Issues in the Use of Human Tissues to Support Precision Medicine.

Precision medicine is an approach in which the characteristics of patients as well as their diseases are used to identify optimal therapy; it links researchers, patients, health care providers, and clinical laboratories. In precision medicine, specific molecular characteristics of an untreatable cancer can be targeted by specific molecular-based therapy. Access to high-quality human tissues is necessary to determine many characteristics of patients and their diseases (such as targetable molecules). There are ethical issues in using human tissues in precision medicine, including informed consent and confidentiality, optimal utilization, quality of tissues, and minimization of bias. When human tissues are obtained for patient therapy, the bioresource should be a component certified by Clinical Laboratory Improvement Amendments. For precision medicine to benefit medically underserved populations requires extensive focused research, planning, and resources, some of which are currently unavailable at rural and other sites where care is provided to underserved populations.