related to human subjects from our study, it is important to note that these issues can act as barriers to data access. Some data are not released because of confidentiality or privacy considerations, such as data related to biomedical research or the social sciences. For example, the 1996 Health Insurance Portability and Accountability Act established rules for disclosure of individually identifiable health information (known as protected health information, or PHI).8 If PHI is used in research, the researcher must comply with regulations regarding its use and storage in the project. There are instances where PHI may be disclosed, but the need to support published research is not among them. For PHI to be made publicly available, a subject must agree to the disclosure of the information.

For some medical research data, privacy and confidentiality obstacles can be overcome by removing identifiers prior to the private sharing of data or the public release of data. However, this remains an area of ongoing concern and investigation. Efforts are now under way to make medical research data available while ensuring that the data cannot be used to identify individuals.

Research data also can be kept private because they pertain to intelligence, military, or terrorist activities.9 Examples include research related to nuclear, radiological, and biological threats; human and agricultural health systems; chemicals and explosives; and information technology infrastructure. National Security Decision Directive 189 (NSDD 189), which was issued by President Ronald Reagan in 1985, states that the policy of the U.S. government is not to restrict, to the maximum extent possible, the products of unclassified fundamental research.10 The challenge to policy makers and researchers is where to draw the line between classified and unclassified information and how to balance restrictions on access to sensitive information with the potential costs of such restrictions.

Our committee was not asked to examine national security issues in depth. Other National Research Council committees, including the Committee on Scientific Communication and National Security (CSCANS), are directly focused on issues such as classified information, export controls, and nonimmigrant visa policies. A recent CSCANS report points out that many federal government policies and practices since the September 11 attacks have effectively reversed NSDD 189.11 The report calls for a standing entity to review policies in order to

8

Institute of Medicine. 2006. Effect of the HIPAA Privacy Rule on Health Research: Proceedings of a Workshop Presented to the National Cancer Policy Forum. Washington, DC: The National Academies Press.

9

National Research Council. 2007. Science and Security in a Post 9/11 World: A Report Based on Regional Discussions Between the Science and Security Communities. Washington, DC: The National Academies Press.

10

National Policy on the Transfer of Scientific, Technical and Engineering Information. September 21, 1985.

11

Ibid.



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