Students and faculty sponsors work in tandem to design and implement a research or scholarly project, and its important to support the student aspect of the equation. Graphic by Miguel Tovar/University of Houston

Do you remember the feeling you had the first time sitting at the wheel of a car? Were you overcome by the feeling of excitement, anticipation, fear, or perhaps a combination of them all? For many, obtaining a driver’s license is a rite of passage; a symbol that you are equipped with both the knowledge and skill of how to safely operate a motor vehicle. This achievement, however, would not have been made possible without the sacrifice of devoting hours to driver’s education and training under a supervisor.

Forging new paths

By the same token, college students who have dedicated years of study in various academic fields may also be ambivalent about conducting research. They will be in dire need of an experienced researcher’s guidance as they navigate down the unfamiliar road of academic research. It is their responsibility to help shape the student’s research interests and forge new paths.

By fostering student-led research, faculty sponsors can assist students by aligning their educational experiences with their career goals. This positions them for compelling careers in academic research.

Student at the wheel

Before a student can be placed in the driver’s seat of their own research protocol, they must be fully equipped with the right tools. If not, they will begin this journey without clear direction. Such was the case of several students at an unnamed university who conducted more than minimal risk studies without IRB approval.

The students started the protocol but were advised by their faculty sponsor that IRB approval wasn’t necessary before conducting research. One of the students rode in ambulances collecting data. They published their findings and even graduated before this was brought to the attention of the university’s Office of Compliance. This is a clear case of noncompliance and the severity of this issue is similar to driving a car without a license.

The Institutional Review Board (IRB) is the governing entity for human subject research. Their role isn’t primarily a research review process. It ensures that human subjects are treated ethically and that their rights are protected. This brought up issues of consent, confidentiality, and potential risk to human subjects and was an example of significant non-compliance.

Federal regulations and university policy mandate IRB approval for research involving human subjects. The requisite applies to faculty, staff and students. The availability of options may create more questions than answers when submitting their first student-led research protocol.

Mapping it out

The University of Houston has taken steps to manage research compliance and optimize student success. It established an Institutional Review Board that reviews only student-led protocols. It’s unique in that very few institutions have this sort of program available. In the two years since its inception, the program has become a transformative resource for both students and their faculty advisors.

Faculty and student protocols are typically grouped together. However, the UH Student IRB Program gives them a single point of contact for IRB-related concerns and individualized support.

The UH Office of Research Integrity and Oversight (RIO) has established an infrastructure to support student-led research through their pre-IRB review process. Students are encouraged to drop by to seek advice or brainstorm with a coordinator. Services, training and educational materials, such as the Faculty Sponsor Manual, are also available to support faculty sponsors.

The submission process can be pretty daunting. Kirstin Holzschuh, executive director of RIO, mentioned that students are unfamilar with the IRB requirements and process. As a result, their protocols would often be sent back for significant revisions. The pre-review system helps eliminate the possibility of their protocols getting stuck in the review process.

Representatives from this office regularly interface with the UH research community. They travel to various colleges and departments across campus and guest lecture on the IRB submission process. They also talk about the ethics of conducting research with human subjects.

Students and faculty sponsors work in tandem to design and implement a research or scholarly project. Therefore, it’s imperative to cultivate an environment where student researchers feel informed and supported by their advisors and the UH community.

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This article originally appeared on the University of Houston's The Big Idea. Nitiya Spearman, the author of this post, is the internal communications coordinator for the UH Division of Research.

To err is human, after all. Graphic by Miguel Tovar/University of Houston

University of Houston: Navigating non-compliance and human error in research

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To comply is to obey, or conform to instruction or official requirements. In a perfect world, research non-compliance wouldn’t occur and following the rules would be a behavioral norm. But the reality is, to err is human.

To err is human

Often times the judgement of our own, and others, poor decision-making is rooted in the innate tendency to view things in black or white – categorizing behaviors as either right or wrong, good or bad, thus deeming them as either ethical or unethical.

But this way of thinking often conflicts with the gray world in which we exist. So what happens when research decisions land somewhere in the moral gray area?

Before answering, here are two situations to consider that involve the over-enrollment of research participants:

Case 1:
The IRB has approved a survey for 40 subjects. The PI realizes after the survey has been open for several weeks that she forgot to set a participant limit within the survey program and 60 subjects have completed the survey.

Case 2:

A study involving a new drug to control diabetes symptoms is approved to enroll 30 participants. The study doctor thinks the drug may be beneficial, so she continues enrolling, for a total of 80 subjects.

The devil is in the details

Why is over-enrollment of subjects considered non-compliance?

Many institutions have agreed, within their assurance to the U.S. Department of Health and Human Services (HHS), to apply the Common Rule to all human subjects research, whether the research is funded or not.

The Common Rule regulations found at 45 CFR 46.109(a) and 45 CFR 46.111 (1) state that the IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all research activities. This includes the maximum number of research .

And what must the IRB review?

