Why its important to support student researchers, according to this Houston expert

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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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4 Houston health tech startups advancing medical innovation

meet the finalists

Houston has been driving medical innovation for decades. And thanks to leading hospitals, cutting-edge research and breakthrough technologies, the region’s healthcare ecosystem continues to improve how patients are diagnosed, treated and cared for.

The Health Tech Business category in our 2025 Houston Innovation Awards will honor an innovative startup within the health and medical technology sectors.

Four forward-thinking businesses have been named finalists for the 2026 award. This year's finalists, selected by our esteemed panel of judges, range from a startup developing miniaturized medical technologies for space to a company using AI to help develop cancer treatment plans.

Read more about these businesses, their innovative founders, and how they're shaping the future of health care below.. The 2026 winners will be announced on InnovationMap.com in mid-November.

Bairitone Health

Bairitone Health is bringing anatomy imaging for sleep apnea to the home environment. The company's platform maps users' anatomy during natural sleep using a facial patch to determine the root cause of airway obstruction. It then offers effective therapies for each patient.

The company was founded in 2022 in the Texas Medical Center's Biodesign program by CEO Meagan Pitcher, CTO Onur Kilic and chief medical officer Britt Cross. It was a member of Activate Houston's inaugural cohort and has participated in numerous accelerators and incubators. The company raised an oversubscribed seed round for $2.4 million earlier this year and received Breakthrough Device Designation from the Food and Drug Administration in April.

InformAI Inc.

InformAI Inc. develops fit-to-purpose AI solutions for the clinical setting. Its RadOncAI product recently received FDA 510(k) clearance. The product uses AI to create a first-pass radiation therapy dose plan for complex head and neck cancers in an effort to eliminate bottlenecks in radiation planning and ultimately cancer treatment. The company has also developed AI products for sinus disease detection and 3D organ reconstruction.

CEO Jim Havelka founded the company in 2017. It is participating in the Mayo Clinic Accelerate Platform. It has raised about $4 million in seed funding and has received numerous non-dilutive grants from the National Science Foundation, the National Institutes of Health and the Cancer Prevention and Research Institute of Texas. The company shared in its application that it plans to launch a Series A fundraising round and submit an FDA 510K application for its organ reconstruction product, Voluquant, by the end of 2026.

Prana Surgical

Prana Surgical is developing a minimally invasive surgical platform for small, hard-to-reach lung nodules that may be cancerous. The company's Prana System cleared U.S. Food and Drug Administration (FDA) approval earlier this year.

Prana Surgical was originally founded as Prana Thoracic in 2022. It has participated in numerous accelerators, including the Texas Medical Center Innovation Accelerator in 2023 and the IGNITE Health accelerator in 2022. It raised $6 million in Series A funding rounds in 2023 and 2024 , with a Series B currently ongoing. The company said in its application that it is currently moving into the next stage of clinical validation and revenue generation in the U.S., in addition to preparing its manufacturing and commercial infrastructure for broader use.

Skybound MedTech

Skybound MedTech develops technologies that aim to address the health risks of long-duration spaceflight. Its compact, miniaturized medical technologies can deliver complex therapies without a physician.

CEO Matthew Kuhn, who previously founded Taurus Vascular, founded Skybound last year. The company emerged from stealth in January after raising a $1.25 million Series A round. It plans to advance its lead dual-use platform into critical preclinical validation in November, the company shared in its application. It is currently raising a $25 million Series A round and is pursuing federal research partnerships with DARPA and ARPA-H.

Generation Park lands new facility to scale xeno-organ production

Organ innovation

Maryland-based United Therapeutics Corp. has opened a new 77,448-square-foot facility to manufacture xeno-organs in Northeast Houston’s growing biotech hub, Generation Park.

The new Houston location is United Therapeutics’ third Designated Pathogen-Free (DPF) site, named for transplant pioneers Dr. Bartley P. Griffith and Dr. Robert A. Montgomery. The company says the new facility will enable it to scale commercial production of its xeno-organs once they receive regulatory approval.

An existing DPF facility in Virginia is supporting clinical trials for the xeno-organs, and a third site in Minnesota will also focus on commercialization with the Houston site, according to the company.

Xeno-organs are organs taken from a non-human animal source and transplanted, implanted or infused into a human recipient.

Currently, United Therapeutics is advancing clinical trials to support a Biologics License Application with the U.S. Food and Drug Administration for its investigational-stage xenotransplantation, UKidney, UThymoKidney and UHeart products. The products all involve working with the genes from humans and pigs.

In 2025, Chron.com reported the company was working to construct an estimated $96 million facility to breed genetically engineered animals. Head of investor relations at United Therapeutics Dewey Steadman told the Houston Business Journal in 2025 that the pigs’ DNA will be edited. In November 2024, a 53-year-old woman in Alabama received a transplanted kidney from UKidney that had 10 gene edits. She had the transplant removed in April 2025, after her body rejected it.

