HCDM 42 | IRB Managers

 

Every researcher knows the pains of having to go through the process of getting your proposals approved, most especially in the medical field, where almost everything involves life and death situations. Playing a vital role in this are IRB managers. They are the ones who are responsible for helping researchers think about their studies and, likewise, patients who undergo clinical trials. In this episode, Dr. Richard Marn, M.D. interviews Marilyn Eshikena, who is the IRB Manager at Mount Sinai. Together, they explore the tasks of IRB Managers, the rewarding parts of the job, and the misconceptions surrounding them. Marilyn then takes us to the day in the life of an IRB Manager and then shares what one needs to have when trying to pursue this area.

Listen to the podcast here:

A Day In The Life Of IRB Managers With Marilyn Eshikena, MS CIP

If you’re interested in being at the forefront of the latest research that’s being performed or being developed, the latest clinical studies for patients that are being thought of, especially with the technology and advances in medicine that are going on, then this career, this profession is maybe for you. We’re going to talk with Marilyn Eshikena, a wonderful guest who’s passionate about her job and very knowledgeable about it as well, a real expert in this field. She is an IRB Manager and you’re going to learn how important and interesting and vital that is to getting research done the right way, but also learning about what the newest and latest thinking is in research out there. Let’s jump into it.

I have the pleasure of having Marilyn Eshikena with me. Welcome, Marilyn. How are you doing?

Thanks, Dr. Marn. I’m doing very well. Thanks for having me.

It’s my pleasure. We’re recording this just as 2021 has started. I’m so happy that we’ve got you on this show. I want to start off with some real quick questions to get into things, these quick-hit questions as we talked about before. Marilyn, give me a quick bio, the highlights of what you think that people should know about you.

My name is Marilyn. My last name Eshikena. I born and raised in Nigeria. I moved to the UK for my undergraduate degree. I went to Sheffield University where I studied Biomedical Science. I then moved to New York to Columbia University. I got my Master’s in Bioethics. Right after that, I started working at Mount Sinai doing IRB work and I’ve been doing that since.

What exactly is your job title? What do you do?

At Mount Sinai, my job title is IRB Manager and I manage IRB analysts and contribute to the function of the IRB office.

In your work, how do you help people?

We help people, the immediate customers as it were, are biomedical researchers. We help them think about the studies that they’re doing or proposing to do. We help them navigate the regulatory waters because we are the experts. We provide that help to them. Down the line, we are helping patients who benefit from these different biomedical research studies, either immediately through clinical trials that may benefit them or down the line through what we learned about the different conditions.

What is the best part of your profession in a sentence or two?

Contributing to the growth of science and medicine.

What is the least favorite part of your profession?

Reading, it’s a lot of reading.

What are misconceptions people have about your profession?

That we hinder research. There’s a lot of paperwork that goes into what people need to give to us. Some people may take that as not having so much freedom to start their work when they want to start it. There is that misconception about hindering research.

One of the misconceptions about IRB Managers is that they hinder research. Share on X

Marilyn, thank you for answering those quick-hit questions. I do want to get to the meat now, Marilyn. You told me that you were an IRB manager. What exactly is that? How is your day like?

An IRB manager, it’s best for me to talk to you about the IRB piece. The manager piece is management. The IRB piece speaks to what I do day-in and day-out. We receive proposals from biomedical researchers at Mount Sinai. These are research proposals either to do a clinical trial on a new experimental drug, new experimental device or observational, trying to figure out what’s going on in a certain condition in different parts of the body. They write it up and submit it to us. We read what they’ve given to us. We try to figure out if what they plan to do is possible under the confines of the regulations that govern what we do. If there are any ethical, moral issues, we think 100% on the fore of our minds, the subject’s patients and people who will be volunteering their time, samples and bodies to scientists are learning about this.

We’re thinking about them and making sure that there’s no part of this project or these projects are taking unfair advantage of these patients. That’s what we do. That accounts for, I would say 95% of our job. The rest of it is educating these researchers as well through different outreach programs, talking to them about what to think about when you want to plan projects in the future or they call us for consults, “I’m thinking of putting something together. What do you think?” That would account for the other 5%.

In a very general sense, there are two types of research in medicine. You can do clinical and basic research or bench research. Are you focusing on clinical research or do you also look at studies on basic sciences as well?

