Jon M: [00:00:15] Hi. I’m Jon Moscow.
Amy H-L: [00:00:16] And I’m Amy Halpern-Laff. Welcome to Ethical Schools. Our guest today is Marianna Azar, Director and Chair of the Institutional Review Boards, or IRBs, of the New York City Department of Education. This is Part One of a two-part interview. Today we’ll be talking about how the IRBs function and their significance to researchers, schools, students and parents. Next week, we’ll continue exploring the ethical issues that the boards grapple with. Ms. Azar’s comments represent her own views. She is not speaking as a representative of the Department of Education. Welcome, Marianna!
Marianna A: [00:00:55] Thank you so much for having me.
Jon M: [00:00:57] What are the New York City Department of Education’s IRBs?
Marianna A: [00:01:01] Sure. So an Institutional Review Board is a regulatory and an ethical panel that’s established for the purposes of protecting the rights, welfare, and privacy of participants in research. Research very generally is defined as a systematic investigation aimed at producing generalizable findings, and a human subject for the purposes of this content is a living individual with whom you interact or design an intervention or collect private information about for the purposes of the research study.
Amy H-L: [00:01:39] What do the IRBs do?
Marianna A: [00:01:41] So the New York City Department of Education has two separate Institutional Review Boards. And because we are the largest and most diverse school district in this country, what we do is we review the hundreds of proposals to conduct studies with our students, with our staff, with our families. And the studies are very diverse, as diverse as the populations of New York City. So we review these research proposals for the purposes of ensuring that the rights, the data collected, that the nature of the research is ethically designed and sound, that the data that’s collected is not going to cause any unnecessary risk to the participants in the research. And beyond that, that the research itself is not designed for the purposes of benefiting the researcher, but for the purposes of providing some benefits, some direct benefit to the research participants or to the New York City public school system.
Jon M: [00:02:42] You came to this position from a background in philosophy and ethics. How did your background prepare you for this job?
Marianna A: [00:02:50] Yeah. So I should say maybe, as a point of background, I really fell into this work. So I spent eight years in my doctoral program and I’m actually still ABD. I have yet to defend my dissertation. So I’m still not a doctor. I spent eight years in graduate school, specifically working on a project that was looking at conceptions of informed consent and personal autonomy. And I was looking at all of this from the perspective of clinical research. And in 2013, with both parents battling cancer, I opted to withdraw from my doctoral program and move back to New York. At the time, I was living in Toronto. That’s where my, my PhD program was. And, you know, when I moved back to New York City, I started to think about entering the workforce. And I was sure that I wouldn’t be able to find work that correlated with what I had just spent, you know, a very large portion of my life studying. And it turned out that I was wrong, that the background in philosophy was actually a very good fit for the kind of work that’s done by what is typically referred to as a human research protection office. So this is an administrative office that generally supports the work of institutional review boards. And I started applying for a variety of positions and someone with a very kindhearted Columbia university’s human resource office forwarded my resume to the human research protection program at Columbia. And they saw my background is as a good thing for the work that they did there. So I was recruited by them and I was trained. You know, I knew the ethics, but I had absolutely no understanding of the regulatory framework, governing human subjects research in the United States, in large part, because I had attended graduate school in Canada, but also because the regulations really don’t factor into the kind of research or the kind of education that a philosopher typically pursues.
And so having been trained in the regulatory framework. I began to see the direct application of the ethics, right? So this is the way that it plays out in real life and specifically there in clinical research. But you know, the, the more time that you spend reviewing research, the more you recognize that research ethics more broadly apply to all types of research that while historically the rules and regulations came about as a result of unethical biomedical studies, that research on the whole has various aspects to it that require an ethical lens.
