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 maritime startup raises $43M to electrify vessels, opens new HQ

Maritime Mission

A Houston-based maritime technology company that is working to reduce emissions in the cargo and shipping industry has raised VC funding and opened a new Houston headquarters.

Fleetzero announced that it closed a $43 million Series A financing round this month led by Obvious Ventures with participation from Maersk Growth, Breakthrough Energy Ventures, 8090 Industries, Y Combinator, Shorewind, Benson Capital and others. The funding will go toward expanding manufacturing of its Leviathan hybrid and electric marine propulsion system, according to a news release.

The technology is optimized for high-energy and zero-emission operation of large vessels. It uses EV technology but is built for maritime environments and can be used on new or existing ships with hybrid or all-electric functions, according to Fleetzero's website. The propulsion system was retrofitted and tested on Fleetzero’s test ship, the Pacific Joule, and has been deployed globally on commercial vessels.

Fleetzero is also developing unmanned cargo vessel technology.

"Fleetzero is making robotic ships a reality today. The team is moving us from dirty, dangerous, and expensive to clean, safe, and cost-effective. It's like watching the future today," Andrew Beebe, managing director at Obvious Ventures, said in the news release. "We backed the team because they are mariners and engineers, know the industry deeply, and are scaling with real ships and customers, not just renderings."

Fleetzero also announced that it has opened a new manufacturing and research and development facility, which will serve as the company's new headquarters. The facility features a marine robotics and autonomy lab, a marine propulsion R&D center and a production line with a capacity of 300 megawatt-hours per year. The company reports that it plans to increase production to three gigawatt-hours per year over the next five years.

"Houston has the people who know how to build and operate big hardware–ships, rigs, refineries and power systems," Mike Carter, co-founder and COO of Fleetzero, added in the release. "We're pairing that industrial DNA with modern batteries, autonomy, and software to bring back shipbuilding to the U.S."

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This article originally appeared on EnergyCapitalHTX.com.

Innovative Houston-area hardtech startup closes $5M seed round

fresh funding

Conroe-based hardtech startup FluxWorks has closed a $5 million seed round.

The funding was led by Austin-based Scout Ventures, which invests in early-stage startups working to solve national security challenges.

Michigan Capital Network also contributed to the round from its MCN Venture Fund V. The fund is one of 18 selected by the Department of Defense and Small Business Administration to participate in the Small Business Investment Company Critical Technologies Initiative, which will invest $4 billion into over 1,700 portfolio companies.

FluxWorks reports that it will use the funding to drive the commercialization of its flagship Celestial Gear technology.

"At Scout, we invest in 'frontier tech' that is essential to national interest. FluxWorks is doing exactly that by solving critical hardware bottlenecks with its flagship Celestial Gear technology ... This is about more than just gears; it’s about strengthening our industrial infrastructure," Scout Ventures shared in a LinkedIn post.

Fluxworks specializes in making contactless magnetic gears for use in extreme conditions, which can enhance in-space manufacturing. Its contactless design leads to less wear, debris and maintenance. Its technology is particularly suited for space applications because it does not require lubricants, which can be difficult to control at harsh temperatures and in microgravity.

The company received a grant from the Texas Space Commission last year and was one of two startups to receive the Technology in Space Prize, funded by Boeing and the Center for the Advancement of Science in Space (CASIS), in 2024. It also landed $1.2 million through the National Science Foundation's SBIR Phase II grant this fall.

Fluxworks was founded in College Station by CEO Bryton Praslicka in 2021. Praslicka moved the company to Conroe 2024.