By: ABRS- Academic Team
Introduction
Informed consent stands as one of the most critical safeguards in clinical research, ensuring that participants fully understand and voluntarily agree to take part in a study. Yet, despite decades of regulation and training, it remains one of the most frequent findings in Good Clinical Practice (GCP) audits. These issues are rarely a reflection of poor ethics; more often, they reveal systemic process gaps, training inconsistencies, and operational pressures.
For organizations like ABRS, which operates as a trusted Functional Service Provider (FSP), these recurring challenges highlight the importance of embedding compliance expertise directly into study operations. By providing experienced clinical oversight, robust training programs, and quality monitoring, an FSP partner can help sponsors and sites not only avoid costly findings but also strengthen the ethical integrity of their trials. In today’s increasingly complex regulatory landscape, having that level of embedded support can make the difference between simply meeting compliance requirements and consistently exceeding them.
The Persistent Challenge of Informed Consent in GCP Audits
Informed consent is not just a regulatory formality—it is the cornerstone of ethical clinical research. Yet, patterns from multiple GCP audit reports show that deficiencies in this area remain strikingly common. As highlighted in an article by Solutions OP Clinical Trials, one of the top recurring issues is the use of outdated consent form versions, often caused by poor version control between sponsor and site teams. These lapses are not always intentional, but they can have significant regulatory consequences, from protocol deviations to delays in trial timelines.
Other industry voices have echoed this concern. In a presentation from Boston University’s Clinical Research Resources Office, common findings included incomplete consent documentation, missing participant signatures, and instances where research activities began before the consent process was finalized. These situations are often traced back to operational pressures—tight recruitment targets, last-minute protocol amendments, or unclear delegation of responsibilities—factors that can erode compliance even in experienced sites.
The problem also has a human factor. A post from Clinical Research Made Simple explains that even well-trained teams can struggle with informed consent if refresher training is infrequent or if staff turnover leads to gaps in understanding the correct process. In high-volume or long-running studies, new staff members may inherit processes without adequate onboarding, increasing the risk of oversight errors.
Beyond the technical and procedural aspects, there’s also the challenge of communication. Obtaining consent is not just about presenting information—it is about ensuring comprehension and voluntary agreement. When complex protocols are explained in overly technical terms, or when translations are poorly adapted to local languages and cultural contexts, the integrity of the process can be compromised. Moreover, the growing use of remote and electronic consent tools adds a new dimension: ensuring that digital interfaces are accessible, secure, and compliant with regional data protection laws.
In short, informed consent compliance is not a one-time achievement at study initiation—it is a continuous process that requires vigilance, coordination, and a strong culture of quality. This means embedding checks into daily site operations, maintaining open communication between investigators, sponsors, and ethics committees, and fostering a mindset where protecting participant rights is as operationally critical as meeting recruitment milestones.
Root Causes Behind Informed Consent Findings
While the symptoms of informed consent non-compliance—such as outdated forms or missing signatures—are easy to spot, the underlying causes often run deeper. As noted in the Solutions OP Clinical Trials analysis, one recurring root cause is the lack of a robust document control process. When there is no clear, enforced procedure for updating and distributing the most recent version of the consent form, misalignment between sponsor and site becomes inevitable. In practice, this can happen when amended forms are sent to the site but are not properly filed, or when older versions remain accessible in the investigator site file and are mistakenly used. Such oversights not only violate GCP requirements but also risk invalidating participant consent, creating both ethical concerns and delays in trial progress.
The challenge is compounded by human factors. According to Clinical Research Made Simple, turnover among site staff and infrequent refresher training often leave gaps in understanding the precise requirements of the consent process. This is especially true in long-running trials or multi-center studies, where staff changes are inevitable. Without comprehensive onboarding and structured handover processes, incoming team members may inherit responsibilities without knowing key details—such as the exact sequence of steps in obtaining consent or the documentation needed for regulatory inspection readiness. Over time, even small misunderstandings can lead to systemic errors, like failing to ensure the participant receives a copy of the signed form or omitting the date on a witness signature.
Operational pressures also play a critical role. In the PharmaMax review of common GCP violations, investigators often cited tight recruitment deadlines, last-minute protocol changes, and insufficient oversight as factors that lead to consent-related errors. The pace of enrollment can sometimes tempt teams to move participants quickly into study procedures, bypassing important verification steps in the consent process. Protocol amendments—especially those requiring updated consent forms—can further complicate matters if sites are not given adequate time or support to implement changes before continuing recruitment. When oversight is stretched thin, whether due to limited monitoring visits or competing priorities, these procedural cracks can widen, increasing the likelihood of findings in future audits.
Ultimately, addressing these root causes requires more than correcting errors after they occur. It calls for preventive strategies: implementing a centralized and trackable document control system to ensure all forms in circulation are current; scheduling mandatory refresher training sessions for all site staff, including backup personnel; and integrating informed consent checkpoints into routine site workflows. By embedding these safeguards into everyday operations, organizations can significantly reduce the risk of non-compliance—protecting both participant rights and the credibility of the research.
Innovations and Future Directions: Enhancing Informed Consent Compliance
While traditional challenges in informed consent remain prevalent, emerging innovations are offering new pathways to improve compliance and participant understanding. As highlighted in the PharmaMax piece, inadequate informed consent remains a frequent GCP violation—one that can be mitigated through systematic process improvements and embracing digital tools. This article underscores that proactive procedural adaptation is essential for elevating ethical standards in clinical research.
Adding a level of innovation, a systematic review published in Trials found that electronic informed consent (e‑IC) has the potential to enhance enrolment rates and strengthen participant comprehension and recall. Though findings on enrolment impact were mixed, the study emphasized the capacity of e‑IC to enrich understanding of study-related information compared to traditional methods
Another forward-looking strategy involves quality improvement frameworks embedded within institutional oversight. A study published in BMC Medical Ethics described how applying a Plan‑Do‑Check‑Act (PDCA) cycle at a hospital led to a marked reduction in errors related to ICF signing—such as missing signatures or incorrect dates—by enhancing procedural oversight and reinforcing team training.
Together, these approaches—digital consent platforms and structured quality cycles—represent a meaningful shift from reactive correction to proactive design in informed consent processes. By integrating e-IC tools that improve comprehension and deploying continuous improvement frameworks like PDCA, sponsors and sites can evolve from compliance-focused to participant-centered operations.
Conclusion:
The recurring presence of informed consent findings in GCP audits serves as a reminder that compliance is not a static achievement but a continuous process. From outdated form versions to insufficiently documented consent discussions, each finding underscores the need for proactive systems, ongoing training, and adaptive operational planning.
Here, the role of an FSP partner such as ABRS becomes invaluable. By integrating skilled professionals into sponsor teams, ABRS can ensure that consent processes are monitored, documentation is accurate, and regulatory updates are swiftly implemented across all trial sites. This model not only reduces the likelihood of findings but also fosters a culture where participant rights and study integrity remain at the forefront.
In the evolving world of clinical research—where digital consent tools, decentralized trials, and adaptive protocols are becoming the norm—sponsors will benefit most from partners who combine regulatory rigor with operational agility. Addressing informed consent challenges isn’t just about avoiding audit findings; it’s about building a research environment where compliance, efficiency, and ethics work hand in hand.