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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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Here's what Houston-based online programs are ranked as best in the country. Photo by Luis Alvarez/Getty Images

Rice University's online MBA program has something to brag about. According to a new report, the program has risen through the ranks of other online MBA curriculums.

MBA@Rice, the online program at the Jones Graduate School of Business at Rice, has ranked higher in four categories in the latest edition of U.S. News & World Report’s Best Online Programs. The report evaluated schools based on data specifically related to their distance education MBA programs, and U.S. News has a separate ranking for non-MBA graduate business degrees in areas such as finance, marketing and management. The MBA list focused on engagement, peer assessment, faculty credentials and training, student excellence, and services and technologies.

“We use the same professors to deliver the same rigorous, high-touch MBA in our online MBA as we do in all our campus-based programs,” said Rice Business Dean Peter Rodriguez. “The strong national rankings recognize our success in reaching highly talented working professionals who don’t live near enough to our campus or for whom an online program is the best option.”

Rice's virtual MBA program ranked No. 12 (tied) in the 2023 list, which was up several spots from its 2022 ranking, which was No. 20. Additionally, Rice stood out in these other three categories:

  • Best Online MBA Programs for Veterans: tied for No. 10 (No. 14 last year).
  • Best Online Business Analytics MBA Programs: tied for No. 10 (tied for No. 12 last year).
  • Best Online General Management MBA Programs: tied for No. 7 (tied for No. 11 last year).

Rice recently announced a hybrid MBA program that combines online instruction with in-person engagement. The first cohort is slated to start this summer.

The MBA@Rice program is the top-ranked Texas-based program on the virtual MBA list. Several other programs from the Lone Star State make the list of 366 schools, including:

  • University of Texas at Dallas at No. 17
  • Texas Tech University at No. 33
  • Baylor University, University of North Texas, and West Texas A&M University tied for No, 65

U.S News & World Report ranked other online programs. Here's how Houston schools placed on the other lists:

  • The University of Houston tied for No. 10 in Best Online Master's in Education Programs and tied for No. 75 in Best Online Master's in Business Programs
  • Rice University, in addition to its MBA ranking, tied for No. 27 on the Online Master’s in Computer Information Technology Programs ranking after being tied for No. 49 last year
  • University of Houston-Downtown ranked No. 26 in Best Online Master's in Criminal Justice Programs and tied for No. 55 in Best Online Bachelor's Programs

The full list of best online higher education programs ranked by U.S. News & World Report is available online.

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