Harmonising the human biobanking consent process: an Irish experience.

Area of Science:

• Biobanking and Health Research Ethics
• Clinical Research Participant Engagement

Background:

• Biobanks collect human samples and data for research, requiring informed consent from participants.
• Current Participant Information Leaflets and Informed Consent Forms (PILs/ICFs) are often complex and difficult for laypersons to understand.
• The General Data Protection Regulation (GDPR) and Health Research Regulation (HRR) introduced new compliance challenges for Irish biobanks.

Purpose of the Study:

• To describe the development process of a national biobank Participant Information Leaflet and Informed Consent Form (PIL/ICF) template in Ireland.
• To create accessible, GDPR/HRR-compliant resources for health research biobanks through patient engagement.
• To enhance the clarity and intelligibility of information provided to research participants.

Main Methods:

• Establishment of the National Biobanking Working Group (NBWG) with diverse research and patient representation.
• Collaborative development of a national PIL/ICF template.
• Review of the template by key stakeholders, including the Patient Voice in Cancer Research and the Health Research Data Protection Network.

Main Results:

• A national PIL/ICF template was produced through a collaborative and patient-engaged process.
• The developed template aims to be accessible, GDPR/HRR-compliant, and suitable for national use.
• The process involved input from various research institutions and patient advocacy groups.

Conclusions:

• The developed national PIL/ICF template represents a significant step towards improving participant understanding and engagement in biobank research.
• This initiative addresses the challenges posed by complex documentation and regulatory requirements.
• The template facilitates informed decision-making for research participants in Ireland.