Under the above regulatory requirements, the IRB must evaluate all instances of non-compliance.

In these cases of over-enrollment, the IRB must review the number of subjects over-enrolled and assess any potential effects on additional subjects and/or the research, as well as determine if the noncompliant data may be used for research purposes.

What UH IRB says about Case 1:

While over-enrollment in a survey seems low-risk, depending on the content of the survey questions, the IRB could determine the issue to be more serious, such as for a study collecting data related to illegal substance use or questions about traumatic events (legal or psychological harm). The IRB must ensure that risks to subjects are minimized; only the number of subjects needed to statistically justify the research are approved. Depending on the number of subjects over-enrolled and the time period over which they participated, the non-compliance could also be considered continuing.

What UH IRB says about Case 2:

Investigational drug studies often pose more than minimal risk of harm to subjects. In these studies, it is even more critical to ensure that additional subjects are not exposed to potential harms without scientific justification

In a drug study, the PI may not continue a study based on opinion; the reason a physician is blinded to treatment assignment in many drug studies is to avoid potential bias.

Finding non-compliance: What can you do?

If the number of subjects enrolled exceeds the number approved by the IRB, a finding of non-compliance is justified. The IRB will review the numbers, the Principal Investigator’s reasons for over-enrollment and assess what procedures were conducted in these subjects. Often over-enrollment is inadvertent, however the committee also has the ultimate authority to determine whether the data may be used for research purposes.

Corrective actions, such as continuing education of the PI and/or study team to ensure this issue does not occur again in the future, are often required. In the most serious cases, the IRB may suspend or terminate approval.

If the non-compliance rises to the level of being serious (harms or has the potential to harm subjects or others) and/or continuing in nature, it must be reported to federal oversight agencies such as the Health and Human Services Office for Human Research Protections (OHRP) and the FDA. These agencies ensure that the institution is monitoring for these activities and puts appropriate fixes in place.

The importance of intetrity

Non-compliant research can be due to inadvertent errors or deliberate acts of noncompliance. The results could be the same. Human subjects could be harmed. Funding and reputation at an institution conducting research could be negatively affected. In times of reduced federal funding for basic research, there are direct financial costs to the agencies when funds and resources are misused.

The responsibility of ensuring that research protocols are adhered to rests upon the shoulders of the researchers involved.

If you were a member on the IRB, what would you consider to be appropriate consequences for the PI in these situations?

It’s important to note that non-compliance, whether it’s a “little white lie/inadvertent error” or a deliberate violation of the approved protocol can undermine the integrity of both the research process and the academic research enterprise.

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This article originally appeared on the University of Houston's The Big Idea. Nitiya Spearman, the author of this post, is the internal communications coordinator for the UH Division of Research.

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Houston professor awarded $2.6M grant for retina, neurological research

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University of Houston College of Optometry Professor John O’Brien has received a $2.6 million grant from the National Eye Institute to continue his research on the retina and neurological functions.

O’Brien is considered a leading expert in retinal neuroscience with more than 20 years of research in the field. The new funding will allow O’Brien and his team to continue to study the dense assembly of proteins associated with electrical synapses, or gap junctions, in the retina.

Gap junctions transfer electrical signals between neurons. And the plasticity of gap junctions changes the strength of a synapse, in turn changing how visual information is processed. Previous research has shown that reduced functions of electrical synapses could be linked to autism, while their hyperfunction may lead to seizures.

“The research we propose will significantly advance our understanding of the molecular complexes that control the function of electrical synapses,” O’Brien said in a news release.

The team at UH will work to identify the proteins and examine how they impact electrical synapses. It is particularly interested in the Connexin 36, or Cx36, protein. According to O’Brien, phosphorylation of Cx36, a short-term chemical modification of the protein, serves as a key driver of plasticity. And the protein has been linked to refractive error development, which is one of the largest vision problems in the world today.

Additionally, OBrien’s research has shown that plasticity is essential for all-day vision, allowing the retina to adjust sensitivity and sharpen images. He has also built a catalog of the core set of proteins surrounding electrical synapses that are conserved across species. His research has been funded by the NEI since 2000.

5 minority-founded Houston startups shine as Innovation Awards finalists

Meet the Finalists

Houston is one of the most diverse cities in the nation, and that trend carries over into its innovation and startup ecosystem.

As part of the 2025 Houston Innovation Awards, our Minority-founded Businesses category will honor an innovative Houston startup founded or co-founded by BIPOC or LGBTQ+ representation.

Five minority-founded businesses have been named finalists for the 2025 award. The finalists, selected by our esteemed panel of judges, range from a wearable health tech device company to a clean chemical manufacturing business to a startup with a lunar mission.

Read more about these innovative businesses, their initiatives, and their inspirational founders below. Then join us at the Houston Innovation Awards on Nov. 13 at Greentown Labs, when the winner will be unveiled at our live awards ceremony.

Tickets are on now for this exclusive event celebrating all things Houston Innovation.