We only do clinical research.

You said you vet all these studies that come through other researchers in Mount Sinai. How many research studies are you reviewing a year?

In our portfolio, we have 5,000 active projects every year.

There are literally 5,000 researchers that are sent to the IRB a year?

Yes. They are researches that have wide portfolios. One researcher may account for maybe twenty-something of those 5,000 but individual unique projects, we have 5,000 active.

How many per month do you usually get?

I would say anywhere between 250 and 300.

You read literally hundreds of proposals a month?

Yes, in office.

When you’re doing this reading, who are you working with? Are you working with the person that’s submitted that study? Who else are you working with when you’re reading the proposal from, say, this researcher?

For the most part, we’re working with that team. It’s usually a team. Sometimes depending on the project, you may have one researcher working with that person, but in general, working with the team, which may include the PI who’s the lead investigator. Most times we’re speaking directly, at least at first, with their research coordinator who was hired to interface with our office. Sometimes we may need the PIs input because the PI is the one who knows exactly what’s going on. We may talk to other co-investigators if we need clarification.

HCDM 42 | IRB Managers

IRB Managers: IRB Managers may not be scientists, but to guide that proposed study to the right path, they need to understand the concepts and conceptualize them.

 

For the most part, that’s who we’re working with but there are times when we have to work with the FDA directly. We have to call them. We have questions because some of the studies that we see aren’t studies that Mount Sinai researchers have put together. We may be working on a multicenter study and not a wide national study where we aren’t responsible for. It needs FDA oversight. We may work with them on that with questions that we may have. We may work with other institutions as well outside of Mount Sinai. Back to home within Mount Sinai, we may have to work with other research administration offices. That’s what we call them.

For example, if a study is using experimental medication that hasn’t been approved by the FDA, we will work with this department that’s called investigational drug services or research pharmacy, since they will be responsible for getting that experimental job and dispensing it to the study team. We want to make sure that all that ease is done properly. In 2020, so there’s a lot of research and a lot of things being done with software and apps and IT. The world of IT is fully ingrained in medicine and science. We have an information security department, they deal with the security of data, making sure that data and any of this stuff doesn’t get hacked into. We worked with them very closely, depending on what the student’s doing.

As you’re an IRB manager for Mount Sinai, which is a major academic institution based in New York, you’re dealing with hundreds of different studies regularly every month. I presume in 2020, you probably saw a huge influx of COVID or Coronavirus-related research. What percentage of studies were COVID related in 2020 for you?

It’s anywhere between 30% and 40%. At the peak of COVID, so between March and June, it probably accounted for well over 50% of our research portfolio. In the summer and then now, it’s still coming in but it’s dropped. I would say, now it’s going to be about 30% but altogether if we are taking it as a chunk, I’ll put it somewhere between 30% and 40%.

As a department division, you are at the forefront of a lot of research that’s out there. What people are thinking about, what they think they want to test and trial. You’re getting the researcher’s perspective of what they think is going on out there and how to test it. How do you feel about that?

It was a reminder of why I love what I do so much, which is getting a first look at where science and research are going and getting that first look before it’s even tried, before the experiment happens.

At least you’re getting the idea and you’re like, “I never thought about that.” They’re trying to test this aspect of this disease. Especially with the pandemic going on, this must be very intellectually stimulating and exciting.

Besides the work that we’ve been getting about COVID, I’ve taken to daily checking in on clinicaltrials.gov, which is where any research that has happened in clinical trials get posted publicly. I go on there to see what other institutions, both nationally and internationally, are doing regarding COVID to see, “Are we doing that as well? I haven’t heard of this.” It is interesting learning because in the work that we do, we may not be scientists, but in order to guide that proposed study the right path, we need to understand the concepts and conceptualize it. I’m learning a lot here.

You even have to understand it as well to make an educated decision of whether this study meets certain criteria to get through IRB. By the way, what does IRB stand for?

It’s Institutional Review Board.

Just to give everybody a sense, an IRB is at every academic institution in this country that wants to do research, correct?

Yes. Either you have one as a department in your institution or you pay for an external IRB to use them as your IRB. In order to do the search, you need to have an IRB that you’re affiliated with.

That involves patients or living things.

