goods in terms of respecting personal dignity and protecting patients from discrimination. Privacy also holds societal value because it encourages individuals to participate in socially desirable activities like research. At the same time, research is an equally compelling individual and societal good that can help address some of the nation’s most pressing health problems. Indeed, research on the determinants of health can help guide national efforts to focus life-saving interventions where they can do the most good in terms of improving individual and public health (Gostin and Nass, 2009).
Although informed consent is meant as a safeguard, it can also be a barrier to valuable research. The Institute of Medicine has proposed new rules that would make health research exempt from HIPAA privacy rules and emphasize data security, transparency, and accountability, regardless of the funding source. The proposed rules would add consistency in regulatory oversight and ensure protection of participants. In addition, the new system would include two alternatives to consent: (1) a system with ethical oversight to protect data privacy and security and (2) a certification system that would allow researchers to link deidentified data sets. The panel supports these recommendations.