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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Axiom Space taps solar array developer for first space station module

space contract

Houston-based Axiom Space is making progress on developing its commercial space station.

The company awarded Florida-based Redwire Corporation a contract to develop and deliver roll-out solar array (ROSA) wings to power the Axiom Payload Power Thermal Module (AxPPTM), which will be the first module for the new space station.

AxPPTM will initially attach to the International Space Station. AxPPTM will later separate from the ISS and rendezvous with Axiom’s Habitat 1 (AxH1) on orbit. Eventually, an airlock, Habitat 2 (AxH2) and finally the Research and Manufacturing Facility (AxRMF) will be added to the first two Axiom modules.

AxPPTM is anticipated to launch toward the end of 2027. The two-module station (AxPPTM and AxH1) is expected to be operational as a free-flying station by 2028, and the full four-module station around 2030.

The modules will be integrated and assembled at Axiom Space’s Assembly and Integration facility, making them the first human-rated spacecraft built in Houston.

Redwire’s ROSA technology was originally developed for the ISS, according to Space News. It has yielded a 100 percent success rate on on-orbit performance. The technology has also been used on NASA’s Double Asteroid Redirection Test mission, the Maxar-built Power and Propulsion Element for the Artemis Lunar Gateway and Thales Alenia Space’s Space Inspire satellites.

“As a market leader for space power solutions, Redwire is proud to be selected as a strategic supplier to deliver ROSAs for Axiom Space’s first space station module,” Mike Gold, Redwire president of civil and international space, said in a news release. “As NASA and industry take the next steps to build out commercial space stations to maintain U.S. leadership in low-Earth orbit, Redwire continues to be the partner of choice, enabling critical capabilities to ensure on-orbit success.”

Greentown Houston to add new AI lab for energy startups

AI partnership

Greentown Labs has partnered with Shoreless to launch an AI lab within its Houston climatetech incubator.

"Climatetech and energy startups are transforming industries, and AI is a critical tool in that journey," Lawson Gow, Greentown's Head of Houston, said in a news release. "We're excited to bring this new offering to our entrepreneurs and corporate partners to enhance the way they think about reducing costs and emissions across the value chain."

Shoreless, a Houston-based company that enables AI adoption for enterprise systems, will support startups developing solutions for supply-chain optimization and decarbonization. They will offer Greentown members climate sprint sessions that will deliver AI-driven insights to assist companies in reducing Scope 3 emissions, driving new revenue streams and lowering expenses. Additionally, the lab will help companies test their ideas before attempting to scale them globally.

"The future of climatetech is intertwined with the future of AI," Ken Myers, Founder and CEO of Shoreless, said in a news release. "By launching this AI lab with Greentown Labs, we are creating a collaborative ecosystem where innovation can flourish. Our agentic AI is designed to help companies make a real difference, and we are excited to see the groundbreaking solutions that will emerge from this partnership."

Greentown and Shoreless will collaborate on workshops that address industry needs for technical teams, and Shoreless will also work to provide engagement opportunities and tailored workshops for Greentown’s startups and residents. Interested companies can inquire here.

Recently, Greentown Labs also partnered with Los Angeles-based software development firm Nominal to launch the new Industrial Center of Excellence at Greentown's Houston incubator. It also announced a partnership with Houston-based EnergyTech Nexus, which will also open an investor lounge on-site last month. Read more here.

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

Houston medical institutions launch $6M kidney research incubator

NIH funding

Institutions within Houston’s Texas Medical Center have launched the Houston Area Incubator for Kidney, Urologic and Hematologic Research Training (HAI-KUH) program. The incubator will be backed by $6.25 million over five years from the National Institutes of Health and aims to create a training pipeline for researchers.

HAI-KUH will include 58 investigators from Baylor College of Medicine, Texas Children’s Hospital, the University of Texas Health Science Center at Houston, University of Houston, Houston Methodist Research Institute, MD Anderson Cancer Center, Rice University and Texas A&M University Institute of Biosciences and Technology. The program will fund six predoctoral students and six postdoctoral associates. Trainees will receive support in scientific research, professional development and networking.

According to the organizations, Houston has a high burden of kidney diseases, hypertension, sickle cell disease and other nonmalignant hematologic conditions. HAI-KUH will work to improve the health of patients by building a strong scientific workforce that leverages the team's biomedical research resources to develop research skills of students and trainees and prepare them for sustained and impactful careers. The funding comes through the National Institute of Diabetes and Digestive and Kidney Diseases.

The principal investigators of the project include Dr. Alison Bertuch, professor of pediatric oncology and molecular and human genetics at BCM; Peter Doris, professor and director of the Institute of Molecular Medicine Center for Human Genetics at UT Health; and Margaret Goodell, professor and chair of the Department of Molecular and Cellular Biology at Baylor.

“This new award provides unique collaborative training experiences that extend beyond the outstanding kidney, urology, and hematology research going on in the Texas Medical Center,” Doris said in a news release. “In conceiving this award, the National Institute of Diabetes and Digestive and Kidney Diseases envisioned trainee development across the full spectrum of skills required for professional success.”

Jeffrey Rimer, a professor of Chemical Engineering, is a core investigator on the project and program director at UH. Rimer is known for his breakthroughs in using innovative methods in control crystals to help treat malaria and kidney stones. Other co-investigators include Dr. Wolfgang Winkelmeyer (Baylor), Oleh Pochynyuk (UTHealth), Dr. Rose Khavari (Houston Methodist) and Pamela Wenzel (UT Health).

“This new NIH-sponsored training program will enable us to recruit talented students and postdocs to work on these challenging areas of research,” Rimer added in a release.

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