batangas medical center research ethics review committee

• Open access
• Published: 01 July 2021

How ethics committees and requirements are structuring health research in the Philippines: a qualitative study

• Gideon Lasco 1 , 2 , 3 ,
• Vincen Gregory Yu 1 , 3 &
• Lia Palileo-Villanueva 3  

BMC Medical Ethics volume  22 , Article number:  85 ( 2021 ) Cite this article

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The last few decades have seen the rising global acknowledgment of the importance of ethics in the conduct of health research. But research ethics committees or institutional review boards (IRBs) have also been criticized for being barriers to research. This article examines the case of the Philippines, where little has been done to interrogate the health research and IRB culture, and whose circumstances can serve as reflection points for other low- and middle-income countries.

Semi-structured interviews were conducted from July to October 2020 to elicit health researchers’ perspectives and experiences regarding IRBs and the ethics approval process in the country, as well as counterpoint narratives from researchers who have also worked for IRBs.

Across the fields of clinical, public health, and social science research, the issue of ethics review revealed itself to be foremost an issue of inequity. IRB processes serve as a barrier for those outside the academe; those belonging to institutions, cities, or entire regions without their own accredited IRBs; and researchers working independently, without ample budget, or on highly specialized topics—more so for non-clinical researchers who must grapple with the primarily biomedical framework of most IRBs. Consequently, the research landscape invariably favors those with the resources to do research, and researches that tend to attract funding.

The broader challenge of equity in health research will entail more fundamental reforms, but proximal interventions can be done to make the ethics approval process more equitable, such as enhancing institutional oversight, regulating IRB fees, and enabling a more supportive and welcoming environment for early-career, student, independent, and non-clinical health researchers. This article ends by reflecting on the implications of our findings toward the larger research culture.

Peer Review reports

The past few decades have witnessed an increasing acknowledgment of the importance of ethics in the conduct of human research. Consequently, professional organizations and academic institutions around the world have organized ethical guidelines and review committees (here on alternately referred to as ethics boards or institutional review boards [IRBs]) to ensure researchers’ adherence to ethical principles. As such, securing ethics approval has become essential to the initiation, funding, and publication of health research.

But IRB processes have also been criticized for being a barrier to research. Examining two multi-center Australian researches, Barnett et al. found high costs—both in terms of time and money—in obtaining ethics approval [ 1 ]. Kendall and Halliday highlighted particular issues faced by qualitative researchers, including the challenges posed by a “biomedical research ethics paradigm” to researchers with “a social justice agenda.” [ 2 ] (p. 308) Summarizing concerns raised by existing scholarship, Nicholls et al. wrote:

While few would disagree with the general need for ethics review, existing review processes are often criticized; common complaints include the amount of paperwork required, inconsistency of decisions between review boards, and suggestions that ethics review systems may not be equipped to properly review specific types of research [ 3 ].

Nicholls et al. further underscored the absence of “gold standards against which to evaluate research ethics review processes”; and, crucially for the Philippine context, how “there has been little in the way of published research on the subject of assessment of research ethics review.” [ 3 ] In fact, a quick PubMed search, coupled with our preliminary library research, revealed no studies dealing with this topic in the Philippines.

Following the above and other researches, we set out to examine the ethics approval process in the Philippines according to these three questions:

1. How are demands for ethical research structuring the health research landscape?; 2. What are the experiences and particular challenges of Filipino health researchers with regards to IRBs?; and 3. How exactly do researchers from specific disciplines (e.g. clinical researchers versus social scientists) feel about ethics and IRBs?

Our study builds a preliminary knowledge base—and not necessarily an exhaustive picture—for this particular topic in the Philippines. Through qualitative interviews that elicited the perspectives and experiences of Filipino researchers themselves, as well as people involved in Philippine IRBs, this study charts the ethics approval process in the country and identifies contemporary barriers and facilitators along the way. Building on this data, we offer policy recommendations for academic institutions, IRBs, and government bodies that not only speak to the situation of health research in the Philippines, but are also relevant to other contexts, especially in low- and middle-income countries where researchers and institutions alike have likewise adapted to the demands of ethics in research.

Ethics review in the Philippines

Relative to the Global North, the institutionalization of research ethics processes in the Philippines is a fairly late trend. In the late 1980s, for example, IRBs were already present in over 60 percent of hospitals in the United States [ 4 ]; while by 2000, “more than 95% of Portuguese hospitals had established” an IRB [ 5 ] (p. 485).

In contrast, in the 1980s the Philippines was only seeing the formation of a National Ethics Committee, tasked to “promote ethics review in health research.” [ 6 ] Within that decade, the only major academic or research institution in the country with a self-run IRB was the Research Institute for Tropical Medicine under the Department of Health (DOH) [ 7 ]. By the early 2000s, “only 50 percent of [Philippine] institutions [had] an [IRB].” [ 8 ] (p. 24).

In 2006, the Philippine Health Research Ethics Board (PHREB) was officially established. Consisting of members from various research disciplines, the board’s mandate includes overseeing the establishment and performance of IRBs in the country, as well as “[networking] with relevant local, national and international organizations.” [ 9 ] As of January 2021, the PHREB website lists 104 accredited IRBs in the country, 40 of which are found in the capital region of Metro Manila.

The country’s leading academic institutions established their own IRBs only within the last 15 years—for example, in 2010 for the University of the Philippines (UP) Manila, which houses the National Institutes of Health and is widely considered the country’s premiere health-sciences university [ 10 ]; and in 2015 for Ateneo de Manila University [ 11 ]. For the social sciences, the country’s mother organization, the Philippine Social Science Council, instituted its dedicated IRB only in 2017 [ 12 ].

Significantly, the Single Joint Research Ethics Board (SJREB) was formed under the DOH in 2017. Tailored specifically to ease the ethics approval process for multisited studies, the SJREB is the closest to a one-size-fits-all mechanism for multisited protocols in the country, in that it furnishes such protocols with blanket approval applicable to all hospitals under the DOH, allowing researches to proceed with data gathering without needing to obtain separate approval for each site [ 13 ].

Methodology

From July to October 2020, we conducted semi-structured interviews with a total of 40 researchers in the Philippines. Because of the coronavirus disease 2019 (COVID-19) pandemic, we had to conduct the study remotely; at the time, our team members, all health researchers with experience in qualitative work, were each based in a different part of the country. Heeding Mays and Pope’s [ 14 ] call for purposive, theoretically informed sampling, and drawing on what Marshall describes as the “researchers’ practical knowledge of the research area,” [ 15 ] (p. 523) we purposively recruited our participants through peer referrals and targeted searches via Google Scholar, keeping the list as inclusive as possible so long as the interviewee was relevant to the ethics review process (e.g. as a researcher, board member, journal editor, government health official, hospital residency training officer). However, navigating the ‘new normal’ of the pandemic, and the changes it imposed upon academia and research culture, meant that realistically we had to simplify our participant selection and also consider the fact that our potential interviewees—all fellow researchers—were imaginably in similar straits with regards to adjusting to the pandemic. As such, for ease of access, we first approached individuals who were already known to us (e.g. at work), either through phone call, text message, or e-mail, before blindly contacting those with whom we were completely unacquainted. Prior to the interviews, our participants were sent the interview guides for their perusal; this preliminary correspondence also served as an avenue for them to raise questions about the study or concerns regarding their participation.

We initially categorized our participants according to three major disciplines: clinical research, public health research, and social science research. IRB members constituted a fourth category, and key informants—ranging from journal editors, heads of private research firms, to past and present government officials in health- and research-related fields—constituted the fifth. However, many participants did not necessarily belong to only one category, thus accounting for the participant distribution according to discipline exceeding the total number of actual participants. Save for three participants—two from the Northern Mindanao region and one from Cavite province—all interviewees were based in Metro Manila. Nearly half were affiliated with the UP system. Fifteen participants were early-career researchers (including graduate students), while the rest were considered established researchers. Data saturation became our determinant for the final sample size: During data gathering, our team regularly consulted with one another regarding the findings of an interview in order to determine whether we had attained some form of data saturation in each category of interviewees. Cognizant of our study’s aim to provide a preliminary—and not necessarily a definitive or exhaustive—picture of our subject matter, we would still encounter considerable saturation usually by the 10th interviewee, after which we would cap interviews for that category. In the end, our selection also considered a gender balance, workplace affiliation, and research discipline, all summarized in Table 1 .

Our remote interviews were conducted either through phone call or video-conferencing software like Zoom. This capability to participate in a remote interview became our sole exclusion criterion. These interviews usually took 30 to 45 min. Although the interviews followed a general format—one that began with the interviewee’s personal experiences (e.g. their professional background, their individual experiences in research and with IRBs) before transitioning to more general topics like their views on ethical research, IRB practices in the country, and the impact of IRBs on research culture—we still tailored our questions according to the participant’s background and therefore used four separate guides (see Additional file 1 for the final interview guides). To reduce bias during the interviews, given that our team members all had prior interactions with IRBs, we strove as much as possible to follow the interview guide, sticking to one open-ended question at a time, and to remember that we were there as interviewers only, and not co-generators of insight. Our initial interviews served as pilot tests, but as we conducted more interviews, we also adjusted and tweaked specific questions that were inconspicuously biased, as well as allowed the participant’s response to shape succeeding or follow-up questions.

Consent forms were signed electronically; likewise, participant tokens were delivered via an online medium. The audio copies of the interviews were sent to transcribers who had signed nondisclosure agreements, and upon receiving the finished transcripts, our research team proceeded to ensure participant anonymity by removing as much identifying information as possible in each transcript. Only our research team has access to all 40 transcripts, which have been secured in a password-encrypted folder.

All transcripts were uploaded to a secure, offline NVivo 10.0 database and approached by way of deductive thematic analysis. Guided by our literature review, our research team first read the transcripts individually to come up with initial codes. We consulted with our team members regularly to ensure our individual readings of the text were devoid of researcher bias. Comparing codes led to our preliminary themes, after which we did another round of reading to arrive at the final themes by consensus. Our study was approved by the UP Manila Research Ethics Board (UPMREB 2019–259-01).

Across all three sectors of health research, researchers are one in recognizing the importance of ethics in the conduct of their work. All our clinical researchers, for example, agreed that it is now safer than ever to conduct trials precisely because IRBs exert rigid measures in evaluating protocols. But such procedural rigidity has also been criticized, with one participant describing the whole application process as “intimidating.” In this section, we discuss these criticisms and offer perspectives from researchers who are also IRB members, with particular attention to the differences among the three sectors.

Ethics review takes a long time

The researchers’ most common and prominent complaint is that the review process in the Philippines is time-consuming. According to them, it takes anywhere between two weeks to a month from the time of protocol submission before IRBs even give an initial decision, and between two to three months before a final decision can be reached. Accounting for protocol revisions and resubmissions, the whole process can sometimes last as long as “almost a year,” disrupting research timelines even when a long process has been anticipated. A public health researcher said a project she was involved in was delayed for almost a year only because the protocol was not approved immediately—despite zero requests for revisions from the reviewers. Separately, a consultant at a tertiary training hospital shared:

Our hospital was supposed to participate in an international clinical trial. But it took a long time for the ethics board to approve the study that by the time we got approval, the trial was about to close. We ended up withdrawing our participation.

As the latter quote suggests, the time-consuming nature of the review process is of great concern particularly for researchers who are working on urgent studies or operating on a limited timeline. A head of a private research firm counted at least three recent instances of potential international collaborators backing out of a Philippines-based study for this reason alone. Even non-professional settings experience similar constraints: A university professor talked of instances when students got delayed or had to drop out simply because their thesis proposals were not approved promptly. Consequently, researchers are either forced to meticulously account for the estimated review duration in structuring their studies—or altogether abandon certain aspects of proposed projects, if not their entirety, that cannot afford longer time frames.

Another impact is that, within the health research community in the Philippines, certain IRBs have gained reputations in terms of how fast they can process applications. Our participants spoke of knowing exactly which boards have fast turnaround times and can be relied upon to approve studies with limited timelines. One researcher described an IRB based in a private hospital as almost “machine-like” in its predictability to approve a study swiftly, making it a favorite among those in a hurry despite being “less prestigious” than university-based boards.

Our participants did identify experiences with efficient IRBs that can produce initial results within two weeks and finish the whole process in a month. Some also said the COVID-19 pandemic has forced IRBs to be more efficient—for instance, by finally accepting email submissions and carrying out correspondences accordingly. Nevertheless, on the whole, the researchers felt that IRBs don’t expedite reviews as often as they should or provide more manageable timelines.

