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 hospital performs first fully robotic heart transplant in the U.S.

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A team at Baylor St. Luke’s Medical Center, led by Dr. Kenneth Liao, successfully performed the first fully robotic heart transplant in the United States earlier this year, the Houston hospital recently shared.

Liao, a professor and chief of cardiothoracic transplantation and circulatory support at Baylor College of Medicine and chief of cardiothoracic transplantation and mechanical circulatory support at Baylor St. Luke’s Medical Center, used a surgical robot to implant a new heart in a 45-year-old male patient through preperitoneal space in the abdomen by making small incisions.

The robotic technology allowed the medical team to avoid opening the chest and breaking the breast bone, which reduces the risk of infection, blood transfusions and excessive bleeding. It also leads to an easier recovery, according to Liao.

"Opening the chest and spreading the breastbone can affect wound healing and delay rehabilitation and prolong the patient's recovery, especially in heart transplant patients who take immunosuppressants," Liao said in a news release. "With the robotic approach, we preserve the integrity of the chest wall, which reduces the risk of infection and helps with early mobility, respiratory function and overall recovery."

The patient received the heart transplant in March, after spending about four months in the hospital due to advanced heart failure. According to Baylor, he was discharged home after recovering from the surgery in the hospital for a month without complications.

"This transplant shows what is possible when innovation and surgical experience come together to improve patient care," Liao added in the release. "Our goal is to offer patients the safest, most effective and least invasive procedures, and robotic technology allows us to do that in extraordinary ways."

7 can't miss Houston business and innovation events for July

where to be

Editor's note: While many Houstonians are flocking to vacation destinations, there are still plenty of opportunities to network and learn at tech and business events for those sticking close to home this month. From an inaugural biotech summit to the 12th edition of a local pitch showcase, here are the Houston business and innovation events you can't miss in July and how to register. Please note: this article might be updated to add more events.

July 10 - Out in Tech Mixer 

Out in Tech Houston provides an inclusive networking space for LGBTQ+ people and allies working in tech. Check out this relaxed, social-mixer event, hosted on the second Thursday of every month.

This event is Thursday, July 10, from 7 to 8:30 p.m. at Second Draught. Register here.

July 14 – Latinas in Tech Coworking Day 

Connect with fellow Latinas in the industry at Sesh Coworking. Network or work alongside peers, board members and community leaders in a shared office environment.

This event is Monday, July 14, from 9-11:30 a.m. at Sesh Coworking. Find more information here.

July 17 – UTMB Innovation VentureX Summit

Attend the inaugural UTMB Innovation VentureX Summit, where innovators, entrepreneurs, researchers and investors will dive into the future of biotech. Expect panel discussions, fireside chats, a technology showcase and networking opportunities.

This event is Thursday, July 17, from 7:30 a.m.-4 p.m. at The University of Texas Medical Branch at Galveston. Find more information here.

July 17 – Open Project Night 

Collaborate on solutions for some of Houston’s most pressing issues at this month’s Open Project Night at Impact Hub Houston. Hear from guest speakers and listen to open mic pitches. July’s theme is Decent Work & Economic Growth.

This event is Thursday, July 17, from 5:30-7:30 p.m at Impact Hub Houston. Register here.

July 24 – NASA Tech Talks

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, July 24, from 6-7 p.m. at the Ion. Register here.

July 30 – Ion Bike Club

Join Bike Houston at the Ion for a 45-minute guided cruise through the Ion District and Midtown. Afterward, enjoy a complimentary beer and network with like-minded riders at Second Draught.

This event is Wednesday, July 30, from 5:30-7:30 p.m. at the Ion. Register here.

July 31 – Bayou Startup Showcase

Hear pitches from startups and small businesses from Rice University’s OwlSpark and the University of Houston’s RED Labs accelerators at the 12th annual Bayou Startup Showcase. Read more about this year’s teams here.

This event is Thursday, July 31, from 3:30-7 p.m. at the Ion. Register here.

Houston researchers: Here's what it takes to spot a great new idea

houston voices

Having a “promotion focus” really does create a mental lens through which new ideas are more visible.

