Home Research on Human Tissue What is Human Tissue Research

What is human tissue research?

Advances in human genetics and molecular biology, such as the sequencing of the human genome, have led to new avenues for medical research. Medical researchers are particularly interested in identifying the role genes play in maintaining health or causing disease. To understand gene and protein activity in disease, researchers in the new fields of clinical genomics and proteomics engage in experiments that usually require diseased and normal tissue samples from relatively large numbers of individuals, along with related clinical information. Many bio-medical researchers are interested in correlating gene expression changes or protein differences that prove to be statistically significant across samples, with response to specific therapies or overall disease outcomes. The goal of these studies is to develop better predictive and prognostic markers that could more effectively guide patients' treatment through a better understanding of genetics.

By looking at genetic variation or protein differences across many samples, researchers hope to develop new diagnostic markers, identify potential new drug targets and other therapies, and to understand the biochemical basis of disease. Clinical genomic and proteomic research relies upon large inventories of research quality human tissue, ideally with associated medical data. Never before has the demand for human tissue in research been so large or the potential scientific value so immense and promising. Experiments on actual human tissue, rather than animal models or cell cultures, are an important part of a medical science referred to as "translational research."

Human tissue research is distinct from both clinical trials and tissue collection protocols. Clinical trials involve interventions on patients who have consented to be a part of a study of a new drug, device or test. While more trials, particularly in cancer medicine, are requesting a blood sample or diseased tissue sample from participating patients, research on banked human tissue samples (such as genomic or proteomic research) is different. This research does not influence the tissue donors' (patients') medical care in any way. It is laboratory research conducted on a sample of their excised tissue but not on the individuals themselves. Likewise, the initial process of collecting, processing, freezing,"anonymizing", and associating tissue with its corresponding clinical information in a database is not research, in and of itself. These activities are a necessary precursor for research, but there is no experimental analysis carried out during these steps. Rather, these steps are necessary to accumulate sufficient research-quality tissue. Because the process of tissue banking is associated with later research, has inherent ethical issues, and requires patient consent, most institutions considering creation of a tissue repository involve their IRB. However the banking process itself has no human subject research elements.