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 researchers develop dissolvable implant for targeted cancer drug delivery

cancer research

Researchers at Houston Methodist have developed a biodegradable implant that can be used to safely and consistently deliver drug treatments to tumors and then dissolve without the need for further surgery.

The implant is only the size of a grain of rice, but its potential is staggering. The biodegradable nanofibrous drug-eluting seed (b-NDES) works as a reservoir parked inside a soft tumor, where it can slowly release immune-stimulating drugs over time. This overcomes a consistent problem with drugs such as immune checkpoint inhibitors. Normal systemic administration sees comparatively little of the drug making its way to the tumor, with most of it circulating throughout the body. The b-NDES is like deploying a small guerrilla fighting force embedded in enemy territory, doing maximum damage to the entrenched tumor.

"To improve cancer treatment, we're trying to start a fire inside the tumor itself," Corrine Chua, associate professor in the Center for BioNanoengineering at Houston Methodist Research Institute, said in a news release. "By activating immune cells directly within the tumor microenvironment, those cells can then travel throughout the body and seek out cancer wherever it exists. The b-NDES platform was developed to help keep therapeutic drugs concentrated inside tumors while minimizing exposure to healthy tissues.”

Chua co-led the study with Alessandro Grattoni, chair and director of the Center for BioNanoengineering at Houston Methodist Research Institute.

The study included support from the Nancy Owens Breast Cancer Foundation and the National Institutes of Health/National Cancer Institute.

Chau and Grattoni used preclinical models of triple-negative breast cancer, an aggressive form of cancer that is estrogen receptor-negative, progesterone receptor-negative and HER2-negative. Because of the receptor negativity, some popular treatments like tamoxifen and trastuzumab are ineffective. Chemotherapy has been shown to be the best course of action.

The b-NDES implant is deployed alongside radiation drugs. It keeps the drugs focused on the tumor, reducing the amount of harmful side effects typically seen when drugs are circulated more widely in the body. In 60 percent of the models, tumors were eliminated and did not cause side effects beyond the tumor site. Once the drugs have been deployed, the implant breaks down naturally.

While promising, more research will have to be done to expand use to other tumor types.

"Although the study focused on triple-negative breast cancer models, the approach could have broader applications for solid tumors," Grattoni added in the release. "It could potentially be used in cancers where there is a tumor lesion accessible for placement, including pancreatic or lung cancers."

New Houston platform Same Day Reels launches for on-demand content creation

In The Moment

If an event doesn't happen on Instagram, did it even really happen? In today's social media-driven age of branding and audience engagement, the answer increasingly is no.

Houston entrepreneur Karen De Amat is looking to fill the online content creation needs of companies with her new venture, Same Day Reels, which launched in early August. It will serve as a platform to connect companies and brands with talent that can help turn an event into a viral moment as it is happening.

"Events move quickly, and social media moves even faster,” said De Amat. “Same Day Reels was built to help brands capture the moment while it still matters. We are creating a more efficient way for businesses and creators to work together. Brands need content faster, and creators need more opportunities to turn their talent into real work. Same Day Reels brings those needs together.”

The company is focused on adding livestreams and concurrent short video content to "activations, launches, fundraisers, grand openings, conferences, hospitality experiences, and private celebrations." Such content can significantly increase the visibility of a product or brand according to digital marketing brands like Wyzowl, whose data found 63 percent of people in 2026 prefer to learn about new products via short video.

Packages offered by Same Day Reels will include filming, editing, and publishing content within hours of the targeted event.

De Amat says that her content creation platform will be a way to preserve the excitement of events and launches by enshrining them with immediate social media-driven memories.

“Event content is no longer just something you post after the fact,” De Amat said. “It is part of how people experience, remember and share the moment.”

Previously, De Amat is also the founder and CEO of Social Behavior, an influencer marketing company she launched from her home in 2014. It quickly garnered an array of clients and thrust De Amat into the spotlight, including numerous appearances on Fox 26's The Isiah Factor. Influencer Marketing Hub named her one of the top CEOs of influencer marketing companies in Houston in 2025.

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This article originally appeared on CultureMap.com.

Bristol Myers Squibb to build $2.3B Houston pharma manufacturing campus

coming soon

New Jersey-based pharmaceutical giant Bristol Myers Squibb Co. has officially named Houston as the home of its new state-of-the-art manufacturing site.

The 60,000-square-foot facility represents a $2.3 billion investment, according to a news release. It is expected to create 500 skilled jobs and will be located in Houston's Generation Park.

BMS first announced that it was considering Houston among 16 other cities for the facility in May. The new hub will manufacture small molecule, biologic and antibody-drug conjugates and is part of a $40 billion commitment to invest in the United States over five years. Construction is slated to begin next year, with the facility coming online in 2030.

"We're building the domestic manufacturing capabilities needed to deliver the next generation of medicines and support future scientific breakthroughs. Houston and the state of Texas offer the talent, infrastructure, and partnership needed to help bring that vision to life," Christopher Boerner, CEO and board chair of BMS, said in the release.

The new facility will feature a modular, multi-modal design, which will allow the company to reconfigure and add to its manufacturing capabilities over time. BMS says it expects the facility to "(grow) in scale and capability well beyond its opening configuration."

"Our decision to build this state-of-the-art manufacturing campus in Houston, Texas, reflects our confidence in the region’s ability to support a world-class, digitally advanced supply operation,” Karin Shanahan, EVP and chief supply chain and operations officer of BMS, added in the release. “This facility is designed to deliver the speed, quality, and reliability that patients depend on, combining flexible, modular manufacturing with advanced digital capabilities to ensure consistent supply across multiple modalities. It strengthens our ability to operate with resilience and positions us to reliably deliver medicines to patients today while adapting future demands.”

Texas Gov. Greg Abbott shared that the state has granted BMS a $4.89 million Texas Enterprise Fund (TEF) grant for the project. TEF grants, administered by the Texas Economic Development & Tourism Office, support business relocation or expansion projects that create "new, good-paying jobs in the community and attract significant new capital investment to the state." The development is also a qualified project under the Texas Jobs, Energy, Technology, and Innovation (JETI) program.

“Texas is a global hub for life sciences, where today’s innovations shape the future of healthcare,” Abbott said in a news release. “This $2.3 billion investment by Bristol Myers Squibb in the dynamic biotech ecosystem in Houston is a testament to the depth of our skilled workforce and the pipeline of talent coming through our nation-leading technical colleges and research universities. With lower operating costs and easy access to markets across the U.S. and the world, Texas drives affordability for consumers.”

"Bristol Myers Squibb’s announcement is a tremendous win for Texas and the Houston region, further reinforcing our position as a premier destination for life sciences and advanced manufacturing,” added Greater Houston Partnership President and CEO Steve Kean.

Last fall, Eli Lilly and Co. selected Generation Park, a 4,300-acre, master-planned commercial district near Lake Houston, for its $6.5 billion manufacturing plant. More than 300 locations in the U.S. competed for the factory. Read more here.