Key findings:

  • New ideas can be crucially important to businesses, driving innovation and preventing stagnation.
  • Recognizing those ideas, though, isn’t always easy.
  • Nurturing what is known as “promotion focus” can help managers spot fresh ideas.

Whenever the late surgeon Michael DeBakey opened a human chest, he drew on a lifetime of resources: the conviction that heart surgery could and should be vastly improved, the skill to venture beyond medicine’s known horizons and the vision to recognize new ideas in everyone around him, no matter how little formal training they had.

Appreciating new ideas is the heartbeat of business as well as medicine. But innovation is surprisingly hard to recognize. In a pioneering 2017 article, Rice Business Professor Jing Zhou and her colleagues published their findings on the first-ever study of the traits and environments that allow leaders to recognize new ideas.

Recent decades have produced a surge of research looking at how and when employees generate fresh ideas. But almost nothing has been written on another crucial part of workplace creativity: a leader’s ability to appreciate new thinking when she sees it.

Novelty, after all, is what drives company differentiation and competitiveness. Work that springs from new concepts sparks more investigation than work based on worn, already established thought. Companies invest millions to recruit and pay star creatives.

Yet not every leader can spot a fresh idea, and not every workplace brings out that kind of discernment. In four separate studies, Zhou and her coauthors examined exactly what it takes to see a glittering new idea wherever it appears. Their work sets the stage for an entirely new field of future research.

First, though, the team had to define their key terms. “Novelty recognition” is the ability to spot a new idea when someone else presents it. “Promotion focus,” previous research has shown, is a comfort level with new experiences that evokes feelings of adventure and excitement. “Prevention focus” is the opposite trait: the tendency to associate new ideas with danger, and respond to them with caution.

But does having “promotion focus” as opposed to “prevention focus” color the ability to see novelty? To find out, Zhou’s team came up with an ingenious test, artificially inducing these two perspectives through a series of exercises. First, they told 92 undergraduate participants that they would be asked to perform a set of unrelated tasks. Then the subjects guided a fictional mouse through two pencil and paper maze exercises.

While one exercise showed a piece of cheese awaiting the mouse at the end of the maze (the promise of a reward), the other maze depicted a menacing owl nearby (motivation to flee).

Once the participants had traced their way through the mazes with pencils, they were asked to rate the novelty of 33 pictures — nine drawings of space aliens and 24 unrelated images. The students who were prepped to feel an adventurous promotion focus by seeking a reward were much better at spotting the new or different details among these images than the students who’d been cued to have a prevention focus by fleeing a threat.

The conclusion: a promotion focus really does create a mental lens through which new ideas are more visible.

Zhou’s team followed this study with three additional studies, including one that surveyed 44 human resource managers from a variety of companies. For this study, independent coders rated the mission statements of each firm, assessing their cultures as “innovative” or “not innovative.” The HR managers then evaluated a set of written practices — three that had been in use for years, and three new ones that relied on recent technology. The managers from the innovative companies were much better at rating the new HR practices for novelty and creativity. To recognize novelty, in other words, both interior and external environments make a difference.

The implications of the research are groundbreaking. The first ever done on this subject, it opens up a completely new research field with profound questions. Can promotion focus be created? How much of this trait is genetic, and how much based on natural temperament, culture, environment and life experience? Should promotion focus be cultivated in education? If so, what would be the impact? After all, there are important uses for prevention focus, such as corporate security and compliance. Meanwhile, how can workplaces be organized to bring out the best in both kinds of focus?

Leaders eager to put Zhou’s findings to use right away, meanwhile, might look to the real-world model of Michael DeBakey. Practice viewing new ideas as adventures, seek workplaces that actively push innovation and, above all, cultivate the view that every coworker, high or low, is a potential source of glittering new ideas.

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This article originally appeared on Rice Business Wisdom.

Jing Zhou is the Mary Gibbs Jones Professor of Management and Psychology in Organizational Behavior at the Jones Graduate School of Business of Rice University. Zhou, J., Wang, X., Song, J., & Wu, J. (2017). "Is it new? Personal and contextual influences on perceptions of novelty and creativity." Journal of Applied Psychology, 102(2): 180-202.