Research involving humans is overseen by a special board
Host Amber Smith: Upstate Medical University in Syracuse, New York, invites you to be The Informed Patient with the podcast that features experts from Central New York's only academic medical center. I'm your host, Amber Smith. Research universities are required to have institutional review boards in place to review and monitor any biomedical research involving human subjects.
Today, we'll learn more about the role of the IRB from Michelle Saya, Upstate's institutional review board administrator and chief compliance officer for research administration. Welcome to "The Informed Patient," Ms. Saya.
Michelle Saya: Thank you, Amber. Thank you for having me.
Host Amber Smith: What are the day-to-day responsibilities of the IRB?
Michelle Saya: We review all research projects that are submitted to the SUNY Upstate IRB office, and IRB stands for institutional review board. So we review any FDA (Food and Drug Administration) regulated studies, from expedited studies, which may involve a blood draw, to quality improvement projects. So we're basically in the middle of a triangle, and we review everything that comes in.
Host Amber Smith: How many people are on this board?
Michelle Saya: Within research administration in the IRB office, we have five people that work within our group that review the studies and also administrative help, but our actual IRB board, where we have faculty, researchers, scientists, there's 13 members.
Host Amber Smith: And are they all from Upstate?
Michelle Saya: Most of them are from Upstate, but we do have two community members and a prisoner representative, because per federal regulations, we have to ensure that we have those folks that sit on our board or any IRB board, for that matter. And they are not employed by Upstate.
Host Amber Smith: Does the board meet regularly? Do you have, like, monthly meetings or quarterly meetings?
Michelle Saya: Yes. Anything that is reviewed by a convened IRB meeting would happen once a month, and we have those meetings via Zoom.
Host Amber Smith: And you describe that you pretty much have oversight over all sorts of studies that might take place at Upstate. Are there any geographic boundaries? Because I know Upstate has some researchers doing work in other countries.
Michelle Saya: Yes, we actually do have a couple of researchers that do international work, in Ecuador. We do have multi-site, center-initiated studies, so we kind of work with them, along with the IRB office, to ensure that all of the regulations are followed.
Host Amber Smith: How do you describe the IRB's role and duties? Because I'm wondering, does the IRB exist to protect the institution, in this case, Upstate, or the subjects, the people that are participating in the clinical trials and research?
Michelle Saya: So both, Amber. We, under our FWA, which is our Federalwide Assurance, we have to ensure that we are protecting human subjects. And that is the main responsibility of the IRB office.
At the same time, we want to, of course, protect the institution to ensure that federal and state regulations are followed, that we have standard operating procedures, that we have created guidelines that ensure the protection and welfare of subjects.
Host Amber Smith: Does the board approve projects before they even start? Like, if a researcher has a theory, and they're thinking about doing something, do they come to the board then to ask permission?
Michelle Saya: All studies are either approved or disapproved by that full, convened IRB meeting that we have once a month. So when studies come in to us, we review them, and if we feel it needs to sit at that level on an IRB board, then we discuss that, in its entirety at that board. And then along with all of the faculty scientists, researchers that sit on our board will come to a decision, whether we should approve or disapprove the study.
Host Amber Smith: Do the researchers come in person to make a presentation, or do they submit paperwork that you review?
Michelle Saya: We use IRBNet, which is our software, for all study submissions, so basically any researcher that would want to do any type of research would use that platform, and they would submit their protocol, their ideas, the consent forms that we would review here in the IRB office. And we make sure that that whole package is put together before it gets to the IRB board.
Host Amber Smith: How long does it typically take to review each project? Because I imagine some are pretty complicated.
Michelle Saya: They are. We could have a very simple, easy study that takes five minutes to review, and then others, if there are vulnerable populations, it might take a little bit longer, maybe even up to an hour.
Host Amber Smith: Are there particular things that board members look for?
Michelle Saya: We always want to make sure that we're minimizing risks, for the patient, or the subject -- in the research world they're called subjects -- so we want to always make sure we're looking at the risk versus benefit. And does that align together?
Host Amber Smith: If you had a project, that you had some questions about, or concerns, does it ever happen that the researcher's able to make some changes and then come back with an edited version to get acceptance?
