetera. Are there things that they can do themselves? I know I think often we assume that the chair of the committee will help equalize participation, but what do you bring to say, “Okay, doctor so-and-so is in the room, but I can speak up too.” What drives you in that sense internally?

Sally Mann: Well, I think, one, everybody’s opinion should be tolerated and welcomed, and it simply may be something that a researcher didn’t think about or another board member, because they looked at the study from a different perspective. And I suppose I’m not particularly shy, so I will speak up, but my experience on this board where we at one point had four community members, is that once I spoke up, everybody else did too. That’s something that you can give to the community in this arena.

Jamie Arango: Do you have any sense of, it doesn’t sound like there’s been a lot of rotation, so I don’t know if there’s been a lot of chair change on the committees you’re on, but I wonder if the culture that that person has created has also kind of helped you feel comfortable sharing?

Sally Mann: Yeah, I think so. They’ve reorganized some of the boards. So while I was on committee A at one point, I’m on committee B or something now, they’ve changed where they send various types of studies. The chairman I think is important in promoting an accepting atmosphere. But I think it’s also important for the members who are already there to do that, for any new members that come in, because I’m sure even the scientific members don’t know what an IRB does, haven’t experienced it. And I think you just need to be welcoming and supportive.

Jamie Arango: What’s your relationship like as a non-affiliated member to the staff that work the IRB? Do you have one?

Sally Mann: Well, we’re in a little bit of transition right now because the person who was the main coordinator and facilitator took a promotion in another office. And so the ethics officer is actually having to handle all of this. And even with the ethics officer, the relationship is fine. I could email her or call her with a question without any problem. And yeah, it’s not an easy job to coordinate all that stuff.

Jamie Arango: I wonder if sometimes non-affiliated members may have a little bit more of interaction with those staff because they are sort of that external voice where the other folks are in the system. And so maybe there’s a little bit of less of a tendency to have those interactions, whereas an external person connect with the individuals who maybe even are the folks who originally reached out to have you join the committee. So that may help to have a relationship with them.

Sally Mann: Yeah, I think that’s true. I mean, you certainly need to know all the people that are working in the office, and I think then that gives them a better sense of what you’re likely to need or questions that you may have.

Jamie Arango: Are there things that as a non-affiliated member, you feel you should get or should receive the get-go? And then are there things that you found that you expressed that would help you do the job better?

Sally Mann: Actually, I was required to take what’s called the TCPS two training, which is an online training with quiz questions about the regulations. And that was very helpful. And it was funny, one of the first meetings that I attended, there has to be a statement in a consent form about how long information will be retained. And the study we were reviewing had a length of time, and I just raised my hand and said, “But the training I just took said it should be this number of years.” And they’re like, “Okay, glad somebody is up-to-date.”

Jamie Arango: So you successfully transitioned from full-time, I think maybe quasi part-time and then maybe retired, but are still actively engaged. And we have so many folks professionally in our fields that are in those different stages of their professional, I would say trajectory. It is an ongoing thing. In the spirit of your earlier comment about it’s ongoing education and ongoing sort of self-training, self-development, et cetera. What suggestions do you have for folks who are in those different stages that may want to stay engaged or even do a role like this? As a non-affiliated member?

Sally Mann: I think you should be open to any possibilities that come your way. There are always new things to be learned. You always will have something to contribute, and it’s a way to help other people and potentially yourself or your family in the long run.

Jamie Arango: I think I would also have maybe in some ways a self-advocacy. When I was an IRB director, I lost a community member or non-affiliated member, and it was hard to find somebody to replace the person. And I think if individuals are desiring to stay engaged, and this might be an interest, is to reach out to certainly local IRBs, but you can be an IRB non-affiliated member anywhere.

Sally Mann: It’s true. I think people don’t necessarily take advantage of that. They might feel intimidated. They might not know who to contact, but if you look up the research ethics board office or the Office of Regulatory Affairs, they’ll be able to guide you and help you.

Jamie Arango: Let me ask you final question. How else would you like the CITI Program community to know about what it means to be a non-affiliated member?

Sally Mann: I guess I would like them to appreciate how rewarding it can be. It is a volunteer position, but you continue to learn, but you also continue to teach and contribute. And I think that’s really important. I think it’s important to protect the human volunteer subjects. And at the same time, it’s not just the subjects, you’re helping the research community, because once they appreciate some of these things, then their knowledge base is going to be much better.

Jamie Arango: Great. Agreed. Well, Sally, it’s been great chatting with you.

Sally Mann: Oh, it’s been terrific. Thank you for inviting me.

Jamie Arango: Thank you again, Sally. And thanks to our listeners for tuning in for today’s conversation. I invite you to visit www.citiprogram.org to learn more about our courses and webinars that address human subjects protections, including content for IRB members and IRB administrators.