Optimising consent for blood donors taking part in research
Research type
Research Study
Full title
Developing a tiered consent process for individuals recruited to longitudinal biobank research using a case study of NHS blood donors
IRAS ID
230217
Contact name
Mary Dixon-Woods
Contact email
Sponsor organisation
School of Clinical Medicine, University of Cambridge
Duration of Study in the UK
1 years, 2 months, 28 days
Research summary
This mixed-method study seeks to develop the content of options to be used in a tiered consent process for whole blood donors who wish to take part in research. The study will be conducted in a participatory way that takes account of the preferences and priorities of a range of stakeholders, and will reflect on the approach as a methodology that can be used in other contexts.
It responds to a number of imperatives for an improved consenting process for research that is more bespoke to the preferences of individual donors. Tiered consent is an attractive option, as it offers participants structured choices up front when consenting to participate in research, while providing broader options for those who do not wish to make more granular choices. However, little is known about what kinds of choices different stakeholders prioritise and how they can be integrated into a consenting process that satisfies legal and ethical requirements, the needs of researchers, and the operational requirements of NHS Blood and Transplant (NHSBT).
The study will involve engagement and partnership with key stakeholders (whole blood donors, NHSBT staff, and research scientists) using a mix of telephone interviews, an on-line consensus-building exercise, and focus groups. It is proposed that, in total, ~55 whole blood donors, ~35 NHSBT staff, and ~35 research scientists will take part.
The study is funded by the NIHR Cambridge Biomedical Research Centre and is being conducted in collaboration with the NIHR Blood and Transplant Research Unit in Donor Health and Genomics at the University of Cambridge and the NIHR BioResource for Translational Research.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
17/NW/0671
Date of REC Opinion
28 Nov 2017
REC opinion
Favourable Opinion