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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Baylor College of Medicine launches VC fund to invest in biotech startups

fresh funding

Houston’s Baylor College of Medicine just unveiled a new venture capital fund that backs early-stage biotech startups—and it’s already made its first investment.

BCM Legacy Fund I, funded by philanthropies, invested an undisclosed amount in Houston biotech startup Nemea Therapeutics. Nemea, a spinout of the Baylor College of Medicine and Germany’s Lead Discovery Center, is developing an oral drug to treat metastatic triple-negative breast cancer that no longer responds to currently available therapies.

This type of aggressive cancer spreads from the breast to other areas of the body, such as the bones, liver, lungs or brain. Roughly 38,000 to 57,000 Americans are diagnosed each year with metastatic triple-negative breast cancer. One study showed about half of patients survive past the one-year mark following diagnosis and about one-third survive two years.

“Baylor College of Medicine’s laboratories produce discoveries with the potential to change patients’ lives, and too many of them stall where academic funding ends and private investment has not yet begun,” Dr. Jakub Tolar, president, CEO and executive dean of the Baylor College of Medicine, said in a press release. “The BCM Legacy Fund fills that gap, giving our scientists a path to advance their discoveries to patients.”

The National Institutes of Health awards more than $36 billion per year for biomedical research in the U.S., Baylor said. But some biomedical discoveries “never leave the starting line because they don’t yet fit the economics of venture capital,” the college said.

“The forefront of a new model”

The BCM Legacy Fund aggregates philanthropic capital from private foundations and donor-advised funds. It then invests in startups so they can move beyond that starting line and into later-stage investment rounds. The Greater Houston Community Foundation is the fund’s philanthropic partner.

“It’s exciting to be on the forefront of a new model for philanthropic capital,” said Houston entrepreneur and investor Burton Hanson, managing partner of the fund.

“Not only do we hope to solve a real problem by advancing these therapies to the patients who need them most, but we also hope this model will inspire others in the city and beyond toward philanthropic creativity and a posture of ‘I sacrifice; we win.’”

The fund expects to invest in about 15 early-stage startups over a five-year span. Baylor declined to divulge the amount of money in the fund and the size of the investment in Nemea.

Nemea’s “world-class chemistry”

Hanson oversees the Baylor fund alongside Chicago investor Steve Lehmann, who led the University of Chicago’s Innovation Fund.

Lehmann said Nemea, the fund’s first portfolio company, “has world-class chemistry, Baylor biology, and patients with no good options. Our job is to fund the experiments that carry it to the next handoff, so that industry and later-stage investors can take it from there.”

Based at Houston’s massive Texas Medical Center, Nemea plans to start clinical trials next year in collaboration with Baylor’s Lester and Sue Smith Breast Center.

Nemea previously received $9 million from the Lead Discovery Center and a $1.6 million grant from Baylor. Last year, the startup said it was seeking $25 million to $30 million in seed and Series A funding.

Debra McCoy of Houston, a former managing director at BlackRock and former partner at Bain & Co., and Paul Thomas, co-founder and CEO of Spring-based benefits manager Luscinia Health, sit on the Baylor fund’s governing board. Dr. Paul Klotman, former president, CEO and executive dean of Baylor, is a senior strategic adviser.

How does the fund find investment targets?

The Baylor Legacy Fund relies on two tools to help unearth early-stage biotech startups:

  • High-resolution “innovation maps” of research institutions. These maps surface hidden clusters of innovation, identify rising-star researchers and tie pockets of “innovation supply” at Baylor to areas of “innovation demand” in biotech.
  • AI-enhanced due diligence. AI agents assist with due diligence of early-stage biotech startups. The fund says the platform “distills the frameworks we’ve developed over a decade of teaching and investing into a flexible … diligence environment.”

MD Anderson unveils $3.4B expansion with two new Houston cancer care facilities

major expansion

The cutting edge of cancer-fighting technology and science is getting even sharper after MD Anderson announced last week that it will open two new facilities in the Texas Medical Center within the next five years. Inspiration Tower and Prism will expand MD Anderson’s annual patient load in the TMC to 250,000 annually and will incorporate a variety of new techniques.

The $3.4 billion project will add 2 million square feet to MD Anderson's TMC footprint, bringing its total campus size to 22 million square feet by 2032. Located at the corner of Fannin Street and Holcombe Boulevard, the cancer center says the two new facilities will serve as its new "front door" to the TMC.

“Every detail of these buildings, from the technology to the treatment rooms, was designed around our patients who will receive their care in them and our employees who will work in them. The facilities will serve as a physical representation of hope for the patients and their families who will walk through the doors,” Dr. Jeffrey E. Lee, president ad interim of UT MD Anderson, said in a news release. “Inspiration Tower and Prism are the future of cancer care, and we are grateful for the longstanding support and guidance we’ve received from the UT System Board of Regents to bring these projects to life. These facilities are part of the most impactful capital expansion in UT MD Anderson’s history.”

Prism is especially exciting as it will represent fully half of the linear accelerator treatment in the TMC. Linear accelerator is a radiation treatment that uses magnetically charged fields to deliver targeted external radiation therapy, like shooting cancer with a rail gun. The treatment is safer and has fewer side effects than older radiation treatments.