And so when I joined the CUNY Graduate Center shortly after leaving Columbia University, I began to review almost wholesale social and behavioral studies. Right? So the CUNY Graduate Center is the. PhD awarding institution for the other 23 CUNY campuses. And you have graduate students pursuing degrees in anthropology and political science. I mean any humanities or social science discipline that you can imagine, and they all do research. And so you begin to see the kinds of research that’s carried out and you start thinking about these rules and regulations from that perspective and, and it all fits, right, because the same concerns, the same need to protect the privacy of the participants, the same focus on what’s being done with the data, the same consideration of “well, are the benefits to be gained from this research sufficient to account for the potential risks that are involved?” And, you know, when I, when I came to the New York City Department of Education and the focus became almost exclusive education research, and we’ll speak more about this moving forward, but education research is very broad, right? I mean, anything can be education research there, you start to look at it also from the perspective of this is research involving children. This is research involving populations that are traditionally or, you know more generally economically or educationally disadvantaged, right. And their families. And not to mention staff who are working in an environment that’s highly political in nature that’s incredibly challenging for them to navigate. And so you start to consider all of these additional factors in reviewing the studies. And again, the ethics background is, is helpful because you start to think outside the box and you need to think outside the box and you apply these general ethical principles to these specific cases, but I think in ways that you wouldn’t otherwise be able to do, had you not been given that kind of ethics training or background.
Jon M: [00:07:20] You mentioned a couple of times how diverse the research projects are. Could you talk a little bit, what are some of the kinds of, what are some examples of the kinds of research projects that are submitted to the IRPs?
Marianna A: [00:07:33] Yeah. So the, the last time the three of us spoke, you framed this question for me, and I spent the weekend sort of wrapping my head around the best way to characterize the research that’s carried out in the New York City public school system. And what I’ve come up with is three specific categories.
So I think that you can say that the majority of the research is either descriptive, right. So this is research that places an emphasis on the, “what” of the situation. So the research generally that is descriptive in nature would be observational or would utilize that methodology such as surveys or interviews.
The research can be correlational. So this is research that seeks insight into two variables for the purposes of establishing the connection between them. So an example of that can be research that’s carried out for the purposes of discovering the relationship between the student’s behavior and their classroom performance.
And the third area of research, and I think that this is probably the broadest or the prevalent area, is experimental research, right. So this is research that seeks to establish the causal relationship between two variables. And an example of this can be a study that is designed to determine the best teaching and learning methodologies in a school or a study that seeks to understand how an extracurricular activity affects the learning process.
So in this type of research, you would generally have both an intervention group and a control group. And so a randomized controlled trial is an example of an experimental study. Most of the research in and of itself utilizes qualitative methodologies, right. So observations, direct interviews or focus group interviews, document analysis, right. So collecting student work or artifacts that are produced by students for the purposes of the research activity or for the purposes of the classroom assignment and analyzing particular products, right, such as journals, diaries, images, or blogs. So we see everything from case studies to ethnographic research, to phenomenological research, to narrative research, to historical research, to participatory action research, right, research that actually utilizes students for the purposes of collecting data from their friends or from their classmates.
And, you know, I can go on, but I think these general categories are a good sort of blanket summation of the types of studies that we generally see.
Jon M: [00:10:10] And what are some of the topics that researchers are asking about it?
Marianna A: [00:10:15] Yeah. So the topics again are quite diverse. So we can see studies that look into sexuality or sexual orientation of our students. So gender nonconforming students can be asked to participate in a study that looks at the way that their gender identity impacts their standing within the school.
We have studies that are highly sensitive in nature and that look at internal DOE operations, right. So we can have a research study that’s designed to directly involve teachers, but for the purposes of ascertaining, let’s say that, I don’t know, the way that promotions are handled, right, or the way that disciplinary action is carried out within the school system. So interviews with teachers that specifically delve into these topics. “Tell me, do you know of a teacher that’s been disciplined or terminated as a result of her involvement in activity X?”
We have a lot of studies that look at the family dynamics. So a study that may inquire into the rates of incarcerated family members or the immigration status or the use of public assistance programs. I mean, just generally aiming to gauge the background of the student or the family composition and how that may impact to the educational outcomes to home environment research.
So the use of drug use abuse, et cetera. A lot of the research looks at the emotional status of our students or the psychological profiles or their mental states. You can have a research study, that’s, for example funded by the Manhattan DA that looks at criminal activity, such as gang affiliation, drug use, et cetera.
