By Linda C. Ashar, J.D., Faculty Member, Dr. Wallace E. Boston School of Business and
Dr. Jennifer Douglas, Dean, Graduate Studies and Research

When conducting a research project involving human subjects, certain standards must be in place to protect test subjects and the integrity of the research. In this episode, Dr. Linda Ashar talks to Dr. Jennifer Douglas about American Public University’s IRB process, the historic events that led to these mandates, the review process, and more.

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Linda Ashar: Hello everyone, I’m Linda Ashar, your host for this podcast. Today, our topic is one I think everyone will find of special interest. It’s about the watchdog process for researching with human subjects. Most people have a general awareness that research is done where human participants or subjects are involved, but likely they don’t think about how it works unless they’ve been involved in a study themselves.

Today, I’m pleased to have as our guest, Dr. Jennifer Douglas, Dean of Graduate Studies and Research at American Public University. Jennifer will share with us how the IRB process works. In a nutshell, this is a mandated program that ensures appropriate steps are taken to protect the interests of human subjects in research programs. Dr. Douglas chairs APU’s IRB board, and under her leadership, our students and faculty are very much involved in various research projects. Dr. Douglas, thank you for being with us today.

Dr. Jennifer Douglas: Thank you so much for asking me, Linda.

Linda Ashar: Can you give our listeners some background about why there are rules prescribing how human research is conducted?

Dr. Jennifer Douglas: Absolutely, and it’s an important question to ask. Really human subjects research is an issue of human rights fundamentally and ethics. The reason that we have rules around human subjects research is because people have the agency and the autonomy to make decisions about their own participation in research.

So, at the most basic level, this is about human dignity and respect for individuals. One of the reasons why these kind of rules are in place now are because of some historical examples where people—human subjects—were involved in research and were actually harmed due to that research happening.

One example in the United States is a study that was known as the Tuskegee Syphilis Study. And in this study, there were Black men, African-American men with syphilis, who were studied to see how the disease progressed. However, they were not offered antibiotics even when those antibiotics became available. They were not informed that there were treatments available for them; and they were studied over several decades as they endured all the progressive, debilitating conditions that came with that disease, without ever being offered treatment or being informed of the true purpose of that study.

That’s a really egregious example, but that’s one of the examples that actually prompted the current regulations that are in place. The federal government actually stopped that study in 1972 after 40 years of it taking place. And there have been reparations made to the surviving members of that study and to their family members because of what they endured.

But that study is one of the reasons why the federal government then put in place the National Research Act of 1974. And from that Act, they created a commission that wrote a fundamental piece of literature in this area called The Belmont Report, and that was published in 1976. And The Belmont Report is really our fundamental document that we still use as the basis of human subjects review today. And that has three core principles that we can delve into more. Those are respect for persons, beneficence, and justice. So, that in a nutshell is why the IRB has come into existence.

Linda Ashar: And what does “IRB” specifically stand for?

Dr. Jennifer Douglas: The IRB is the Institutional Review Board. And this is a federal term, so we didn’t create this term. The IRB, that’s a standard term that’s used across the United States for these kind of review committees. And we’re also then using the guidelines that are coming from the federal government regarding the protection for human subjects.

Linda Ashar: So who has IRBs? Where are they?

Dr. Jennifer Douglas: So, most academic institutions, meaning universities and colleges, have IRB boards for their faculty or students who are conducting human subjects research at that institution. So, it’s very common at most colleges and universities, but you’ll also see them at medical centers, sometimes in the K-12 education system, a school or a school district will have an IRB board. At nonprofits, there are sometimes research boards, and even sometimes in government or corporations there will be research offices that are called IRB or perform the IRB function. So, pretty widely but they look a little bit different depending on what kind of institution it is.

Linda Ashar: Okay. I think we’ll probably get into what the boards do, but let’s pause for a minute on who makes up boards, because you mentioned regulations that drives this process, for good reason. Do the regulations or does a government body select who’s on boards? How do boards come to be formed? Who’s on them?