I want to speak a little bit on that. The IRB has been mandated by the government for any institution that’s going to receive federal dollars to do research, you must follow their regulations, which includes submitting to an IRB and having an IRB approve your work. There are private like you in private practice, for example. If you wanted to do research, looking through patient’s data to see some trend, you’re not receiving federal dollars. You can go ahead and do that without coming to us first.

What’s your typical day like, Marilyn?

There are people who think that IRB Managers are not here to stay because there are people who are for self-regulation. Share on X

Now with COVID, a typical day begins at 8:30.

Did it start differently before that?

I start it 30 minutes later. We start with a high-level management meeting, which is very important for us to establish the day. Usually, there may be things that have come up at the night before that needs to be discussed in terms of projects. You may have highly sensitive projects. Any project that’s funded by the NIH is highly sensitive because their process is different. By the time they come to us, they need it yesterday. We want to know any of those that we have any problematic projects, any projects that are hard for us to conceptualize and want to talk about it together.

The rest of the day is spent as a manager. I’m overseeing the work of my people. Many times, they have questions as they’re reviewing these projects so they are honest with the reviews, I’ll help them with that. I may have meetings schedules to talk to study teams to provide consults as they work on putting their research together. Many times, we may have questions for the study teams based on what they submitted. We get on the phone because that’s the fittest way to understand what’s going on. We do that as well. A small part of my day is spent looking at the metrics and the data of what we’re doing all the time.

You mentioned as a misconception people have about your career is that there’s this misconception that IRB and their managers hinder research. Why do people get that misconception? Why is that a misconception?

I believe that it’s come about because we’re in an office. We get audited. We need to have paperwork and records kept in a certain way. A researcher who wants to get their work off the ground wants to tell you, “Here’s what I’m doing. Is it fine to do or not?” We’re asking them to fill out this form. You need to answer these questions. You need to provide us with X, Y, Z information. We need your CV. We need you to do this course. We need to make sure you’re training this. People who do clinical research also have clinical work that day that’s taking their time or other things that they’re doing. Research isn’t 100% of their time. They’re juggling all of that with the IRB requirements that they need to meet.

They can’t meet it at the time when they would like and the IRB can’t move forward with us reviewing and approving their proposed research until we get that. It takes long for us to get to that point because of that. I have met a few researchers, especially if they don’t have any help in terms of hiring a person to interface with the IRB and if they think that it’s not worth it, they abandon the research and they don’t do it. They don’t do it because they’re like, “I can’t figure this out.” That’s where that misconception is coming from but what we’ve been doing in our office and I’ve been trying to do, when we speak to researchers, “We’re collaborators in the research process. You are an expert in what you do. You’re an expert in the idea that you have. You’re very smart in that. We are the expert in regulation. We want to work together. If you need help, ask us and talk to us,” as opposed to assuming.

It’s oral tradition, word of mouth. People hear that the IRB is difficult. They approach us with that outlook. The moment you say, “Can you change this?” That becomes like, “They started again. They’re not going to make this. They’re not going to let me go through.” We try. Customer service is at the forefront in our office of what we do. We have three tenets that govern us, accuracy, customer service and timeliness. Customer service and timeliness of both linked because the quicker we’re able to produce to the researchers, the better light they see us. They say, “It’s not too bad. I can do this again.” The next time they have a great idea, they don’t have to think, “IRB, I have to go through them. How can I do this without coming through IRB? Let me find a workaround.”

These regulations from the government or other governing bodies, like the FDA, are put in place to ensure those three tenets. Therefore, when the research does come out, the research is reliable, which is the whole point. We don’t want to be doing studies that aren’t reliable, which is why it’s great that we’re talking because in early January of 2021, the vaccines are coming out. I would presume that you’ve seen the research on those vaccines. If someone like you or even me or anybody in the scientific community use it, they want to make sure that these vaccine trials went through the appropriate IRB steps.

Giving vigorous attention, throwing us in our review enforces that because when someone sees something and they say, “This was reviewed by an IRB,” that carries a lot of weight. You shouldn’t need to dig down. “IRB reviewed this. I trust it.” In order for that to continue being the case, we, as the IRB, needs to make sure that we’re being thorough enough, that we’re knowledgeable, that we’re getting all the information and that we’re only approving research that meets certain standards.

