Privacy issues in personalized medicine research: Proposing a novel framework for policy

Background:

Clinical research in personalized medicine (PM) has been steadily increasing. However, concerns over the privacy of genetic information have persisted as an important unresolved challenge to consumers’ and patients’ willingness to participate in PM clinical research.

Objective:

To examine the privacy issues associated with genetic information on the implementation of personalized medicine into clinical research.

Methods:

We reviewed the literature on privacy issues in personalized medicine. We examined the perspectives of patients, employers, insurers and the federal government in the protection of privacy and discrimination based on genetic information. The impact of government regulations on clinical research of personalized medicine was also explored.

Results:

Several legislative and regulatory hurdles were found including increased institutional bureaucratic barriers, a lengthy informed consent process, and complex language which all serve as barriers to the conduct of PM clinical research. We propose a new policy framework to overcome some of the current regulatory hurdles.

Conclusion:

Federal government regulations have significantly improved patient privacy protection but have hampered research in personalized medicine by lengthening the consent process and setting up additional liabilities for institutions conducting clinical research. There is a need for policies that will reduce the barriers to research without affecting the privacy of patients.