A lot of the research is also more benign. So you can have studies that are specifically focused on curriculum design. This is where some of those randomized controlled trials factor in. You may offer two different sets of curriculum and see which one has better outcomes. You have studies that, you know, let’s say offer an extracurricular or an afterschool program for the purposes of addressing,fill in the topics. So you target teens that are known to be obese. And the afterschool program is teaching ways of cooking at home for the purposes of not eating out and for the purposes of understanding nutrition or, you know, whatever. I mean, you can fill in the gap from there.
A lot of the studies also aim to ascertain the impact of DOE programs or initiatives. Or let’s say our mayor has put forward the Equity and Excellence agenda, which has resulted in, in various programs delivered across the DOE. How do you know if any of that is working? You conduct the research study. How do you know if UPK is truly impacting the educational outcomes of the students who were in the initial cohorts. You do a research study, right?
So a lot of the research is longitudinal in nature, where you track students for years to gauge the impact of a specific program. A lot of the research is federally mandated, right. So the federal government funds a very wide variety of studies that are carried out in the New York City public school system, teen pregnancy prevention programs.
The Department of Health and Human Services funds various programs that require a research component. So specifically the research has to be carried out for the purposes of gauging the efficacy of the program. So have teen pregnancy rates actually gone down as a result of this education or intervention that Health and Human Services has sponsored. The Department of Education also, likewise offers a lot of programming or allows the New York City Department of Education to offer a variety of programs the impact of which must also be gauged by virtue of the research study. So any type of research that you can generally imagine, right. And we haven’t even talked about the biomedical studies that are carried out any research that would generally need to involve, let’s say teens. You can imagine taking place in the New York City public school system, any research that looks at specific populations. So I want to do a study with recent immigrants to New York City, for the purposes of gauging, you know, again, fill in, fill in the gap. You can do that research within the New York City public school system, because that’s where that population is.
Jon M: [00:14:49] What are some of the biomedical studies you mentioned?
Marianna A: [00:14:53] Let’s say that you are a sleep apnea specialist. And in your mind there is, or likely is, a correlation between sleep apnea and educational outcomes. You can work with the New York City public school system for the purposes of identifying students with a diagnosis of sleep apnea, and then utilize their education data for the purposes of drawing that correlation between the biomedical disorder and the educational outcomes, and then you can design an intervention, right. So I am going to prescribe the use of this machine or some kind of breathing device, or, you know, I mean, again, you can, you can imagine the variety of methods that could be utilized and then you can do a comparison, right? So post intervention, have the educational outcomes improved? We have a lot of students with asthma. So you can design a study that will look at the way that physical education is delivered by the New York City public school system. And specifically the way that that programming impacts students with a specific biological condition such as asthma or any other kind of breathing disorder.
We do have a lot of psychology studies as well. We are incredibly careful or conservative about allowing them to be carried out within the New York City public school system, largely because they can be done outside of, but various psychological conditions can also be studied within the student population.
Jon M: [00:16:21] Why are there two IRB?s
Marianna A: [00:16:24] So, as I mentioned, we see a very high volume of, of research proposed on an annual basis. It is not uncommon for us to receive approximately 500 unique submissions. So traditionally, what we’ve had is a single panel that met just once a month for the duration of three hours. Within a three hour time span, the most that you can review is let’s say between 10 and 15 unique submissions. I mean, bear in mind that every protocol is a research study. So if you hear me say protocol, that’s synonymous with a research study. Every protocol requires careful consideration and deliberation of the board. So in presenting the study to your fellow board members and then introducing the topics that you want, the rest of us to deliberate, that can necessitate approximately 10 to 15 to 20 minutes devoted to each study. So what we were seeing were very long turnaround times. So it would take us months to get to a submission and then it would take us months to approve it because we simply didn’t have the capacity and we didn’t have the board members that were available to conduct the reviews. So one of the things that I’ve done in my time with the New York City Department of Education is establish a second IRB, which of course also necessitated the recruitment of 15 additional volunteers to do this work. But now that we’ve been able to do this, we are meeting twice a month. And on a monthly basis, we’re able to review, let’s say, 30 studies rather than the original 10.
Amy H-L: [00:17:56] How do you select the volunteer members of these boards?
