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 for patients to opt into sharing their biological specimens with researchers. This starts with a larger conversation around the importance of biological research on human tissue, as opposed to mice models. It must be followed by education on the actual research process and the safeguards that are in place to protect individual patient rights. In a world increasingly moving toward personalized and precision medicine, it has never been more important to have a large library of biological specimens to study and research on.
We would all do anything in the world we could to relieve a loved one from suffering from disease. If we were told that the cost of a cure could be a potential and minor loss of privacy for ourselves, many of us would still agree. The question now, with an opt-in system, is if we agree because we believe that we might be able to save someone else's loved one. Can we, as a patient community, put our own personal fears aside in order to enable a greater outcome for healthcare research?
To be clear, no one wants to infringe on patient rights or privacy. However, as we try to find the balance between research and privacy, we need to create greater awareness. Increasing education around research processes may just be the silver bullet to do so. If at this point, we fail to educate patients on how their contributions to science matter and create a safe space in which they do contribute, we could be significantly slowing down the pace of scientific innovation.