As research projects increase in complexity, so does the number of regulatory boards charged with overseeing the work. While these bodies improve safety by ensuring best practices and ethical standards, they also create a maze of acronyms administrators must navigate to keep research on track. Otherwise, they can face serious consequences, from fines to loss of funding.
To identify and reduce compliance risks, research administrators must implement proven methods to establish a culture of compliance. The first step is understanding the various standards.
Understand compliance standards
One of the primary reasons administrators struggle to manage compliance standards is their inability to comprehend the full scope of regulatory board directives. In clinical research alone, more than eight agencies oversee human subject research — each with separate guidelines and standards.
To decrease compliance risks, research administrators must verify the boards with jurisdiction over their projects, such as:
- The Institutional Animal Care and Use Committee (IACUC) for animal oversight
- The institutional review board (IRB) for human ethics
- The U.S. Food and Drug Administration (FDA) for novel medical interventions
- The International Building Code (IBC) and National Institutes of Health (NIH) for biological materials and hazardous agents
While these efforts can significantly increase administrative burden, the guidelines from these regulatory boards have been created for a good reason. Consider the FDA’s protocol for its Investigational New Drug (IND) program. The need for this particular application came from tragedy when a healthy 24-year-old volunteer died after hexamethonium exposure damaged their lungs. Had the requirement of an IND application been set forth, this loss of life could have been avoided.
Given such dangers to the public, compliance is strictly monitored. Any inconsistencies can result in noncompliance, which leads to monetary consequences and damage to an organization’s reputation, as seen in the censure of Biotrial. This French research organization showed negligence in numerous operations during a 2015 clinical trial, including:
- Inconsistencies in the exclusion criteria
- Failure to follow up with participants complaining of adverse reactions
- Violation of the informed consent forms by failing to inform participants about the condition of an ill participant
- Failure to inform the regulatory board of the issues, which made it impossible for the agency to protect earlier volunteers and resulted in the death of a participant and serious injuries to four others
Monitor, review, and report
Internal oversight is the most effective method of ensuring compliance, which is why every operation within the bounds of research must be monitored. This is only possible with the right infrastructure to facilitate real-time oversight. Administrators must invest in tools to achieve this degree of supervision not only to help them oversee their projects but also to identify risks.
You may want to establish quality assurance teams dedicated to monitoring compliance. This proactive approach improves the likelihood of catching potential compliance risks and enacting preventative actions to eliminate issues.
While it may seem counterintuitive, timely reporting can also improve the validity of research work. For example, in the event of any concerns, reporting in a timely manner can minimize damage, protecting researchers, participants, and organizations.
Consider the case of a 2006 phase I clinical study involving a novel drug meant to treat autoimmune disease. While animal testing showed this drug was safe, the first infusion led to life-threatening organ failure in human volunteers. The study was terminated and reported immediately, providing other researchers with key information concerning the dangers of this investigational drug and the importance of developing animal-testing models to better mimic humans.
Benefits of a risk management system
Research administrators have no room for noncompliance. They must stay ahead of any risks before serious problems arise. Most legacy systems are not equipped to handle the multidisciplinary needs of current research. By modernizing your risk management system with integrated digital solutions, you can better identify risks and ensure compliance.
At Cayuse, we understand the importance of adhering to regulatory compliance, which is why we have developed specialized risk management solutions. Our software can enhance safety, privacy, and accountability while improving oversight from planning to project completion.
