Wanted: Human Biospecimens (Essays) (Report‪)‬

Collecting and using tissue, blood, urine, and other human biospecimens for various types of research is not new. But for personalized medicine to realize its potential, researchers will need thousands more of these samples for genetic studies. And the particular nature of genetic research--the sensitivity of the information it reveals--has raised a host of ethical questions, some which are new to human subjects research. What counts as informed consent when a biospecimen may be stored for years and used for unforeseen research? How freely can the biospecimens and the genetic information they contain be shared with other researchers? If research uncovers a genetic risk factor or some other important medical information about an individual, should that person be told? Biospecimens are collected and used in a number of different ways. Sometimes researchers ask individuals to contribute biospecimens for a specific type of genetic study. For example, the National Cancer Institute is recruiting thirty-five hundred patients with inherited urologic malignancies and their relatives to provide blood and tissue samples for a study on the genetic contributions to these cancers. (1) Researchers also ask patients enrolled in clinical drug trials, especially cancer studies, to contribute biospecimens to learn more about the genetic contributions to their disease. A different approach is to ask individuals to donate their biospecimens to a large biorepository, or biobank, to be used for unspecified future research.