Marianna A: [00:18:00] Excellent question. So we haven’t really talked about, you know, the composition of the IRB. The federal regulations that govern this work require that at minimum, every IRB have five members. One of the members has to be a scientist. One of them has to be a non-scientist and one of them has to be a community member. But beyond that, the general requirement or expectation is that you have a board that has the necessary credentials or understanding to review the kind of research that’s being proposed. So generally speaking, what you look for are subject area experts, again, in our case, this is a challenge because of the variety of research that we see. But, you know, one of the things where I think we’ve been tremendously lucky is a lot of the people who do the research in our school system are also committed to serving on the boards.
So, you know, we work very closely with Teachers College at Columbia, with NYU, with CUNY, with various research institutes. They have been very generous with their time. And many of their researchers or university faculty have been willing to volunteer their time and service to the Institutional Review Board.
Beyond that, the requirement is that you have someone that understands the research from the participant’s perspective, right. So the, the person who would likely participate in this study should be reflected on the board. The way that you fulfill that requirement is by, in my mind, recruiting. You know, let’s say, former graduates of the New York City public school system. So I’m one of them. So hopefully I check off that box, but you also want to look at parents, right. Because again, with the participation of a child, consent for research participation has to come not only from the child but also from the parent. And so from that perspective, you want to look at current parents of New York City public school students. And you want to look at people that are also employees of the New York City public school system, because a lot of our research works with staff. And so you can recruit people from central divisions, from schools, from our various community boards that work with us and community-based organizations.
The way that we generally recruit is, the way that I generally recruit is, I look at the people submitting and I look at the people impacted and I use both professional and personal networks to reach out and to really spread the word about the need to do this work. People usually come to us, you know, and I think that this is, again, something that’s [unintelligible] surprising because this is unpaid. Nobody will give you any kind of compensation, including time, for the work that you do. And it’s not only a monthly three hour meeting, right. It’s also the work that goes into receiving the studies, reading them, really considering the regulatory and the institutional requirements. And a lot of it is also, I mean, there’s a, there’s a commitment above and beyond simply the reviews. There’s also the need to maintain understanding of the regulations, right. To keep learning about the work, to continue to stay abreast on the current, let’s say, trends in research or the new challenges or the new ethical or legal concerns associated with the new research that’s being proposed. But I think anybody who does this work almost immediately recognizes the need for it, even those that are, you know, that are skeptical at the beginning. So I should say quite honestly, that a lot of social and behavioral researchers are skeptical about the work of the IRB and the need for an institutional review board. They see the general setup of an IRB and the federal rules and regulations that govern the work as focused almost exclusively, if not predominantly, on biomedical studies. And so there’s often the argument that this does not apply or this should not apply. And yet when they come on board and they begin to do the work, they recognize that that’s actually not true, right, that the rules and regulations are what they are, but they’re subject to interpretation on a case by case basis.
And that when you really come into the work with the understanding that something may not have an answer and that the answer will depend on you and the deliberation and the, you know, the careful consideration of the research that’s being proposed, then it becomes interesting. And then it also becomes obvious that this is indeed quite necessary.
Amy H-L: [00:22:19] Do you have the capacity to review every application you receive or do you have to reject some without review?
Marianna A: [00:22:28] So we’re committed to conducting a review of everything that’s submitted. Beyond that, I think for the purposes of our own integrity, we’re committed to doing due diligence with every submission, meaning it’s never the case that, you know, taking, let’s say a very surface read of a submission, we can say offhand that this is going to be rejected. We are also quite forthcoming about our reasons for rejection. So I think, in large part because we are a public institution, we feel the need to be as transparent as we can be about what we’re doing and why we’re doing it and why we’re making the decisions that we’re making. And so in rejecting a study, in fact, it’s, it’s more work to reject something than it is to approve it because we find ourselves having to justify the rejection in a letter to the researcher or to the research team. And so, you know, the work that goes into a rejecting the study means having to justify the reasons on which our proposal is being rejected. But you’re you’re right, I mean, the, the volume is quite high. I think the problem with the volume is the length of time that it takes to review something, but know in light of the volume, nothing is rejected simply because we don’t have the capacity to review.