Ethics review is costly

Regarding the financial aspect of applying for ethics approval, most of our participants said that the cost is usually not a problem—so long as the concerned study has funding. That said, our interviews showed notable variability in the rates that IRBs charge per application. Some university boards, for example, completely waive their fees for all student and faculty applications, while others provide considerable discounts. On average, however, the fees range between PHP 20,000–50,000 (US$ 416–1,040), and can go as steep as PHP 80,000 (US$ 1,664) per application.

Even with funding, our participants admitted to being concerned at how these rates eat up a considerable chunk of the budget. But for independent and student researchers, the grim and obvious implication is that these fees must come from their own pockets—leading one public health researcher to speculate that the barrier inevitably imposed by these fees may not only be limiting the country’s research landscape to certain circles where funding is easily available (e.g. academe), but may also be discouraging independent or starting researchers from pursuing their work. That participant continued:

As head of [redacted private research firm], even I find a fee of PHP 30,000 [US$ 624] exorbitant. But I’ve also been approached by friends from abroad, PhD students who want to do research in the Philippines, who are just shocked at how much our ethics boards want to charge them.

Moreover, precisely because there is no rigid regulation enforcing some semblance of uniformity upon IRB rates, some participants were concerned that IRBs have been taking advantage of this “financial opportunity,” as this public health researcher illustrated:

The bill for ethics review can include two items. One is the ‘ethics review fee’, which is manageable, say, at around PHP 20,000 (US$ 416). But a lot of hospital boards add the second item, a so-called institutional fee—and that’s where it gets super arbitrary. For a project that I did with an American government agency, for example, one of our hospital sites charged us something close to PHP 100,000 [US$ 2,081], which was way above what we could have expected. When we asked for justification for the fee, they couldn’t even provide one, which to us was code for, ‘We know you have a lot of money, so cough it up’. It’s ironic that so-called ethics boards engage in such a gray area of practice.

As that excerpt shows, the apparent inconsistencies in and unpredictability of these fees are worrying enough—but more troubling is the idea that ethics review is fast becoming a business. One social scientist said it best:

I’m convinced there is a market for ethics review—that it can be a lucrative industry if you want to go down that path. I mean, reviewers just have to read a protocol, comment on it, eventually give a decision—and the board can earn something like PHP 50,000 [US$ 1,040] from it? And if they’re fast, it will only take a month to do that, even less.

That, in fact, is precisely what a member of a private hospital’s in-house board confided:

It’s easy to say that having their own in-house IRB can position hospitals as prime movers and innovators when it comes to research. But an IRB is also admittedly a huge source of funds. There is so much money [to be earned from participating] in multi-country clinical drug trials. Coming from a private-hospital standpoint, I’d say that is one very compelling reason to form an IRB.

Ethics committees are concentrated in major cities

Aside from the time and cost, our participants also identified the concentration of IRBs in Metro Manila as a concern, particularly for researchers based in the provinces. A clinical researcher from a major Northern Mindanao city, for example, said that in her city, she “wouldn’t know of any other ethics board to go to besides the one in my hospital.” Likewise, a social scientist from a neighboring town said that, as far as his field of research is concerned, he always has to go “out of town” to get ethics approval.

Many researchers agreed that the SJREB has been a welcome solution for multisited studies. But, as one researcher from the DOH noted, this solution has its own shortcomings: “One of the earlier challenges [encountered by SJREB] was resistance from the individual ethics review boards, who felt like they were surrendering their power and feared they would not be paid anymore individually.” Another public health researcher pointed out a second shortcoming of this system: Since the SJREB strictly applies only to hospitals under the DOH, private institutions can refuse to recognize that blanket approval and still require researchers to apply for separate approval under their own boards (as was this participant’s experience). “Instead of going through one board [SJREB only], in the span of a year our team ended up going through three [including two private institutions that acted as described],” that participant said. Thus, up to now, the need to obtain ethics approval remains a preliminary obstacle among those whose institutions—or cities—do not have their own IRBs.

Ethics review is designed for clinical research

Non-clinical researchers highlighted a pressing concern not shared by their clinical counterparts: Their perception that IRB processes have been designed with clinical research in mind—and therefore inappropriate for non-clinical disciplines. Fundamentally, this clinical orientation manifests in the paperwork that IRBs require researchers to accomplish. As a public health researcher said:

It’s bad enough that [IRBs] that have yet to transition to digital require you to fill out a ton of paperwork. But many of those questions and forms are actually irrelevant to non-clinical studies. It would be more efficient for everyone if, for example, template forms were already designed according to specific types of studies.

This bias is also reflected in IRBs’ compositions—and the kind of mindset and expertise, or lack thereof, that members consequently bring into their work. For example, one social scientist pointed out how hospital-based IRBs are usually composed of clinicians—and therefore

cannot be expected to competently evaluate social science researches... [Moreover,] it’s not just a matter of board composition—a certain sector being overrepresented or underrepresented—but also a matter of lack of training. Boards in the Philippines just aren’t as interdisciplinary as they ought to be.

As such, to quote a clinician who does mostly qualitative research:

Ethics boards can disapprove or question protocols not because they are ethically unsound, but because they have subjective qualms over methodology—and most of the time these qualms result from the simple fact that the board members are unfamiliar with how that methodology works.

What happens in such cases, a participant from a firm that specializes in outsourced processing of hospital-based protocols said, is that IRBs then tend to act in a reactionary manner. “They react to what you show them rather than knowing the right questions to ask. I’ve handled many studies with novel or unfamiliar data-collection tools that got questioned relentlessly over their design alone.”

It is easy to see, then, where the complaints regarding IRBs overstepping their mandate or “meddling with the study,” to use one participant’s words, are partly rooted on—and why, when IRBs justify such 'overreach' by saying that “a study cannot be ethically sound if it is not methodologically or technically sound,” researchers would not believe them. Across all three sectors, we had participants who raised that exact point, identifying the frequent overreach of authority on the part of IRBs as a major cause of tension between researchers and boards. This tension becomes more discernible as one deviates farther from clinical research and is most pronounced in the social sciences.

More than one social scientist experienced working with a board that insisted on written informed consent for non-clinical studies on vulnerable populations where non-written consent has long been established as the safer practice. In one such study, the board refused to back down, giving the researcher no choice but to forego the project. One researcher working on an ethnographic study with indigenous peoples—a field where study populations are now recognized as co-generators and co-owners of the data yielded during fieldwork—related the difficulty of convincing an IRB that the biomedical norm of destroying data after a certain time was not applicable in this case. A university professor shared how an IRB once refused to approve a thesis advisee’s proposal not on ethical concerns, but on objections to the methodology:

It was an online survey with nothing particularly sensitive about it—I should know because I had already vetted it—so after all the back-and-forth with the board, I put my foot down and sent them a stern letter telling them to stop messing with our methodology. They backed down and let the study proceed as originally designed.

Ethics review for ethics review’s sake?

Taken together, the above complaints shape Filipino researchers’ attitudes toward the ethics approval process—and influence decisions on which topics to do research on, which IRBs to apply to, and whether to pursue a research idea in the first place. As one social scientist confessed:

It quickly becomes discouraging to do research in the country because your mindset, as far as IRBs are concerned, is that you will really have to fight to get approval. I have had experiments in mind that I’ve had to abandon over the mere thought that I wouldn’t get approved.

Given how the ethics review landscape is only in its relative infancy, the same participant continued, “the way these boards are operating right now, it’s almost like they think they’re at a dissertation defense and researchers are there to defend their study.”

“Here in the Philippines it’s almost as if IRBs are dictating to researchers, treating them like they don’t know any better,” said the head of a private research firm, going on to say how

it becomes difficult to accept that kind of treatment when you know these boards are not perfect themselves. The worst experience I’ve had was when a study was returned to me after quite some time with comments that had absolutely nothing to do with my paper—because they were meant for another study.

Such experiences have led researchers to adopt a pragmatic view of ethics: as a necessary, if bureaucratic, step in their projects. “We only look at two things,” a private-sector researcher said, “fast turnaround times and inexpensive costs.”

A public health researcher separately added that the ethics review process is all about working toward an approval, and the moment that approval is obtained, the whole process abruptly comes to an end: There is usually no active follow-up from the IRBs during the course of fieldwork and beyond, even as the requirements for approval emphasize the necessity of such a process; in fact, most of the time, the burden of follow-up falls on the researchers themselves, who end up actively updating the boards regarding their progress. In this sense, ethics approval is reduced to a mere piece of paper, something to be obtained, rather than a thorough evaluation of the conduct and impact of the study both from within and without. In the end, that same researcher said, the demands of IRB application processes take away time that would have been better devoted to preparing for the actual analysis, writing, and publication of a study.

In fact, some participants fear that ethics boards may be fomenting a culture of gatekeeping insofar as research is concerned, given their lack of accountability. Despite the existence of PHREB, these researchers complain that there is no feedback mechanism to air their concerns regarding the approval process and no discernible metric system to evaluate the performance of IRBs.

In many ways, all these criticisms are reflective not only of IRB practices in the country, but of the larger research landscape. Commenting on the inordinate amount of time it takes IRBs to process applications, a participant from a firm specializing in outsourced processing of hospital-based protocols said:

The perfect way to describe our research landscape is that there is a lot of research waste going on, and it’s all rooted in the lack of protected time for research. I’ve seen how it is in other countries, where even junior researchers are really given protected time to do research, where the whole system is very accessible. Here, the fact that we don’t have such dedicated time already affects the quality of writing in our protocols to begin with.

“Ethics should be ingrained in every researcher and must go beyond the IRB,” said a social scientist. At the very least, that same scientist said,

IRBs should place a certain level of trust on the researchers they are working with or the technical review boards who have separately screened the protocols... Right now, how IRBs are shaping the way we do research is in the mode of ‘I'll develop a research protocol that will be so benign, it will be immediately approved by an ethics committee’, instead of ‘I will be making a protocol that will not affect the lives, health, and well-being of my respondents’. Those are two completely different things.

Counterpoint: perspectives of IRB members

From the standpoint of researchers who have worked in or are currently members of IRBs, the logistical limitations of IRBs can be explained by the simple fact that unlike other countries, the Philippines has yet to professionalize research ethics. One participant said one of the birthing pains of “building a culture of research ethics” is getting people to appreciate and participate in research ethics, to serve as reviewers and panel members. A participant from the DOH observed how “most hospitals have no actual budget dedicated to sustaining an ethics board. That is why ethics boards become highly dependent on the fees that they charge to, say, pay for the office space, the secretariat and administrative staff, etc.” As a clinician-researcher put it:

The operation of IRBs is governed by a lot of privacy and confidentiality. But even in big universities, we are not always assured of lockable cabinets. We should not be sharing a fax machine with another office. We should have our own shredder.

Protracted turnaround times can be easily explained by the fact that IRBs are often understaffed and swamped with protocols. Almost always, IRB members also have other responsibilities, such as being university professors or clinicians, and cannot devote all of their working time to just evaluating protocols. Almost always, as well, the compensation for IRB members is hardly commensurate to the amount of time and effort that they devote to the work. One participant described present conditions succinctly:

Reviewers are asked to read 300-page protocols and paid for only an hour of the job. So you really have to question why, in a clinical trial, for example, an IRB would charge PHP 60,000–70,000 [US$ 1,250–1,455] for review but pay its reviewers only PHP 1,000–2,000 [US$ 20–42] per protocol reviewed.

Where the perspectives of IRB members diverge from our other participants is in the mandate of an IRB. “Many researchers cling to this belief that ethics boards are barriers to research,” said one board member. “Researchers tend to become preoccupied with the science of their protocols and end up ignoring the ethics of their protocols.”

According to this subset of participants, a lot of the back-and-forth that researchers complain about in their dealings with IRBs has to do with the simple fact that these protocols tend to be badly written. Researchers can overlook the major, complicated issues such as the study design, but, as one participant noted, the oversight can be far simpler: “I have received studies that, in the objectives, stated the intent to compare this and that, but this intent to compare is not even reflected at all in the study design.”

They also emphasize that the existence of technical review boards is not an excuse for IRBs to be less strict. According to one participant,

preliminary technical review is helpful, but in my experience, most of the time it pays for me as an ethics reviewer to also assess the technical aspects simply because the technical review can miss out on a lot of things that then make the study ethically unsound.

Ideally, that participant continued, if the finances and manpower can make it possible, only one committee should do both ethical and technical reviews to streamline the whole process. In the end, another participant said,

researchers don’t realize that when an IRB ‘oversteps’ and points out technical issues, it’s not because of overreach or a matter of gatekeeping. It’s because as an IRB member, you realize that the study goes beyond the researcher; it will affect individuals and communities.

