Failure to properly store data and neglecting to maintain project records are the two most common IRB violations, according to a recent survey of 242 faculty members at research-intensive universities in the United States.1
“Prior research has typically focused on general forms of researcher misbehavior,” notes Michael D. Reisig, PhD, the study’s lead author and a professor in the School of Criminology and Criminal Justice at Arizona State University.
The authors of those previous studies did not examine violations of IRB protocol, or they relied on survey questions that did not allow researchers to assess perceived differences between specific IRB violations thought to be major and minor. “The primary motivation for the study was to capture perceptions of IRB violations, both in terms of prevalence and seriousness,” Reisig shares.
Problems with data storage and recordkeeping were viewed as relatively serious violations, especially in the applied sciences when compared to the natural sciences. But such differences were uncommon.
“Perhaps the most surprising set of findings concerned the lack of differences in terms of the perceived prevalence of IRB violations across the social, natural, and applied sciences,” Reisig reports.
Considering the many types of studies that are conducted across scientific fields, Reisig and colleagues anticipated some differences might emerge. “Universities and research organizations should provide resources, such as data archiving services, to assist researchers in meeting IRB requirements,” Reisig offers.
These findings underscore the importance of making ethics training available to researchers at all career stages, as well as the need to protect human subjects, to educate researchers on the possible consequences of violating protections, and to inform researchers of changing rules and regulations. “Ethicists can play a role in developing and participating in training curricula,” Reisig suggests.
Common protocol deviations include missed study visits, taking protocol-prohibited medications, and not following protocol-prescribed drug administration regimens, reports Michael Linke, PhD, chair of the University of Cincinnati IRB. The main IRB concerns with these types of deviations is whether they exposed the participants to increased risk or negatively affected the integrity of the study. “IRBs will have to consider whether the violations constitute serious noncompliance,” Linke says.
For example, if a participant took a prohibited drug that increased the study risks, or if the protocol was not followed and too much study drug was administered, that would increase risk to the participant. Those could be considered reportable unanticipated problems involving risks to subjects or others. Reports must include a description of the corrective and preventive actions (CAPA) that were taken to prevent the deviations from occurring again. “The CAPA should include a root cause analysis to identify the cause of the deviations to identify appropriate actions,” Linke says.
The IRB must review the CAPA to ensure it addresses the problems that led to the deviation. “Even if the deviations do not constitute serious noncompliance or an unanticipated problem involving risk to subjects or others, a CAPA should still be developed,” Linke says.
REFERENCE
- Reisig MD, Flippin M, Holtfreter K. Toward the development of a perceived IRB violation scale. Account Res 2021;May 5:1-15.
Failure to properly store data and neglecting to maintain project records are the two most common IRB violations, according to a recent survey of 242 faculty members at research-intensive universities in the United States.
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