Jon M: [00:23:43] When a research project is submitted, can you walk us through the process of what would actually happen to it. And as I understand that you’re the only paid staff person in this process, is that right?
Marianna A: [00:23:56] That’s right. I am, as I like to tell people, an office of one. Um, so when, when a project is submitted through an electronic, a lot of the work went into the form that’s used to submit a project because one of the things that I recognized from the beginning of doing this work is you need to collect the information that you need to perform the review and no more. And beyond that, you, you really need to collect the information in a uniform fashion, because what needs to happen in the work of an IRB is consistency, right. You need to be able to consistently review all research and treat like a, like, so what happens in the submission process is researchers complete a form that we’ve created. They provide all the information that we generally need to perform our review.
So that information involves: What is the research? What are you aiming to obtain information about? Or what are the research questions that you’re aiming to answer? So you can say something like, since the introduction of remote learning, how are students ages 13 to 18 performing on standardized math assessments? So this research will aim to…. and then you can fill in the information from there. So you can say something like this research aims to examine the use of the following app that the New York City department of education has introduced to the standard math curriculum. And this research aims to assess the impact of this map on educational outcomes in this age population.
So in order to perform this study, I will do…, and this is where you tell us specifically what the research procedures will involve. So you can say, I will conduct the interviews with the students. Specifically, I will conduct one-on-one interviews, utilizing Zoom or utilizing any other kind of telecommunication platform. And beyond that, I also aim to conduct focus groups. So I will collect information both individually and in a focus group setting. Beyond that I will also administer a survey to the teachers. I will perform some level of classroom observations and I will request a tremendous amount of data from the DOE to gauge the impact of this app for the foreseeable future. So this is also a prospective request for DOE data. And so in the process of obtaining consent from my subjects, I will also seek consent for prospective collection of this data for the purposes of this study. Beyond that, what you generally need to tell the IRB is how everything is going to be done, right.
So the IRB is required to consider procedures such as recruitment, right. So you don’t currently have access to your intended study subject population. How will you recruit them? You specifically need to tell us the methods that will be used and the language that will be used. A lot of the language that we look at is how is the research being framed? So one of the key things that we didn’t really talk about is research has to be voluntary, right. And so from this perspective, every introduction to the research or every request to participate in the research study has to be transparent about the voluntary nature of participation. So the way that you word that recruitment email or that recruitment flyer or any other tool that will be used to introduce the study to your research population has to be incredibly careful in its wording so that there’s no misconception regarding the voluntary nature of participation.
You also want to tell us how informed consent is going to be sought. So one of the additional responsibilities of the IRB is to ensure that participants have truly consented that the research is voluntary and that that voluntariness is documented in an informed consent. So what is the informed consent going to look like? “I am going to email an informed consent documents to my participants. They’re going to read through it. I’m going to offer myself for a short telephone conversation in the event that they have questions, answer any of those questions and from there, ask them to sign the document to, you know, affirmatively confirm that their participation in this study is voluntary.”
And then beyond that, you know, you’re going to tell us about how the procedures that you’re proposing are going to ensure the privacy of the participants. So in the event that you’re planning individual interviews, where will those interviews be carried out? Will they be in a public space where others will be able to, to hear the responses of your research subject, to the degree that their privacy may be compromised? You’re proposing focus groups. Will you be sharing with the focus group participants that all of the content shared in the course of the interview must be maintained in a confidential fashion specifically for the purposes of protecting all participants in the focus group interview?
Beyond that, the IRB is very focused on data confidentiality. So you’ve collected all this data. How will you safeguard it? Who will you share it with? When will identifiers be discarded for the purposes of protecting the privacy of your participants? How will the findings be published or presented? Will they be presented in a way that will allow for re identification of a specific subject? So let’s say that you’re proposing to do the study in just a handful of New York City public schools. And you’re collecting demographic information and some of your participants will fall into demographic groups that may be easily identified in light of their unique background. Will your research findings also share those identifiers so that someone in the event that they want to we’ll be able to really identify the study subject? Or will you be sharing the identifiers, you know, upfront, because it is necessary for you to say who the participants were and why their responses were, what they were?