Dr. Jennifer Douglas: Really the IRB is a type of peer review in the sense that they’re usually composed of experts who come from a variety of subject areas or represent a range of disciplines. The federal regulations provide some guidelines around membership, but they do not provide strict guidance or select who the members are.

So, at a university, oftentimes faculty will serve on IRBs, faculty representing different disciplines. At larger universities, and especially those that have significant medical centers, oftentimes there are dedicated IRB staff whose sole purpose is to work with the IRB process and help to review studies.

But, generally, those IRB committees have to be well-rounded in the sense that they need to represent the different disciplines of those who would be applying or submitting IRB applications. And it’s also important that there is an external member who’s outside the institution as well, who can be called on to provide perspective and to kind of be a check and balance with those who are internal to the institution.

Linda Ashar: How many people are generally on an IRB?

Dr. Jennifer Douglas: Anywhere from maybe five to 20. The larger the institution and the more volume that the IRB has to review, the larger those IRB committees generally are. So, at a large university, I’ve seen instances where they have maybe two or three rotating committees and they might have 25 members serving on the IRB at any given time. And at small colleges, that could be as small as a three- or four-person committee. So it really depends on the demand and the volume that’s likely to come into that IRB and what they need in order to keep applications moving through the process.

Linda Ashar: So, you mentioned the Tuskegee Study that was one of the prime stories behind bringing the necessity of this type of review into being. So, what is the range or scope of types of research that is required to come under an IRB review process? What kinds of human subject studies are we talking about?

Dr. Jennifer Douglas: There’s basically two big criteria for research that needs to be reviewed by the IRB. The first criteria is that the study is actually research, meaning that it is an intentionally designed study that is designed to contribute to knowledge in that discipline and has some generalizable component to it. So, first the study has to be intended for research purposes in order to be considered human subjects research. There’s sort of those two parts, the research and the human subjects.

So, first, is it research? And second, the human subjects part means collecting data from or about living individuals. So, it does have to involve people, but there’s a wide range of ways that research can involve people. It doesn’t have to be only medical research, which is one type, but many kinds of social science research also fall into the category of needing IRB review.

So, research that includes survey research, interviews, focus groups, ethnographic type research at times. There’s really a broad swath of academic disciplines where research may need to have IRB review if it involves collecting data from individuals.

Linda Ashar: So, for an IRB, our job is to protect rights of the people involved in the study and also make sure it’s being conducted properly. Is that a correct statement?

Dr. Jennifer Douglas: Yes, it is. Really what the IRB is doing is looking to see, one, are the individuals who are being asked to participate, our human subjects participants, are they given the opportunity to have informed consent? Which means they are actively consenting to participate in the study, they are informed of what it is about, and they are choosing to do so. So, that’s a big part of it, making sure that that procedure is followed and that that’s part of the study.

The IRB is also looking at mitigating or minimizing risks to the human subjects participants who are in the study and how the researcher is anticipating and ensuring that anyone who’s participating in that research is not engaging in any unnecessary risk. And that can be not just physical risk as you might see in a medical trial, but emotional risk, professional risk, anything that may result from that participant being part of the study.

We’re also looking at, how is that research providing a benefit? And that can be a benefit to moving forward the discipline or to a specific group, but we’re trying to balance out the risk benefit of that study. So, how is it that the researcher is justifying the need to go out and involve these people in collecting data versus any risk that they might have by participating?

Linda Ashar: So, when you say benefit, are we looking to benefit the people involved themselves? Or is it more about a benefit to the body of knowledge of that science that’s being researched?

Dr. Jennifer Douglas: It’s often more about the benefit to the body of knowledge than it is to the individuals themselves, although that depends a little bit on the study. But, oftentimes, it’s the benefit to the body of knowledge. Some research is fairly targeted in that it’s taking place in an organization and part of the benefit is helping that organization in some way by providing the results back and helping them formulate recommendations.

Linda Ashar: So, it would be fair to say there’s an indirect benefit of research to the people involved because they’re part of the community that knowledge is being collected for?

Dr. Jennifer Douglas: Yeah, absolutely. And that’s part of the overall context and why when a researcher’s proposing a study, we always want to make sure they’re explaining it to the participants to the extent that they can before the participants take part so that those people realize that they’re actually doing something helpful if they choose to participate and how it is that that’s providing some benefit back to themselves or to the larger society or to the organization maybe.

