What is NCI doing to ensure that informed consent is part of the biorepository process?
According to the NCI, informed consent is not only a document signed by patients who participate in research studies; rather, it is an educational process between the investigator and the prospective subject as a means to ensure respect for persons; mutual understanding of research procedures, risks, rights, and responsibilities; and continuous voluntary participation (NBN Blueprint, 2003). The NCI Best Practices for Biospecimen Resources specify that NCI-supported biorepositories should use clear and specific informed consent language to ensure that people who contribute specimens and/or data are fully informed about the purpose, risks and benefits of the proposed research. The NCI Best Practices recommend specific concepts related to biospecimen research that should be addressed in informed consent documents, depending on the nature of the research.
