Patient consent: A major obstacle in tissue banking? Perspectives from the UC Davis Cancer Center

Regulatory and ethical standards require that patient tissue donors be provided a proper informed consent process prior to having their tissues used for medical research. At UC Davis, our Cancer Center Specimen Repository (CCSR) is a shared resource for our National Center Institute (NCI) designated cancer center and began tissue collection in August 2004. Our local board mandated a postoperative consent process to be both institutional review board and HIPAA compliant. Our research associate initially contacts patients by telephone 2-3 weeks postsurgery. If the patient agrees verbally to use of their tissue for research, the consent form is mailed. Data analyzed included patient gender, tumor type, and consent outcome. These were obtained from our in-house database and from log records. Tissue samples have been obtained from 554 between August 2004 and November 2006. Our overall consent rate was 66%, with a range of 37-84% by tumor type. The lowest rate was for patients having cranial surgery and highest for prostatectomy. Gender distribution for positive consent was 71% for men (N = 254) and 66% for women (N = 350). Lack of obtaining an informed consent was due to failure to return forms via mail (50%), patient deceased (15%), non-English speaking (12%), refusal to participate (9%), and unable to contact by telephone (7%). Our overall consent rate (66%) is less than anticipated using our current process. We plan to redeploy CCSR staff to allow the consent process to be performed during postoperative appointments and to use interpreting services as needed.