Patient Reflections on the Consent Process for Donating Extra Bone Marrow Research Samples to a Hematology Biobank: A Qualitative Interview Study
Authors: Gordon Madeleine , Motalo Oksana , Camilleri Erika , Chesser Taryn , Davis Gary , Fox Grace , Godard Katya , Ito Caryn Y , Lepage Jocelyn , Lewis Krystina B. , Nuttall Wendy , Peloshok Craig , Nicholls Stuart , Sabloff Mitchell 
Published: December 2024

Background: Bone marrow samples taken at the time of diagnosis are essential for early diagnosis and treatment of acute leukemia (AL) and additionally can be used to understand the underlying biology. This requires bone marrow samples to be taken for clinical purposes as well as for research. Due to the rapid onset and progression of AL, there is a narrow time frame from initial disease suspicion to diagnosis confirmation and treatment initiation. This can present challenges with consenting patients for additional, research-specific bone marrow samples to be obtained during the diagnostic procedure. While patients with cancer are generally positive towards contributing to medical research, recruitment rates for bone marrow samples are low, hindering translational research aimed at improving patients' outcomes in AL. Little is known about patient perspectives with respect to the informed consent process under these time-sensitive circumstances, or how these processes can improve research sample provision while also maintaining respect for patient autonomy and supporting their decision-making during a stressful time. The current study is aimed to better understand the experiences of patients with AL in relation to consenting to provide extra bone marrow samples for research during the diagnostic procedure.

Methods: Semi-structured interviews were conducted with patients treated for AL between January 1, 2017 and December 31, 2021 at The Ottawa Hospital. Patients were eligible if they were admitted to hospital urgently to confirm AL diagnosis, received intensive induction chemotherapy and spoke English or French. Interviews proceeded until data saturation was reached.

Results: Seventeen patients were interviewed. Patient experiences centred on three key areas within the consent process: Preparation and awareness of research, logistical challenges related to obtaining consent within the limited time frame and having emotional and psychological support. Patients were supportive of increasing public knowledge about research and noted the important roles that friends and family members played in providing support and retaining information. Despite the time pressure and anxiety that came with a diagnosis of AL, the decision to give a research sample did not in itself require much deliberation. Decisions were informed by proximal factors such as impact on patient health and family, the anticipated pain associated with the bone marrow procedure and its duration, as well as distal factors such as altruism and trust in the healthcare team. Patients valued as much time as possible between the consent process and the bone marrow extraction. Further, they valued information about the level of anticipated procedure-associated pain, the purpose of ongoing research and its use of samples, and details regarding the privacy and security of the research samples.

Conclusion: Our findings suggest that the success of consenting for additional bone marrow samples for research may be optimised through multiple changes, such as those pertaining to the environment where the consent discussion takes place as well as a period of time for reflection on the discussion prior to the procedure, in addition to the type of information provided, the recognition of patient concerns surrounding discomfort and how it will be mitigated and, finally, the value of current and future research.