Aims: Informed consent is a vital but challenging aspect of research and clinical practice, particularly in genomic settings characterised by unprecedented uncertainty and complexity. We are developing an innovative intervention for cancer patients to improve the quality of decision making and COnsent in GENomic Testing (CoGenT). The intervention incorporates an online Dynamic Consent Platform (DCP) and Question Prompt List (QPL).
Methods: Participants included cancer patients who were and were not taking part in genomic research, carers, study coordinators, and clinicians. We conducted semi-structured qualitative interviews to elicit information needs around genomic testing/research (for the QPL) and ‘think aloud’ feedback on a DCP previously developed for non-cancer genomic research. Interviews were content-analysed, and recruitment continued until data saturation.
Results: Interviews (n=34) identified key information needs around genomic testing, results and their implications, and aspects of research participation. To address these, we drafted the world-first genomics QPL including brief answers on which consent staff can elaborate if desired. The QPL is being pilot-tested and refined via further interviews (n=22 to date) with patient and professional stakeholders. Views on the DCP highlighted its potential value to inform patients, let them enact their preferences, and identify areas where they need more support. The data also showed the importance of optimising clarity, accessibility and engagement in the content and navigation of the CoGenT DCP – now under development.
Conclusions: This work will facilitate equitable access to cancer genomic research by ensuring consent processes meet the needs of key stakeholders. Moreover, CoGenT evidence-based resources will help ensure ethical processes are followed when genomic testing enters routine care, with patients and families well prepared and supported before, during and after testing.