Navigating the complexities of Data Protection in clinical trials: Common pitfalls and solutions

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Trilateral Research |

Date: 6 May 2024

In the fast-paced world of clinical trials, bringing life-changing treatments to market is the ultimate goal. However, fully understanding and dealing with the challenges of data protection in clinical trials can significantly impact a study’s success. Organisations in Ireland, the US, and beyond must navigate a labyrinth of regulations, such as the EU GDPR, UK GDPR, HIPAA, and the EU Clinical Trials Regulation, all while ensuring the scientific integrity of the study and the rights of trial participants are fiercely protected.

This article examines the most common data protection shortcomings when implementing clinical trials and explores how Trilateral Research can help you mitigate them with confidence.

Common Data Protection pitfalls in clinical trials

Insufficient informed consent processes

The informed consent process is critical to ethical clinical trials. However, scientific consent is different from consent under data protection law. Organisations must provide clear, concise information about how participants’ data will be used, who will have access to it, and how long it will be retained. As such, informed consent documents that pass scientific assessments may not be sufficient for data protection purposes.

Common issues include:

  • Consent forms that are too lengthy or complex for participants to understand easily.
  • Insufficient detail when seeking specific, granular consent for different data processing activities.
  • Not providing participants with easy ways to withdraw their consent.

By distinguishing scientific informed consent and consent under data protection law, organisations will strengthen their compliance and streamline the data protection approval process with partner organisations.

Lack of Data Protection by design and default

Data protection-by-design and -default is a legal requirement under the EU and UK GDPR. It means organisations must consider data protection at the outset of any project and build in safeguards by default.

In the context of clinical trials, this could involve:

  • Pseudonymising or anonymising personal data wherever possible.
  • Carefully considering data access protocols and restricting access to those who need it.
  • Implementing robust security measures to protect sensitive health data.

Many clinical trial organisations struggle with data protection-by-design, often because the necessary expertise or resources are difficult to access in this specialist area. This can lead to data breaches, non-compliance, and costly retrofitting of data protection measures.

Inadequate data sharing agreements

Clinical trials often involve multiple parties, such as sponsors, research sites, and service providers. Data may need to be shared across organisational and geographical boundaries, which presents additional data protection requirements.

Organisations must put in place robust data sharing agreements that clearly set out each party’s responsibilities and ensure appropriate safeguards are in place. Common issues include:

  • Lack of clarity around data controller/processor roles and responsibilities.
  • Insufficient contractual protections around data security and breach notification.
  • Insufficient due diligence assessment of third parties’ data protection practices.

With clearly delineated roles and responsibility as well as stronger clauses in data sharing agreements, organisations can avoid costly and time-consuming contract negotiations with other parties.

By considering each of these issues more carefully, sponsors, clinical research organisations, healthcare sites and other organisations can streamline the process of obtaining data protection approvals for clinical trial activities. This will positively impact both the quality and timeliness of the research which will have knock-on effects on the efficacy of the interventions being tested.

How Trilateral Research can help

At Trilateral Research, we understand the unique data protection challenges faced by organisations involved in clinical trials. Our team of experienced data protection experts can help you navigate this complex landscape with confidence.

Bespoke training

We offer tailored training to improve data protection proficiency across your organisation. Our training is designed specifically for the clinical trials context, covering key topics such as informed consent, data sharing agreements, and data protection impact assessments.

Audits and assessments

Our comprehensive audits and assessments will help you evaluate your current data protection practices and identify areas for improvement. We can review your consent processes, data sharing agreements, and technical and organisational safeguards to ensure they meet regulatory requirements.

Ongoing compliance support

We provide ongoing compliance support to help you tackle your most complex data protection challenges. Whether you need help with data protection-by-design, drafting data sharing agreements, or managing data subject rights requests, our team is here to support you every step of the way.

Data protection compliance is an ongoing journey, not a one-time box-ticking exercise. By partnering with Trilateral Research, you can confidently navigate data protection challenges throughout your clinical trials. Working to build a strong data protection culture across your organisation, we can help you safeguard participants’ rights while bringing vital new treatments to patients faster.

To discover how our data protection solutions can help you meet your clinical trial objectives, visit our data protection page.

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