Michelle Saya: Yes. That's a great question. So anything that's submitted here to our office gets sent out for a scientific reviewer that has expertise in that particular discipline. Then it's brought to the board, where then we review it in its entirety. After the board approves it, if a researcher or investigator wants to make any changes a month, two months, a year down the road, then they can submit an amendment to their project here, to our office. And then, again, we review it.
Host Amber Smith: This is Upstate's "The Informed Patient" podcast. I'm your host, Amber Smith, talking with Michelle Saya. She's the administrator for the institutional review board and chief compliance officer for research administration at Upstate.
Now we've talked about getting approval before a project begins. Does the institutional review board monitor ongoing projects?
Michelle Saya: Yes. So, per federal regulations, we have to review those projects at least once per year. And anything that is FDA regulated has to go through our IRB board. And additionally, as I mentioned, if amendments are put into the study, we review those as well.
Host Amber Smith: Can you describe what you do as the chief compliance officer for research administration? That's a different role than being part of the IRB, right?
Michelle Saya: To a certain extent, yes. I do sit as a board member on our IRB. And what I do is, I manage the human subject protection program. So under, again, under our FWA, our Federalwide Assurance, we have to adhere that we are instituting best practices for our patients and that we're proceeding with safe, ethical care for our patients.
So I review all of the studies that come in. I review the protocol and the consent form to ensure there's no exculpatory language and that patients know exactly what they're getting into before a trial, and then again, it's sent out for a scientific review before it even hits the IRB board. So we do a lot of things here in the office.
Besides the review of studies, we do a lot of IRB education. We've restarted that status post-COVID here, and we're doing hot topics, online educational programs, IRBNet training things of that nature.
Host Amber Smith: What about when a project is finished? Does the IRB ever look back to make sure all the rules were followed, essentially?
Michelle Saya: Yes, so we actually have a program, a quality assessment improvement program, where we have another individual that works with us, on, our research administration team that actually goes in and has conversations with the investigator to ensure that rules were followed, that consent forms were signed, things of that nature.
We, even though a project may be ongoing, we review it by amendments throughout the year, we review it at least once a year by continuing review, and then if the project has concluded, they can actually submit a closure to us to close out the study.
Host Amber Smith: Does the IRB have any oversight of research involving mammals other than humans? Because I know you're focused on human subjects, but what about laboratory animals, for instance?
Michelle Saya: Here in our, the IRB, office, we don't do any work with mammals or animals. That is covered under our IACUC department, which is our Institutional Animal Care and Use Committee, and the director is Dr. Bob Quinn there.
Host Amber Smith: What about cells? If there's any research being done on human cell lines, does that fall within the IRB's oversight?
Michelle Saya: Yes, it does. With the new immunotherapies that are going on, we are in the process of re-creating our stem cell oversight committee. That will actually be reestablished in August. And that's if moving forward there's any research on any embryonic cell lines, that it will be reviewed and approved by this committee.
Host Amber Smith: Well, I'd like to ask you: From the patient's point of view, or the subject's point of view, what is informed consent?
Michelle Saya: I always like to say that consent is not just giving a piece of paper to a patient or a subject and having them sign. Consent is a process. It is a method of collaborating and communicating, with that physician or investigator or scientist, with that -- we say subject in the research world, not patient -- but we're having conversations with that subject to know that they have complete understanding about what would be asked of them if they are going to enroll themselves in a clinical trial or any type of research study. It's a process.
Host Amber Smith: Can people who agree to participate in research, and they read this informed consent ahead of time, can they believe or expect that what they're going to do is going to be safe?
Michelle Saya: Yes. So what I can say is that by method of informed consent, the patient would be able to read the first page or two of the consent form, since the federal regulations changed in 2018, to make that consent form a more readable document, to have information that's most needed for a patient in those first two pages so that they can get a clear idea of what's expected.
If there were to be an adverse event in regards to any type of drug or device that, say, malfunctioned, or there was a reaction or a side effect, those can be submitted to the IRB office, and we would review them and send them to our chair for review.