A social scientist belonging to an IRB provided this illustrative summary to the argument:

Let’s say you are doing a study on the impact of COVID to mental health. If you settle for 400 as your study population, imagine asking 400 people these intrusive questions that would only magnify the risks that they may have already been exposed to. Inserting ethics into the question makes you ask, for example, whether you can achieve the same results with half the population size. It makes you think about the responsibilities of a researcher, so before you submit your protocol for approval, you are already considering the soundness of the design and other questions that you would have otherwise ignored if you were solely focused on the science.

An issue of inequity

On the whole, our study resonates with the global literature that have examined—and/or have been critical of—the role, culture, and practices of research ethics committees, beginning with an acknowledgment of their necessity: Faced with the prospect of ethical review, most of our participants echoed Schrag’s observation, in that their first instinct is generally one of “eager cooperation.” [ 16 ] (p. 122)

But as our findings also showed, the rift between the perspectives of researchers and IRBs regarding the review process transcends mere diverging views on what constitutes “ethical research.” And in any case, the problems raised by Filipino researchers regarding that process are only part of the continuum of ongoing debates worldwide—from the time-consuming and paperwork-heavy nature of ethics approval described by Gold and Dewa [ 17 ] in their study of multisited researches; imbalances in board composition that, as Schuppli and Fraser [ 18 ] wrote, render evaluations ineffective; and the highly clinical framework of current review processes that Flicker et al. have criticized for possibly doing more harm than good and “placing communities at risk” through an insistence on inappropriate measures of evaluation, particularly as imposed upon the social sciences and participatory research [ 19 ]. To go by Abbott and Grady, the Philippine situation is similarly riddled with all forms of inefficiencies and inconsistencies, be it in terms of application fees, duration of review, or outcomes of evaluations [ 20 ]. Additionally, although our limited findings disallow us from fully arriving at the same, incontrovertible conclusion, the anecdotes of our participants regarding commercial IRBs nonetheless find some measure of resonance in Lemmens and Freedman [ 21 ], who, a full two decades earlier, already voiced concerns regarding profit-related conflicts of interests as regards the operation of these ethics boards, and how these conflicts may eventually compromise the quality of review and erode public trust in IRBs.

In its most fundamental sense, then, ethics review is an issue of inequity. The existing system serves as yet another barrier for those outside the academe; those belonging to institutions, cities, or entire regions without their own accredited IRBs; and researchers working independently, without ample budget, or on highly specialized topics. And even for researchers affiliated with institutions that have their own IRBs, the balance invariably tips toward those with sufficient funding and/or those working on topics that tend to receive funding. All of these contribute to the rise of what Patterson [ 22 ] calls “spaces of marginalization” that privilege certain types of research, and research topics—and eventually, knowledge production—over others.

As our own research demonstrates, non-clinical researchers find themselves at the marginal end of that divide. For these researchers, the inequitable landscape is also one where they must abide by what Schrag describes as “silly restrictions” that are inapplicable to their respective fields, and which are imposed mostly by IRBs that lack the expertise to properly evaluate protocols and end up applying “inappropriate” principles to such evaluations [ 16 ]. Often, IRBs operating on a highly biomedical framework have exaggerated “protectionist concerns,” [ 23 ] (p. 483) the imposition of which do not necessarily result in more ethical research practices [ 24 ]. Instead, in such a landscape, current guidelines may only serve to actually “[impede] ethically sound or potentially beneficial research,” [ 25 ] (p. 161) and may be entirely unable to address more complex, field-related situations already raised by existing scholarship [ 26 ]—further straining researcher-IRB relations and aggravating researchers’ feelings of mistrust, if not outright antagonism [ 27 , 28 ]. At worst, this “unquestioning transposition of ethical principles from [clinical to non-clinical] research [may] lead to inappropriate practices that… actually encourage less ethical practice.” [ 24 ] (pp. 94–95).

Ultimately the demands that the ethics application process imposes upon researchers cannot simply be reduced to discrete complaints—on matters of time, or finances, or geographical proximity, or expertise from the side of IRBs; it is an interplay of these factors that breeds an environment that favors those with the resources to do research—and those with researches that are more likely to attract funding. In this manner, indeed, the ethics review process becomes a matter of (in)equity.

Recommendations

While the broader challenge of equity in health research will entail more fundamental reforms (as detailed by Pratt, Merritt and Hyder [ 29 ]), more proximal interventions can be done to improve the research ethics process and make it more equitable. For instance, an oversight committee—in the case of the Philippines, PHREB—should take a more proactive role in mediating the debates of research culture, and go far and beyond its mandate to promote the proliferation and evaluate the performance of IRBs—with special emphasis on what Coleman and Bouësseau [ 30 ] term outcomes assessment, or ensuring from the IRBs’ end that so-called ethical research actually carries on to the field. This is not to undermine the trust between researchers and IRBs once a research has been approved, but to say that IRBs that require researchers to submit regular updates during data gathering, for example, should also be more proactive in seeking those updates or tackling unforeseen ethical dilemmas that may arise after protocol review. Else, what persists is the image of ethics approval as the ‘golden calf’ of the research process, a mere objective to be attained and surmounted.

Moreover, such a committee could also act as a mediator in the financial burden of ethics review—for example, by regulating and imposing uniformity on fees—thereby potentially eliminating conflicts of interest where money and/or power relations is concerned, making ethics approval more equitable while still allowing IRBs a comfortable measure of financial self-sufficiency (see, for example, the arguments of Emanuel, Lemmens and Elliot [ 31 ]). That the complaints of our participants who have worked or are part of IRBs centered mostly around the lack of material support (in terms of personnel, office resources, and/or protected, compensated time for IRB-related duties) only makes this kind of financial self-sufficiency an imperative—and all the more so when one considers how this problem has been perennially recognized across global literature [ 20 , 32 ].

For researchers, the institutions they represent, and IRBs, the spirit of equity should extend to supporting research topics that have not enjoyed as much scholarly attention and making the landscape more hospitable for early-career, student, and independent researchers. To paraphrase Chatfield et al. [ 33 ], making this possible includes ensuring that IRBs are staffed with the right kind of ‘qualified experts’—given that there are “no absolute standards upon which IRBs can rely [in evaluating protocols]” and ethics boards must therefore bank on “a fair exercise of intelligence and discretion on the part of [their] members” [ 21 ] (p. 562)—and lessening the bureaucratic roadblocks that make even getting ethics approval already a laborious process. To recapitulate a point made earlier, a change in research culture requires not taking time away from the actual conduct of the study—from data gathering, analysis, and paper writing. In other words, fostering “a culture of ethics” instead of “a culture of red tape,” to quote Burris and Welsh in Coleman and Bouësseau [ 30 ] (p. 4).

Doing so eventually boils down to the kind of larger research culture that we foster, where: (1) research is seen as an integral part of knowledge production, in the academe as in other fields of society, and therefore granted protected time and sufficient funding; (2) IRBs are seen as instrumental partners in research and therefore granted sufficient human, material, and financial resources to fulfill their mandate; (3) “ethical research” is not viewed as culminating in IRB approval, but as foundational to research—and practiced deliberately, from the writing of the study protocol to the final study analysis; and (4) a certain level of ‘trust’ is established between researchers and IRBs [ 34 , 35 ], manifesting not through what Makhoul [ 36 ] aptly labels “policing,” but through a “collaborative and supportive relationship” that makes ‘allies’ out of IRBs and researchers [ 32 ].

Our study has certain limitations. First of all, our limited sample size means that our findings cannot be interpreted as unequivocal generalizations of the health research landscape in the Philippines, or even as definitive pictures of each sub-field of health research as far as IRBs are concerned. Moreover, almost all of our participants hailed from Metro Manila, making it impossible to account for specific experiences in the country’s many other cities and regions, given the variability in academic and research culture across the nation. Our participants’ affiliations were likewise limiting: We had no interviewees who were undergraduate students, for instance, and nearly half of our participants were affiliated with the state-funded UP system—a fact that would have no doubt colored our participants’ careers and narratives. The focus of our study itself—IRBs in the context of health research—disallows our findings from being considered as entirely valid conclusions for other fields of academic, and even non-academic, research in the country. As such, future avenues for research may include IRB culture and practices in non-health research, as well as the relative infancy of multisited common review in the country.

Nevertheless, our study shows how the case of the Philippines can serve as a point of reflection for similar low- and middle-income countries where research inequities have persisted. The narratives of our participants show how, despite growing recognition of the fundamental role of IRBs to research ethics, the research landscape remains one that is riddled with structural biases and deficiencies—problems that are challenging to overcome, but which are definitely not without solutions. Arguing that ethics review is essential even for non-medical research, Lindoff [ 37 ] calls for opening up lines of dialogue between researchers and IRBs, highlighting the importance of such partnership between the two parties. To this, we concur—but with the caveat that such a partnership may flourish only when the ethics approval process ceases to be a barrier for researchers. Should a middle ground exist, it should be one where researchers need not surmount numerous structural inequities even before a study has commenced; one where researchers don’t have to “fight” for ethics approval.

Availability of data and materials

Data sharing is not applicable to this article, which is grounded on qualitative interviews with key informants.

Abbreviations

Coronavirus disease 2019

Department of Health

Institutional review board

Philippine Health Research Ethics Board

Single Joint Research Ethics Board

University of the Philippines

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Acknowledgements

The authors would like to thank all of their interviewees, who made the generous effort to participate in this study at a time when we were all still navigating the ‘new normal’ of the COVID-19 pandemic, as well as the reviewers for their insightful comments.

This study was funded by the National Institutes of Health, University of the Philippines Manila.

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GL and LPV conceptualized and designed the study, acquired funding, and initiated participant recruitment. VGY led the data gathering and manuscript writing. GL and VGY co-led data interpretation. All authors read and approved the final manuscript.

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Our study was approved by the UP Manila Research Ethics Board (UPMREB 2019-259-01). Informed consent was obtained from all study participants; consent to participate was obtained from each interviewee prior to the interview. No participants were under the age of 16. Additionally, all methods were performed in accordance with existing guidelines and regulations relevant to our study.

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. Interview guides tailored according to participant background (e.g. researcher, ethics board member, hospital administrator, etc.).

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Lasco, G., Yu, V.G. & Palileo-Villanueva, L. How ethics committees and requirements are structuring health research in the Philippines: a qualitative study. BMC Med Ethics 22 , 85 (2021). https://doi.org/10.1186/s12910-021-00653-z

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Received : 28 April 2021

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CN-027 | Institutional Review Board of LongHua Hospital Shanghai University of Traditional Chinese Medicine [Shanghai] Recognized in: 2012 Recognition renewed in: 2015

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CN-029 | Institutional Review Board of Chinese PLA General Hospital [Beijing] Recognized in: 2012 Recognition renewed in: 2015

CN-030 | Medical Ethics Committee of The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine [Hefei] Recognized in: 2012 Recognition renewed in: 2015

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CN-034 | Institutional Review Board of The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine [Shenyang] Recognized in: 2013 Recognition renewed in: 2016

CN-035 | Ethics Committee for Clinical Trial and Medical Devices of Ruijin Hospital, Shanghai JiaoTong University School of Medicine [Shanghai] Recognized in: 2013 Recognition renewed in: 2016

CN-036 | Ethics Committee of The First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine [Guiyang] Recognized in: 2013 Recognition renewed in: 2016

CN-037 | Institutional Review Board of Wuxi People’s Hospital [Wuxi] Recognized in: 2013 Recognition renewed in: 2016

CN-038 | Independent Ethics Committee for Clinical Research of Zhongda Hospital, Affiliated to Southeast Universityn [Nanjing] Recognized in: 2013 Recognition renewed in: 2016

CN-039 | Ethics Committee of Xinhua Hospital Affiliated to Shanghai JiaoTong University School of Medicine [Shanghai] Recognized in: 2013 Recognition renewed in: 2016

CN-040 | Human Subject Research Ethics Committee of the Second Affiliated Hospital, School of Medicine, Zhejiang University [Hangzhou/Zhejiang Province] Recognized in: 2013 Recognition renewed in: 2016

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CN-067 | The Clinical Research Ethics Committee of the Affiliated Hospital of Xuzhou Medical College [Jiangsu] Recognized in: 2015 Recognition renewed in: 2018

CN-068 | Ethics Committee of Obstetrics and Gynecology Hospital of Fudan University [Shanghai] Recognized in: 2015 Recognition renewed in: 2018

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CN-070 | Institutional Review Board of Beijing Chao-Yang Hospital, Capital Medical University [Beijing] Recognized in: 2015 Recognition renewed in: 2018

