Developing model biobanking consent language: what matters to prospective participants?

Area of Science:

• Genomic Research
• Bioethics
• Public Health

Background:

• Informed consent is crucial for genomic research, requiring clear communication of risks and benefits.
• Large-scale genomic studies present unique opportunities and risks for participants, families, and communities.
• Effective consent materials must facilitate understanding of participation reasons.

Purpose of the Study:

• To develop model consent language and values-based questions for genomic research using empirical data.
• To assess public understanding and concerns regarding biobanking and genomic study participation.
• To enhance the alignment of participation decisions with individual values.

Main Methods:

• Conducted in-person interviews with a diverse sample (n=32) of the general population.
• Gathered preliminary input on model consent materials and values questions.
• Assessed participant reactions to specific consent disclosures and hypothetical willingness to participate.

Main Results:

• Reassuring information included biobank purpose, oversight committees, privacy protection, and controlled data access.
• Concerning information involved public data deposition, unintended access risks, non-research data use, and medical record utilization.
• Initial willingness to participate was 75%, decreasing to 66% after detailed consideration; values questions were rated as helpful.

Conclusions:

• Model consent language effectively captures public perspectives on biobanking and genomic studies.
• Qualitative data reveals specific concerns and reassurances influencing participation decisions.
• Interventions promoting engagement with consent information can lead to value-aligned participation choices.