Marilyn, can you tell me what is your most rewarding part of your job and some examples?

Probably in my first year in this field, we talked about a study and eventually approved it that had to do with trachea transplant. In reading up about that, I realized that was going to be the first time there would be that kind of transplant using the method that they were going to use. I thought, “This is great. This is amazing to be in a room, to have access to this information, seeing that this is the first time we are at the forefront of doing this first in humans.” Being that this is the first time, we don’t have the legal term B, an in case of. There there’s no precedence for us to go to and look to see how this is done.

We as smart people who know the regulations and who are trained to think about ethical and moral dilemmas, we’re thinking about this novel case, this novel proposal in this way. That was when it hit me for the first time the kind of impact that this work has in patient care and helping humanity in general, with things that come up. I learned that for big children, boys especially, who have cancer and have to go through cancer treatment, especially radiation, there’s the risk of impotency, of not being ever able to be fertile. We learned that there is research that’s in the early stages, trying to grow a sperm in a dish from testicular tissue. That’s something that’s currently being done and it was brought to our attention.

We’ve done a little bit of consult working on that. Hearing about the future impact that it will have in the life of a five-year-old boy who goes through chemo or radiation therapy, gets healed and goes into remission. Without future advancement in science, he’ll probably go through his life without being able to fertilize an egg to then have a baby. He probably wants that. Science is at the point where we’re trying to make that happen for this five-year-old boy down the line. Many 5 to 10-year old boys, pre-pubescent boys. That’s fascinating. Certainly with COVID, it’s interesting. My friend has sent me an article that had mentioned Mount Sinai in early stages, talking about how they found COVID antibodies in breast milk. She sent that to me and I was like, “I worked on that.”

You can talk to me first, off the record. You said you have to do a lot of reading in your profession. Is that almost burdensome?

HCDM 42 | IRB Managers

IRB Managers: Customer service and timeliness are both linked because the quicker we’re able to produce to the researchers, the better light they see IRB Managers.

 

Yes. I’m not a reader. I’m a slow reader and I enjoy writing and I realized early on that I’m not a voracious reader. That can get burdensome because it’s not leisure reading. It’s serious stuff. It’s critical reading because you’re reading to both understand and find any holes and gaps that need to be filled. You need to be alert. In one day, if you’ve read 6, 7 protocols, that’s a lot. By the time you opened the eighth one, it’s like, “I don’t know.”

That’s why it’s important to know what time of day you’re best alert and you’re able to take in all this information. We intersperse it with different things when you have a meeting with someone. If I call you up to tell me about your research, it’s different from me reading what you’ve written down to me. I would say another part of the reading too is people and their different writing styles. Not everyone is as eloquent in writing. That can also pose a challenge in trying to figure out what people are trying to say.

Would you say your work-life balance is pretty good overall or not or something in between?

I would say something in between and that’s a personal choice. This field that I’m in makes for excellent work-life balance but I enjoy what I do. I put in the extra time, not out of necessity but because I enjoy it. I don’t have to work on the weekends. I have set hours for work, 9:00 to 5:00 is a business hour. I do love it. I do think that it has great work-life balance. Especially the work that we do can be done anywhere. You don’t have to be tied to one specific location.

You told me you used to go into the office every day until March and then you haven’t been to the office since March of 2020. Thank goodness for Zoom and internet connection. Do you recommend this career to students? If so, what kind of students you think best flourish in this type of career that you’re doing as an IRB, manager?

I recommend this because I’m biased. I’m in it. I love it, so I recommend it. If you are a curious person, curious about the inner workings of biomedical science, biomedical medicine, how the things that we use in medicine and science come to be, this is perfect for you because you get the first look and you need that curious mind. That’s what helps with the numbness of reading and reading. If you’re curious, each thing you’re reading is different from the other. That interest is what fuels you to keep going when you open a new one and they’re saying something different. “I wonder what is this is? I want to know what this is and learn about it.”

If you are curious and interested in the inner workings of science, for me, I was both those things but I didn’t want to be a researcher myself and confine myself to one area of interest. I found that this was a great fit for me because I’m exposed to all aspects, cancer, COVID, infectious diseases, HIV, even pain management using VR technology and anxiety management. The first game to treat ADHD was approved by the FDA in 2020. You’re exposed to all kinds of things in the field of science and medicine. If all those things interest you, then this is where you should be.