Linda Ashar: And that’s part of the informed consent that you referred to a minute ago?

Dr. Jennifer Douglas: It is, right. So in the informed consent process, we have a template for that in our particular process, but we ask the researcher to give a brief explanation of what they’re studying, why they’re studying it, why they’re asking these participants to be involved and what they’re hoping to produce as a result of that study so that participants can have that context and weigh whether they want to participate or not.

Linda Ashar: How is informed consent obtained. Do they sign something? Each participant sign a specific, you mentioned a template, so there’s a form they sign? And how is that maintained?

Dr. Jennifer Douglas: The standard is really a written consent, and that’s either in the form of a form that they do sign if it’s given on paper. In a lot of cases where researchers are doing surveys, we include that informed consent as the opening question of the survey so that if they say yes, they agree, then they continue on to take the survey. And if they choose not to, then they can exit at that point.

In some cases, verbal consent is considered, and that occurs in more special settings I think where it might be difficult to get written consent. But part of the review process is, if a researcher wants to bypass the written consent and move to something like a verbal consent, then they need to provide justification of that and explain how they’re going to do so.

And then kind of a special case there is in research that might involve children, for example. Parents also have to give informed consent. So, there’s a more detailed process to make sure that a parent or guardian receiving informed consent is the one approving it, and that there’s also age-specific language and explanation given to the children themselves so they understand what’s going on and they feel comfortable with the study. So, it can be really straightforward in some studies or it can be a little more complicated in others depending on who the participants are and how they’re being recruited to participate.

Linda Ashar: What happens with a proposal for a study that wants to include participants that are not aware they’re being involved?

Dr. Jennifer Douglas: That’s a really interesting question. It becomes a little bit tricky there because we do have questions when we have the IRB application to say, “Are you telling the participants the true purpose of this study or are you concealing something from them in order to avoid biasing their response, for instance?” It is possible to conduct studies where the participants are not told everything ahead of time because the researchers are trying not to influence the way they react or respond in a given situation. They still have to be told something at the beginning, and otherwise they have to consent to be involved if they’re being brought into a room to do an activity or answering questions or clicking things on a computer screen, whatever it might be. So, they have to be given some general idea, and it has to be clear to the IRB committee that there is not the risk of harm involved by their not being told what’s going to happen.

It doesn’t happen all that often. In our particular case for research we see, but there are some cases. I can think of some psychology research studies or maybe other social science areas where the researcher is asking for participants to come in and giving them just a very general idea of why they’re there, but not wanting to give them too much information.

There’s also kinds of studies that involve observation. They don’t always fall completely under IRB purview if someone is in a public place and maybe just observing what’s happening if they’re not interacting really directly with people there. So, there’s always a lot of nuance. One of the things about the IRB is that no two studies are the same and every study is really unique in how we have to look at it and the questions we might ask.

Linda Ashar: That’s a good explanation. Thank you. When you mentioned The Belmont Report, you mentioned some ethical principles. One was respect for persons and I think we have been discussing that quite a bit with the informed consent and making sure that people understand that they are part of a study and agreeing to it.

You mentioned and explained there’s a minimal risk of harm to participants. So, I think that covers respect for persons pretty well. What about beneficence? You mentioned that as a cornerstone ethical consideration of The Belmont Report. What does beneficence mean?

Dr. Jennifer Douglas: I might broaden the question a little bit and talk about beneficence and justice together a little bit. Those are some of the other two of the three main criteria that are given in The Belmont Report. And part of that has to do with, again, going back to our discussion on providing benefit. The study itself has an intention to provide benefit, but also that those who are involved in it are treated equitably and fairly throughout the study.

One other kind of core principle there that intersects with these ideas is the privacy and confidentiality issues related to research. One of the things that we’re most looking for from the IRB’s perspective is, how are the data being presented or collected in such a way to protect the privacy and confidentiality of the participants?

