The Science populations, as contrasted with studies of animals or isolated molecules. In many ways, studies with human volunteer participants or patients are much more complicated than basic laboratory studies. This is due in part to the many physiological and pathological variables, and in part to a stringent process of protection of the privacy of research participants under institutional review boards (IRBs). The IRB process of review and approval of proposed studies and of well-documented informed consent from participants is essential, yet challenging for individual researchers and costly for the institutions. External funding for additional staff and infrastructure frequently is quite inadequate. Privacy requirements mandated by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) put additional cost burdens on clinical research. Despite the rapidly rising bill for pharmaceuticals and the seeming avalanche of direct-to-consumer advertising about new drugs from pharmaceutical and biotechnology companies, the yield of new drug candidates and new approved drugs has diminished. There has been rather limited benefit so far from genomics in drug development. While the molecularly targeted cancer drugs (Herceptin for certain breast cancers and Gleevec for a specific form of leukemia) have been touted like overnight "hits" produced by the new biology, these agents actually were developed quite a few years earlier and initially were considered failures in trials for much more common conditions. The overriding challenge for clinical research is to go from reductionist work on the roles of specific genes, to work on the functions of those genes and their products in the whole body of an animal, and then to address both favorable and adverse effects. Evidence to support clear communications about the risks and 33
RkJQdWJsaXNoZXIy NDMwNDAx