The Health Research Authority (HRA) in the UK has released updated, approved language for the privacy sections of informed consent forms (ICFs) and participant information sheets (PIS) used in clinical trials. This new guidance offers sponsors standardized language that complies with GDPR and UK data protection laws, helping sponsors clearly communicate data privacy practices to participants.

What is the HRA’s New Privacy Language?

The new HRA-approved privacy language is designed to simplify complex data protection concepts, making them accessible and transparent for clinical trial participants. This language covers core GDPR principles, including how personal data will be processed, stored, shared, and retained, as well as participants’ rights regarding their data.

Sponsors can access the full wording templates on the HRA website. These templates offer standardized sections that can be incorporated directly into ICFs and PIS, allowing sponsors to ensure compliance while promoting trust and transparency.

Key Components of the HRA-Approved Privacy Wording

The HRA templates provide detailed guidance on the essential information that should be included in the privacy sections of ICFs and PIS. Here are the main components:

1. Data Collection and Purpose of Use

Sponsors are advised to inform participants about the types of data being collected (e.g., health data, genetic data) and the purpose of data collection. The language explains how data will be used solely for research objectives and ensures that participants understand the rationale for data processing.

2. Lawful Basis for Data Processing

The approved language clarifies the lawful basis under GDPR for processing personal data, typically “public interest” or “legitimate interest.” This transparency ensures participants are informed about the legal grounds for data processing, establishing compliance and clarity.

3. Data Security and Confidentiality

Sponsors must include information on how participant data will be protected, detailing the security measures in place to prevent unauthorized access, data breaches, or misuse. This section reassures participants that their privacy is a priority.

4. Data Sharing and Access by Third Parties

Participants should be informed about who may have access to their data, including regulatory authorities, ethics committees, and approved third parties. The HRA language specifies the conditions for data sharing and highlights that only authorized personnel involved in the trial will have access to the data.

5. Data Retention and Storage Duration

The language also includes information on data retention, specifying how long data will be stored, even after the conclusion of the trial. This helps set expectations around data lifecycle management and supports GDPR’s principle of data minimization.

6. Participant Rights

Under GDPR, participants have specific rights regarding their data, including the right to access, correct, or withdraw consent. The HRA template provides sponsors with language that explains these rights clearly, including contact information for inquiries or requests to exercise these rights.

7. International Data Transfers

If data is transferred outside the UK or European Economic Area (EEA), sponsors are required to disclose this in the privacy language. The HRA wording includes guidance on explaining international transfers and the safeguards in place to protect data under GDPR’s data transfer requirements.

Why Should Sponsors Use the HRA-Approved Language?

Using the HRA’s standardized language offers numerous benefits for clinical trial sponsors:

- Compliance with GDPR and Data Protection Standards: The HRA templates align with GDPR and UK data protection requirements, ensuring sponsors meet legal obligations in their data handling practices.

- Enhanced Participant Understanding: Clear, consistent privacy language helps participants make informed decisions about their involvement in the trial, improving transparency and trust.

- Streamlined Documentation: The HRA templates provide a standardized format, simplifying the process of drafting and reviewing ICFs and PIS.

- Risk Mitigation: By using HRA-approved language, sponsors can reduce the risk of regulatory non-compliance and potential data privacy disputes with participants.

Implementing the New Privacy Language

To adopt the HRA-approved language in the ICF and PIS, sponsors should:

1. Review Existing Documents: Compare current privacy language with the HRA templates, identifying areas where revisions may be necessary to align with the new guidance.

2. Customize as Needed: While the templates provide a foundation, sponsors may need to tailor certain sections to reflect specific data processing practices or study requirements. However, it’s essential to maintain the core HRA-approved wording to ensure compliance.

3. Train Staff: Ensure that clinical trial staff, particularly those involved in participant enrollment, understand the updated language and can address any questions or concerns participants may have.

4. Regularly Monitor Compliance: As data protection regulations evolve, sponsors should periodically review and update privacy sections in line with any new HRA or GDPR guidelines.

Conclusion

The HRA’s new privacy language for ICFs and PIS represents a valuable resource for clinical trial sponsors seeking to enhance GDPR compliance and transparency. By adopting this standardized language, sponsors can simplify the consent process, safeguard participant data rights, and foster trust in clinical research. Utilizing this approved language helps sponsors not only meet legal requirements but also promote ethical and responsible data practices in clinical trials.

Need help aligning your clinical trial consents with HRA standards? Contact us for expert support!

Regards

DA