In addition, Prism will contain 12 MRI machines, four CT scanners, two PET-CT units, 18 radiation vaults and seven radiation simulators. Patient comfort has also been put at a premium with multiple gardens and roof overlooks.

“Every patient we treat deserves an environment that reflects the excellence of the care they receive at UT MD Anderson,” Chris McKee, executive vice president and chief strategy officer at UT MD Anderson, added in the release. “Our new facilities will be innovative, agile, adaptable and beautiful, and they will allow us to care for more patients, more effectively – in an environment that enhances healing and well-being. We are building for our future and for every patient who will be counting on us.”

Prism is slated to open in 2030.

Inspiration Tower will have 25 floors of surgical, diagnostic, and treatment services. At 1.4 million square feet, it’s currently expected to be the largest cancer-specific treatment facility in the United States. The tower will be divided into units for specific types of cancer, making it easy to integrate the advancing research being done all over Houston.

Like Prism, Inspiration Tower is specifically designed to offer comfort and reassurance, with more garden space, terraces, and beautiful scenery to ease patient distress. It is expected to open in 2032.

Tesla will pull the plug on Cybertruck production at Texas factory in 2027

Tesla Talk

Tesla’s Cybertruck, the hulking, stainless-steel pickup that inspired devotion and derision with its science-fiction looks, will cease production next year.

CEO Elon Musk announced the model’s demise Friday, November 6, with a curt post on X, his social media site, simply noting production of the vehicle “will be winding down” around the middle of 2027 at its facility outside Austin, Texas. Musk said the move was to allow increased production of its Cybercab robotaxi.

For the Cybertruck, a pet project of Musk who insisted it was Tesla’s best product, it marks an unceremonious end to one of the auto industry’s most ballyhooed debuts.

“Few vehicles in history have generated as much attention,” said Armen Hareyan, whose Torque News site covers autos. “The Cybertruck became a cultural symbol – loved, mocked and impossible to ignore.”

The Cybertruck rolled onto the scene in a dramatic unveiling in 2019, when a Tesla designer hurled a metal ball at the vehicle to demonstrate its supposedly unbreakable glass, only to see it shatter. He repeated the stunt on another window of the truck only to shatter that one, too.

Even as some critics scoffed, Musk was steadfast.

“I just wanted to make a futuristic battle tank — something that looks like it could come out of ‘Blade Runner’ or ‘Aliens’ or something like that but was also highly functional,” he told Automotive News. He called it “a better sports car than a Porsche 911” and “a better truck than an F-150.”

It struck some as the perfect vehicular reflection of the brash, convention-busting Musk.

“A really controversial vehicle unveiled by a controversial individual into a market where none of the electric trucks have been able to really capture demand,” said Spencer Penn, a former Tesla executive who left the company before the Cybertruck’s launch and now heads software developer LightSource.

Penn remembered watching the unveiling and feeling initially revolted by the sight of the Cybertruck, calling its appearance “madness.” But the more he looked at it, the more his opinion changed. He signed up for a pre-sale reservation, though ended up not getting a Cybertruck when Musk’s promises of a price tag under $40,000 went unmet and the first trucks sold for double or more. Penn called the Cybertruck part of Tesla’s adventurous spirit that drives innovation.

“Some of these bets work and some of these bets don’t,” he said.

While the decision to end Cybertruck production may be driven by sales realities, it's also a reflection of Tesla’s shift to autonomous vehicles, on which Musk is betting the company’s future.

Musk once forecast he’d make 250,000 Cybertrucks a year. Kelley Blue Book estimated Tesla sold just 20,237 of the vehicles last year, down about half from the year prior. Sales through the end of September this year were down another 28%, according to Kelley Blue Book.

If the imposing, sharp-angled, dystopian appearance of the Cybertruck weren’t enough to turn many potential buyers away, Musk did so himself by allying with a panoply of right-wing figures, most notably U.S. President Donald Trump. He alienated some customers as his image morphed from eccentric innovator to polarizing force trading his billions for political influence.

Once-passionate Tesla drivers rushed to sell off their cars, or slapped stickers on the bumper declaring, “I bought this before Elon went crazy.” Organizers staged demonstrations outside Tesla showrooms and urged investors to dump shares of the company’s stock. Anger spilled into violence, with Molotov cocktails hurled at Tesla vehicles, charging stations set ablaze, and dealerships covered in graffiti.

Lovers of the Cybertruck became targets, too, subjected to shouts of “Nazi!” and extended middle fingers.

Ross Blankenship is one of them. When he first laid eyes on the Cybertruck, he felt transported to a world from his childhood, when he would play “Halo,” the sci-fi video game. He had to have it.

“I had that sort of child in me wanting to be part of something cool that would change the future of automotive,” Blankenship said in a call from his Cybertruck as he drove through Sunnyside, Colorado. Even as Blankenship found he agreed with Musk on politics, he hated seeing a vehicle he loved turned into a political symbol. “I never bought it for any other reason than the fascination with the future technology of trucks … so that was a little heartbreaking.”

He would buy another Cybertruck again in a heartbeat, calling its end “a sad moment.”

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