So the way that the process works is once that form is completed and submitted to us, I, as the sole administrative individual, I sort of do a surface review of, of that submission. And then from there assign it to the full committee for review. So generally two board members are assigned a project and they two weeks ahead of the meeting, take the time to read through the submission and consider all the study materials that have been provided. Generally, they also meet to discuss the project amongst themselves. And then in the course of the meeting, they present the study to the rest of the board and, you know, generally focus on the more high level issues. So some of our deliberation can focus on, let’s say, the school selection equity. You’re proposing to do a study, you know, the possible benefit of which will directly impact the students. So you’re proposing to introduce a new novel curriculum, which elsewhere has been shown to improve test scores four-fold. And yet the research that you’re proposing to do is only going to involve New York City’s specialized high schools without any justification offered as to why these four schools, as opposed to any of the hundreds of other New York City public high schools. Why is the selection of sites, what it is, right.? So the board can ask the submission team to provide additional justification for the selected sites.
Or on the opposite end, let’s say that you’re proposing to, to do a study that’s looking at a specific population. This population happens to be in practically every school that you can imagine. And yet you’re intending to only utilize a handful of schools in the Bronx. Now the benefit of this study is quite minimum, right? So let’s, let’s imagine this study where the benefit is really nothing above and beyond, you know, minor contribution to generalizable knowledge or discourse. And yet the burden of research participation involves the commitment of six hours of one’s personal time for participation in extensive interviews. And beyond that, the sharing of one’s personal data, including, let’s say student level, student records or related. Why is this research being proposed for just a handful of schools in the Bronx? Right. So why are the burdens of this research only being distributed to these four selected sites rather than across the entire New York City public school system?
So those are just some of the items that we can look at beyond that. We can say that the kind of questions that are being asked are inappropriate from the perspective of the data that’s being collected is, is too sensitive and unnecessarily. So that you’re looking at things that don’t really have anything to do with the study that you’re proposing. And so it seems like a gratuitous collection of confidential, sensitive information for purposes that are not justified by the research that’s being proposed, right. So again, to give you a concrete example, you’re looking at the impact of this curriculum. And yet simultaneously you’re asking the students to share if anyone in their household has been or is currently incarcerated. Well, why do you need this information? What is the relationship between the collection of this information and the research that you’re proposing? We can look at the appropriateness of the research, right? So you’re intending to do a reading intervention. But your target study subject population are universal pre-kindergarten students, ages four. Are they truly capable in participating in the kind of research that you’re proposing? Have you considered the actual challenges of working with the population that you intend? Um, we can look at things like the research is really small scale. So the intent is to recruit no more than 10 students, but to draw conclusions that would apply to the entire New York City public school system. Is it sufficient to conduct this type of study in a single school with no more than 10 students and yet draw conclusions that you will make the argument should apply to the New York City public school system. Beyond that, we look at the documents. Specifically, the consent forms require a lot of attention.
Consent is really, I think, the linchpin to all of this because the way that you communicate to the perspective research subject, what it is that you’re intending to do, is generally captured in the informed consent form. So the things that we look at are the language that’s used. Is the consent form plainly written? Is it on an appropriate age level, right? So again, you’re working with seven year olds, but the consent form reads like it’s written for an adult with a PhD. Your population that you’re intending to work with are recent immigrants to the United States. And yet you’ve made absolutely no plans to translate your study instruments into the language that’s likely to be spoken by your intended study subject population.
We also honestly look at the credentials of the researchers themselves. So as you can imagine, we see a lot of studies from graduate students. We see a lot of studies from individuals associated with for-profit or, or possibly nonprofit research institutes. But some of the researchers submitting may have no prior research experience. They may be a recent graduate of a master’s program with no training in conducting human subjects research. So in those cases, we consider things like, are you truly equipped to work with a population with, let’s say, you know, a known diagnosis of, I don’t know, like, let’s say a psychological disorder, one in which the research itself may pose a trigger of emotional distress or some other kind of research related risk? Are you, the researcher, actually credentialed and equipped to handle this type of risk in the population that you’re intending to work with? And in doing the kind of research that you propose, once we have these meetings, once we have these discussions, again, as I said, we really try to be as transparent about this as we can be. And so the way that we capture all of that is in the letter that we send back to the researchers. So this is where we communicate the challenges of the research as we see them. This is where we make recommendations for how the research can be redesigned or modified to better accommodate the standards of the board and the requirements of the New York City public school system. And then the process repeats, right. So this study goes back, it’s revised or it’s abandoned. Or the study team works closely with us to really maybe change the research on the whole, to more closely align with some of our expectations. And then, you know, once they satisfy the criteria, that’s when the study is finally eligible for approval. And that’s when the research actually moves forward.