CN-071 | Medical Ethics Committee of the First Hospital of China Medical University [Shenyang] Recognized in: 2015 Recognition renewed in: -

CN-072 | Institutional Review Board of the Second Affiliated Hospital of Nanchang University [Nanchang] Recognized in: 2016 Recognition renewed in: -

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CN-076 | Ethics Committee of the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine [Guangzhou] Recognized in: 2016 Recognition renewed in: -

CN-077 | Institutional Review Ethics Committee of Affiliated Hospital of Guangdong Medical University [Zhanjiang, Guangdong] Recognized in: 2017 Recognition renewed in: -

CN-078 | Ethics Committee of Huangshi Central Hospital Affiliated to Hubei Polytechnic University [Hubei] Recognized in: 2017 Recognition renewed in: -

CN-079 | The Medical Ethics Committee of Zhejiang Provincial People’s Hospital [Hangzhou] Recognized in: 2018 Recognition renewed in: -

CN-080 | Ethics Committee of Pingxiang People's Hospital in Jiangxi Province [Jiangxi] Recognized in: 2018 Recognition renewed in: -

CN-081 | Ethics Committee of the Affiliated Hospital of Guizhou Medical University [Guiyang] Recognized in: 2018 Recognition renewed in: -

CN-082 | Institutional Review Board of Shanghai Children's Medical Center [Shanghai] Recognized in: 2018 Recognition renewed in: -

ET-001 | Institutional Review Board, College of Health Sciences, Addis Ababa University [Addis Ababa] Recognized in: 2009 Recognition renewed in: 2015, 2021, 2023

ET-002 | Armauer Hansen Research Institute (AHRI)-All Africa Leprosy Rehabilitation and Training Center (ALERT) Institutional Review Board [Addis Ababa] Recognized in: 2009 Recognition renewed in: 2015, 2019, 2023

ET-003 | Ethiopian Public Health Institute (EPHI) Institutional Review Board [Addis Ababa] Recognized in: 2019 Recognition renewed in: 2023

IN-001 | Tata Memorial Centre, Institutional Ethics Committee I & II [Mumbai] Recognized in: 2009 Recognition renewed in: 2012, 2016

IN-002 | Seth Gordhandas Sunderdas Medical College and King Edward Memorial Hospital, Institutional Ethics Committee I & II [Mumbai] Recognized in: 2009 Recognition renewed in: 2012, 2016

IN-003 | Institutional Ethics Committee, Sanjay Gandhi Post Graduate Institute of Medical Sciences [Lucknow] Recognized in: 2011 Recognition renewed in: 2015, 2018

IN-004 | Institutional Human Ethics Committee, PSG Institute of Medical Sciences and Research [Coimbatore] Recognized in: 2012 Recognition renewed in: 2015, 2019

IN-005 | Institutional Ethics Committee, National Institute for Research in Tuberculosis (NIRT), Indian Council of Medical Research (ICMR) [Chennai] Recognized in: 2013 Recognition renewed in: 2016

IN-006 | Institutional Human Ethics Committee, National Institute of Epidemiology (NIE), Indian Council of Medical Research (ICMR) [Chennai] Recognized in: 2014 Recognition renewed in: 2017

IN-007 | Institutional Review Board, Y.R. Gaitonde Centre for AIDS Research and Education (YRG CARE) [Chennai] Recognized in: 2014 Recognition renewed in: 2017

IN-008 | National Institute for Research in Reproductive and Child Health (NIRRCH) Ethics Committee for Clinical Studies, Indian Council of Medical Research (ICMR) [Mumbai] Recognized in: 2014 Recognition renewed in: 2017, 2021

IN-009 | Institutional Ethics Committee, Fortis Escorts Heart Institute [New Delhi] Recognized in: 2015 Recognition renewed in: 2022

IN-010 | Yenepoya Ethics Committee-1, Yenepoya (Deemed to be University) [Mangalore] Recognized in: 2016 Recognition renewed in: 2019, 2022

IN-011 | Advanced Centre for Treatment, Research, Education in Cancer (ACTREC), Tata Memorial Centre, Institutional Ethics Committee-III [Mumbai] Recognized in: 2016 Recognition renewed in: 2019

IN-012 | Institutional Ethics Committee, JIPMER [Puducherry] Recognized in: 2016 Recognition renewed in: -

IN-013 | Tata Medical Center - Institutional Review Board [Kolkata] Recognized in: 2017 Recognition renewed in: -

IN-014 | Institutional Ethics Committee of KLE Academy of Higher Education and Research (IEC, KAHER) [Nehru Nagar, Belagavi] Recognized in: 2017 Recognition renewed in: 2022

IN-015 | Sri Manakula Vinayagar Medical College and Hospital (SMVMCH)-Ethics Committee [Puducherry] Recognized in: 2018 Recognition renewed in: -

IN-016 | Rajiv Gandhi Centre for Biotechnology Institutional Human Ethics Committee [Thiruvananthapuram] Recognized in: 2019 Recognition renewed in: -

IN-017 | Institutional Human Ethics Committee, Mahatma Gandhi Medical College & Research Institute [Puducherry] Recognized in: 2019 Recognition renewed in: -

ID-001 | Health Research Ethics Committee, National Institute of Health Research and Development, Ministry of Health, Republic of Indonesia (HREC-NIHRD) [Jakarta] Recognized in: 2009 Recognition renewed in: 2012, 2018

ID-002 | Komisi Etik Penelitian Kesehatan Fakultas Kedokteran Universitas Hasanuddin, Rumah Sakit Universitas Hasanuddin Dan RSUP Dr. Wahidin Sudirohusodo (Joint Ethics Committee of Faculty of Medicine Hasanuddin University, Hasanuddin University Hospital, and Dr. Wahidin Sudirohusodo Hospital) [Makassar] Recognized in: 2011 Recognition renewed in: 2014, 2018, 2022

ID-003 | Health Research Ethics Committee, Faculty of Medicine Universitas Indonesia - dr. Cipto Mangunkusumo Hospital (Komite Etik Penelitian Kesehatan, Fakultas Kedokteran Universitas Indonesia - dr. RSUPN Cipto Mangunkusumo) [Jakarta] Recognized in: 2012 Recognition renewed in: 2016, 2019, 2023

ID-004 | Medical and Health Research Ethics Committee Faculty of Medicine, Public Health and Nursing Universitas Gadjah Mada/Dr. Sardjito General Hospital [Yogyakarta] Recognized in: 2012 Recognition renewed in: 2015, 2019, 2023

ID-005 | Komisi Etik Penelitian Fakultas Kedokteran Universitas Udayana (Research Ethics Committee, Faculty of Medicine, Udayana University) - Sanglah Hospital [Denpasar, Bali] Recognized in: 2013 Recognition renewed in: 2016, 2021

ID-006 | Health Research Ethics Committee Faculty of Medicine Universitas Brawijaya [Malang, East Java] Recognized in: 2013 Recognition renewed in: 2017, 2021

ID-007 | Mochtar Riady Institute for Nanotechnology (MRIN)-Ethics Committee [Tangerang] Recognized in: 2014 Recognition renewed in: 2017, 2021

ID-008 | Komisi Etik Penelitian Universitas Padjadjaran (Research Ethics Committee University of Padjadjaran) [Bandung] Recognized in: 2014 Recognition renewed in: 2017, 2021

ID-009 | Health Research Ethics Committee Medical School Universitas Sumatera Utara/Adam Malik Hospital [Medan, North Sumatra] Recognized in: 2015 Recognition renewed in: -

ID-010 | Dental Research Ethics Committee, Faculty of Dentistry Universitas Indonesia [Komisi Etik Penelitian Kedokteran Gigi (KEPKG), Fakultas Kedokteran Gigi Universitas Indonesia] [Jakarta] Recognized in: 2016 Recognition renewed in: 2019, 2023

ID-011 | Health Research Ethics Committee, Universitas Pembangunan Nasional “Veteran” Jakarta [Jakarta] Recognized in: 2016 Recognition renewed in: 2019, 2023

ID-012 | Dr. Soetomo General Academic Hospital Health Research Ethics Committee [Surabaya] Recognized in: 2021 Recognition renewed in: -

ID-013 | Komisi Etik Penelitian Kesehatan Politeknik Kesehatan Kemenkes Jakarta II/KEPK PKJ II (Health Research Ethics Committee of Health Polytechnics, Ministry of Health Jakarta II) [Jakarta] Recognized in: 2021 Recognition renewed in: -

ID-014 | Human Research Ethics Committee, Faculty of Medicine, Universitas Jenderal Soedirman [Purwokerto] Recognized in: 2022 Recognition renewed in: -

ID-015 | Human Research Ethics Committee, Faculty of Medicine, Universitas Muhammadiyah [Makassar] Recognized in: 2022 Recognition renewed in: -

ID-016 | The Ethics Committee of Health Research of Persahabatan Central General Hospital (Komite Etik Penelitian Kesehatan Rumah Sakit Umum Pusat Persahabatan) [Jakarta] Recognized in: 2023 Recognition renewed in: -

ID-017 | Health Research Ethics Committee Faculty of Medicine and Health Universitas Muhammadiyah Jakarta [Jakarta] Recognized in: 2023 Recognition renewed in: -

JP-001 | Nagasaki University Hospital Clinical Research Ethics Committee [Nagasaki] Recognized in: 2015 Recognition renewed in: 2018, 2023

KZ-001 | Central Ethics Commission of the Ministry of Health, the Republic of Kazakhstan [Astana City] Recognized in: 2017 Recognition renewed in: -

MY-001 | Medical Research & Ethics Committee (MREC), Ministry of Health (MOH) - Malaysia [Kuala Lumpur] Recognized in: 2013 Recognition renewed in: 2016, 2022

MY-002 | Human Research Ethics Committee (Jawatankuasa Etika Penyelidikan Manusia - JEPeM), Universiti Sains Malaysia [Kelantan] Recognized in: 2014 Recognition renewed in: 2017, 2022

MY-003 | University of Malaya Medical Centre (UMMC) Medical Research Ethics Committee (MREC) [Kuala Lumpur] Recognized in: 2016 Recognition renewed in: 2019, 2022

MY-004 | Ethics Committee for Research Involving Human Subjects (Jawatankuasa Etika Universiti untuk Penyelidikan Melibatkan Manusia - JKEUPM), Universiti Putra Malaysia [Selangor] Recognized in: 2017 Recognition renewed in: 2022

MM-001 | Ethics Review Committee, Department of Medical Research, Ministry of Health and Sports, Republic of the Union of Myanmar [Yangon] Recognized in: 2018 Recognition renewed in: -

NP-001 | Ethical Review Board, Nepal Health Research Council [Kathmandu] Recognized in: 2019 Recognition renewed in: 2022

PH-001 | University of the Philippines Manila Research Ethics Board (UPMREB) [Manila] Recognized in: 2007 Recognition renewed in: 2010, 2013, 2017, 2022

PH-002 | Research Institute for Tropical Medicine - Institutional Review Board [Muntinlupa, Metro Manila] Recognized in: 2007 Recognition renewed in: 2010, 2014, 2017, 2022

PH-003 | Philippine Heart Center - Institutional Ethics Review Board [Quezon City, Metro Manila] Recognized in: 2012 Recognition renewed in: 2015, 2019

PH-004 | The Medical City Institutional Review Board [Pasig City, Metro Manila] Recognized in: 2012 Recognition renewed in: 2015, 2019

PH-005 | St. Luke’s-Institutional Ethics Review Committee (SL-IERC) [Quezon City, Metro Manila] Recognized in: 2012 Recognition renewed in: 2015, 2019

PH-006 | Manila Doctors Hospital Institutional Review Board [Manila] Recognized in: 2013 Recognition renewed in: 2016

PH-007 | Makati Medical Center (MMC) Institutional Review Board [Makati, Metro Manila] Recognized in: 2013 Recognition renewed in: 2016

PH-008 | Department of Health XI Cluster Ethics Review Committee (DOH XI CERC) [Davao] Recognized in: 2013 Recognition renewed in: 2016

PH-009 | Veterans Memorial Medical Center Institutional Review Board [Quezon City, Metro Manila] Recognized in: 2013 Recognition renewed in: 2016, 2022

PH-010 | Mariano Marcos Memorial Hospital and Medical Center Research Ethics Review Committee [City of Batac, Ilocos Norte] Recognized in: 2014 Recognition renewed in: 2017

PH-011 | Davao Doctors Hospital Institutional Ethics Review Committee (DDH IERC) [Davao City] Recognized in: 2014 Recognition renewed in: 2017, 2023