The Dr. Bartley P. Griffith and Dr. Robert A. Montgomery Xenograft Production Facility requires a “strictly controlled, biosecure barrier environment, including air filtration, filtered water, filtered feed supplies, and state-of-the-art decontamination entryways,” according to the company. Being pathogen-free means it includes calibrated air and water conduits to support the transplantability of xenograft products and to prevent contamination. For energy considerations, the building also features solar arrays.

“With our third xenograft production facility now open and clinical trials underway, United Therapeutics is moving closer to its goal of providing transplantable organs to the people who need them,” Martine Rothblatt, chairperson and CEO of United Therapeutics, said in a news release. “It is fitting that this facility is named for Dr. Griffith and Dr. Montgomery, whose first-in-human surgeries turned xenotransplantation from a theoretical possibility into a clinical reality.”

The facility, which wrapped construction in August, is located at 11848 Common Dock Dr. in Generation Park, which will house manufacturing sites for pharmaceutical heavyweights Bristol Myers Squibb and Eli Lilly. Last fall, Eli Lilly tapped Generation Park for its $6.5 billion manufacturing plant, and Bristol Myers Squibb made a $2.3 billion investment in August to bring its state-of-the-art site to the master-planned commercial district.

Elon Musk's SpaceX reports profit as AI and satellite businesses booms

Booming Business

SpaceX reported a bigger quarterly profit than expected on Tuesday, October 20, as its satellite communications and artificial intelligence businesses boomed.

The company, run by Elon Musk, posted a profit for the three months through September 2026 of $4.4 billion, or 35 cents per share, reversing a year-ago loss and easily topping Wall Street's expectations. Revenue soared to $14.6 billion, up 161%.

On a conference call with analysts, Musk suggested a merger with his electric car company Tesla might be in the works, something that has been rumored for months. He said both companies formed “special committees” of independent directors to discuss the issue, though he played down the chances of an imminent deal.

“Some people out there assume that a SpaceX and Tesla merger is a certainty,” he said. “I think that would be overstating it.”

The AI business became SpaceX's largest by revenue in the third quarter, although the Starlink satellite service remains the biggest profit generator.

“They beat across all metrics and the Starlink business looks to be accelerating,” said Dan Ives, an analyst at Yorkville Ives. “This is just what (Wall) Street wanted.”

The stock rose 7.5% in after-hours trading.

Musk also told analysts that for next month's launch of its Starship rocket, SpaceX will attempt to grab both the booster and ship with mechanical arms upon return to base, a key step toward demonstrating it can reuse the massive spacecraft.

“The only way that we can extend consciousness beyond Earth on a sustained basis is with a fully reusable orbital launch vehicle,” Musk said, calling the attempt, if successful, “a massive technology milestone.”

SpaceX hopes to get Starship on a regular launch pattern in preparation for NASA's upcoming lunar missions.

The company already has huge contracts with the federal government, and House Democrats have called for investigations into those contracts and Musk’s work with the Department of Government Efficiency. Musk has spent $276 million since July in support of Republican candidates.

In a filing for its initial public offering in June, SpaceX warned that a change in control of Congress could have a “material and adverse impact on our growth and competitive position.”

Musk recently drew criticism from politicians in Washington after speeds for a military version of SpaceX's satellite communications service were slowed for Ukraine following President Donald Trump's deal to get more diesel oil from Russia amid a push to end the war. The Wall Street Journal reported Tuesday that it was Musk who ordered the slowdown, impeding Ukraine’s use of drones along the front. SpaceX did not immediately respond to an Associated Press request for comment on the Journal story.

Both Trump and Musk have denied responsibility for the slowdown.

As midterm elections near, Musk on Monday promised to give one share of SpaceX to “every kid in America” next year, though he provided no details on how the distribution would be carried out. With communities nationwide protesting the construction of large data centers and concerns about AI safety, AI companies are trying to build goodwill. Anthropic pledged to commit 5% of its shares to a new “public benefit” fund.

SpaceX shares have been under pressure over concerns that the company was spending too much on major projects to compete with rivals such as Anthropic. The company said capital expenditures totaled $19.6 billion last quarter, nearly triple the figure from a year earlier, and it forecast spending would grow to $35 billion to $40 billion in the current quarter.

Shares of SpaceX closed Tuesday at $147.79, down from a peak near $201 after its IPO, which made Musk the world’s first trillionaire at the time. But the share prices for SpaceX and Tesla have since dropped, reducing his net worth to $925 billion, according to Forbes magazine.

Tesla reports third-quarter financial results Wednesday. Last week, Tesla unveiled a new Roadster sports car that in some versions may include thrusters allowing it to briefly fly using SpaceX technology — though experts say anything usable for drivers is a long shot.

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