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New Institute of Medicine study to examine privacy protection practices of institutional review boards

The Institute of Medicine (IOM) of the National Academy of Sciences will examine the ways that institutional review boards protect against the disclosure of personal health information in health services research projects, determine whether there are any current "best practices," and then develop broadly applicable recommendations on how institutional review boards can improve their current practices.

Because very little is known currently about the ways that these boards address privacy concerns, the IOM report will provide useful guidance to the Congress, the Department of Health and Human Services, and the research community as they consider options for improving patient privacy. The Agency for Health Care Policy and Research and the Department of Health and Human Service's Office of the Assistant Secretary for Planning and Evaluation are cofunding the project. The study is expected to be completed in the summer of 2000.

Institutional review boards (IRBs) are committees formed by universities and other research institutions to review federally funded research projects and research projects funded by other sources at institutions—mostly academic—that voluntarily submit their study applications. These committees possess the authority to approve, disapprove, suspend, or terminate previous approval of such research in order to protect the rights and welfare of human subjects. An IRB approval means the research has been reviewed and may be conducted at an institution within the constraints set forth by the board. However, not enough is known about how IRBs can adequately protect patients from potential harm resulting from the disclosure of personal health information in patient databases used in studies. Furthermore, the ways IRBs review health services research projects may vary.

The broad principles and best practices developed under this new initiative should inform the debate on how best to protect personal health information used in health services research.

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