PH-012 | University of Perpetual Help System-Institutional Ethics Review Board [Las Piñas City, Metro Manila] Recognized in: 2014 Recognition renewed in: 2017, 2022, 2023

PH-013 | University of the East-Ramon Magsaysay Memorial Medical Center, Inc. Research Institute for the Health Sciences Ethics Review Committee (UERMMMCI RIHS ERC) [Quezon City, Metro Manila] Recognized in: 2014 Recognition renewed in: 2017, 2022

PH-014 | Chong Hua Hospital Institutional Review Board [Cebu] Recognized in: 2014 Recognition renewed in: 2017

PH-015 | National Kidney and Transplant Institute Research Ethics Committee [Quezon City, Metro Manila] Recognized in: 2014 Recognition renewed in: 2017

PH-016 | Baguio General Hospital and Medical Center Ethics Review Committee [Baguio City] Recognized in: 2014 Recognition renewed in: 2017, 2022

PH-017 | Lung Center of the Philippines Institutional Ethics Review Board (LCPIERB) [Quezon City, Metro Manila] Recognized in: 2014 Recognition renewed in: 2017, 2022

PH-018 | Medical Center Manila - ManilaMed Ethics Review Committee (MMERC) [Manila] Recognized in: 2014 Recognition renewed in: 2017

PH-019 | Far Eastern University-Nicanor Reyes Medical Foundation Institutional Ethics Review Committee (FEU-NRMF IERC) [Quezon City, Metro Manila] Recognized in: 2014 Recognition renewed in: 2017, 2022

PH-020 | Cardinal Santos Medical Center Research Ethics Review Committee [San Juan City, Metro Manila] Recognized in: 2015 Recognition renewed in: 2018, 2022

PH-021 | National Children’s Hospital-Institutional Review Board [Quezon City, Metro Manila] Recognized in: 2015 Recognition renewed in: 2018

PH-022 | San Juan de Dios Educational Foundation, Inc. Institutional Review Board (SJDEFIIRB) [Pasay City, Metro Manila] Recognized in: 2015 Recognition renewed in: 2019

PH-023 | Mary Mediatrix Medical Center - Research Ethics Review Committee [Lipa City, Batangas] Recognized in: 2015 Recognition renewed in: 2018

PH-024 | Perpetual Succour Hospital - Institutional Ethics and Review Board [Cebu] Recognized in: 2015 Recognition renewed in: 2018

PH-025 | West Visayas State University-Unified Biomedical Research Ethics Review Committee (UBRERC) [Iloilo City] Recognized in: 2015 Recognition renewed in: 2018, 2023

PH-026 | University of Santo Tomas Hospital - Research Ethics Committee (USTH-REC) [Manila] Recognized in: 2015 Recognition renewed in: 2019, 2023

PH-027 | Philippine Children’s Medical Center Institutional Research-Ethics Committee (PCMC IR-EC) [Quezon City, Metro Manila] Recognized in: 2015 Recognition renewed in: 2020, 2023

PH-028 | Chinese General Hospital and Medical Center Research Ethics Review Board [Manila] Recognized in: 2015 Recognition renewed in: 2018

PH-029 | Corazon Locsin Montelibano Memorial Regional Hospital Research Ethics Review Committee [Bacolod City] Recognized in: 2016 Recognition renewed in: 2018

PH-030 | Bicol Regional Training and Teaching Hospital - Institutional Review Board [Legazpi City, Albay] Recognized in: 2018 Recognition renewed in: 2023

PH-031 | Single Joint Research Ethics Board (SJREB) [Manila] Recognized in: 2019 Recognition renewed in: 2023

PH-032 | Quirino Memorial Medical Center (QMMC) - Research Ethics Board (REB) [Quezon City, Metro Manila] Recognized in: 2019 Recognition renewed in: -

PH-033 | Cebu Institute of Medicine - Cebu Velez General Hospital Institutional Review Board (CIM-CVGH IRB) [Cebu] Recognized in: 2020 Recognition renewed in: -

PH-034 | Asian Hospital and Medical Center Research Ethics Committtee (AHMC-REC) [Muntinlupa City, Metro Manila] Recognized in: 2020 Recognition renewed in: -

PH-035 | Batangas Medical Center Research Ethics Review Committee [Batangas City] Recognized in: 2021 Recognition renewed in: -

PH-036 | Western Visayas Medical Center Research Ethics Review Committee (WVMC-RERC) [Iloilo City] Recognized in: 2021 Recognition renewed in: -

PH-037 | Jose R. Reyes Memorial Medical Center (JRRMMC) Institutional Review Board [Manila] Recognized in: 2021 Recognition renewed in: -

PH-038 | St. Cabrini Medical Center - Asian Eye Institute Ethics Review Committee [Makati City] Recognized in: 2021 Recognition renewed in: -

PH-039 | Vicente Sotto Memorial Medical Center (VSMMC) - Research Ethics Committee (REC) [Cebu City] Recognized in: 2022 Recognition renewed in: -

PH-040 | Gov. Celestino Gallares Memorial Medical Center (GCGMMC) Institutional Review Board [Tagbilaran City, Bohol] Recognized in: 2023 Recognition renewed in: -

KR-001 | Seoul National University College of Medicine/Seoul National University Hospital Institutional Review Board (SNUCM/SNUH IRB) [Seoul] Recognized in: 2006 Recognition renewed in: 2009, 2012, 2016

KR-002 | Asan Medical Centre Institutional Review Board [Seoul] Recognized in: 2006 Recognition renewed in: 2009, 2012, 2016

KR-003 | Kangnam St. Mary’s Hospital (KSMH) Institutional Review Board [Seoul] Recognized in: 2007 Recognition renewed in: -

KR-004 | Chonnam National University Hospital Institutional Review Board [Gwangju] Recognized in: 2007 Recognition renewed in: 2010, 2014, 2018

KR-005 | Inje University Busan Paik Hospital Institutional Review Board [Busan] Recognized in: 2007 Recognition renewed in: 2010, 2014, 2018

KR-006 | Hallym University Sacred Heart Hospital Institutional Review Board [Gyeonggi-do] Recognized in: 2008 Recognition renewed in: 2011, 2016

KR-007 | Daegu Catholic University Medical Center (DCUMC) Institutional Review Board [Daegu] Recognized in: 2008 Recognition renewed in: 2011, 2015, 2019

KR-008 | Kyung Hee University Hospital (KHUH) Institutional Review Board [Seoul] Recognized in: 2008 Recognition renewed in: -

KR-009 | Ajou University Hospital Institutional Review Board [Gyeonggi-do] Recognized in: 2008 Recognition renewed in: 2011, 2015

KR-010 | Inha University Hospital Institutional Review Board [Incheon] Recognized in: 2009 Recognition renewed in: 2012

KR-011 | Kangbuk Samsung Hospital Institutional Review Board [Seoul] Recognized in: 2009 Recognition renewed in: 2012, 2016

KR-012 | Chungnam National University Hospital Institutional Review Board (CNUH-IRB) [Daejeon] Recognized in: 2009 Recognition renewed in: 2012, 2016, 2023

KR-013 | International Vaccine Institute (IVI) Institutional Review Board [Seoul] Recognized in: 2009 Recognition renewed in: 2012, 2016

KR-014 | Keimyung University Dongsan Hospital Institutional Review Board [Daegu] Recognized in: 2010 Recognition renewed in: 2013

KR-015 | Kyungpook National University Hospital Institutional Review Board [Daegu] Recognized in: 2010 Recognition renewed in: 2013

KR-016 | Yeungnam University Medical Center Institutional Review Board [Daegu] Recognized in: 2010 Recognition renewed in: 2013

KR-017 | Kangdong Sacred Heart Hospital Institutional Review Board [Seoul] Recognized in: 2010 Recognition renewed in: 2013, 2017

KR-018 | National Cancer Center Hospital Institutional Review Board [Seoul] Recognized in: 2010 Recognition renewed in: 2013

KR-019 | CHA Bundang Medical Center Institutional Review Board, CHA University [Gyeonggi-do] Recognized in: 2010 Recognition renewed in: 2013

KR-020 | Busan Dong-A University Hospital Institutional Review Board [Busan] Recognized in: 2010 Recognition renewed in: 2013

KR-021 | Institutional Review Board of Anam Hospital, Korea University Medical Center [Seoul] Recognized in: 2010 Recognition renewed in: 2013, 2017

KR-022 | Soon Chun Hyang University Bucheon Hospital Institutional Review Board [Gyeonggi-do] Recognized in: 2011 Recognition renewed in: -

KR-023 | Korea University Guro Hospital Institutional Review Board [Seoul] Recognized in: 2011 Recognition renewed in: 2014, 2018

KR-024 | Gachon University Gil Medical Center Institutional Review Board [Incheon] Recognized in: 2011 Recognition renewed in: 2014

KR-025 | Daegu Haany University Medical Center Institutional Review Board [Daegu] Recognized in: 2012 Recognition renewed in: 2015

KR-026 | Dankook University Hospital Institutional Review Board [Cheonan] Recognized in: 2012 Recognition renewed in: 2015, 2019

KR-027 | Ewha Womans University Institutional Review Board [Seoul] Recognized in: 2013 Recognition renewed in: 2016

KR-028 | Chonbuk National University Hospital Institutional Review Board [Jeonju] Recognized in: 2013 Recognition renewed in: 2016

KR-029 | Kyung Hee University Korean Medicine Hospital Institutional Review Board [Seoul] Recognized in: 2014 Recognition renewed in: -

KR-030 | Pusan National University Yangsan Hospital Institutional Review Board [Gyeongnam] Recognized in: 2016 Recognition renewed in: -

KR-031 | Dunsan Korean Medicine Hospital of Daejeon University Institutional Review Board [Daejeon] Recognized in: 2017 Recognition renewed in: -

LK-001 | Ethics Review Committee, Faculty of Medicine, University of Colombo [Colombo] Recognized in: 2009 Recognition renewed in: 2012, 2016

LK-002 | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura [Nugegoda] Recognized in: 2012 Recognition renewed in: 2015, 2019

LK-003 | Ethics Review Committee, Faculty of Medicine, University of Peradeniya [Peradeniya] Recognized in: 2014 Recognition renewed in: 2018

LK-004 | Ethics Review Committee, Faculty of Medicine, University of Kelaniya [Ragama] Recognized in: 2015 Recognition renewed in: 2018

LK-005 | Ethics Review Committee, Sri Lanka Medical Association [Colombo] Recognized in: 2016 Recognition renewed in: 2019

LK-006 | Ethics Review Committee (ERC), Faculty of Medicine and Allied Sciences (FMAS), Rajarata University of Sri Lanka (RUSL) [Saliyapura] Recognized in: 2017 Recognition renewed in: -

LK-007 | Ethics Review Committee, Faculty of Medicine, University of Jaffna [Jaffna] Recognized in: 2017 Recognition renewed in: -

LK-008 | EEthics Review Committee, Faculty of Medicine, University of Ruhuna [Galle] Recognized in: 2018 Recognition renewed in: -

LK-009 | Ethics Review Committee, Postgraduate Institute of Medicine (PGIM) [Colombo] Recognized in: 2018 Recognition renewed in: -

TW-001 | Medical Research Ethics Foundation Joint Institutional Review Board [Taipei] Recognized in: 2005 Recognition renewed in: 2008, 2011, 2015

TW-002 | Changhua Christian Hospital Institutional Review Board [Changhua] Recognized in: 2005 Recognition renewed in: 2010, 2013, 2016

TW-003 | National Taiwan University Hospital Research Ethics Committee (NTUH REC) [Taipei] Recognized in: 2006 Recognition renewed in: 2009

TW-004 | Chang Gung Memorial Hospital (CGMH) Institutional Review Board [Taoyuan] Recognized in: 2006 Recognition renewed in: 2009

TW-005 | Institutional Review Board of Taipei Veterans General Hospital [Taipei] Recognized in: 2006 Recognition renewed in: 2010, 2013, 2017, 2021

TW-006 | Institutional Review Board, Tri-Service General Hospital, National Defense Medical Center [Taipei] Recognized in: 2006 Recognition renewed in: 2009, 2013, 2017, 2021

TW-007 | Chi-Mei Medical Center Institutional Review Board of Human Study Committee [Tainan] Recognized in: 2007 Recognition renewed in: 2010

TW-008 | National Cheng Kung University Hospital (NCKUH) Human Experiment and Ethics Committee [Tainan] Recognized in: 2007 Recognition renewed in: 2010