Host Amber Smith: How do you obtain consent from someone who doesn't speak or understand English?
Michelle Saya: We have 28 different languages of, we call them short forms, in IRBNet, and they are specific to, again, 28 different languages that we could hand a patient so that they are in their native language. We also can utilize a legally authorized representative to be on that actual study as well and help the patient make those decisions.
Host Amber Smith: Can children give their own permission to participate, or does that have to come from a parent or guardian?
Michelle Saya: Under Subpart D of the federal regulations, CFR (Code of Federal Regulations) 45, 46, children can be engaged in research. It's always a good idea to obtain their assent, depending on their age and maturity, but most times we'll need a parent to actually say, yes, it's OK to proceed with this study for my child.
Host Amber Smith: Because I remember recently with the COVID vaccinations, there were little children, babies, that were involved. So I assume their parents had to give permission.
Michelle Saya: Yes, yes, absolutely.
Host Amber Smith: What about looking at the other end of the spectrum -- Alzheimer's disease, people who are losing their faculties -- can those people enroll in studies?
Michelle Saya: Yes. So what we do here in the IRB office is also to determine, do we need to have a legally authorized representative on this study if someone is compromised mentally? That is something that we review when studies are submitted to this office, and we also have guidance for capacity that investigators can use to help determine if their patient needs a little more help or assistance.
Host Amber Smith: What happens if something goes wrong during the trial, and a human subject is injured in some way?
Michelle Saya: If that happens, and if it's an FDA-regulated study, the FDA and the sponsor would have to be aware. It would have to be reported to them as well as here, to the IRB office. And if this study falls under an external IRB, because we do work with other external IRBs, they would have to be notified as well. And then we have a form that's submitted to our office that tells us in its entirety, what exactly happened so that we can review it and then send it to our chair of the IRB for any input or recommendations.
Host Amber Smith: If someone does become ill or injured during a trial, and they need medical treatment, is that covered by the trial, or does the person have to pay for that?
Michelle Saya: If a patient has any types of injuries sustained from a medical treatment, then the sponsor is usually the one that pays for any type of injuries relating to that. The patient's insurance would not be involved whatsoever.
Host Amber Smith: Why would you say that a person might want to consider participating in a clinical trial if they're ever given the opportunity?
Michelle Saya: The most important thing is that some patients have exhausted all of their efforts medically, and there's no other options for them but to be enrolled in a clinical trial. So in order to maintain the principle of autonomy and beneficence under the federal regulations, we want to be able to extend them and afford them every opportunity to take advantage of any type of medical treatment that they might not normally get. And to also contribute towards society in general. Some folks just want to do that.
Host Amber Smith: Are subjects ever compensated for participating in trials?
Michelle Saya: Yes, absolutely. We have to make sure that we feel that it's not extravagant in nature and that that money amount, is suitable for what is being done or asked of a patient. But again, that is something that our IRB office looks at to make sure that the monetary piece is OK.
Host Amber Smith: If a person participates in a trial, do they get a front-row seat to looking at the results and learning more about what it is they're trying to help researchers learn about?
Michelle Saya: Sometimes. So say, if it's a drug trial in the cancer center and someone's getting a new drug because their cancer has advanced, and there's no other alternatives, and they get involved in this clinical trial. That physician will be able to talk to that patient when they're in the office to say, Hey, this looks like it's working, your tumors are decreasing in size, or this is not working. So there's always going to be conversations where a patient is going to know in that particular example if that research medication is working for them.
Other times, if we're dealing with genetic data, we cannot release that information. So normally we tell investigators to get a geneticist involved and have the geneticist be involved in returning those results to the patients.
Host Amber Smith: I appreciate you making time for this interview, Ms. Saya.
Michelle Saya: Of course.
Host Amber Smith: My guest has been Michelle Saya. She's the administrator for Upstate's institutional review board and the chief compliance officer for research administration. "The Informed Patient" is a podcast covering health, science and medicine, brought to you by Upstate Medical University in Syracuse, New York, and produced by Jim Howe.
Find our archive of previous episodes at upstate.edu/informed. This is your host, Amber Smith, thanking you for listening.