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The Agency for Health Care Policy and Research (AHCPR) has announced it is developing recommendations for helping institutional review boards and like bodies protect against the disclosure of personal health information in research that could be used to identify individual patients.
The recommendations will help provide guidance to research reviewers as they look at research projects using identifiable information and as they implement the agency’s privacy regulations mandated by the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Proposed regulations for this act were announced by President Clinton on Oct. 29, 1999. Under HIPAA, a final rule is to be issued by Feb. 21, 2000, with a two-year implementation period for most covered entities.
The guiding national principles will be based on a study now under way by the Institute on Medicine of the National Academy of Sciences, which is expected to be completed in the summer of 2000. The Health and Human Services’ Office of the Assistant Secretary for Planning and Evaluation is co-funding the contract with AHCPR.
Institutional review boards (IRBs) are committees formed by universities and other research institutions to review research projects institutions — mostly academic — that voluntarily submit their study applications. These committees have 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 recommendations for IRBs and the researchers they oversee will also provide guidance to for-profit and other organizations that use patient databases for marketing research, health benefits management, quality assurance and other analytical purposes, according to a statement from AHCPR.
"The guiding principles and best practices developed under this initiative," according to the statement, "should provide a basis for identifying how to protect personal health information wherever, and by whomever, it is used for research."
[For additional information, contact AHCPR at (301) 594-1364, or visit its Web site at www.ahcpr. gov/.]