TW-009 | Kaohsiung Medical University, Chung-Ho Memorial Hospital Institutional Review Board [Kaohsiung] Recognized in: 2007 Recognition renewed in: 2010

TW-010 | Taichung Veterans General Hospital (TCVGH) Institutional Review Board [Taichung] Recognized in: 2007 Recognition renewed in: 2010, 2014, 2018

TW-011 | Chung Shan Medical University Hospital Institutional Review Board [Taichung] Recognized in: 2007 Recognition renewed in: 2010, 2014

TW-012 | Cathay General Hospital Institutional Review Board [Taipei] Recognized in: 2008 Recognition renewed in: 2011, 2015, 2019, 2023

TW-013 | Research Ethics Committee of Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation [Hualien] Recognized in: 2008 Recognition renewed in: 2011, 2015, 2019

TW-014 | Kaohsiung Veterans General Hospital Institutional Review Board [Kaohsiung] Recognized in: 2008 Recognition renewed in: 2011, 2021

TW-015 | MacKay Memorial Hospital Institutional Review Board [Taipei] Recognized in: 2008 Recognition renewed in: 2011, 2015, 2019, 2023

TW-016 | China Medical University Hospital Institutional Review Board [Taichung] Recognized in: 2009 Recognition renewed in: 2012

TW-017 | Institutional Review Board on Biomedical Science Research (IRB-BM), Academia Sinica [Taipei] Recognized in: 2009 Recognition renewed in: 2012, 2016

TW-018 | Shin Kong Wu Ho-Su Memorial Hospital (SKH) Institutional Review Board [Taipei] Recognized in: 2009 Recognition renewed in: 2012, 2016

TW-019 | Institutional Review Board, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation [Taipei] Recognized in: 2009 Recognition renewed in: 2017, 2022

TW-020 | Taipei Medical University-Joint Institutional Review Board (TMU-JIRB) [Taipei] Recognized in: 2010 Recognition renewed in: -

TW-021 | Research Ethics Review Committee of Far Eastern Memorial Hospital [Taipei] Recognized in: 2010 Recognition renewed in: 2013, 2017, 2021

TW-022 | Taipei City Hospital Research Ethics Committee [Taipei] Recognized in: 2011 Recognition renewed in: 2014, 2018, 2022

TW-023 | Kaohsiung Kai-Suan Psychiatric Hospital Institutional Review Board [Kaohsiung] Recognized in: 2011 Recognition renewed in: -

TW-024 | Fu Jen Catholic University Institutional Review Board [Taipei] Recognized in: 2015 Recognition renewed in: -

TH-001 | Royal Thai Army Medical Department Institutional Review Board [Bangkok] Recognized in: 2005 Recognition renewed in: 2009, 2012, 2016, 2021

TH-002 | Institutional Review Board, Faculty of Medicine, Chulalongkorn University [Bangkok] Recognized in: 2006 Recognition renewed in: 2009, 2012, 2016, 2021

TH-003 | The Ethics Committee for Research in Human Subjects in the Fields of Thai Traditional and Alternative Medicine (TAMEC), Department for Development of Thai Traditional and Alternative Medicine (DTAM), Ministry of Public Health (MOPH) [Nonthaburi] Recognized in: 2007 Recognition renewed in: 2010, 2013, 2017, 2023

TH-004 | Central Research Ethics Committees (CREC) [Bangkok] Recognized in: 2008 Recognition renewed in: 2012, 2015, 2019

TH-005 | Ethics Committee of the Faculty of Tropical Medicine, Mahidol University [Bangkok] Recognized in: 2008 Recognition renewed in: 2011, 2015, 2019

TH-006 | Research Ethics Committee, Faculty of Medicine, Chiang Mai University [Chiang Mai] Recognized in: 2008 Recognition renewed in: 2011, 2015, 2019, 2021

TH-007 | Research Institute for Health Sciences (RIHES) Human Experimentation Committee, Chiang Mai University [Chiang Mai] Recognized in: 2008 Recognition renewed in: 2011, 2015, 2019, 2023

TH-008 | The Research Ethics Review Committee for Research Involving Human Research Participants, Health Sciences Group I, Chulalongkorn University [Bangkok] Recognized in: 2008 Recognition renewed in: 2011, 2015, 2019

TH-009 | The Khon Kaen University Ethics Committee in Human Research [Khon Kaen] Recognized in: 2008 Recognition renewed in: 2011, 2015, 2019, 2023

TH-010 | Siriraj Institutional Review Board (SIRB), Faculty of Medicine Siriraj Hospital, Mahidol University [Bangkok] Recognized in: 2009 Recognition renewed in: 2012, 2016, 2021

TH-011 | Human Research Ethics Committee of Thammasat University No. 1 (Faculty of Medicine) [Rangsit, Pathumthani] Recognized in: 2010 Recognition renewed in: 2013, 2017, 2022

TH-012 | Vajira Institutional Review Board (VIRB) Faculty of Medicine Vajira Hospital [Bangkok] Recognized in: 2012 Recognition renewed in: 2015, 2021

TH-013 | Mahidol University Central Institutional Review Board (MU-CIRB) [Salaya, Nakhon Pathom] Recognized in: 2013 Recognition renewed in: -

TH-014 | Research Ethics Committee, Faculty of Nursing, Chiang Mai University [Chiang Mai] Recognized in: 2013 Recognition renewed in: 2016, 2021

TH-015 | Naresuan University Institutional Review Board (NU-IRB) [Phitsanulok] Recognized in: 2013 Recognition renewed in: 2016, 2023

TH-016 | Institutional Review Board of the Bamrasnaradura Infectious Diseases Institute (IRB BIDI) [Nonthaburi] Recognized in: 2014 Recognition renewed in: 2017

TH-017 | Human Research Ethics Committee, Faculty of Medicine, Prince of Songkla University [Songkhla] Recognized in: 2014 Recognition renewed in: 2017, 2022

TH-018 | The Research Ethics Review Committee of Queen Sirikit National Institute of Child Health [Bangkok] Recognized in: 2015 Recognition renewed in: 2018, 2023

TH-019 | Institutional Review Board of Neurological Institute of Thailand (NITIRB) [Bangkok] Recognized in: 2015 Recognition renewed in: 2018, 2022

TH-020 | Khon Kaen Hospital Institute Review Board in Human Research [Khon Kaen] Recognized in: 2015 Recognition renewed in: 2018, 2022

TH-021 | Ethical Review Board Boromarajonani College of Nursing, Nopparat Vajira [Bangkok] Recognized in: 2015 Recognition renewed in: 2018, 2023

TH-022 | Bumrungrad International-Institutional Review Board (BI-IRB) [Bangkok] Recognized in: 2016 Recognition renewed in: 2019

TH-023 | Bangkok Hospital Headquarters - Institutional Review Board [Bangkok] Recognized in: 2017 Recognition renewed in: 2022

TH-024 | The Ethics in Human Research Review Committee of Panyananthaphikkhu Chonprathan Medical Center Srinakharinwirot University [Nonthaburi] Recognized in: 2017 Recognition renewed in: 2022

TH-025 | The Human Research Ethics Committee of Srinakharinwirot University [Bangkok] Recognized in: 2017 Recognition renewed in: 2022

TH-026 | Human Research Ethics Committee of Suranaree University of Technology (HREC-SUT) [Nakorn Ratchasima] Recognized in: 2019 Recognition renewed in: 2023

TH-027 | Burapha University Institutional Review Board (BUU-IRB) [Chonburi] Recognized in: 2019 Recognition renewed in: 2023

TH-028 | Human Research Ethics Committee, Faculty of Medicine Ramathibodi Hospital, Mahidol University [Bangkok] Recognized in: 2019 Recognition renewed in: 2023

TH-029 | The Ethical Committee for Research in Human Subject Chiangrai Prachanukroh Hospital [Chiangrai] Recognized in: 2019 Recognition renewed in: 2022

TH-030 | Ethics Committee of Sunpasitthiprasong Hospital [Ubon Ratchathani] Recognized in: 2019 Recognition renewed in: -

TH-031 | Bangkok Metropolitan Administration Human Research Ethics Committee (BMAHREC) [Bangkok] Recognized in: 2020 Recognition renewed in: -

TH-032 | Human Research Ethics Committee Saraburi Hospital [Saraburi] Recognized in: 2020 Recognition renewed in: -

TH-033 | Chanthaburi Research Ethics Committee [Chanthaburi] Recognized in: 2021 Recognition renewed in: -

TH-034 | Institutional Review Board of Chonburi Hospital (IRB CBH) [Chonburi] Recognized in: 2021 Recognition renewed in: -

TH-035 | The Ethical Committee for Research on Human Subjects Hatyai Hospital [Hatyai, Songkhla] Recognized in: 2021 Recognition renewed in: -

TH-036 | Research Ethics Committee Rajavithi Hospital [Bangkok] Recognized in: 2022 Recognition renewed in: -

TH-037 | Ethics Committee of Naval Medical Department, Royal Thai Navy [Bangkok] Recognized in: 2022 Recognition renewed in: -

TH-038 | The Sakon Nakhon Hospital Research Ethics Committee (SKNH REC) [Sakon Nakhon] Recognized in: 2022 Recognition renewed in: -

TH-039 | The Mae Fah Luang University Ethics Committee on Human Research [Chaingrai] Recognized in: 2022 Recognition renewed in: -

TH-040 | Nakhon Pathom Hospital Research Ethics Committee (NPH REC) [Nakhon Pathom] Recognized in: 2022 Recognition renewed in: -

TH-041 | Vachira Phuket Hospital Research Ethics Committee (VPH-REC) [Phuket] Recognized in: 2022 Recognition renewed in: -

TH-042 | The Roi Et Hospital Ethics Committee in Human Research [Roi Et] Recognized in: 2022 Recognition renewed in: -

TH-043 | Prince of Songkla University: Human Research Ethics Committee (PSU-HREC) [Songkla] Recognized in: 2022 Recognition renewed in: -

TH-044 | Human Research Ethics Committee of Buddhachinaraj Phitsanulok Hospital [Phitsanulok] Recognized in: 2022 Recognition renewed in: -

TH-045 | Sirindhorn College of Public Health Khon Kaen Institutional Review Board [Khon Kaen] Recognized in: 2022 Recognition renewed in: -

TH-046 | Human Research Ethics Committee, Ratchaburi Hospital [Ratchaburi] Recognized in: 2023 Recognition renewed in: -

TH-047 | Phetchabun Hospital Independent Ethics Committee [Phetchabun] Recognized in: 2023 Recognition renewed in: -

TH-048 | The Human Research Ethics Committee of Thammasat University (Science) [Rangsit, Pathumthani] Recognized in: 2023 Recognition renewed in: -

TH-049 | Human Research Ethics Review Committee of Boromarajonani College of Nursing, Bangkok [Bangkok] Recognized in: 2023 Recognition renewed in: -

SIDCER-FERCAP RECOGNITION PROGRAM 2005-2018

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ANX005 in Subjects with Guillain Barré Syndrome (GBS)

PHRR220318-004438

Unspecified

2021-CT0633

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ANX005 in Subjects with Guillain Barré Syndrome (GBS)

This study is intended to evaluate the efficacy and safety of  ANX005  administered by intravenous (IV) infusion to participants recently diagnosed with Guillain-Barré Syndrome (GBS). The total duration of study participation is approximately 6 months.

Guillain-Barré Syndrome (GBS)

• To compare the efficacy of each dose level of ANX005 vs. placebo by measuring GBS Disability Score at week 8 (2 months) in subjects recently diagnosed with GBS (GBS-DS at Week 8)
• Number (proportion) of subjects with treatment-emergent adverse events (AEs) Laboratory changes and abnormalities, Vital signs, Columbia Suicide Severity Rating Scale (C-SSRS)

• MRC sum score at Week 8 • MRC sum score at Day 8 • Duration (days) of ventilation support over 26 week

• GBS-DS at Week 26 • Incidence and duration (in number of days) of intensive care unit (ICU) stay over 26 weeks • Patient Global Impression of Change (PGIC) scores at Week 8 and Week 26 • Longitudinal profile of GBS-DS through 26 weeks

• Serum NfL levels

• Time to return to walking independently (GBS-DS ≤2) • Time to be able to run (GBS-DS of 0-1) • Time to resolution of GBS (GBS-DS of 0) • Proportion of subjects with GBS-DS improvement of 1 level at Week 4 and Week 8 • Values and changes from baseline in ONLS, rFSS, and R-ODS by visit • Values of EQ-5D-5L • Values and change from baseline by visit in GBS clinical progression scale, pain numerical rating scale (NRS), standing heel rise, timed up and go, and hand-held dynamometry

• Serum concentrations of ANX005

• CH50 and C1q serum concentrations over 6 months

• Serum anti-drug (ANX005) antibodies (ADA) • ANX005-related immune reactions

• Philippines

Clinical Trial

20210902082141

Inclusion Criteria:

• Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for Guillain-Barré Syndrome.
• Onset of GBS-related weakness ≤10 days prior to start of infusion.
• GBS-DS score of 3,4, or 5 at screening and at Day 1 prior to infusion.

