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 byMiguel 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 byMiguel 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 innovation leaders secure SBA funding to start equitability-focused energy lab

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A group of Houston's innovation and energy leaders teamed up to establish an initiative supporting equitability in the energy transition.

Impact Hub Houston, a nonprofit incubator and ecosystem builder, partnered with Energy Tech Nexus to establish the Equitable Energy Transition Alliance and Lab to accelerate startup pilots for underserved communities. The initiative announced that it's won the 2024 U.S. Small Business Administration Growth Accelerator Fund Competition, or GAFC, Stage One award.

"We are incredibly honored to be recognized by the SBA alongside our esteemed partners at Energy Tech Nexus," Grace Rodriguez, co-founder and executive director of Impact Hub Houston, says in a news release. "This award validates our shared commitment to building a robust innovation ecosystem in Houston, especially for solutions that advance the Sustainable Development Goals at the critical intersections of industry, innovation, sustainability, and reducing inequality."

The GAFC award, which honors and supports small business research and development, provides $50,000 prize to its winners. The Houston collaboration aligns with the program's theme area of Sustainability and Biotechnology.

“This award offers us a great opportunity to amplify the innovations of Houston’s clean energy and decarbonization pioneers,” adds Juliana Garaizar, founding partner of the Energy Tech Nexus. “By combining Impact Hub Houston’s entrepreneurial resources with Energy Tech Nexus’ deep industry expertise, we can create a truly transformative force for positive change.”

Per the release, Impact Hub Houston and Energy Tech Nexus will use the funding to recruit new partners, strengthen existing alliances, and host impactful events and programs to help sustainable startups access pilots, contracts, and capital to grow.

"SBA’s Growth Accelerator Fund Competition Stage One winners join the SBA’s incredible network of entrepreneurial support organizations contributing to America’s innovative startup ecosystem, ensuring the next generation of science and technology-based innovations scale into thriving businesses," says U.S. SBA Administrator Isabel Casillas Guzman.

Grace Rodriguez (left) and Juliana Garaizar have partnered up — along with their teams — to collaborate on the Equitable Energy Transition Alliance and Lab. Photos courtesy

Houston fitness entrepreneur serves up smart baby gear line

betting on bibs

Ashley Gooch has taken her entrepreneurial spirit from the fitness studio to the finger foods.

The Houston-based founder of high-end cycling studio RYDE and mom of three has launched a new baby gear brand, Babynetic. The company debuted its first product this month: the Babynetic bib.

Using a patented magnetic closure, the colorful platinum-grade silicone bibs are designed to snap and stay secured while holding up to four pounds of food. The snap is intended to be easy for parents to use, but more difficult for messy little hands to remove without assistance.

Thanks to their magnetic snap, the bibs can also be stored or hung on the fridge or dishwasher for easy access for busy parents and caregivers. The smooth silicone (free of BPA, BPS, phthalate and PVC) is intended to be easy to wipe down and clean and comes in a variety of bold fruit-inspired colors.

The product was born out of necessity for Gooch and her Austin-based business partner and fellow mom Jennifer Zimmer. The duo met while attending Texas A&M University. Zimmer currently works full-time as a customer success manager for the Central South region at California-based software development firm Workday, according to her LinkedIn.

“As busy moms ourselves juggling careers and with five kids between us, we needed baby gear we could rely on,” Gooch said in a statement.

“All of our kids could pull of their bibs at mealtime,” Zimmer added.

Gooch and Zimmer worked with product Los Angeles-based full-stack produce development company Mvnifest to prototype and build the line. Mvnifest was launched by Samantha Rose, founder and CEO of Sorry Robots, who got her start designing a silicone kitchen spatula, eventually growing into a full line of kitchen tools known as the brand GIR.

Babynetic is currently taking orders for the Babynetic bibs on its website, and shipping began last week on April 24. By Spring 2025, the team aims to release baby onesies that feature their patented magnetic closure.

“We wanted people to use Babynetic products and think, ‘This is so much better,’” Gooch said.

Ashley Gooch (right) co-founded the company with Austin-based business partner and fellow mom Jennifer Zimmer. Photo courtesy of Babynetic

3 Houston innovators to know this week

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Editor's note: Every week, I introduce you to three Houston innovators to know recently making headlines with news of innovative technology, investment activity, and more. This week's batch includes a podcast with an angel investment evangelist, an academic-turned-startup-founder celebrating a big win, and a leader of a brand new accelerator.

Mitra Miller, vice president and board member of the Houston Angel Network

Mitra Miller, vice president and board member of the Houston Angel Network, joins the Houston Innovators Podcast to share her passion for growing angel investors in Houston. Photo via LinkedIn

One of the biggest components of a well-functioning startup ecosystem is inarguably access to capital, and Mitra Miller is dedicated to enhancing education around investment and growing Houston's investor base.

As vice president and board member of the Houston Angel Network, the oldest angel network in Texas and one of the most active angel networks in the country, Miller strives to provide guidance to new and emerging angel investors as well as founders seeking to raise money from them.

"Most founders have no idea or understanding of how investors think — we are not an ATM," Miller says on the Houston Innovators Podcast. "We are really partners you are getting married to for the next 5, 8, 10 years — sometimes longer. We need to bring your allies in every sense of the word." Continue reading.

Richard Baraniuk, Rice University professor and founder of OpenStax

At an event at the Ion, OpenStax and Rice University announced a $90 million NSF-backed initiative. Photo by Jeff Fitlow/Rice

An educational technology company based out of Rice University has received $90 million to create and lead a research and development hub for inclusive learning and education research. It's the largest research award in the history of the university.

OpenStax received the grant funding from the U.S. National Science Foundation for a five-year project create the R&D hub called SafeInsights. Richard Baraniuk, who founded OpenStax and is a Rice professor, will lead SafeInsights. He says he hopes the initiative will allow progress to be made for students learning in various contexts.

“Learning is complex," Baraniuk says in the release. "Research can tackle this complexity and help get the right tools into the hands of educators and students, but to do so, we need reliable information on how students learn. Just as progress in health care research sparked stunning advances in personalized medicine, we need similar precision in education to support all students, particularly those from underrepresented and low-income backgrounds.” Continue reading.

Carlos Estrada, head of venture acceleration at BioWell

Calling all biotechnology startups. Photo via LinkedIn

A Houston organization — freshly funded by a $700,000 U.S. Economic Development Administration’s “Build to Scale” grant — is seeking its first accelerator cohort of industrial biology startups.

Founded by Houston-based First Bight Ventures, the BioWell has launched a virtual accelerator program that will provide programming, networking, mentorship, and financial resources to its inaugural cohort of 10 bioindustrial startups. The selected companies will also have access to specialized pilot bioproduction infrastructure throughout the nine-month program.

“BioWell equips startups with more than just capital. We provide a foundation for breakthrough innovations by combining access to cutting-edge bioproduction facilities with expertise that nurtures scalability. This comprehensive support is crucial for transforming pioneering ideas into market-ready solutions that can address pressing global challenges,” Carlos Estrada, head of venture acceleration at BioWell, says in a news release. Continue reading.

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