In some studies, that’s relatively simple to do. For example, if there’s a survey going out and it’s going out maybe on a social media platform, and those who are choosing to take it are truly unknown to the researcher and they’re not providing identifying information, then their privacy is being protected through those means.

Where it gets a little bit trickier is in situations where the participants are known to the researcher. So they might be interviewing a set of people or doing a smaller scale survey where they know the distinct group of people to whom they’re sending the survey. And in those cases, what’s really important is that the participants don’t feel that answering or participating in that activity is going to pose any risk back to them.

For example, if there’s a survey in the workplace and it’s maybe asking about management style, participants may be especially sensitive to answering questions where they could be seen to criticize their managers or their leaders. And so, it’s really important in those cases that their identity is protected and that there’s not a way to trace responses back to the individuals who answered.

So, from the IRB perspective, that’s part of what we’re looking for in the design is to say, “How is it that you as the researcher are collecting this data such that you’re not presenting a risk to participants that their answers could in some way be used against them or come back to them?”

So, one of the ways that we look at that from the IRB perspective is, a lot of researchers when they’re first drafting, let’s say a survey, may ask a lot of demographic questions. And this can become problematic if their survey pool of participants is relatively small. So, for example, if you’re surveying people within one organization and you ask age, work area, gender, length of time with the company, those kind of characteristics, well, pretty soon you could actually narrow that down to one or two people in a lot of cases.

So, as the IRB, we are often asking those questions back to the researcher to say, “Do you really need all those demographic questions? Are they part of your analysis? And how are you going to mitigate the privacy issues that may arise?”

Linda Ashar: And then there’s the matter of storage of data after a study is concluded.

Dr. Jennifer Douglas: Yeah. And that’s something that a lot of people don’t think about upfront. But in the digital age, that’s become increasingly important. There’s hard copy storage. Obviously, if you print something off or you have it on paper to begin with, making sure that it’s securely stored.

But for digital storage or cloud storage, it’s making sure that it’s protected, it’s password protected. That if you have a system for maybe de-identifying your research participants, that you’re careful that the coding for their identities is maybe not kept in the same place as their responses so that other people cannot easily connect the dots between the responses and the people involved in the study.

And then, generally keeping that in an encrypted format or in a password-protected format at the very least. IRBs generally have a data retention policy for a certain number of years to keep the data. And then, at this point, the hardest part in some ways is how to delete it after that time, especially if it’s backed up in various cloud-based formats. And there are some programs out there that people will generally look to that help to kind of go erase data and backups and to remove them at that point when they’re not needed anymore. But it’s a tricky question these days because, as we all know, when things go into the cloud, they tend to stay somewhere in the cloud. And so, it’s just being aware of how the data is managed along the way.

Linda Ashar: What is the procedure? If a researcher finds that data access has been compromised in some way, let’s say a laptop is stolen or they’ve been hacked, what do they do? Do they report that to the IRB? Is there something else they have to do? What happens?

Dr. Jennifer Douglas: If they find that they’ve been hacked or data breached in some way with IRB data, it certainly is a good idea to report it back to the IRB to say what happened. And then the question from there is really, how sensitive is that data? Is it something that in the most sensitive case includes a lot of identifying information, in which case it’s sort of like a data breach in a company these days. You’d really have to report it back to the participants so that they’re fully aware of what’s happened.

If the data is de-identified or stored in such a way that it’s not necessarily connectable back to any individuals, then that’s a little bit simpler from the IRB perspective anyway because it’s not as likely to pose a direct risk.

I will say, and this is sort of a larger question, that in the research world these days, a lot of federally funded studies actually require that raw data are made public as part of funded research. So, there’s an increasing trend to actually put data sets out there into different repositories, which is a good move for transparency, but also important to keep data de-identified. So, I guess in connection to the question that you asked, in some ways we’re very stringent about protecting data, but in other ways, the research world has become increasingly transparent about sharing the data sets once they’re clean and fully de-identified with the larger research world.

Linda Ashar: Oh, that’s very interesting, but I’m glad you pointed out that it’s de-identified when it’s published that way, because there’s also all the government regulations for some types of personal information that, for example, in a medical study, there would be HIPAA-protected information I would imagine that would have to be not published.