Exclusion Criteria:

• Body weight >150 kg.
• Unresponsive nerve conduction study results in all nerves tested during screening.
• Previous or intended, future treatment with either plasma exchange or intravenous immunoglobulin for GBS.
• Diagnosis of a variant of GBS, including Miller Fisher syndrome, Bickerstaff's encephalitis, and overlap syndromes.
• Prior treatment with any monoclonal antibody.
• History of hypercoagulable diseases, hyper viscosity, thrombosis, or acute renal failure.
• Documented, clinically significant, pre-existing polyneuropathy from another cause.
• Females who are pregnant, breastfeeding, or unable or unwilling to use 2 methods of contraception throughout the study.

Interventional

• Drug:  ANX005 Solution for intravenous infusion

Double Blind

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Mary Mediatrix | Providing Better And Quality Healthcare For All

Cancer institute philippines, mediatrix heart institute, renal and transplant institute philippines, cardio vascular unit philippines, gastrointestinal center philippines, neonatal intensive care unit philippines, breast center philippines.

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Research Ethics

Establishment & mandate of the mary mediatrix medical center-research ethics review committee (mmmc-rerc).

The MMMC-RERC is an independent body created by the MMMC under the President of the Hospital, whose responsibility is to ensure the protection of the rights, safety, and well-being of human subjects involved in health-related research and to provide public assurance of that protection. In accordance with applicable national/international regulations, the MMMC-RERC has the authority to approve, require modifications to, or disapprove research protocols and related documents as well as to ensure compliance with its relevant procedures after approval.

The MMMC-RERC reviews and monitors health research that involves:

• Nephrology/Dialysis Center
• Oncology/Chemotherapy & Blood Transfusion Unit
• Rheumatology
• Endocrinology/ Diabetes Clinic

HISTORY OF THE MMMC - RERC

Mary Mediatrix Medical Center- Research Ethics Review Committee formerly the Institutional Review Board/ Research Ethics Committee was established in 2007. Dr. Robert Magsino, the President and CEO (former Medical Director) of Mary Mediatrix Medical Center (MMMC), appointed Dr. Narcisa Sonia Comia to be the Chair of the Research Ethics Committee. Having no experience at all in Research Ethics, she was assisted by Dr. Tito Atienza, a seasoned investigator at Veterans Memorial Medical Center.

Mr. Jherrist Gorayeb, was head of the marketing department of MMMC at that time, but a nurse by profession was the first recruited member. Since there should be at least five (5) members, Dr. Narcisa Sonia Comia invited a male pediatrician, a female cardiologist, a retired engineer, and a former member of the Good Samaritan to complete the team. The ethics committee was then called MMMC Institutional Review Board (IRB). There was no office, no secretariat, and definitely no Standard Operating Procedure to guide them. To aid the need for secretariat staff as well as the office, Ms. Sheryl Paradero, the secretariat staff of the Department of Medicine, was requested to also serve as the secretariat of the IRB. During that time, IRB shared an office and equipment with the Department of Medicine.

During its first year of existence, one protocol was received and approved. In the next few years, more pharmaceutical-sponsored research protocols were submitted and approved by MMMC-IRB. The members increased to seven (7).

One time, as informed by Dr. Tito Atienza, Japanese auditors came to do a site visit at Mary Mediatrix to check how MMMC-IRB functions, where and how files are being kept, and how many members MMMC-IRB has. In preparation for their visit, an office was thus given to IRB equipped with a desktop computer and cabinets with locks and keys.

Later on, more and more protocols were submitted. By 2011, MMMC-IRB already had a Chairman, a Co-chair, a member secretary, four members, and a full-time secretariat. For the creation of the SOP, an SOP workshop was attended by the Chair, Co-Chair, and Member Secretary. By the last quarter of 2012, the first version of SOP was approved by the former Medical Director, Dr. Robert Magsino. Another SOP workshop was attended in March 2014 and towards the end of August 2014, SOP version 2 was submitted to the Medical Director for approval.

Since the formation of the MMMC-IRB, it has approved more than sixty (60) industry-sponsored clinical trials and to date we still have 33 ongoing trials.

The name MMMC-IRB has been replaced by MMMC Research Ethics Review Committee (RERC). Currently, RERC is composed of nine (9) members.

CONTACT DETAILS

Research ethics review committee.

Address: Mary Mediatrix Medical Center Medical Arts Building 3, 6th floor, JP. Laurel Highway, Lipa City Batangas

Contact Numbers:

Ms. Shiela P. Belarma Administrative Staff (043) 773-6800 local 1194

E-mail:  [email protected]

Office Hours:

Monday – Friday 7:00 AM to 4:00 PM

Note: Submissions are done via email.

that uses one or more anti-cancer drugs as part of a standardized chemotherapy regimen. Chemotherapy may be given with a curative intent or it may aim to prolong life or to reduce symptoms

• Acknowledgement

The  Mary Mediatrix Medical Center – Research Ethics Review Committee (MMMC-RERC)  would like thank  Dr. Robert M. Magsino , our President, for his unwavering support and belief in this committee to achieve its goal and purpose.

This SOP however, will not be possible without the help of the institutions that help us shape this manual.  In no particular order, we would like to thank the following institutions,  University of the Philippines Research Ethics Board, Veterans Memorial Medical Center   Institutional Review Board, ‘Amang’ Rodriquez Memorial Medical Center Hospital   Research/ Bioethics Review Board, and the Department of Health  for making our task possible and achievable.

Finally, we would like to thank the members of the MMMC – RERC, past and present, for all the time, effort, and dedication. Without them the committee will cease to exist.

• Table of Content
• Introduction
• Appendix A - Glossary
• Appendix B - References
• Appendix D - Index Cover
• (A) Member notification & Appointment
• (B) Notification Nomination and Appointment
• (C) CURRICULUM VITAE
• (D) TRAINING RECORD
• (E) Training Referral Form
• (F-A) Confidentiality Agreement and Conflict of Interest Disclosure Chair
• (F-B) Confidentiality Agreement and Conflict of Interest Disclosure Independent Consultants
• (F-C) Confidentiality Agreement and Conflict of Interest Disclosure Secretariat
• (G) Service agreement for IC
• (A) Review Checklist
• (B)Registration and Application Form
• (C) Study Protocol Assessment Form
• (C2) Assessment Medical Device Form
• (D) Informed Consent Assessment Form
• (E) Notice of Review
• (F) Site Resources Checklist
• (G) Site Resources Checklist-outside MMMC
• (H) Acknowlegement Letter
• (I) Review of Resubmitted Study Protocol Form
• (A) Reminder Letter for continuing review progress or final report
• (B) Progress Report Form
• (C) Final Report Form
• (D) Study Protocol Informed Consent Amendment amendment Form
• (E) Continuing Review Application Form
• (G) Serious Adverse Events Report
• (H) SAE REPORT SUMMARY
• (I) Suspected Unexpected Serious Adverse Reaction Summary Offsite
• (J) Checklist for SAE and SUSARs Report
• (J) Study Protocol NonCompliance Report
• (K) Early Study Termination Application Form
• (A) Meeting Agenda
• (B) Confidentiality Agreement for Guests
• (C) Letter for Clarificatory Interview
• (A) Format of the Minutes of the Meeting
• (B) Approval Letter to the Study Protocol
• (C) Action Letter to study protocol submission, Resubmission and Amendments
• (D) Approval Letter to the Study Protocol Amendment
• (E) Action Letter Progress Report, Continuing Review Application, Final Report, Deviation, AE, Site VIsit
• (E-b) Action Letter (No Further Action) to Continuing Review Application, Deviation, AE, Site Visit
• (F) Archiving Notification
• (G) Certification of MMMC RERC Committee action
• (H) Submissions Log
• (I) Borrowers Log
• (A) Site Visit Report Form
• (B) Notice of Site Visit
• (C) Notice of Site Visit for PI
• (A) Queries Notification and Complaints
• (A) Document History
• (B) SOP or Guideline Template
• (C) SOP or Guideline Cover Page
• (D) Request for Revision of an SOP or Guideline
• Document History

Herber Arrellano, MD

Position: Chairman Profession: IM – Endocrinology Affiliation to MMMC: Consultant Date of 1st Appointment: July 2023

Von Andre Medina, MD

Position: Vice Chairman Profession: Internal Medicine Affiliation to MMMC: Consultant Date of 1st Appointment: July 2023

Oscar Paulo Mertola, MD

Position: Member Secretary Profession: Internal Medicine Affiliation to MMMC: Consultant Date of 1st Appointment: July 2023

Narcisa Sonia Comia, MD

Position: Member-Institutional Profession: IM – Hematology/Oncology Affiliation to MMMC: Consultant Date of 1st Appointment: July 2023

Mary Warren Ilaga, MD

Position: Member-Institutional Profession: Neurology Psychiatry Affiliation to MMMC: Consultant Date of 1st Appointment: July 2023

Rev. Fr. Rey Salvador

Position: Non-medical member Profession: Priest Affiliation to MMMC: Non-affiliated Date of 1st Appointment: October 2019

Maria Assumpta Tan

Position: Non-medical member Profession: Retired Bank Manager Affiliation to MMMC: Non-affiliated Date of 1st Appointment: October 2023

Wilfredo Lianco, MD

Position: Member-Institutional Profession: Medical Oncology Affiliation to MMMC: Consultant Date of 1st Appointment: April 2015

Imei Joy Landchico-Cajulis

Position: Non-medical member Profession: Licensed Psychometrician Affiliation to MMMC: Non-affiliated Date of 1st Appointment: December 2022

Gerald Natanauan, MD

Position: Independent Consultant Profession: Rheumatologist Affiliation to MMMC: Consultant Date of 1st Appointment: September 2023

Elvin Garcia, MD

Position: Independent Consultant Profession: Pulmonologist Affiliation to MMMC: Consultant Date of 1st Appointment: September 2023

Cut-off date of Submission : October 3, 2023 FULL BOARD Meeting : October 18, 2023

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SCMC-AEI Ethics Review Commitee SOP

The SCMC-AEI Ethics Review Committee is responsible for ensuring the protection of the rights, safety and welfare of study participants and the whole community. It provides ethical reviews for all clinical, operational and policy research projects in the Philippines, based on local and international standards and guidelines.

Established in 2002, the committee has reviewed over 100 researches – both sponsored clinical trials and investigator-initiated researches. 11 years later, it expanded its scope by reviewing health policies and operational studies.

As its sets its sight on creating a more independent, diverse and well-rounded committee, Asian Eye partnered with St. Frances Cabrini Medical Center (SCMC), an accredited third level referral hospital in Sto. Tomas, Batangas that specializes in cancer and organ transplant services. This partnership allows both institutions to review researches that concern overall health.

In March 2016, the SCMC-AEI Ethics Review Committee was granted Level 3 Accreditation by the Philippine Health Research Ethics Board (PHREB). PHREB develops standards and guidelines to ensure that ethics review committees are efficient and effective.

In the next five (5) years, SCMC-AEI ERC will be a reviewer of clinical, operational and policy studies in the Philippines

We deliver to all stakeholders a standard of ethical review that is based on national and international ethical standards and guidelines protecting the welfare of Filipino and regional patients.

Click “SCMC-AEI Ethics Review Committee SOP” for more information about submission procedures and requirements. You may reach the SCMC-AEI ERC Secretariat through [email protected] .

Organizational structure:

For forms and other templates, you may click these files:

Continuing Review Application/Progress Report Form

Early Study Termination Application Form

Feedback Form

Final Report Form

Letter for the Withdrawal of Protocol Application

Nomination Form

Protocol Amendment Submission Form

Protocol Decision Form

Protocol Deviation Report Form

Request Letter for Review

Serious Adverse Event/s (SAE) / Suspected Unexpected Serious Adverse Reaction/s (SUSAR) Report Form

Site Visit Report Form

Study Protocol and Informed Consent Assessment Form

These forms and templates are also available in Microsoft Word format:

Questions? Ask us!

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The West Visayas State University URERC is guided in its reflection, advice, and decision by the ethical principles and procedures expressed in the Declaration of Helsinki (2013 and subsequent revisions) and Council for International Organization of Medical Sciences (CIOMS) 2002 and 2009.

