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University of Houston: Navigating non-compliance and human error in research

To err is human, after all. Graphic byMiguel Tovar/University of Houston

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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Building Houston

 
 

Want to work for one of the top startups in Houston? These ones are hiring. Photo by Tima Miroshnichenko from Pexels

After scouring Houston for the best of the Houston innovation ecosystem and evaluating dozens of companies, InnovationMap and Houston Exponential have announced the finalists that will be honored at the 2022 Houston Innovation Awards. But which of these companies are growing their teams?

Turns out, almost all of them have open positions — some planning to double their teams over the next year. In fact, the 30 companies that make up the cohort of finalists are looking for over 150 new employees — some have these positions open now and others are seeking these new team members over the next 12 months.

Click here to get your tickets to the 2022 Houston Innovation Awards Gala.
Let's look at how many new hires these top startups are looking for.

Double-digit growth

When it comes to the awards finalists looking to scale their team by 10 or more new employees, five companies are looking to enter this type of hiring spree. Blue People, a finalist in the BIPOC-Founded Category, is hiring 25 new employees. The company was founded in 2015 in Mexico and relocated its primary operations to Houston in 2020. Blue People, which develops software innovation for tis clients, has over 150 employees — seven of whom, including C-level executives, are based in Houston. Some of the company's new hires will be based in town.

Another company that's also relocated its operations to Houston recently and is growing its team significantly is Venus Aerospace, creator of a hypersonic spaceplane capable of one-hour global travel. Venus, a finalist in the New to Hou category, currently has a team of 60 people and is based out of the Houston Spaceport. The company is hiring an additional 20 people.

Fast-growing B2B Software finalist Solidatus — a data management software solution — has 16 open positions, including five in the US. According to the company, they hope to have reached a headcount of about 140 within the next 12 months — up from their current 110 employees.

NanoTech, a Green Impact finalist and materials science company, is looking to nearly double its team of 20 to add an additional 15 new employees.

Competing in the People's Choice category, LevelField Financial — a financial service platform that serves customers interested in the digital asset class — is looking to hire 10 people to join its team of 19 employees.

Steady as she grows

Six Houston Innovation Awards finalists are in the process of adding more than a few new team members. Rivalry Technologies, a finalist in the B2B Software and People's Choice categories, is hiring seven people to join its team of 13. The company created a mobile ordering solution — called sEATz — for arenas and recently rebranded and expanded to provide the technology to other industries.

Founded in New Orleans and relocated to the Houston area last year, Fluence Analytics has a total of 30 employees and is looking to hire an additional six new team members. The company, which created a real-time analytics solution for the chemicals industry, is also a finalist in two categories: Hardtech and New to Hou.

Biotech company Cemvita Factory — both a Green Impact and People's choice finalist — has already scaled to employ 75 team members. Now, the company is hiring an additional five more.

Encina Development Group — circular chemicals company for the consumer products and packaging, pharmaceuticals, construction, and other industries — is also looking to add five more team members to its 30 employees. The company is a finalist in the Green Impact category.

Another Green Impact finalist is IncentiFind, a database for green building incentives that's transforming real estate, is hiring five new employees to almost double their team of eight.

INGU, a New to Hou finalist, is a pipeline inspection solution to achieve Net Zero and ESG compliance for the water and oil and gas pipeline infrastructure. The company is seeking five new team members to join its 19 employees based in Houston and Canada.

Seeking selectively

The following awards finalists are looking to grow their teams by just a handful or so — between one and four — of new hires:

Find out which of these employers take home the win at the November 9 gala at the Ion. Click here to RSVP.

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