In some way, also working on the IRB, you are the gatekeeper of the quality of research that comes in and through the IRB and eventually what gets out to the public. What do you think the future is for your profession as an IRB manager?

That question is interesting. Since you asked me the first time, I’ve been pondering on it. It’s a mixed bag. There are people who think that we’re not here to stay because there are people who are for self-regulation, meaning having the researchers regulate themselves, having the researchers do what the IRB essentially is doing. I think the opposite and I’ve checked my biases and I do think that this is maybe a little bit in it but that this field is here to stay and it will keep growing. The reason I say this is if you look at the history of regulation of science and medical research, we’ve come a long way. This whole body was put in place because of all the missteps that happened when researchers were pretty much regulating themselves. That’s not to say anyone goes out with the intent of doing unethical research.

The truth is when you are wearing many hats, you drop the ball on one or the other. If you’re a researcher, you want to advance science and research. Many times, you may forget the people who are facilitating that, which is your patients who you’re doing the research on, the volunteers and all those people. That’s what our office is here to protect. At Mount Sinai, our department is called the Program for the Protection of Human Subjects. That’s what we’re there to do. We are the expert in that. The more technology grows, the more science grows, the more there’s medical advancement, there’ll be more interesting, ethically ambiguous research coming out in the forefront. That’s more work for us. The more there will be need for people like us who are experts in this topic to weigh in and regulate. I do think that we’re here to stay.

You were born and raised in Nigeria but you went to college at the UK. When you were in your high school or college, were you thinking about going into an area like being an IRB manager or the area of research? Was this on your mind?

No, not at all. It’s interesting. I applied to my undergraduate university to study dentistry. My mom’s a dentist. I grew up around that and growing up in Nigeria and going to high school there, if you’re smart and you’re interested in the sciences, everyone says, “Go be a doctor. Go study medicine.” I didn’t want to do that but my mom’s a dentist. I said, “I’ll do that instead. It’s different. It’s not medicine, which everyone’s saying I should do. I’m going to do something different, which is dentistry.” I applied to that. I didn’t get in but then they said, “There’s this course, Biomedical Science, which you might be interested in. We can give that to you. In a year, you can reapply for dentistry and probably have a better chance of getting in.” I took that course and started studying that course with the intention of switching gears.

I was supposed to do that and after my first semester, I said, “Why do I want to do dentistry again?” I have no answer for why I want to do this. In that first year, we had a career session where they brought in some alumni of our program to talk about what they’re doing right now. Most people went on to study medicine. Some people did dentistry. Some people were researchers. Some people went out of the field and were in the banking sector and doing other work there. There was this one girl who worked for pharma. She worked at a pharmaceutical firm and she said what she did was regulatory affairs. She explained it. I said, “That sounds interesting. I want to do that. What is that?” I went away and I did my research and that’s how I found out about bioethics as a concept, as a field of study. My degree in the UK was for three years. After that first year learning about this, I spent my last two years working towards getting myself ready for a Master’s in Bioethics and eventually getting into this field.

Taking that course, hearing from that one person, learning more about it, and then it launched you into this whole area of research and the regulations of such. Reflecting back, would you have done anything differently?

No. All the decisions and all the steps that were made brought me here right now. I wouldn’t have done anything differently.

The more technology grows, the more science grows, and the more there's medical advancement. Share on X

What do you tell a high school student or a college student about actionable advice that you could give them? Is there anything that you could say to them with what reflecting back on what you’re doing now and how you got there?

I would say talk to people whose jobs sound interesting to you and start doing that early because then you’d get firsthand accounts of what it’s like. Your show comes to mind. I think it is highly valuable. I wish something like this existed because it’s very easy to confine ourselves to the careers that we hear about all the time. “I want to be a doctor,” because you know what doctors do or a nurse.

Not to say that’s not important. It seems very tunnel vision very early on.

