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

houston voices

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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7+ can't-miss Houston business and innovation events in June 2026

where to be

Editor's note: The FIFA World Cup comes to Houston this month, joined by major energy conferences and a lineup of fan-favorite, recurring events. Here’s what not to miss and how to register. Please note: this article may be updated to add more events.


June 1-4 — CLEANPOWER 2026 Conference and Exhibition

CLEANPOWER unites policymakers, experts, and corporate leaders to solve the challenges that none can solve alone. This must-attend, four-day conference is packed with cutting-edge discussions about wind, solar, storage, and transmission; dealmaking; networking; and fun.

This event begins June 1 at the George R. Brown Convention Center. Register here.

June 2 — Humans of Healthcare

Houston Methodist Center for Innovation will present its quarterly speaker series, Humans of Healthcare. The series will feature a panel of experts who will share about their career paths and discuss the nuances of the health care industry. This month's session will focus on today’s nursing landscape, the industry’s expectations of nurses and what career paths are possible in the field.

The event is Tuesday, June 2, from 5-6:30 p.m. at the Ion. Register here.

June 9 — Greentown Go Make Kickoff

Head to the Ion to celebrate the Greentown Go Make 2026 cohort. The open-innovation program with Shell Catalysts & Technologies and Technip Energies focuses on catalytic solutions for industrial decarbonization and the energy transition. Hear pitches from the founders and network with a select group of startups while enjoying food and drink.

This event is Tuesday, June 9, from 5:30-8 p.m. Register here.

June 9-10 — Texas Brain Economy Summit

The Center for Houston’s Future and UTMB are bringing the Texas Brain Economy Summit back to Houston this summer to continue to position the region as a global leader in brain health. Expect to hear from leaders of global institutions, including the World Economic Forum, U.S. Chamber of Commerce, McKinsey Health Institute, Global Brain Economy Initiative, Davos Alzheimer’s Collaborative, Business Collaborative for Brain Health (UsAgainstAlzheimer’s), Rice University, Memorial Hermann, MD Anderson and many others. Read InnovationMap's full preview of the event here.

This event begins Tuesday, June 9. Purchase tickets here.

June 10 — MIT Future of Healthcare Technology Forum

The MIT Club of South Texas will host an in-person forum to explore how innovation, government and policy are changing the healthcare industry. The event will feature MIT alumni and Houston healthcare leaders, including Dr. Tim Boone, dean of the Texas A&M School of Engineering Medicine; Cynthia Reinhart-King, chair of bioengineering at Rice University; Dr. Tony Lin, CEO and chairman emeritus of Kelsey-Seybold Clinic; and others.

This event is Wednesday, June 10, from 5:15-8:30 p.m. at the TAMU EnMed Building. Register here.

June 11 — Goals & Gigawatts: Houston Energy & Climate Week The Power of & Kickoff Party

Come watch the Mexico City FIFA opening match while celebrating energy and innovation at the Goals & Gigawatts Kickoff Party. The event will feature food, drinks, and a showcase on Houston Energy & Climate Week. Learn what to expect and how to get involved in HECW before closing the night with a DJ and karaoke.

This event is Thursday, June 11, from 1:30-6:30 p.m. Find more information here.

June 16-17 — Energy Projects Conference & Expo

The Energy Projects Conference & Expo (EPC Show) is the largest event in North America for professionals working at the heart of major energy projects. The essential event for engineering, construction, commissioning, operations and maintenance across multiple energy sectors brings together five leading conferences under one roof. Conference subjects span LNG exporting, hydrogen and ammonia, midstream, petrochem and refining, and sustainable aviation fuels.

This event begins June 16 at George R. Brown Convention Center. Register here.

June 25 – NASA Tech Talk

Every fourth Thursday of the month, NASA experts, including longtime engineer Montgomery Goforth, present on technology development challenges NASA’s Johnson Space Center and the larger aerospace community are facing, and how they can be leveraged by Houston’s innovation community. Stick around after for drinks and networking at Second Draught.

This event is Thursday, June 25, from 6-7 p.m. at the Ion. Register here.

Houston researchers report promising first in-human trial for implantable cancer therapy

cancer breakthrough

When it comes to cancer remedies, the treatment can be as challenging for the body as its cause. But what if immunotherapy could be localized? That’s precisely what a Houston team may soon make a reality.

Rice University researchers, in partnership with MD Anderson Cancer Center, recently published their findings from the first in-human trial of an implantable cancer-fighting treatment in the journal Clinical Cancer Research. The paper details testing of AVB-001, encapsulated cells engineered to release interleukin-2 (IL-2)—a naturally occurring signaling protein that boosts immunity—in the peritoneal cavities of 14 patients. The goal is to avoid the toxicity usually experienced with less targeted treatments, as well as find a solution to IL-2s’ abbreviated half-lives.

“Traditional IL-2 therapy has shown potent antitumor activity, but its clinical use has been limited by severe side effects and delivery challenges,” Omid Veiseh, director of the Rice Biotech Launch Pad, professor of bioengineering at Rice and a senior author on the study, said in a press release. “This platform allows us to localize and sustain cytokine exposure directly where tumors reside while minimizing systemic toxicity.”

Serous ovarian carcinoma is especially well-suited to the use of AVB-001 because it tends to spread throughout the abdomen. After a minimally invasive laparoscopic procedure, patients implanted with the cells were noted to tolerate the treatment well. Half of the enrolled patients’ cancer was stabilized, with several among them reporting extended signs of benefit. No maximum tolerated dose was reached and there were no life-threatening events tied to the study.

If that sounds like less-than-earth-shaking results, this is only the beginning. The capsules were implanted for about one week because IL-2 activity drops off after that. The researchers now know that further testing should include either higher levels, repeated doses, or a combination thereof, in order to create stronger advances.

The team has already made early headway on this next step. Preclinical studies in nonhuman primates were not only tolerated well, but without added toxicity, the apes had consistent pharmacological effects.

“This is a foundational step,” Veiseh explained. “We now have evidence that the platform is safe, biologically active and potentially scalable. The next phase is optimizing dosing and exploring combination therapies to unlock its full clinical potential.”

The combination would also include a checkpoint inhibitor, which might improve AVB-001’s tumor-fighting power. “What is exciting is that we are not just delivering a drug, we are programming a microenvironment,” added Dr. Amir Jazaeri, professor of gynecologic oncology at MD Anderson, member of the Rice Biotech Launch Pad’s clinical advisory board and a senior author on the study. “This opens the door to combination strategies that could amplify immune responses in ways that have not been feasible before.”