Improving the Informed Consent Process in Hematopoietic Cell Transplantation: Patient, Caregiver, and Provider Perspectives

One of the significant modifications to the Common Rule is the requirement that prospective participants are given information sufficient for a “reasonable person”. However, there is limited research on what types of information patients, caregivers, and providers consider “key information”. Although certain aspects of informed consent (IC) may be considered standard, considering individualized needs and preferences of patients is necessary for patient-centered consent. In the current study, we qualitatively examined the specific types of information that patients and caregivers involved in hematopoietic cell transplantation (HCT), as well as their providers, believe are important and necessary as part of the IC process in order to make a decision about participating in clinical research; and further, how these perspectives are aligned. Our findings suggest opportunities for improving the IC document and process by emphasizing information of importance to patients such as the benefits to others and contributions to science that are associated with participation in clinical research. Further, increasing patient engagement during the IC process may enable providers to streamline information that is aligned with patient information needs and preferences.