Why its important to support student researchers, according to this Houston expert

houston voices

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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Houston researchers make headway on affordable, sustainable sodium-ion battery

Energy Solutions

A new study by researchers from Rice University’s Department of Materials Science and NanoEngineering, Baylor University and the Indian Institute of Science Education and Research Thiruvananthapuram has introduced a solution that could help develop more affordable and sustainable sodium-ion batteries.

The findings were recently published in the journal Advanced Functional Materials.

The team worked with tiny cone- and disc-shaped carbon materials from oil and gas industry byproducts with a pure graphitic structure. The forms allow for more efficient energy storage with larger sodium and potassium ions, which is a challenge for anodes in battery research. Sodium and potassium are more widely available and cheaper than lithium.

“For years, we’ve known that sodium and potassium are attractive alternatives to lithium,” Pulickel Ajayan, the Benjamin M. and Mary Greenwood Anderson Professor of Engineering at Rice, said in a news release. “But the challenge has always been finding carbon-based anode materials that can store these larger ions efficiently.”

Lithium-ion batteries traditionally rely on graphite as an anode material. However, traditional graphite structures cannot efficiently store sodium or potassium energy, since the atoms are too big and interactions become too complex to slide in and out of graphite’s layers. The cone and disc structures “offer curvature and spacing that welcome sodium and potassium ions without the need for chemical doping (the process of intentionally adding small amounts of specific atoms or molecules to change its properties) or other artificial modifications,” according to the study.

“This is one of the first clear demonstrations of sodium-ion intercalation in pure graphitic materials with such stability,” Atin Pramanik, first author of the study and a postdoctoral associate in Ajayan’s lab, said in the release. “It challenges the belief that pure graphite can’t work with sodium.”

In lab tests, the carbon cones and discs stored about 230 milliamp-hours of charge per gram (mAh/g) by using sodium ions. They still held 151 mAh/g even after 2,000 fast charging cycles. They also worked with potassium-ion batteries.

“We believe this discovery opens up a new design space for battery anodes,” Ajayan added in the release. “Instead of changing the chemistry, we’re changing the shape, and that’s proving to be just as interesting.”

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This story originally appeared on EnergyCapitalHTX.com.

FAA demands investigation into SpaceX's out-of-control Starship flight

Out of this world

The Federal Aviation Administration is demanding an accident investigation into the out-of-control Starship flight by SpaceX on May 27.

Tuesday's test flight from Texas lasted longer than the previous two failed demos of the world's biggest and most powerful rocket, which ended in flames over the Atlantic. The latest spacecraft made it halfway around the world to the Indian Ocean, but not before going into a spin and breaking apart.

The FAA said Friday that no injuries or public damage were reported.

The first-stage booster — recycled from an earlier flight — also burst apart while descending over the Gulf of Mexico. But that was the result of deliberately extreme testing approved by the FAA in advance.

All wreckage from both sections of the 403-foot (123-meter) rocket came down within the designated hazard zones, according to the FAA.

The FAA will oversee SpaceX's investigation, which is required before another Starship can launch.

CEO Elon Musk said he wants to pick up the pace of Starship test flights, with the ultimate goal of launching them to Mars. NASA needs Starship as the means of landing astronauts on the moon in the next few years.

TMC med-tech company closes $2.5M series A, plans expansion

fresh funding

Insight Surgery, a United Kingdom-based startup that specializes in surgical technology, has raised $2.5 million in a series A round led by New York City-based life sciences investor Nodenza Venture Partners. The company launched its U.S. business in 2023 with the opening of a cleanroom manufacturing facility at Houston’s Texas Medical Center.

The startup says the investment comes on the heels of the U.S. Food and Drug Administration (FDA) granting clearance to the company’s surgical guides for orthopedic surgery. Insight says the fresh capital will support its U.S. expansion, including one new manufacturing facility at an East Coast hospital and another at a West Coast hospital.

Insight says the investment “will provide surgeons with rapid access to sophisticated tools that improve patient outcomes, reduce risk, and expedite recovery.”

Insight’s proprietary digital platform, EmbedMed, digitizes the surgical planning process and allows the rapid design and manufacturing of patient-specific guides for orthopedic surgery.

“Our mission is to make advanced surgical planning tools accessible and scalable across the U.S. healthcare system,” Insight CEO Henry Pinchbeck said in a news release. “This investment allows us to accelerate our plan to enable every orthopedic surgeon in the U.S. to have easy access to personalized surgical devices within surgically meaningful timelines.”

Ross Morton, managing Partner at Nodenza, says Insight’s “disruptive” technology may enable the company to become “the leader in the personalized surgery market.”

The startup recently entered a strategic partnership with Ricoh USA, a provider of information management and digital services for businesses. It also has forged partnerships with the Hospital for Special Surgery in New York City, University of Chicago Medicine, University of Florida Health and UAB Medicine in Birmingham, Alabama.

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