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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Houston Tech Rodeo drops schedule for 2023 events

ready to rodeo

Houston Tech Rodeo returns this year — and the lineup of panels and networking opportunities has been released online.

The four-day summit was originally introduced in 2020 by Houston Exponential to shine a spotlight on Houston's tech and startup ecosystem. Last year, HX changed ownership, converted into a for-profit business, and named Natara Branch as the new CEO. With the new ownership comes a new era for HTR — complete with AI-generated media, a goal for a record-breaking finale event with CodeLaunch, and more.

"The biggest theme of Tech Rodeo this year is around being aware," Branch tells InnovationMap. "We want entrepreneurs to know what resources are out there, that they are supported, and that there are all these entities out here that are conducting themselves in a manner that is really centered around supporting them."

"We hope that when entrepreneurs and startups walk away from Tech Rodeo this year, it will really feel to them like there's more momentum in this city than there has been in the past so that we can be a top-tier startup destination," she continues.

This year's schedule is divided across a few themes and all events are being held in the Houston Innovation District in Midtown.

  • Monday, February 27: Space Tech at the Ion
  • Tuesday, February 28: Global Mindset at HCC Central Campus and Energy Tech at Greentown Labs
  • Wednesday, March 1: Bio Economy at TMC Innovation and Emerging Tech at The Cannon - Downtown
  • Thursday, March 2: Townhall and CodeLaunch Finale at Sesh Coworking and 713 Music Hall
The week's events will attract founders, investors, startup development organizers, and more. When HTR launched its free tickets online, Branch says they received around 800 registrants in one day. At the center of everything HX does is the Houston founders, Branch says.
"It was supper important to us to make sure that entrepreneurs have access," she says. "It's free to entrepreneurs — they are number one in who should attend."

More information and registration is available at houstontechrodeo.com.

Head to houstontechrodeo.com for up-to-date schedule information. Graphic courtesy of HX

Houston hospital system grants $6.8M to community nonprofits

access granted

A Houston-area hospital system has announced the latest recipients of its grant program, benefiting nonprofits that are providing essential services to Houstonians.

Houston Methodist announced this month the 32 local nonprofit organizations receiving more than $6.8 million in community grants as a part of the Community Benefits Grant Program. This year, these nonprofits will give access to health care services to more than 188,000 individuals in underserved communities in the Greater Houston area.

“For three decades, the Houston Methodist Community Benefits Grant Program has helped create pathways to care for some of the most vulnerable in the Greater Houston community who often are struggling to afford basic necessities,” says Ryane Jackson, vice president of community benefits at Houston Methodist, in a news release.

Since the program's inception, it's provided $168 million to 82 local charities.

“Access to high quality health care is one of many issues that our community faces, and this grant helps makes much-needed health care resources affordable and accessible," she continues. "I’m proud that we can continue to partner with local organizations focused on expanding the health and well-being of all Houstonians.”

Houston Methodist announced the full list of this year’s Community Benefits grant awardees online.

Last year, Houston Methodist announced grants to 59 Houston-area nonprofit organizations totalling more than $4.6 million thanks to the Houston Methodist Diversity, Equity & Inclusion Grant Program.

3 Houston innovators to know this week

who's who

Editor's note: In this week's roundup of Houston innovators to know, I'm introducing you to three local innovators across industries — from drones to energy tech— recently making headlines in Houston innovation.


Madison Long, co-founder and CEO of Clutch

Madison Long joins the Houston Innovators Podcast to discuss Clutch's recent national launch and the role Houston played in the company's success. Photo courtesy of Clutch

Houston-based creator economy platform Clutch — founded by CEO Madison Long and CTO Simone May — celebrated its nationwide launch earlier this month. The platform connects brands to its network of creators for reliable and authentic work — everything from social media management, video creation, video editing, content creation, graphic design projects, and more.

When the company first launched its beta in Houston, the platform (then called Campus Concierge) rolled out at three Houston-area universities: Texas Southern University, Rice University, and Prairie View A&M. The marketplace connected any students with a side hustle to anyone on campus who needed their services.

Long shares on this week's Houston Innovators Podcast that since that initial pilot, they learned they could be doing more for users.

"We recognized a bigger gap in the market," Long says. "Instead of just working with college-age students and finding them side hustles with one another, we pivoted last January to be able to help these young people get part-time, freelance, or remote work in the creator economy for businesses and emerging brands that are looking for these young minds to help with their digital marketing presence." Read more and listen to the episode.

Ty Audronis, co-founder of Tempest Droneworks

Dana Abramowitz and Ty Audronis co-founded Tempest Droneworks. Photo courtesy of Tempest Droneworx

Ty Audronis, fueled by wanting to move the needle on wildfire prevention, wanted to upgrade existing processes with real-time, three-dimensional, multi-spectral mapping, which exactly where his company, Tempest Droneworx, comes in.

That software is called Harbinger. Audronis explains that the real-time management and visualization solution is viewable on practically any device, including mobile or augmented reality. The system uses a video game engine for viewing, but as Audronis puts it, “the magic happens” on the back end.

The company was just the two founders until five weeks ago, when Tempest’s size doubled, including a full-time developer. Once Tempest receives its SIBR check, the team will grow again to include more developers. They are currently looking for offices in the city. As Audronis says, Tempest Droneworx is “100-percent made in Houston.” Read more.

Juliana Garaizar, chief development and investment officer and head of Houston incubator of Greentown Labs

Juliana Garaizar is now the chief development and investment officer at Greentown Labs, as well as continuing to be head of the Houston incubator. Image courtesy of Greentown

Greentown Labs named a new member to its C-suite. Juliana Garaizar, who originally joined Greentown as launch director ahead of the Houston opening in 2021, has been promoted from vice president of innovation to chief development and investment officer.

"I'm refocusing on the Greentown Labs level in a development role, which means fundraising for both locations and potentially new ones," Garaizar tells InnovationMap. "My role is not only development, but also investment. That's something I'm very glad to be pursuing with my investment hat. Access to capital is key for all our members, and I'm going to be in charge of refining and upgrading our investment program."

While she will also maintain her role as head of the Houston incubator, Greentown Houston is also hiring a general manager position to oversee day-to-day and internal operations of the hub. Garaizar says this role will take some of the internal-facing responsibilities off of her plate. Read more.