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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New UH survey reveals concerns over AI data center growth in Houston

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A new report out of the University of Houston shows that area residents remain wary of the long-term effects of operating data centers.

The recent survey from the University of Houston’s latest SPACE City Panel, conducted by the Center for Public Policy at the Hobby School of Public Affairs, shows that while 85 percent of Houston-area residents use AI, nearly 63 percent oppose the construction of AI data centers within 1 mile of their homes.

Respondents’ concerns centered around data centers’ high energy demand and the area’s power grid reliability. According to the survey, 32 percent of residents who oppose local data center projects would be more likely to support the centers if they relied on renewable energy over fossil fuels.

“Respondents understand that AI can bring economic and educational benefits, but they are also concerned about the physical infrastructure needed to fuel AI, especially data centers,” Soran Mohtadi, post-doctoral fellow at the Hobby School and a researcher on the report, said in a news release. “This physical infrastructure demands more electricity and water, leading to environmental impacts.”

Experts estimate that 6.5 gigawatts of data center capacity will be added to the Texas grid by 2030. And Houston’s data center capacity is predicted to more than double by 2028.

The Electric Reliability Council of Texas also projects electricity demand could reach 218 gigawatts by 2031, which would be more than double the record peak set in August 2023. Data centers are expected to account for 86 gigawatts of that new demand.

Survey respondents also said they are concerned about the state's future water supply, given the large amounts of water that data centers need to stay cool.

In terms of who’s responsible for that issue, 57.6 percent of respondents said they put the onus on Texas lawmakers, while 31.5 percent say tech companies should be responsible.

Additionally, more than 75 percent of respondents believed that data center developers and technology companies—not residents—should bear the cost of infrastructure upgrades to support data centers.

“Every decision legislators make has implications on residents’ everyday lives and local infrastructure now and in the future,” Maria P. Perez Arguelles, lead researcher on the report and research assistant professor at the Hobby School, added in the news release. “This issue is going to become more important in years to come, so this is just the beginning.”

Read the full report here.

Houston-born Cemvita makes breakthrough in sustainable fuel production

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Houston-based biotech company Cemvita announced that it recently reached a critical milestone in the development of its FermOil product, which can be used to create Sustainable Aviation Fuel (SAF) and other renewable fuels at industrial scale.

The company shared in a news release that it completed a 75,000-liter industrial fermentation run at Belgium's Bio Base Europe Pilot Plant.

The campaign achieved target technical metrics for the production of FermOil, Cemvita’s renewable natural oil (RNO). FermOil is produced from industrial crude glycerin, an industrial byproduct, as opposed to traditional sugar-based feedstocks used in many bio-oil fermentation processes. It's designed to be a drop-in feedstock for creating SAFs.

Cemvita had previously advanced its FermOil production process through multiple scale-up stages before successfully reaching the 75,000-liter demonstration campaign, according to the company.

“This is not just a fermentation milestone,” Moji Karimi, CEO at Cemvita, said in the release. “It is a blueprint for how existing industrial infrastructure can evolve into circular bioeconomy infrastructure. Every biodiesel plant generating crude glycerin is a potential platform for renewable natural oil production.”

The milestone also supports the deployment of Cemvita’s industrial biomanufacturing platform, FermWorks, which integrates with existing energy and industrial infrastructure to turn waste carbon streams into SAFs and other materials. According to the release, Cemvita plans to move forward with commercial deployment discussions with partners in Brazil, Europe and in the UK. Cemvita already has a partnership with the Brazilian sustainable research institution REMA.

“We are proud to support innovative companies like Cemvita in scaling breakthrough industrial biotechnology solutions,” Hendrik Waegeman, head of business operations at Bio Base Europe Pilot Plant, added in the release. “Successfully operating at the 75,000-liter scale using a feedstock such as crude glycerin highlights both the maturity of the technology and the quality of the scale-up execution achieved by the Cemvita team.”

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

Eli Lilly scoops up Houston biotech startup in $300 million deal

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Pharmaceutical giant Eli Lilly has acquired Houston biotech startup CrossBridge Bio, which develops antibody-drug conjugates for cancer, in a deal worth up to $300 million. The deal was celebrated by TMC Venture Fund and the University of Texas Health Science Center at Houston last week.

CrossBridge, founded in 2023, is developing ADCs based on research by Kyoji Tsuchikama and Zhiqiang An, both of UT Health Houston. Tsuchikama is an associate professor of medicinal chemistry and a globally recognized ADC pioneer, and An is a professor of molecular science and vice president of drug discovery.

Antibody-drug conjugates (ADCs) are a potent combination of targeted therapy and chemotherapy that kills cancer cells while saving healthy tissue.

Clinical trials for CrossBridge’s primary ADC candidate, CBB-120, are expected to start this year, pending approval from the U.S. Food and Drug Administration (FDA).

“I’m proud of how well our team has executed and advanced our platform in such a short time since the company’s founding,” Michael Torres, co-founder and CEO of CrossBridge, said in a news release. “By becoming a part of Lilly, a leader in patient-focused therapeutic development, we are well-positioned to further accelerate the clinical potential of this approach.”

Under the Lilly deal, CrossBridge shareholders were expected to receive an upfront payment along with a follow-up payment based on the achievement of certain milestones.

In 2024, CrossBridge closed a $10 million seed round. Among the investors in CrossBridge are the Texas Medical Center Venture Fund, CE-Ventures, Alexandria Venture Investments, Portal Innovations, Linden Lake Labs, and the Cancer Prevention and Research Institute of Texas (CPRIT). It was formed in TMC Innovation’s Accelerator for Cancer Therapeutics program."Built within the TMC ecosystem, CrossBridge Bio grew with the support, funding, and resources that helped shape its trajectory. TMC led the company's early financing and watched it evolve from its earliest days to its acquisition by Eli Lilly," William McKeon, president and CEO of the Texas Medical Center, shared in a LinkedIn post. "[This is a] strong reminder that breakthrough science and the right early backing can change what’s possible."
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