Capwell Services

Houston-based methane capture company Capwell Services works to eliminate vented oil and gas emissions economically for operators. According to the company, methane emissions are vented from most oil and gas facilities due to safety protocols, and operators are not able to capture the gas cost-effectively, leading operators to emit more than 14 million metric tons of methane per year in the US and Canada, equivalent to more than 400 million metric tons of CO2e per year. Founded in 2022, Capwell specializes in low and intermittent flow vents for methane capture.

The company began as a University of Pennsylvania senior design project led by current CEO Andrew Lane. It has since participated in programs with Greentown Labs and Rice Clean Energy Accelerator. The company moved to Houston in 2023 and raised a pre-seed round. It has also received federal funding from the DOE. Capwell is currently piloting its commercial unit with oil and gas operators.

Deep Anchor Solutions

Offshore energy consulting and design company Deep Anchor Solutions aims to help expedite the adoption of floating offshore energy infrastructure with its deeply embedded ring anchor (DERA) technology. According to the company, its patented DERA system can be installed quietly without heavy-lift vessels, reducing anchor-related costs by up to 75 percent and lifecycle CO2 emissions by up to 80 percent.

The company was founded in 2023 by current CEO Junho Lee and CTO Charles Aubeny. Lee earned his Ph.D. in geotechnical engineering from Texas A&M University, where Aubeny is a professor of civil and environmental engineering. The company has not raised VC funding, but has participated in numerous accelerators and incubators, including Greentown Labs, MassChallenge, EnergyTechNexus LiftOff and others. Lee is an Activate 2025 fellow.

Mars Materials

Clean chemical manufacturing business Mars Materials is working to convert captured carbon into resources, such as carbon fiber and wastewater treatment chemicals. The company develops and produces its drop-in chemical products in Houston and uses an in-licensed process for the National Renewable Energy Lab to produce acrylonitrile, which is used to produce plastics, synthetic fibers and rubbers. The company reports that it plans to open its first commercial plant in the next 18 months.

Founded in 2019 by CEO Aaron Fitzgerald, CTO Kristian Gubsch and lead engineer Trey Sheridan, the company has raised just under $1 million in capital and is backed by Bill Gates’ Breakthrough Energy, Shell, Black & Veatch and other organizations.

Torres Orbital Mining (TOM)

Space tech company Torres Orbital Mining aims to pioneer the sustainable extraction and processing of lunar regolith and designs and builds robotic systems for excavating, classifying, and delivering lunar material. The company aims to accelerate a permanent and ethical human presence on the Moon.

The company was founded this year by Luis Torres, a current MBA candidate at Rice Business.

Wellysis USA Inc.

Wellysis USA Inc. works to detect heart rhythm disorders with its continuous ECG/EKG monitor with AI reporting. Its S-Patch cardiac monitor is designed for extended testing periods of up to 14 days on a single battery charge. The device weighs only 9 grams, is waterproof and designed to be comfortable to wear, and is considered to have a high detection rate for arrhythmias. It is ideally suited for patient-centric clinical trials to help physicians make diagnoses faster, cheaper and more conveniently.

It was established in Houston in 2023 and participated in the JLABS SFF Program the same year. It closed a $12 million series B last year. It was founded by CEO Young Juhn, CTO Rick Kim, CFO JungSoo Kim and chief strategy officer JoongWoo Kim.

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The Houston Innovation Awards program is sponsored by Houston Community College, Houston Powder Coaters, FLIGHT by Yuengling, and more to be announced soon. For sponsorship opportunities, please contact sales@innovationmap.com.

The Ion taps John Reale for startup and investor role

new hire

The Ion has named John "JR" Reale as its director for startups and investor engagement.

In his new role, Reale, a longtime leader in Houston’s startup ecosystem, will work to strengthen the innovation district's founder and investor network.

"Here’s what I’ve come to believe: the Ion is not just a building, not just a real estate play, and not just another innovation district. COVID, remote work, and shifting market dynamics changed the rules. Key ingredients like co-working, events, and community, while impactful, are no longer enough on their own," Reale shared on a LinkedIn post announcing the move. "What’s needed are advantages ... We need to intentionally design a system that repeatedly delivers advantages so founders can pull forward their visions."

Reale previously served as executive in residence and venture partner at TMC Venture Fund and co-founded Station Houston. He also serves as managing director of Integr8d Capital. He's an investor and serves on the board of directors for a number of venture-backed companies, including Cart.com, Lionguard and others.

The Ion will host "Today Is Day One – A conversation with John (JR) Reale" to welcome Reale to the role on Tuesday, Oct. 21. Reale will be joined at the event by Heath Butler, partner at Mercury, to discuss their thoughts on shaping Houston's founders ecosystem, as well as the Ion’s Founder Advantage Platform.

"On top of this connected architecture, we will build product. That product will be the Founder Advantage Platform to remove friction, compress time, and compound outcomes," Reale continued on LinkedIn. "This is the system that will drive repeatable experiences, and naturally, make these journeys so much more fun."