Jon M: [00:36:09] You mentioned before the issue of time. So in the case of a study that basically is fairly straightforward and where you don’t have, you know, this issue of having to go back and forth these times. What’s the average length of time that it would take from the time somebody submits to you to the time that they can actually start doing their project?
Marianna A: [00:36:30] This is every email that I get from a prospective research team. How long will it take from the point of submission to approval? And I’ll give you the favorite answer of every IRB in this world. It depends. So it really depends. It depends on the quality of the submission that we receive. It depends on the complexity of the research that’s proposed. It depends on the volume of research we’ve received at that particular moment. So there are, there are high points and there are low points and there are periods when, you know, we’re absolutely inundated with them. So it really varies. On average, I would say, from the point of submission to the point of approval, it can be, if I really had to run the numbers, I would say it would be approximately between three to five months. So generally, if you’re aiming to begin a research study for the fall, you submit the prior spring. Again in, in large part, it’s because it takes us as long as it does to get to a protocol after it is submitted. But it’s also because a lot of studies require that modification, right? A lot of them require that redesign or that reconsideration of what’s being proposed to more closely align with our standards.
Amy H-L: [00:37:37] What happens after a project is approved? How do you know whether the researchers are doing what they said they would do?
Marianna A: [00:37:45] Unfortunately, I think we rely in large part on the honor system. So most institutions, most large research institutions, such as universities, have compliance teams or audit teams that follow a project post-approval. So this is typically referred to as post-approval compliance monitoring, where you can have an auditor send you an email requesting that you share all the consent forms that have been signed by the subjects you’ve enrolled in the past month. We don’t have anything of that kind, right, in large part again, because we don’t have the administrative staff to do this.
So once a project is approved, we really rely on people to report to us in the event that something has gone wrong. So if you are a student that’s being asked to participate in research, but it’s unclear to you that it’s voluntary, my contact information is there in the consent form. So the expectation is if you have any questions or concerns, you’ll reach out. Spoiler alert: they never do. If you’re a parent and your child has been involved in the research study without your consent, again, the hope is that they’ll let me know, and we can take action from that information to potentially suspend the research or look into it more closely and see what went wrong. Unfortunately, it never happens.
And again, you know, I, I hate to be so skeptical, but a part of me believes very strongly that it’s not because it never happens. It’s because it goes unnoticed. Um, once a project is approved, can we confirm that the data that’s collected is the data you were approved to collect? No. Once a project is approved, can we confirm that you are truly storing the data in the, in the fashion that we’ve required, that you’re not keeping everything on the personal device that’s un-encrypted and not password protected? No, but these are the standards under which the protocol was approved. And so in theory, in the event that we do become aware of potential deviation or violation of the IRB- approved study, then we can consider a potential case of noncompliance.
Jon M: [00:39:47] Thank you, Mariana Azar of the New York City Department of Education Institutional Review Boards.
Marianna A: [00:39:53] Thank you.
Amy H-L: [00:39:54] And thank you, listeners. If you enjoyed this podcast, please share it with a friend or colleague. Subscribe wherever you get your podcasts and give us a rating or review. This helps others to find the show. Check out our website, ethicalschools.org, for more episodes and articles, and to subscribe to our monthly emails. We post annotated transcripts of our interviews to make them easy to use and workshops or classes. We work with consultants to offer customized SEL programs with afocus on ethics for schools and youth programs in the New York City and San Francisco Bay areas. Contact us at firstname.lastname@example.org. We’re on Facebook, Instagram, and Twitter@ethicalschools. Our editor and social media manager is Amanda Denti. Until next week.