Appendix L Vignette: Life Cycle of a Biospecimen Through the National Biospecimen Network The salient considerations—from tissue donation consent by the patient, through researcher access to specimens and data, and finally to efficacious treatment products—are described in this vignette. The year is 2008. You have just been diagnosed with lung cancer. Your oncologist sends you to your well-respected and familiar community hospital for a biopsy. During the consent process, after the biopsy procedure is thoroughly explained, you are asked if you will donate tissue obtained during the biopsy that is not used for your diagnosis to the National Biospecimen Network (NBN). You vaguely remember hearing public service announcements describing this resource, as well as a pamphlet about it from the National Cancer Institute “cancer cope kit” that your oncologist reviewed with you, and you ask for more information. A hospital staff member, whose ID badge identifies him as a trained consent counselor employed by the NBN, explains that cancerous lung tissue is on a list of biological samples needed for research. You learn that many doctors and hospitals across the nation have agreed to collect needed tissues from cancer patients to donate to the NBN. Research with tissue can help researchers better understand what causes cancer, how to prevent it, and how to treat it. If you agree to donate your tissue, only leftover tissue from the biopsy will be saved for the tissue resource, and whether or not you donate the tissue will not have any impact on your treatment. The counselor explains a detailed consent form to you. You are concerned that your name, social security number, and other identifying information will travel with the tissue, to be recorded in a nationwide database. Who will have access to this information? The counselor assures you that the database is designed to protect the privacy of your medical information. In fact, you will not be recontacted concerning your medical condition unless you choose this option. After the emotional shock of the cancer diagnosis, you feel empowered that in some way you might be able to help contribute to a cure. You agree to donate your tissue. It is the day of the surgery. You are asleep, under the influence of anesthesia, but the operating room staff has the situation well in hand. The NBN surgical liaison, knowing that you have consented to donate tissue and your preliminary diagnosis, arrives in the operating room well ahead of schedule to confirm that all standard operating protocols for the tissue collection are in place. After the tissue has been collected using defined time and condition requirements, a pathologist who has collaborated with the resource since its inception removes sufficient tissue to obtain your diagnosis and assesses a section of the remainder for the tissue bank using internationally accepted terminology, staging and grading criteria, and classification. After quality controls have been completed and documentation has been entered into the resource database according to strict protocols, the sample is transported to a nonprofit regional tissue processing center located near an academic medical center about 50 miles away. A researcher several states away is conducting a study to determine whether there are measurable differences between gene expression samples in normal and lung cancer tissues. His study has been approved by the NBN peer review process and accorded high priority for tissue distribution. The researcher wants to make use of a new proteomic assay for his study, which the NBN Oversight Committee has recently approved for addition to its database system. He turns to his computer, accesses the NBN Web site, and determines that, with the addition of your sample, he now has a sufficient number of tissue samples to proceed with the study. He knows that he will receive, in addition to a standard protocol of preliminary testing results performed by the tissue processing center, your age, sex, race, diagnosis, and possibly treatment and family history. He will not know your name or any other information that might affect your privacy. It is 4 years later. You have survived your bout with cancer, and you now volunteer as an advocate for cancer research. You moved to another state 6 months ago and were able to access your file on record with the NBN and update your address and treatment outcome. The scientist who used your tissue for his research has submitted his raw data into the database and it is easily accessible by other researchers. From your work with the advocacy community, you know that this expanding body of information on lung cancer has produced several opportunities for early detection, therapy, and prevention. In fact, several pharmaceutical companies have produced new products that are in the pipeline or have been fast-tracked by the Food and Drug Administration and are already benefiting patients. You are glad that you have made a contribution to this process. You are even happier that when you talk to newly diagnosed lung cancer patients, you can tell them that there is hope.

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