A Common Community
In the midst of political and national news, a quiet debate is simmering that impacts millions of Americans who may at some point take part in clinical research. These Americans will interact with a little known piece of legislation known as the Common Law. Based on the Belmont Report of 1979 and adopted across the government in 1991, the Common Law lays out the principles of agreement and consent for human subject research within medicine. Revisions to the Common Rule are meant to increase transparency, and further, to allow for participants to opt-in to research of their de-identified biological specimens.
Under the current Common Law, researchers are allowed to use de-identified biological specimens in research without consent. While there are very clear concerns around privacy (particularly related to genetic research) and the ethics of not obtaining consent, this also enables for researchers to have access to a larger set of biological specimens. In other words: if people have to opt in to donating their biological specimens to medicine, they may be significantly less likely to do so. They may be less likely to do so because they fear that certain kinds of samples can be identified later on. They may be less likely to do so because they believe they deserve a share in the profits from the research that is done on their specimens. Further, broad sociological research shows that opt-in processes typically result in lower enrollment than opt-out processes.
It remains to be seen if the proposed legislative changes to Common Law are put into place, and how they are introduced into research practice over the next three years. However, as we consider these changes, it is particularly important to look at how as a scientific community, we can create more motivation and understanding —> Read More