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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Pioneering cohousing development opens in Houston's historic 2nd Ward

Housing in Hou

An experimental, multi-generational building in the East End is now open and accepting residents. Only 10 of the 33 units remain available at East End Commons, the first project from CoHousing Houston.

Located at 115 Lenox, East End Commons was first conceived in 2017 and is designed to combine the security of home ownership with the community aspect of apartment life, essentially a condominium but with added focus on bringing neighbors together.

Units range from 900-2,000 square feet, offering ample private home space, but with a large Common House area and central courtyard for gatherings, working, and interaction. Large front porches encourage people to spend time outside where they can meet their neighbors, as do extensive foot paths for casual meetings.

"At East End Commons, you know your neighbors before you move in — so you have a network of people and spaces that are immediately there for you," said founding resident Kelli Soika. "We designed for larger shared spaces versus larger personal spaces in order to foster the breakdown of the barriers that lead to loneliness."

Combating loneliness and isolation is certainly necessary. A 2025 survey conducted by the American Psychological Association shows that most Americans feel a sense of societal division and lonely. A loss of "third spaces," where people gather outside the home or work, is a prime factor. East End Commons aims to alleviate some of that disconnectedness.

"I wanted to live in a neighborhood that is imbued with a sense of community above the individual, like we have all experienced in Houston during times of disaster recovery," said Lynn Morstead, one of East End Commons‘ founding residents. "In those instances, such as Hurricane Harvey, we surface from our separateness and come together in new and unexpected ways. With East End Commons, the goal is to translate that notion beyond a set period of time and make it a fixture of everyday life. I call it 'disaster-free neighborliness.'"

East End Commons was designed by Kathleen English of English + Associates. Sustainability is part of the project's design, with amenities such as geothermal heating and cooling exchange HVAC, pre-heated water systems, low-energy use air conditioning and heating, and native landscaping.

Prices for units range from $300,000 to the $900,000s, which can be more than double the home price in the rapidly gentrifying East End. HOA fees not only help maintain communal areas, they also cover shared internet, water, and other communal expenses. Similarly, government of the building is handled democratically via a community board that aims to make decisions by building consensus.

For more information, email info@cohousinghouston.com or call 832-900-2919.

MD Anderson president to retire after nine years, interim successor named

retirement plan

An era is ending at The University of Texas MD Anderson Cancer Center.

On Aug. 26, Dr. Peter WT Pisters announced his plans to retire from his role as president of the comprehensive cancer center. He will work on a smooth transition of leadership with interim president Dr. Jeffrey E. Lee throughout September.

“I first arrived at UT MD Anderson 32 years ago with a passion for doing everything I could to advance our mission to end cancer. Serving as the only faculty member to become president, and now marking nine years in the role, I can say with great pride and gratitude that there is no better place than UT MD Anderson to turn hope into healing for patients and families everywhere,” Pisters said in a news release. “With a timeless strategy, a strong leadership team, unprecedented levels of financial health, and a priceless culture anchored in our deeply held Core Values, now is the right time for me to transition to other opportunities. UT MD Anderson has never been stronger, and its future has never been brighter.”

Pisters assumed the presidency in 2017 and helped launch some of the most cutting-edge new clinics in MD Anderson history. One of those was the James P. Allison Institute, named for the Nobel Laureate scientist who discovered a way to suppress immune response on tumors so that immune cells would attack cancer cells instead. As head of his titular clinic, Allison pioneered several new immunotherapies against cancer.

Pisters also oversaw the creation of the Institute for Data Science in Oncology in 2024, an innovative consortium of scientists dedicated to enhancing single-cell imaging to improve precision in cancer treatments. The institute also brought together teams to use data-driven analytics regarding safety, quality and access.

The UT System Board of Regents praised the leadership and work of Pisters in a statement, wishing him well in the next phase of his career.

“The Board of Regents and I are profoundly grateful to Dr. Pisters for his exceptional presidency over the past nine years and for thoughtfully concluding his service when UT MD Anderson is thriving at its best position of peak performance, strength and impact. We wish him our very best with his retirement and in his next chapter,” Kevin P. Eltife, chairman of the UT System Board of Regents, added in the release.

Houston e-commerce giant Cart.com launches government-focused subsidiary

government branch

Houston e-commerce and logistics unicorn Cart.com has launched a new subsidiary.

Cart Government Solutions (CGS), which was announced earlier this week, will provide supply chain and logistics services and software for the federal and state government sectors. The new subsidiary will be headquartered in Washington, D.C., and operate out of about 6 million square feet of secure warehouse space across 14 U.S. facilities, according to a news release from Cart.com. It will support both domestic and overseas logistics.

Industry veteran Gregg Zegras will lead the new entity as president. Zegras previously served as Cart.com's chief revenue officer, according to LinkedIn. Before that, he served as president of Connecticut-based Pitney Bowes Global eCommerce, a digital shipping solutions company.

Remington Tonar, Cart.com's co-founder, will serve as CGS's chief innovation officer.

“Government agencies face procurement and logistics challenges that many commercial platforms simply weren’t built to solve,” Zegras said in the news release. “Cart Government Solutions exists to change that. We’re combining the speed and innovation of a technology company with the compliance rigor, security, and operational depth that federal and state customers require, and we’re doing it with a team that has spent careers working alongside and inside these agencies.”

According to the company, CGS will focus on meeting compliance and security requirements in the public sector. Some of the services the new entity will offer include:

  • Inventory management
  • Cold-chain and specialty storage for pharmaceuticals, medical devices and regulated goods
  • Enterprise-grade supply chain software
  • Government-compliant webstores and online ordering portals
  • Cybersecurity operations

Cart.com has been serving the public sector since 2022, when the company began distributing COVID-19 health supplies nationwide, according to the news release. Through that pandemic-era contract, the company reports it moved more than 725 million units, with an average of under two days per shipment.

Cart.com was founded in Houston in 2020, though it briefly moved its headquarters to Austin. The company reached unicorn status with its $60 million Series C raise in 2023. It most recently raised $180 million in growth capital from private equity firm Springcoast Partners in March, which put the startup over the $1 billion in fundraising mark in just six years.

At the time, Cart.com said it planned to scale its logistics network, expand AI capabilities and develop workflow automation tools.

Houston-based KBR Inc. also recently launched a government services spinoff. Read more here.