Exposing yourself early on to all the different things that people do in this big field of medicine and science will help you start to rethink what you want to do. Think about the things that interest you and how you can tie in all those interests into doing something or entering a career path that you find absolutely rewarding. The best way to do that is to talk to people. When I was at Columbia, before I settled on IRB work, they had encouraged us to do what’s this thing that’s called informational interviewing where you’d go on LinkedIn and reach out to people and ask for fifteen minutes of their time to talk to them. It’s what you’re doing, Dr. Marn, for free. It’s on your show.

Do your research, reach out, hope that they hope that they respond, hope that they give you fifteen minutes of their time and try to cram all your questions in those fifteen minutes. As a student, what did I know? What did I know that I was interested in? I was doing it because it was recommended. After the first few, I found that there is value here. “Does that interest me? Do I want to spend time doing an internship in this and eventually getting a job in this?” That was helpful for me. At Columbia, I did an IRB internship with a different institution, the New York State Psychiatric Institute. That’s where I solidified my desire to stay in this field. When I graduated, then I only looked for jobs in the IRB space.

I’m so glad that Onome Eka introduced us. This is great. Obviously, an expert in research studies and being on the forefront, which is part and parcel with what you do. I want to do some lighthearted questions here. The rapid-fire Dr. Marn questions. Marilyn, what’s your favorite day of the week?

Thursday.

Why is Thursday your favorite day of the week?

It comes from growing up and we ate my favorite meal for dinner on Thursday. Now Thursday has become my favorite day. It’s close to Friday, close to the weekend.

You know it’s coming in at the end of the week. Cats or dogs?

Neither. I’m not into pets.

I can understand that sometimes. What is one of your favorite books of all time?

I would say Hooked by Nir Eyal.

What type of book is that?

It’s a book about habit-forming products are made, the psychology behind habit-forming products. Social media is a habit-forming product and there are many like that. I found it fascinating and opened my mind and got me thinking a lot.

HCDM 42 | IRB Managers

IRB Managers: The whole body of IRB Managers was put in place because of all the missteps that happened when researchers were pretty much regulating themselves.

 

Who is the most influential person in your life to whom you are not related to?

I would say my boss, Lori Jennex.

What’s the most beautiful place you’ve ever been?

Colombia, the country.

Favorite ice cream flavor.

Butter pecan.

How many hours of sleep do you need?

Twelve, if possible. I never get it.

If you could ask God one question, what would it be?

Why?

Finally, can you say something about yourself that most people at your workplace would not know about you?

My calf tickles.

The back of your leg?

Yes.

I don’t think most anybody would know that. Marilyn, thanks for answering my quick questions. I know you also do some things outside of work with hair. That’s very interesting. Can you tell me a little bit about that?

Talk to people whose jobs sound interesting to you and start doing that early because then you'd get firsthand accounts of what it's like. Share on X

For several years, I run a hair blog called The Kink and I.

What’s the web address?

TheKinkAndI.com.

What is this blog about?

I’m passionate about hair and hair care. It’s all about that. We do tutorials. I run it with my best friend. We share our hair progress. We are reading and doing research a lot about what’s new in that space. We share a lot about that as well. We share on the blog and we also share on Instagram.

Is it featured mainly for people of Nigerian descent?

No. It’s featured mainly for black women with our type of hair texture.

You have something that you’re interested in and passionate about outside of work. That’s awesome. Is that one way that people can get ahold of you if they want to get ahold of you?

Yes, on Instagram @TheKinkAndI. That’s the handle. You can reach me there.

Marilyn, I am so happy we got to talk. You gave me a real clear sense of what the IRB does and how you function in that role. Thank you so much for coming on this episode.

Thank you so much for having me. This is great work that you’re doing.

Thank you very much. I’d like to keep it going for a long time.

For sure.

That’s our show. Thanks for reading, to learn more about our guest or other past guests, check out my website, HealthCareersWithDrMarn.com or HCWithDrMarn.com. If you like what you read, then please enter your name and email to my email list. That way, you can get the latest announcements and news as they arise. You can also find me on Instagram @DrRichardMarn. Thank you so much for reading and I’ll catch you on the next episode.

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About Marilyn Eshikena

HCDM 41 | Private Practice PsychologistA highly qualified regulatory professional that combines education, biomedical and pharmaceutical regulatory experience, and management capabilities to deliver exceptional results.

Strong knowledge of IRB procedures and other research study protocols.

Highly accomplished in establishing and nurturing positive team relationships.