The URERC will function in accordance with national laws, regulations, and guidelines.

The URERC provides its own standard operating procedures based on:

Operational Guidelines for Ethics Committees that Review Biomedical Research (2000) by the World Health Organization (WHO)

Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants (2011) by the World Health Organization (WHO)

International Conference on the Harmonization of Good Clinical Practice (ICH-GCP)

National Ethical Guidelines for Health Research (2022) by the Philippine Health Research Ethics Board (PHREB)

Philippine Food and Drug Authority regulations and other relevant laws and regulation

The URERC adheres to national and international ethical standards and recognizes that the protocols it approves may also be approved by national and/or local ethics committees prior to their implementation in specific localities.

In evaluating protocols and ethical issues, the URERC is cognizant of the diversity of laws, cultures and practices governing health research in various countries around the world.

It attempts to inform itself, whenever possible, of the regulations and requirements of sponsor countries conducting global protocols in the Philippines; and of the requirements and conditions of various localities where a proposed West Visayas State University research is being considered.

The URERC will take the initiative to be informed, as appropriate, by national/local ethics committees and researchers of the impact of the research that it has approved.

MANDATE and SCOPE of AUTHORITY:

In compliance with the provisions Rule 23 (b) of the Implementing Rules and Regulations of the PNHRS Act (RA 10532) as well as the provisions of DOST, DOH, CHED, UPM Joint Memorandum Order No. 2012-001 dated December 28, 2012, the subject of which is the Requirement for Ethical Review of Health Research Involving Human Participants, it shall be the policy of the West Visayas State University (WVSU) that, effective_______, all Health Research involving human subjects belonging to any category described below, shall undergo ethics review by the University’s PHREB Accredited Ethics Review Committee(s). This policy shall apply to:

The URERC accepts the following proposals/protocols for review:

All researches from West Visayas State University Faculty, students and staff from main and external campuses;

Researches done by residents, students, consultants and hospital employees in West Visayas State University Medical Center (WVSUMC);

Researches done by researchers outside WVSU and WVSUMC whose participants are employees/students of WVSU or whose research site is located in any campus/facility of the WVSU and WVSUMC system;

Researches referred from the PNHRS, PCHRD, DOST, PHIC, PHREB, DOH, FDA, CHED, industry organizations, etc. on the condition that the host hospital/institution where the proposal will be done accepts the review of University’s Ethics Committee and agrees to abide by the rules, regulations and local and international guidelines that the Committee follows;

Approved researches by other REC’s done in sites outside the WVSU and WVSUMC for continuing review in case study has not been completed and the original REC ceases to function or becomes irrelevant for whatever reason.

The researchers submitting research proposals belonging to no. 3-5 as described above or their research sites shall enter into a Memorandum of Agreement with the WVSU which shall provide, among others, that they or their research site agree to provide the proper environment to ensure the safe and ethical conduct of the research, including oversight and stewardship functions, and that they agree to monitor procedures that the committee may deem necessary. These conditions, together with the conditions stated above in their specific category, shall be written in a document and signed by other hospitals/institutions that accept WVSU-URERC review.

List of Requirements And Downloadables

List of Requirements for Initial Submission:

• Application for Review (letter of request addressed to the ERC Chair)
• Results of Technical Review Approval Form
• Ethical Review from other ERCs (if applicable)
• Rationale and Significance of the Study
• Objectives of the Study
• Review of Related Literature
• Description of the Study Population
• Methodology and Procedures
• Exclusion/Inclusion Criteria
• Ethical Considerations
• Data Analysis
• English ICF (with version and date)
• Hiligaynon ICF (if applicable, with version and date)
• Assent (with version and date)
• LAR (with version and date)
• Study Tools (Questionnaires, Case Report Form, Posters/Advertisements for Recruitment, etc. with version and date)
• Study Drug/Medical Device Information like Investigator Brochures/Published Literature/Medical Device Manufacture’s Design, if relevant
• CV of Principal Investigators/Researcher and Co-Investigators (signed and dated)
• Proof of GCP Training (in cases of a Clinical Drug Trial)
• Information regarding Funding, Sponsors, Institutional Affiliations, other potential Conflicts of Interest
• Contracts and Approval of relevant offices (Memorandum of Agreement (MOA) if study is collaborative in nature: Materials Transfer Agreement (MTA), Intellectual Property Approval, Investigational Device Exemption (IDE), when relevant
• GANTT Chart (as necessary)
• Study Proposal Budget
• Footers to indicate document version and date; Page numbers (Continuous Paging)
• Footers to indicate document version and date
• Page numbers (Continuous Paging)
• Form 2.1 (Application for Review)
• Form 2.2 (Protocol Summary Sheet)
• Form 2.3 (Protocol Evaluation)
• Form 2.4 (Informed Consent/Assent Evaluation)
• Form 2.10 (Summary of Recommendation)
• Form 2.11 (Application for Waiver of Consent)
• Form 3.1 (Protocol Amendment Review)
• Form 3.2 (Progress Report)
• Form 3.3 (Final Report)
• Form 3.4 (Serious Adverse Event Report)
• Form 3.5 (Deviation Non Compliance Violation Report)
• Form 3.6 (Request or Quer)
• Form 3.8 (Study Termination)
• Form 3.9 (Pregnancy Report ).
• URERC SOP Chapter 1
• URERC SOP Chapter 2
• URERC SOP Chapter 3
• URERC SOP Chapter 4
• URERC SOP Chapter 5
• ICF Template
• Pediatric Study Subject Assent Form

List of Unified Research Ethics Review Committee Members

Roberto P. Villanueva, M.D., J.D.​

Position on URERC: Chair Profession/Specialty: Physician - Pediatrics/Lawyer Institution: WVSU Affiliated with the Institution: Yes

Mary Giselle S. Alfeche, M.D.

Position on URERC: Vice Chair for Student Researches Profession/Specialty: Physician/Internist-Hematology Institution: WVSU Affiliated with the Institution: Yes

Tomasito R. Sy, M.D.

Position on URERC: Vice Chair for Professional Researches Profession/Specialty: Physician/ Internist-Pulmonology Institution: WVSU Affiliated with the Institution: Yes

Felice G. Molina, M.D.

Position on URERC: Secretary Profession/Specialty: Physician / Infectious-Disease Institution: WVMC Affiliated with the Institution: No

Carol Joy T. Quimpo, M.D.

Position on URERC: Asst. Secretary Profession/Specialty: Physician/ Surgery Institution: WVSU Affiliated with the Institution: Yes

Grace B. Ariete-Albaña, M.D.

Position on URERC: Member Profession/Specialty: Physician-Oncology Institution: WVSU Affiliated with the Institution: YES

Diosdado V. Amargo, Jr., M.D.

Position on URERC: Member Profession/Specialty: Physician - Psychiatry Institution: WVSU Affiliated with the Institution: Yes

Demetrio G. Estenor

Position on URERC: Member Profession/Specialty: Aquaculture Researcher/Lay Person Institution: Lay Affiliated with the Institution: No

Fred P. Guillergan, M.D., Msc.

Position on URERC: Member Profession/Specialty: Physician/ Internist/ Biochemistry Institution: WVSU (FORMERLY) Affiliated with the Institution: No

Anjuli May P. Jaen, M.D.

Position on URERC: Member Profession/Specialty: Physician/ Internist-Pulmonology Institution: WVSU Affiliated with the Institution: Yes

Joy C. Lizada, Ph.D.

Position on URERC: Member Profession/Specialty: Social Scientist/ Environmentalist/ Lay Person Institution: UPV (Formerly) Affiliated with the Institution: No

Edna A. Medez ,M.D.

Position on URERC: Member Profession/Specialty: Physician/Internist-Hematology Institution: WVSU (Formerly) Affiliated with the Institution: No

Ma. Delfa J. Uy

Position on URERC: Member Profession/Specialty/Occupation: Housewife/ Lay Person Institution: Lay Affiliated with the Institution: No

Ma. Victoria C. Villareal, M.D.

Position on URERC: Member Profession/Specialty/Occupation: Pediatrician Institution: WVSU (Formerly) Affiliated with the Institution: No

Gerard Lorenz M. Penecilla, M.D.

Position on URERC: Member Profession/Specialty/Occupation: Physician/ Internist-Toxicology Pharmacology Institution: WVSU Affiliated with the Institution: Yes

URERC Flow Chart

Organizational Chart

Contact Information

Unified research ethics review committee.

West Visayas State University

Luna St., La Paz, Iloilo City

Telephone No: (033) 330 91 02 / 320 08 70 to 78 Loc 1317 

Email Address: [email protected] / [email protected]

URERC Chair

ATTY. ROBERTO P. VILLANUEVA, M.D. Chair, Unified Research Ethics Review Committee West Visayas State University Luna St., La Paz, Iloilo City Telephone No: (033) 330 91 02 / 320 08 70 to 78 Loc 1317  Mobile No:  09563067070 Email Address: [email protected] / [email protected]

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• 2020 DOST and Its Agencies Orientation on Research Ethics
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Cyber policy and ethics students shine in global competition

Meet the team:

Wilhelmina Cuono, Hannah Illingworth and Tammy Nguyen

A team of University of South Carolina students had to solve an international crisis: technology used to monitor the southern American border had been compromised. 

The situation was fictional — part of a competition called   Cyber 9/12 Strategy Challenge   — but their solution to the problem had to be based on real-world policy dealing with technology that crosses borders. 

Hannah Illingworth, a major in cyber policy and ethics at USC, says the challenge gave her a new-found respect for policy makers and the cyber community. 

“There are so many external factors my team had to consider that go beyond governance and policy,” Illingworth says. 

“We were given an intelligence report in which the simulated event was tracked through news and social media, the dark web, confidential government communications and more. Then, we worked together to produce policy recommendations that we presented to the judges.” 

The team made it through two rounds of the competition, which upped the stakes with each stage. As semi-finalists, they had only 12 hours to propose their solutions and worked overnight before presenting to the judges in the morning. 

Wilhelmina Cuono, who is also a cyber policy and ethics major, says the experience gave her a better idea of what her future career might be like. 

“My dream job would be to work for the FBI in a counterterrorism unit,” she says. “So, the challenge was extremely relevant.” 

Cuono initially planned to enroll in a computer science program, but when she learned about USC’s cyber policy and ethics degree, she decided to come to South Carolina. 

“The degree was an option that I didn’t see in any other schools I applied to,” she says. “I’m less interested in software development, but more with keeping computer systems safe. I also wanted to focus on the human aspect and keeping people safe.” 

As a relatively new degree program in the College of Arts and Sciences, the cyber policy and ethics degree program allows students to combine their interest in technology with the social sciences and liberal arts. 

Carl Dahlman, director of the Walker Institute for International and Area Studies, says the name of the program is broad to reflect the global applications of the degree. 

“‘Cyber Policy and Ethics’ was a way of doing something really new, teaching students to understand the way in which our online interactions are fundamentally a question of human behavior,” he says. “It can’t be studied in a localized context. It has to be made relevant to broader world affairs.” 

The degree offers a range of math and technical courses, interdisciplinary courses in areas like sociology, criminal justice and international policy, plus flexible electives and a foreign language requirement. 

In addition, the program offers experiential learning opportunities for students, such as internships for course credit and the Cyber 9/12 Strategy competition. 

Chris Becht, a USC alumnus and veteran who worked with the intelligence community for many years, was one of the program’s earliest supporters. 

“As a member of the college’s Board of Visitors, this degree caught my attention because these kinds of concerns have been around for decades,” he says. “In the intelligence community, the cyber threat became a prominent concern right after 9/11, when folks in leadership recognized how destructive a cyberattack could be.” 

Becht was cheering on USC’s cyber challenge team as they made it to the semi-finals of the competition. This year, the team had to compete virtually, but Becht and his wife, Elizabeth, hope to make it possible for the team to attend in-person next time. 

“Traveling to these kinds of events is so important for students because they meet their peers and professionals in the field, and they can learn so much by asking questions about what they do for their careers,” he says. 

Both Illingworth and Cuono are planning to compete again next spring. Their goal is to make it all the way to the finals, where they'll have only 15 minutes for the challenge. 

“This is very realistic to what they’ll see in their careers,” Becht says. “In a cyberattack, the responding agencies might only have minutes to act.” 

No matter how they place, the students say that participating in itself is a big win. 

“Learning to face real-world challenges and knowing how to navigate government systems to be heard is such an important part of our degree,” Illingworth says. “The policy side is just as important as our technical skills.” 

Challenge the conventional. Create the exceptional. No Limits.