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 cleantech, space startups named to World Economic Forum cohort

top honor

Two Houston-based startups have been selected to join the World Economic Forum's Technology Pioneers community.

The two-year program aims to help mission-driven, early-stage start-ups scale their innovations through multi-stakeholder initiatives, co-creating partnerships and other gatherings for community members. One-hundred startups are selected each year from around the globe, this year hailing from 23 countries and working in AI, energy, space, biotech markets and more.

Cleantech startup Vaulted Deep was one of 11 energy and climate companies to be named to the cohort. Julia Reichelstein and Omar Abou-Sayed founded the company in 2023. Its technology injects excess organic waste underground to remove carbon dioxide from the atmosphere.

Last year, Vaulted Deep inked a 12-year deal with Microsoft to remove up to 4.9 million metric tons of carbon dioxide from the environment.

The startup has earned several accolades in recent years, including a No. 3 spot on Fast Company’s list of the World’s Most Innovative Companies of 2026. It was also recently named to market intelligence and advisory firm Cleantech Group's annual Global Cleantech 100 list for a second year in a row.

"Waste management is one of the world's great invisible infrastructure systems ... The need for new infrastructure is growing as disposal challenges become more complex and regulations evolve. Vaulted is building the first new disposal pathway for organic waste in decades by putting it deep underground, permanently," the company shared in a LinkedIn post. "This year, we're joining the World Economic Forum's 2026 Tech Pioneers alongside innovators working on the many interconnected challenges shaping our future."

Houston-based Venus Aerospace was also selected to join the cohort, along with six other spacetech companies. The company was founded in 2020 by Sassie and Andrew Duggleby.

The startup specializes in next-generation rocket engine propulsion as a cleaner alternative to traditional combustion engines. The company's rotating detonation rocket engine (RDRE) burns fuel more efficiently and completed a successful high-thrust test flight last year. Venus says it’s the only company in the world that makes a flight-proven, high-thrust RDRE with a “clear path to scaled production.”

"Frontier technologies matter most when they expand what people, industries, and nations can do," Sassie Duggleby, co-founder and CEO of Venus, said in a news release. "For Venus, RDRE does not just represent a more efficient engine. It is a foundation for faster movement, more capable space systems, and new forms of connectivity across the planet. Being named a Technology Pioneer validates the potential of this technology to help shape a future where distance is less limiting."

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This article originally appeared on our sister site, EnergyCapitalHTX.com.

Houston Methodist receives record $110M gift, names future tower

historic gift

Houston Methodist has received the largest gift in the health system's history to establish new funds for neurological, neuroscience, and women’s health research and treatment.

The $110 million gift comes from Houston-based The Brockman Medical Research Foundation, which supports education and research in the science, medicine and healthcare fields. In response, Houston Methodist announced that it will name its forthcoming 26-story hospital facility the Brockman Centennial Tower.

The tower’s entrance will be named the Anna Margaret Bellows Centennial Hall to honor Anna Margaret Bellows, a young camper who died during the Camp Mystic flooding last summer.

“This extraordinary gift accelerates discovery and transforms how care is delivered,” Dr. Marc Boom, president and CEO of Houston Methodist, said in a news release. “We are grateful to The Brockman Medical Research Foundation for its incredible generosity and vision that will help change the lives of generations of patients. Naming Centennial Tower in recognition of this gift reflects the scale of this commitment and its impact on the future of neuroscience, neurological care and women’s health.”

The gift will be divided into two parts:

  • $100 million will go toward creating an innovation fund within the Houston Methodist Academic Institute and the Houston Methodist Neurological Institute
  • $10 million will be devoted to Houston Methodist's Department of Obstetrics and Gynecology

“This tremendous gift will accelerate translational research that broadens our understanding of neurological and other diseases,” Dr. Jenny Chang, president and CEO of the Houston Methodist Academic Institute, added in the release. “It will allow us to leverage state-of-the-art platforms to detect, diagnose and deliver therapeutics, keeping patient care at the center of our mission.”

The Brockman Centennial Tower is expected to open next year in the Texas Medical Center. Spanning more than 1 million square feet, it will house 400 patient beds, an expanded emergency department, new operating rooms and a rooftop garden. It will be connected to Houston Methodist's flagship Paula and Joseph C. “Rusty” Walter III Tower, which opened in 2018. The Centennial Tower was estimated to cost $1.4 billion when announced in 2022.

In addition to the news of the Brockman gift, Houston Methodist also announced this month that it has launched the Houston Methodist Center for Cell and Gene Therapy and tapped an internationally recognized scientist as its leader.

The new center is focused on discovering and developing innovative and cost-effective therapies for a variety of congenital and acquired diseases, including cancer, HIV and cardiovascular disease.

Dr. Malcolm Brenner has been named as the center's inaugural leader and will assume the role starting in October. He will work alongside scientists and support staff from Baylor College of Medicine and Texas Children's Hospital.

Brenner is a professor of pediatrics, medicine, molecular and human genetics and translational biology at Baylor College of Medicine. He is known for making early advances in using bone marrow transplantation as a form of cell therapy and in engineered immune-cell treatments for cancer and infections, according to a release from Houston Methodist.

“Malcolm Brenner is a pioneer in the field of cell and gene therapy and is uniquely qualified to lead Houston Methodist’s research efforts in this field,” Chang added. “His vision and leadership will play a pivotal role in advancing our work in this space.”