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 byMiguel 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 byMiguel 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 engineers develop breakthrough device to advance spinal cord treatment

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A team of Rice University engineers has developed an implantable probe over a hundred times smaller than the width of a hair that aims to help develop better treatments for spinal cord disease and injury.

Detailed in a recent study published in Cell Reports, the probe or sensor, known as spinalNET, is used to explore how neurons in the spinal cord process sensation and control movement, according to a statement from Rice. The research was supported by the National Institutes of Health, Rice, the California-based Salk Institute for Biological Studies, and the philanthropic Mary K. Chapman Foundation based in Oklahoma.

The soft and flexible sensor was used to record neuronal activity in freely moving mice with high resolution for multiple days. Historically, tracking this level of activity has been difficult for researchers because the spinal cord and its neurons move so much during normal activity, according to the team.

“We developed a tiny sensor, spinalNET, that records the electrical activity of spinal neurons as the subject performs normal activity without any restraint,” Yu Wu, a research scientist at Rice and lead author of the study said in a statement. “Being able to extract such knowledge is a first but important step to develop cures for millions of people suffering from spinal cord diseases.”

The team says that before now the spinal cord has been considered a "black box." But the device has already helped the team uncover new findings about the body's rhythmic motor patterns, which drive walking, breathing and chewing.

Lan Luan (from left), Yu Wu, and Chong Xie are working on the breakthrough device. Photo by Jeff Fitlow/Rice University

"Some (spinal neurons) are strongly correlated with leg movement, but surprisingly, a lot of neurons have no obvious correlation with movement,” Wu said in the statement. “This indicates that the spinal circuit controlling rhythmic movement is more complicated than we thought.”

The team said they hope to explore these findings further and aim to use the technology for additional medical purposes.

“In addition to scientific insight, we believe that as the technology evolves, it has great potential as a medical device for people with spinal cord neurological disorders and injury,” Lan Luan, an associate professor of electrical and computer engineering at Rice and a corresponding author on the study, added in the statement.

Rice researchers have developed several implantable, minimally invasive devices to address health and mental health issues.

In the spring, the university announced that the United States Department of Defense had awarded a four-year, $7.8 million grant to the Texas Heart Institute and a Rice team led by co-investigator Yaxin Wang to continue to break ground on a novel left ventricular assist device (LVAD) that could be an alternative to current devices that prevent heart transplantation.

That same month, the university shared news that Professor Jacob Robinson had published findings on minimally invasive bioelectronics for treating psychiatric conditions. The 9-millimeter device can deliver precise and programmable stimulation to the brain to help treat depression, obsessive-compulsive disorder and post-traumatic stress disorder.

Houston clean hydrogen startup to pilot tech with O&G co.

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Gold H2, a Houston-based producer of clean hydrogen, is teaming up with a major U.S.-based oil and gas company as the first step in launching a 12-month series of pilot projects.

The tentative agreement with the unnamed oil and gas company kicks off the availability of the startup’s Black 2 Gold microbial technology. The technology underpins the startup’s biotech process for converting crude oil into proprietary Gold Hydrogen.

The cleantech startup plans to sign up several oil and gas companies for the pilot program. Gold H2 says it’s been in discussions with companies in North America, Latin America, India, Eastern Europe and the Middle East.

The pilot program is aimed at demonstrating how Gold H2’s technology can transform old oil wells into hydrogen-generating assets. Gold H2, a spinout of Houston-based biotech company Cemvita, says the technology is capable of producing hydrogen that’s cheaper and cleaner than ever before.

“This business model will reshape the traditional oil and gas industry landscape by further accelerating the clean energy transition and creating new economic opportunities in areas that were previously dismissed as unviable,” Gold H2 says in a news release.

The start of the Black 2 Gold demonstrations follows the recent hiring of oil and gas industry veteran Prabhdeep Singh Sekhon as CEO.

“With the proliferation of AI, growth of data centers, and a national boom in industrial manufacturing underway, affordable … carbon-free energy is more paramount than ever,” says Rayyan Islam, co-founder and general partner at venture capital firm 8090 Industries, an investor in Gold H2. “We’re investing in Gold H2, as we know they’ll play a pivotal role in unleashing a new dawn for energy abundance in partnership with the oil industry.”

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This article originally ran on EnergyCapital.

3 Houston innovators to know this week

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Editor's note: Every week, I introduce you to a handful of Houston innovators to know recently making headlines with news of innovative technology, investment activity, and more. This week's batch includes an e-commerce startup founder, an industrial biologist, and a cellular scientist.

Omair Tariq, co-founder and CEO of Cart.com

Omair Tariq of Cart.com joins the Houston Innovators Podcast to share his confidence in Houston as the right place to scale his unicorn. Photo via Cart.com

Houston-based Cart.com, which operates a multichannel commerce platform, has secured $105 million in debt refinancing from investment manager BlackRock.

The debt refinancing follows a recent $25 million series C extension round, bringing Cart.com’s series C total to $85 million. The scaleup’s valuation now stands at $1.2 billion, making it one of the few $1 billion-plus “unicorns” in the Houston area.

Cart.com was co-founded by CEO Omair Tariq in October 2020. Read more.

Nádia Skorupa Parachin, vice president of industrial biotechnology at Cemvita

Nádia Skorupa Parachin joined Cemvita as vice president of industrial biotechnology. Photo courtesy of Cemvita

Houston-based biotech company Cemvita recently tapped two executives to help commercialize its sustainable fuel made from carbon waste.

Nádia Skorupa Parachin came aboard as vice president of industrial biotechnology, and Phil Garcia was promoted to vice president of commercialization.

Parachin most recently oversaw several projects at Boston-based biotech company Ginkjo Bioworks. She previously co-founded Brazilian biotech startup Integra Bioprocessos. Read more.

Han Xiao, associate professor of chemistry at Rice University

The funds were awarded to Han Xiao, a chemist at Rice University.

A Rice University chemist has landed a $2 million grant from the National Institute of Health for his work that aims to reprogram the genetic code and explore the role certain cells play in causing diseases like cancer and neurological disorders.

The funds were awarded to Han Xiao, the Norman Hackerman-Welch Young Investigator, associate professor of chemistry, from the NIH's Maximizing Investigators’ Research Award (MIRA) program, which supports medically focused laboratories. Xiao will use the five-year grant to advance his work on noncanonical amino acids.

“This innovative approach could revolutionize how we understand and control cellular functions,” Xiao said in the statement. Read more.

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