Dr. Jennifer Douglas: Right. And so that’s something that the principal investigator, whoever is the lead researcher on that study, has to work closely with their research team. And often there’s a data management person, especially at larger universities or institutions, to help them figure out how best to manage that data and what’s publicly accessible and what’s not shared.

Linda Ashar: Well, we have an IRB at American Public University. What kind of research is ongoing at APU?

Dr. Jennifer Douglas: At APU, we are primarily a social science-based institution in terms of the human subjects research that we see, with occasional forays into areas like sports and health sciences and public health for some disciplines. But most of the research that we see coming through the IRB are studies that are using interviews or surveys. So, we’re very much accustomed to seeing that kind of research.

One particular case that I was going to point out that’s kind of common to APU but not necessarily to other places, is we have quite a few people, whether faculty or students, who are doing research in their own employment setting in their own organization. And that’s a wonderful opportunity for a faculty member or a student to leverage their job in order to conduct some research. But there are also some nuances in doing that between what might be a quality improvement project within the workplace and something that’s considered a research study. If you’re interested, I can go into that piece a little bit more.

Linda Ashar: Let’s do that.

Dr. Jennifer Douglas: Sure. So, within an organization, most of us are familiar with the idea of doing a quality improvement project. So that’s a project done for an organization’s own internal benefit. And sometimes those quality improvement projects may involve surveys or focus groups or interviews within an organization in order to assess a particular issue and to create recommendations for the organization.

Those generally don’t go through an IRB in and of themselves, but when you have an employee of that organization who would also like to leverage that project as a piece of research and disseminate it further into a presentation or a publication, or use it for a thesis or a capstone or a dissertation, then it kind of crosses a boundary into being a human subjects research study because the scope and intent of that project changes from being purely internal for the organization’s own benefit to being something that is going to go out into the larger research community and become more generalizable.

So, in those cases, as an IRB, we see researchers coming to us with applications for human subjects research. And some of the questions that we ask at that point are, has your organization provided permission for these data to be collected and shared externally for research purposes?

So, many organizations are fine with collecting data internally for themselves, but they might be a little bit less comfortable with that data being shared in other settings, particularly if they perceive it to be sensitive in some way about the organization. So, getting organizational permission is important, that’s a must.

We also look to see, for the participants in that kind of study, we look at the relationship between the researcher and those participants in terms of reporting areas and if the researcher has any supervisory capacity over those who are being asked to participate. And that’s important because we want to avoid coercion for those who are being asked to participate. And I’ll say, most researchers genuinely have no intent at all to coerce people and they think it’s very innocuous, I’m just going to ask these people to do this survey for me or to participate in a focus group.

But when you look at it from the participants’ perspective, they might think, “Well, this is my supervisor. I kind of have to participate or maybe this will look bad for me if I don’t participate.” So, in those cases, that’s where the privacy and confidentiality of participation comes in. And just being really clear and transparent that the study and the participant’s choice to participate is completely separated from their work performance. And that can get a little tricky. So, those are some of the things we look for an IRB when someone comes to us and they’re looking for a study within their own workplace.

Linda Ashar: That’s a very interesting nuance and I appreciate you sharing that. We could probably spend another hour talking about the IRB process because there is so much involved and different types of participants that we could talk about; prisoner research, for example, is one area in and of itself.

But, I think we’re out of time. Jennifer, thank you so much for taking the time to share this information with us today. This has been a really good topic to share with our listeners and I appreciate your time.

Dr. Jennifer Douglas: Well, thank you, Linda. And I would just close by saying that the IRB is not as intimidating as it may seem at first. And from our perspective, we’re trying very hard to collaborate with researchers to help you keep refining your application and to get you to your end goal with that research. So, don’t be surprised if we ask a lot of questions during the IRB process, but the intent is to make sure that we’re protecting you and the participants of the research itself.

Linda Ashar: Excellent. Thank you. We’ve been talking today with Dr. Jennifer Douglas about the IRB process for human subject research. We hope you’ve enjoyed this podcast. Please stay well. We look forward to seeing you in the future.

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