The Common Rule

The Federal Policy for the Protection of Human Subjects, colloquially referred to as the "Common Rule", regulates federally-funded research that involves doing things to people. All the various departments and agencies of the federal government are supposed to follow the Common Rule, including even the CIA (yeah, right). Last revised about twenty years ago, it is due for some changes, which are currently under review. Many of these changes relate to reporting and auditing issues. Somewhat more interesting is a proposed change to the provisions relating to the disposition of biospecimens collected in the course of such research. Currently, any such biospecimen can continue to be used indefinitely, without the knowledge or permission of the person from whom it was taken, as long as it has been anonymized, i.e., as long as any identifying metadata has been stripped from the specimen.

But since the time the rules were last revised, the field of genomics has developed the ability to identify the individual source of any biospecimen, based on the DNA it contains, increasingly quickly and increasingly inexpensively. In effect, the biospecimen is its own identifying metadata. So the new rule in this area would require that any biospecimen collected in the course of a federally-funded research program must be destroyed at the conclusion of said program, unless the human source of the specimen has explicitly granted permission to retain and/or distribute the specimen for further use.

In my case the point is moot, since I granted such permission when I added myself to the Rare Cancer Genetics Registry.